Connection device and method for its use

Embodiments of the present invention provide a connection device for the transmission of optical and/or electrical signals, specifically for medical purposes, featuring a cable and a coupling element, which is designed to couple to a matching counterpart on the coupling side. The coupling side exhibits an inner part, having a connecting element for connection to the cable, and an outer part, with the outer part being detachably attached to the inner part. The outer part is capable of being detached from the inner part prior to use of the connection device involving the passage of the connection device through an area of the human body.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims International Priority under 35 U.S.C. § 119 to co-pending German Patent Application No. 102006026720.6, filed Jun. 8, 2006, entitled “Verbindungsvorrichtung und Verfahren zu deren Einsatz,” the entire disclosure of which is hereby incorporated by reference in its entirety.

TECHNICAL FIELD

Embodiments of the present invention relate to a connection device for the transmission of optical and/or electrical signals, specifically for medical purposes, having a cable and a coupling element designed for coupling to a matching counterpart on a coupling side, with the coupling element having an inner part with a connection mechanism for connecting to the cable and an outer part. The invention also relates to a method for establishing an electrical and/or optical connection from an internal area of a body, such as a human body, to the outside.

BACKGROUND

Coupling elements for transmitting optical or electrical signals are well known in the field of medicine. In a specific area of application, they are used to transmit signals from the inside of the body of a patient to the outside of the body of the patient and/or vice versa. This is required, for example, when a medical device, such as an insulin pump, is implanted into the patient's body, and the device needs to be addressed or accessed from the outside, for example for control purposes, and/or needs to be capable of emitting signals to the outside, for example to indicate the status of the device. For this purpose, the cable is passed from the implanted device to the outside of the body through an orifice in the body and the coupling element is coupled to a matching counterpart that, in turn, may be connected to a control device and/or an analytical device.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

For the purposes of the description, a phrase in the form “A/B” means A or B. For the purposes of the description, a phrase in the form “A and/or B” means “(A), (B), or (A and B)”. For the purposes of the description, a phrase in the form “at least one of A, B, and C” means “(A), (B), (C), (A and B), (A and C), (B and C), or (A, B and C)”. For the purposes of the description, a phrase in the form “(A)B” means “(B) or (AB)” that is, A is an optional element.

Thus, in an embodiment, there is provided a connection device for the transmission of optical and/or electrical signals, comprising a cable, and a coupling element configured for coupling to a matching counterpart of another device via a coupling end of the coupling element, the coupling element having an inner part with a connecting element for connection to the cable and an outer part, wherein the outer part is detachably coupled to the inner part.

In an embodiment, the cable of the coupling element generally has to be run appropriately. For this purpose, the coupling element may exit the body through an orifice. In an embodiment, the coupling element may be placed such that it enters a body through a first body orifice and exits the body through a second body orifice from the inside of the body to the outside. The body orifices may coincide, but usually they are different openings. This has to do with the fact that a suitable predetermined position may be preferred for the opening for the exit of the coupling element, irrespective of the body area in which the medical device is implanted.

Therefore, in an embodiment, in order to create the electrical and/or optical connection, an invasive procedure is required, in the course of which a passageway into the body of the patient may be created.

Embodiments of the invention are based on the technical problem of providing a coupling element which enables increased minimization of the above-described surgical procedure, in particular the minimization of the dimensions of the passageway.

This problem is solved in accordance with embodiments of the invention by a coupling element of the type described above, in which the outer part is detachably coupled to the inner part, and the inner part is capable of being coupled to the outer part from a side which does not coincide with the coupling side of the outer part.

Therefore, in the coupling element according to an embodiment of the invention, the inner part and the cable may be safely introduced into or led out of the body, since the outer part does not have to be introduced into or led out of the respective orifice(s) along with it, but instead may be attached to the inner part afterwards. In this way, those areas of the body of the patient against which the outer part bumps, pushes and/or on which it pulls when conventional coupling elements are used, are subjected to reduced stress. In an embodiment, it is thus possible, in particular, to make smaller incisions to create the opening(s) than the incisions that were traditionally required in order to make the invasive procedure as minimal as possible.

The coupling element in accordance with an embodiment of the invention therefore exhibits a coupling element which, as compared to traditional coupling elements, has a reduced effective cross-sectional area in relation to the direction of travel of its path to be covered during the insertion/passageway out.

Thus, in embodiments, the terms inner part and outer part should not be understood such that, within the understanding of embodiments of the invention, the outer part has to completely enclose the inner part, but it should be understood that there is a plane relative to which a projection of the coupling element onto the plane given a fixed orientation of the coupling element with respect to a respective projection of the inner part onto the plane given the same orientation is designed such that one dimension of the projection of the coupling element is—in at least one axis lying in the plane and intersecting the projections—larger than a respective dimension of the projection of the inner part.

Since the at least section-wise coupling (e.g. insertion) of the inner part into the outer part proceeds from one side which does not coincide with the coupling side of the outer part, in an embodiment, the outer part does not need to be threaded onto the cable in order to attach it to the inner part. Otherwise, the outer part would have to be passed through the opening(s) of the patient's body.

Thus, in an embodiment, the cable constitutes a kind of topological obstacle for the outer part. Therefore, embodiments of the invention also relate to a connection device for the transmission of optical and/or electrical signals, specifically for medical purposes, via a cable and a coupling element being designed for coupling to a matching counterpart, with the coupling element exhibiting an inner part which may be attached to the cable, as well as an outer part capable of being attached to the inner part in order to create a connected state of the coupling element—starting from a disconnected state of the coupling element, in which the outer part does not enclose the cable in relation to its radial direction—without the outer part having to be penetrated, for this purpose, by an end of the cable that is away from the coupling element or, given that a reversal of motion is effected, an end of the cable that is close to the coupling element.

It is therefore possible, in an embodiment, to attach the outer part to the inner part without having to thread it to the cable. This makes it possible to safely pass the connection device through or into or out of the body in the manner described above.

Advantageously, in an embodiment, the inner part has a longitudinal design so that it has a smaller lateral dimension as compared to its length. In this way, a streamlined form is achieved for the passage through the body.

Such an embodiment may have a lateral dimension in the range of 1 to 12 mm, preferably 2 to 10 mm, specifically 4 to 8 mm. This makes it possible to achieve an even safer use of the connection device, and, in particular, a smaller and thus cosmetically more acceptable exit opening is made possible.

In another embodiment, the ratio of the lateral dimension and the respective dimension of the coupling element expressed as a percentage is in the range of 10% to 85%, for example 30% to 80%, such as 50% to 75%. This enables the safe use of the coupling element, on the one hand, and ensures a high functionality of the coupling element, on the other hand.

Advantageously, in an embodiment, the inner part and/or the coupling element have a circular cross-section making it possible to largely avoid edges or corners presenting a comparatively high risk of injury.

In an embodiment, the outer part envelops the inner part at least in sections in a connected state of the coupling element. Thus, the outer part assumes a protective function for the inner part.

In an embodiment, the inner part is capable of being inserted into, and specifically capable of being retracted from the outer part. This enables the extremely simple and time-saving handling of the connection device.

Advantageously, in an embodiment, a locking mechanism is provided which counteracts the transition from a connected state to a disconnected state of the coupling element, making it possible to largely prevent an undesired and unintended detachment of the inner part and the outer part.

Advantageously, in an embodiment, a guiding device is provided which facilitates the transition from a disconnected state to a connected state of the coupling element, which simplifies the handling of the coupling element.

In an advantageous embodiment of the invention, a positioning device is provided which enables the relative positioning of the inner part with respect to the outer part in the event of a transition from a disconnected state to a connected state of the coupling element. In this way, the inner part may be automatically positioned such that the subsequent coupling to the matching counterpart is possible without any further measures.

In an embodiment of the invention, the outer part does not have a direct connection to a contact side of the inner part designed to create an electrical and/or optical contact with the counterpart, and the inner part is specifically capable of establishing the contact by itself. In this way, the outer part itself is not required for the contact and the functions of contact or protection of the contact are provided separately.

In an advantageous embodiment, the contact side of the inner part has several electrical and/or optical contacts, particularly, in an embodiment, three electrical contacts. In this way, in embodiments, several independent or different signals may be transmitted, on the one hand, and the connection device may thus be particularly adapted to commonly used implantable medical devices.

In an embodiment of the invention, the outer part exhibits a plug device, designed specifically as part of a push-pull mechanism, for the mechanical coupling to the matching counterpart. This makes it possible to ensure a high degree of user-friendliness with respect to the coupling to the matching counterpart.

Advantageously, in an embodiment, the inner part is undetachably connected to the cable. Thus, the connection device features a manageable and small number of individual parts.

Advantageously, in an embodiment, a protective element for its contact side is provided in a section on the coupling side of the inner part, and in particular, the outer part extends further in the direction of the coupling side in its connected state than the coupling-side end of the protective element. Thus, on the one hand, the contact side of the inner part may be protected alone, for example by a kink protection sheath, while, on the other hand, further protection is ensured in the connected state by the outer part.

In an embodiment of the invention, the decoupling of the outer part from the inner part in the direction of the coupling side of the outer part is possible. This ensures simple handling and makes the connection device more user-friendly.

It is furthermore advantageously provided, in an embodiment, that the force required for decoupling is in the range of 0.1 to 20 N, for example 0.8 to 8 N, such as 2.0 to 4.0 N. In this way, a satisfactory connecting force to protect against inadvertent detachment of the inner part from the outer part is ensured, on the one hand, while the user is still able to separate the connection using a comfortable expenditure of energy, on the other hand.

Advantageously, in an embodiment, the connection device is designed such that it is capable of transmitting signals from the body's interior to the outside and vice versa. Thus, this enables not only unilateral but also bilateral communication with an implanted medical device.

Embodiments of the invention also relate to a method for establishing an electrical and/or optical connection from an internal area of a body, such as a human body, to the outside, providing the possibility of the subsequent electrical and/or optical coupling of the connection via a coupling element of a connection device with a matching counterpart, involving the movement of an inner part of the coupling element from the body's interior to the outside, whereby, following the movement and prior to the coupling with the matching counterpart, the inner part and an outer part of the coupling element, capable of being connected with the inner part, are assembled to create a connected state of the coupling element.

The advantages offered by the above-described method as compared to the methods of the state of the art have already been explained above. In summary, it may be said that, according to an embodiment of the invention, only the inner part of the coupling element is moved from the internal area of the human body to the outside, in order to enable a safe surgical procedure, during which the inner part is less protected during the establishment of the connection than it is in conventional methods. But, this reduced protection is of no importance because the protection is reduced only during the establishment of the connection and not during the operation.

In accordance with the above description, the method described above may comprise the further upstream operations of decoupling of the outer part from the inner part and the introduction of solely the inner part into the internal area of the body from the outside. Accordingly, in an embodiment, a connection device designed for such a method is also provided.

In addition, in accordance with the above-stated explanations, an embodiment of the invention provides for the use of a coupling element, having an outer part that is detachable from its inner part, for the introduction of the inner part into the interior of the patient's body through a first orifice and for the exiting of the inner part from the interior of the patient's body through a second orifice, with the coupling element being capable of being put into a disconnected state from the connected state for the introduction and/or the exit.

FIG. 1shows an embodiment of a connection device in accordance with an embodiment of the invention with a coupling element21of the connection device being presented in a connected state.FIG. 1shows outer part1of coupling element21, and an arrow on end area24, which is away from the cable, of outer portion1that points in the direction of coupling side22.1of outer part1. In the connected state, an inner part2of coupling element21is arranged in sections in the interior of outer part1or enveloped by outer part1.

With respect to inner part2,FIG. 1shows—toward coupling side22.1of outer part1—a coupling-side end22.2of inner part2with an output of an electrical contact23.1of contact side23(seeFIG. 2) of inner part2, as well as a cable-side end area of inner part2, which, in an embodiment, is designed as kink protection sheath7, providing protection against kinking in the cable connection area. Furthermore,FIG. 1shows a cable8, capable of transmitting electrical signals in an embodiment, with its end8b(seeFIG. 2) that is close to coupling element21being covered inFIG. 1by inner part2and with its end8a,which is away from the coupling element, being shown disconnected. In embodiments, cable8may be longer than it is shown inFIG. 1.

As is clearly discernible inFIG. 1, both coupling element21and inner part2have a longitudinal design, and both exhibit a circular cross-section, which, however, may be differently sized in the longitudinal direction. Thus, for example, coupling-side area24of outer part1is provided with the largest diameter or the largest lateral dimension, for, within area24, space is being reserved for coupling of a matching counterpart of the connection device.

Coupling element21may be moved from the connected state shown inFIG. 1to the disconnected state shown inFIG. 2, simply by detaching outer part1from inner part2in the direction of the arrow, i.e. in the direction of coupling side22.1of outer part1. Vice versa, coupling element21may be moved back, in an embodiment, from the disconnected state shown inFIG. 2to the connected state shown inFIG. 1, by inserting inner part2from the opposite side of coupling side22.1of outer part1in the direction of the arrow into outer part1. Thus, inner part2is not coupled to or inserted into outer part1from a side coinciding with coupling side22.1of outer part1.

FIG. 2shows a disconnected state of coupling element21, in which outer part1does not enclose cable8relative to its radial direction. Outer part1may be coupled to inner part2in the opposite direction of the arrow shown inFIG. 1, without it having to be threaded first to cable8. This means that there is no need for outer part1to be penetrated by end8a,which is away from coupling element21, of cable8(threading from the side of the distant cable end) or to be penetrated by end8b,which is close to coupling element21, of cable8, given that a reversal of motion is effected.

In addition to outer part1,FIG. 2also shows inner part2in a longitudinal view. One can see that a main body of inner part2is comprised of a front shell3and a rear shell4. Rear shell4tapers off to form the cable-side end and finally, in an embodiment, forms a ring-shaped protrusion4.1in its end area. Ring-shaped protrusion4.1ensures that kink protection sheath7is not detachable from inner part2following the assembly of inner part2so that kink protection sheath7is not subject to the risk of loss as a further individual part. Cable8is attached through a ring5and a ball14via its end8b,which is close to coupling element21, via a connecting element within rear shell4.

In an embodiment, the pins of cable8are connected with contact side23of inner part2, with only an electrical contact23.1of contact side23being visible inFIG. 2.

At its end that is away from cable8, front shell3has an opening, from which a protective element18extends in the direction of coupling side22, which protectively encloses three electrical contacts23.1,23.2and23.3, as can be seen in a front view inFIG. 3. The interior space of inner part2between the connecting mechanism and protective element18exhibits a grouted sheath6. In an embodiment, outer part1is not involved in the electrical contact between inner part2and the counterpart.

Kink protection sheath7is preferably made from a hard rubber or rubber-like material. Front shell3and rear shell4are preferably made from a solid material such as metal, and protective element18is preferably made from a solid material, which is, however, easily moldable in the manufacturing process, such as hard plastic.

As is clearly shown inFIG. 2, inner part2may be inserted into outer part1for part of its length L along a central axis X. It is also clearly shown that the diameter or the lateral dimension D of inner part2is clearly smaller than the corresponding (largest) lateral dimension D′ of outer part1, which at the same time represents the largest lateral dimension of coupling element21. In an embodiment, the diameter D of inner part2is approximately 7 mm and the ratio of the diameters or the lateral dimensions D/D′ is approximately 57%. Coupling element21is therefore dimensioned such that inner part2exhibits a cross-sectional area related to the axis X, which, in an embodiment, amounts to only ⅓ of the respective cross-sectional area of coupling element21in the disconnected state. For this reason, the connection device in accordance with an embodiment of the invention may be used in a considerably safer manner than conventional connection devices having coupling elements of comparable dimensions.

A ring-shaped notch3.1of front shell3of inner part2is part of the locking mechanism which locks inner part2into outer part1. This is shown more clearly inFIG. 4, which shows, in addition to inner part2, an area of outer part1that is not visible inFIG. 1andFIG. 2. This concerns a coupling nut12, which is attached within a center section of outer part1. Coupling nut12is designed such that it pushes an annular flange11.1protruding to the inside into ring-shaped notch3.1. In this way, together with ring-shaped notch3.1, annular flange11.1forms a locking mechanism that protects coupling element21from inadvertent transition to the disconnected state.

In an embodiment, the disengagement of locking mechanism requires a force of approximately 3 N.

FIG. 4also shows a portion of a matching counterpart of the connection device, which has the shape of a claw sleeve11. Claw sleeve11exhibits a flat gasket13facing coupling-side end22.2of protective element18of inner part2.FIG. 4does not show the three electric contact pins that extend from claw sleeve11in the direction of inner part2of coupling element21and that are designed to be inserted into the reception areas of electrical contacts23.1,23.2,23.3of contact side23of inner part2.

FIG. 3shows a front view of protective element18of inner part2, with electrical contacts23.1,23.2,23.3appearing as annular rings which define the areas for the reception of the electrical contact pins of the counterpart.FIG. 3also shows that protective element18has an essentially circular cross-section. More precisely, the cross-section of protective element18is comprised of two semi-circular areas with different radii, so that protective element18exhibits differently shaped partial cylinder surface areas19,19′, which are connected to each other via edge areas20along the central axis X, which is vertical to the paper plane inFIG. 3. The opening area of front shell3, from which protective element18extends, has the same form and size as the cross-section of protective element18shown inFIG. 3. A distant end area of coupling nut12(on the opposite side of annular flange11.1) also features a slightly flexible flange area protruding to the inside, which leaves an opening of exactly the shape corresponding to the cross-section shown inFIG. 3. This, however, is not shown inFIG. 4.

The above-described corresponding form of the cross-section of protective element18constitutes a guiding device by means of which protective element18of inner part2and, consequently, inner part2may be easily inserted into outer part1of coupling element21. In addition, longitudinal edges20between areas19of protective element18serve as a positioning device which establishes the precise position of electrical contacts23.1,23.2,23.3relative to outer part1of coupling element21. Given a respective design of claw area11.2of claw sleeve11of the counterpart, the contact pins of the counterpart are automatically positioned correctly in order to be automatically inserted correctly into the reception areas of electrical contacts23.1,23.2and23.3when claw sleeve11is coupled to contact side23of inner part2.

FIG. 1further shows, suggestively, that outer part1exhibits a ring-shaped notch24.1on the inner side of its coupling-side area24(the area with the largest lateral dimension D′). Ring-shaped notch24.1constitutes a plug device for mechanical coupling to the matching counterpart. It may be designed, for example, as part of a push-pull mechanism and therefore allows the same mechanical coupling quality of coupling element21that is displayed by conventional coupling elements, i.e. the possibility, provided in accordance with an embodiment of the invention, of disconnecting outer part1from inner part2of coupling element21does not affect its quality of coupling to the matching counterpart.

The embodiments of the present invention shown inFIGS. 1,2,3, and4are intended to serve as illustrations of embodiments of the invention protected in the claims and should not be considered as limiting its protection. Instead, the features of the invention disclosed in the above description as well as the claims may be essential both individually and in any combination for the implementation of the invention in its various embodiments.