AU2001281637B2

AU2001281637B2 - Percutaneous or transcutaneous access to the interior of the body

Info

Publication number: AU2001281637B2
Application number: AU2001281637A
Authority: AU
Inventors: Herbert Baechler; Christoph Hans Schmid
Original assignee: Phonak AG
Current assignee: Sonova Holding AG
Priority date: 2001-08-14
Filing date: 2001-08-14
Publication date: 2007-07-26
Anticipated expiration: 2021-08-14
Also published as: EP1417002B1; JP2004531277A; DE50113019D1; CA2456849A1; EP1417002A2

Description

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1 Percutaneous or Transcutaneous Access to the Interior of the Body The present invention relates to a percutaneous or transcutaneous connection system to the interior of a body.

A wide variety of accesses to the interior of the human 00 Cl body are known from the literature and from patents.

10 Artificial accesses of these kinds are needed, for Sexample, for administering medicines or delivering electrical signals or electrical energy into the body.

There is a fundamental difference between percutaneous and transcutaneous access. Percutaneous access extends mechanically through the skin. Transcutaneous access does not actually involve any mechanical access and is often based on an induction principle, and thus provides an electrical connection between the interior of the body and its external environment.

In designing such access, it is not just the functional connection itself that is important, but in particular also the assimilation at the site of implantation and the minimizing of the risk of infection. In addition, it must be possible for the patients, or their medical care providers, to make or break the connection as quickly and as easily as possible (user friendliness).

W098/51367 and W099/34754 propose purely mechanical plugtype connections for coupling and uncoupling the access.

Since a minimal contact pressure is required at the connection site both for electrical leads and for administration of fluids, the connections turn out to be relatively complicated, and the coupling and uncoupling operations are awkward for the user. In contrast, US 5,507,303 proposes, inter alia, that the necessary contact N:\Mclboumc\Cases\Patent\51000-51999\P51390.AUSpecis\P51390 AU Specification 2007-6-13.doc 3/07/07 2 O pressure be generated by magnetostatic means. In this case, both the implanted part and the attachable part each contain a magnet, these magnets ensuring the contact Spressure. However, the external part is guided and oriented relative to the implanted part of the access by mechanical means.

IND

US 5,949,895 discloses a transcutaneous connection 00 C< consisting of a pair of flat, symmetrical coils which are oriented with respect to one another with a pair of Scylindrically symmetrical permanent magnets. This latter configuration, too, is relatively complicated and not user-friendly.

According to one aspect of the invention there is provided a percutaneous or transcutaneous connection system for a living thing which system comprises at least one passage, or a connection devoid of such a passage, through the external surface of the living thing, said system using an implanted permanent magnet located in the region of the external surface with flux lines from the North/South poles extending substantially parallel to the external surface, whereby in use a device can be magnetically coupled therewith to permit the percutaneous or transcutaneous connection.

According to another aspect of the invention there is provided a method for permitting transcutaneous or percutaneous delivery or withdrawal of medicines, samples or other substances into or from the interior of a living thing, or for transmitting, receiving or sending electrical signals or electrical energy into or from the interior of a living thing or for placing a measuring probe in the region of the external surface of a living thing, comprising providing a permanent magnet implanted in the region of the external surface of the living thing, and wherein flux lines from the North/South poles extend N \Mclboumc\Cses\Patent\5 000-51999\PS 390.AU\Specis\P5 390.AU Specification 2007-6-13doc 3/07/07 3 substantially parallel to said external surface, whereby an external device can be connected therewith by magnetic coupling to permit the delivery or withdrawal, or the Sreceiving or sending, or the placement.

The percutaneous or transcutaneous access to the interior

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of the body, as proposed in an example of the invention, utilizes magnetostatic forces both for ensuring the 00 C necessary contact pressure and for orienting and positioning the external part of the access relative to -the implanted part. This results in a connection which is much easier for the user to handle. Positioning can be made easier by using permanent magnets which are asymmetrical, for example elongate. The north and south poles of the magnets are not mutually aligned inward toward the interior of the body as in US 5,507,303, but instead along the body opening. In other words, the permanent magnet extends with its poles parallel to the skin of the body.

Advantages are afforded in particular if the connection between the interior of the body and the external environment of the body has an inherent asymmetry. This is the case, for example, when the number of the individual passages in a percutaneous connection cannot be arranged symmetrically. Such a case likewise arises when two asymmetrical flat coils of a transcutaneous connection are to be oriented relative to each other.

The invention is now explained in greater detail below by way of an example for permitting connection with a living thing, and with reference to the attached figures, where: Figure 1 shows, in longitudinal section view, a percutaneous connection with two individual passages; Figure 2 shows the plan view of the magnets illustrated in 1000-5 1999\PS I39OAU\Specis\PS ]390.AU Specification 2007-6-3.doc 3/07/07 4 Q)Figure 1; and Figure 3 shows a diagrammatic representation of a n transcutaneous connection with two flat, physiologically shaped coils in the region of the outer ear.

SFigure 1 is a longitudinal section view showing a two-part

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percutaneous connection with two individual passages. One 00 C-i part 5 is formed by a permanent magnet 7 which is located underneath the epidermis 1 in the area of the dermis or in the area of a bone 3 lying underneath the epidermis. The north pole and the south pole of the permanent magnet 7 are labelled N and S, respectively. Thus, an imaginary line extends between the North and South poles and extends substantially parallel to the external surface of the living thing. Extending through the permanent magnet are two passages 9, each of these having a widened opening 11 protruding slightly from the epidermis 1. This is of course only one example of the design of the passages, and instead it is also possible to provide just one passage or multiple passages, and these passages do not necessarily need to have an external enlarged opening 11.

The internal openings of the passages open into an area labelled 8, which is provided for the arrangement of delivery and withdrawal conduits.

As a mating piece for this, an external attachable part is provided which for its part has a permanent magnet 17 with a south pole and a north pole, labelled S and N, respectively. Extending from a delivery or withdrawal conduit 19, which for example can be a flexible tubing, and through the permanent magnet 17 there are two conduits or two accesses 21 which for their part each have a connection opening 23 facing toward the openings 11 and may be suitable, for example, for attaching the external part 15 onto the two openings 11. If the force of the two N 1\Melboume\Cascs\Paen\5 ID00-5 1999\P5I 390AU\Specis\P5 1390AU Specification 2007.6-13doc 3/07/07 5 permanent magnets is not sufficient to hold the external part 15 on the permanent magnet 7, catch elements or other c-s retaining members, for example, may additionally be Sprovided.

The conduits in the implanted part 5 and also in the Sexternal plug-in part 15 are suitable both for delivering substances such as medicines, nutrients and the like, and 00 Cl also for withdrawing fluids from inside the body. The latter is the case, for example, in what is called Shemodialysis Figure 2 on the one hand shows the permanent magnet 7 in a plan view from the outside, the omission of the depiction of the epidermis 1 meaning that the permanent magnet is visible, and is also the dermis or bone 3 located underneath the epidermis. Clearly shown are the two passages 9 extending perpendicularly through the permanent magnet 7. The elongate, oval-shaped permanent magnet in Figure 2 can of course be differently configured, for example rectangular, rod-shaped etc.

Analogously thereto, Figure 2 also shows, again in a plan view, the external plug-in part 15 consisting primarily of the permanent magnet 17 and of the accesses and conduits 21 provided for plug-in connection to the passages 9. Of course, the external magnet 17 also does not have to be in the form of an elongate oval, and instead can be differently configured, in adaptation to the shape of the permanent magnet 7. Indeed, it is even possible to arrange a coil in the external part 15 for generating a magnetic field, since the external magnet 17 does not necessarily have to be a permanent magnet.

Finally, Figure 3 shows a possible application of the system proposed according to an example of the invention in the form of a transcutaneous connection with two flat, 000-S999\P5 390 ALT\Specis\PS 1390.AU Specification 2007.6.13 doc 3/07/07 6 Q)physiologically shaped coils in the region of a human ear 31.

V) Given the anatomical and physiological conditions in this region, an arrangement of circular coils, as are otherwise often used in transcutaneous connections, is not suitable Shere. Instead, from this point of view a pair of oval,

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kidney-shaped or otherwise asymmetrically shaped coils is 00 C to be preferred.

The implanted part 25 of a transcutaneous connection has a coil 27 which serves to receive or, respectively, send electrical signals and/or to transmit electrical energy.

The implanted part 25 also has a permanent magnet 29 which serves to orient and fix an external part in relation to the implanted part. This fixing may be necessary in particular when a current does not flow through the coils.

Both the coil 27 and the permanent magnet 29 are implanted underneath the skin and are not visible from the outside.

Therefore, in contrast to percutaneous connections, there is no mechanical passage here from the interior of the body to the outside or from the outside of the living thing to the inside. This system is shown in Figure 3, with the epidermis above the implanted part having been omitted so as to make the implant visible.

The external part (not shown here) of the transcutaneous connection likewise has, on the one hand, a coil for transmitting signals and/or energy and, on the other hand, a permanent magnet for positioning and fixing. The area of the external part of the connection directed toward the implanted part comprises materials and a surface which are compatible with the skin and permit wearing comfort. In terms of their geometric shape and their magnetic strength, the pair of permanent magnets is configured in such a way that the external part of the connection is optimally aligned and positioned over the implanted part N \Melboume\Cases\Paten\51 000-51999\P5I390 AU'Specis\P5I390AU Specification 2007.6-13.doc 3/07/07

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7 Q)as soon as it is brought into the proximity of the implant. The orientation is optimal when the inductive coupling between the coils, in their geometric shape V)dictated by the anatomy, is at a maximum level. The positioning and retaining action of the permanent magnets is effective in this transcutaneous system too, because M the magnetostatic field also acts through the skin.

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00 C Of course, the connections depicted in Figures 1 3 merely represent possible examples, and the present invention is not limited to the illustrative embodiments shown. It follows that great variations are conceivable in terms of the design of the permanent magnet, the arrangement of the permanent magnet directly in the epidermis or underneath the epidermis or in the bone, etc., the use of one, two or more passages, or of inductive, capacitive or other passage-free connections etc., or the configuration of the external plug-in part, etc.

It is to be understood that, if any prior art publication is referred to herein, such reference does not constitute an admission that the publication forms a part of the common general knowledge in the art, in Australia or any other country.

In the claims which follow and in the preceding description, except where the context requires otherwise due to express language or necessary implication, the word "comprise" or variations such as "comprises" or "comprising" is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

N.\Melboume Cases\Patcnt\5 000.51999\P]390 AL\SpecisIM 390AU Specificaion 2007-6-I 3doc 3/07/07

Claims

2. The connection system as claimed in claim 1, wherein the implanted permanent magnet is located .in or underneath the epidermis, and the at least one passage is provided in or on the implanted magnet.
3. The connection system as claimed in claim 1 or claim 2, also comprising a device which can be magnetically connected to the passage by magnetically coupling with the implanted permanent magnet.
4. The connection system as claimed in claim 3, wherein the implanted permanent magnet and the device are provided with positioning members and conduits or access channels to connect with the at least one passage. The connection system as claimed in claim 4, wherein an opening of said at least one passage and a corresponding opening of the conduits or access channels serve as a positioning locator for connecting the device in the correct position to the implanted permanent magnet.
6. The connection system as claimed in claim 1, further comprising at least one inductive, capacitive or other passage connection between the interior of the N \Melboume\Cascs\Patent\5 000-51999\PS 390.ALASpcciis\P 390AU Specification 2007-6-13.doc 3/07107 9 living thing and the outside.
7. The connection system as claimed in any one of Sthe preceding claims, comprising providing at least one coil with the implanted permanent magnet for receiving or sending electrical or electromagnetic signals, and/or for Stransmitting electrical energy therefrom. CO 00 C 8. The connection system as claimed in any one of p 10 the preceding claims wherein the implanted permanent Smagnet is elongate design.
9. The connection system as claimed in any one of the preceding claims, having three or more passages which are arranged asymmetrically with respect to the implanted permanent magnet. The connection system as claimed in any one of claims 1 to 9, with the permanent magnet being implanted in a living thing to create a percutaneous or transcutaneous connection through the skin of the living thing.
11. The connection system as claimed in claim with the permanent magnet implanted at a position in the living thing for a transcutaneous connection in the region of an outer ear of the living thing and having at least one coil implanted in the region of the implanted permanent magnet for the purpose of receiving or, respectively, sending electrical signals and/or for transmitting electrical energy.
12. A method for permitting transcutaneous or percutaneous delivery or withdrawal of medicines, samples or other substances into or from the interior of a living thing, or for transmitting, receiving or sending electrical signals or electrical energy into or from the N \Melbome\Casr,\Paten\S 000-51999SI 390 AASp~s\P5 390.AU Specificaiot 2007-6-I doc 3/07/07 10 Q)interior of a living thing or for placing a measuring probe in the region of the external surface of a living thing, comprising providing a permanent magnet implanted Sin the region of the external surface of the living thing, and wherein flux lines from the North/South poles extend substantially parallel to said external surface, whereby San external device can be connected therewith by magnetic \O coupling to permit the delivery or withdrawal, or the 00 C-i receiving or sending, or the placement. O 13. The method as claimed in claim 12, comprising applying an external device onto the surface of the living thing, said device having a permanent magnet and/or a coil for holding the external device magnetically coupled with the permanent magnet provided in the region of the external surface of the living thing.
14. The method as claimed in claim 12 or claim 13, comprising introducing or withdrawing medicines, samples or other substances with respect to the living thing via passages that extend from the external device to the implanted permanent magnet. The method as claimed in claim 13 or claim 14, comprising conveying electrical or electromagnetic signals and/or electrical energy from the external device to the implanted permanent magnet, and/or vice versa, by passage- free transmission, by means of at least one coil being positioned in the region of the implanted permanent magnet and the region of the external device.
16. The system as claimed in any one of claims 1 to 11, and substantially as herein described with reference to the accompanying drawings.
17. The method as claimed in any one of claims 12 to and substantially as herein described with reference to N \MeIboum\Cso\Patvnt\5 1000-5 1999\PS 1390 AU\Spis\PS I390.AU Spcfication 2007-6-13d"c 3/07/07 11 the accompanying drawings. 00 N \Mlboune\Cascs\Pten\S 1000-5 1999T51 390 AUT\Spccis\P5 1 390 AU Specification 2007-6-13.doc 3/07/07