WO2014033144A1

WO2014033144A1 - Medical device with impact sensor and expandable shock-absorbing substance, structure or airbag

Info

Publication number: WO2014033144A1
Application number: PCT/EP2013/067754
Authority: WO
Inventors: Michael Jugl; Axel Teucher
Original assignee: Sanofi-Aventis Deutschland Gmbh
Priority date: 2012-08-31
Filing date: 2013-08-28
Publication date: 2014-03-06

Abstract

The present invention relates to a medical device protection assembly and to a respective medical device. The protection assembly comprises at least one impact-protection member (18; 28; 38) and an impact sensor (26), which is operable to deploy an expandable shock-absorbing structure (22; 32; 42) such as a foam, a gel or an airbag upon detection that an impact-event will occur.

Description

MEDICAL DEVICE WITH IMPACT SENSOR AND EXPANDABLE SHOCK-ABSORBING SUBSTANCE, STRUCTURE OR AIRBAG

Description Field of the Invention

The present invention relates to the field of portable medical devices and in particular to a protection assembly adapted to protect medical devices against mechanical impact. Background and Prior Art

There exists a variety of portable medical devices such like injection devices or analysis devices, by way of which a patient may conduct self-treatment, in particular self- administration of a medicament.

Especially with patients suffering diabetes, a blood glucose level has to be regularly determined, e.g. by making use of a blood glucose measurement device (BGM).

Depending on the measured data and a determined blood glucose concentration the patient may then individually select a dose of a medicament which is to be administered, e.g. by way of injection.

There exists a large variety of medical devices for analysing and treating patients for diagnostic and/or therapeutic purpose. Such medical devices are sometimes rather fragile and sensitive to mechanical impact.

In general, medical devices may comprise a variety of sensitive components which require sufficient protection against external hazards. Portable or mobile medical devices may also comprise a large variety of electronic components, by way of which various functionalities of the device can be configured, controlled and conducted. Additionally, such devices may comprise various input and/or output means, such like a display, operating buttons and knobs, regulators, dose dials and so on.

Moreover, medical devices may also comprise a storage module by way of which repeated use of the medical device can be monitored and logged. Also, medical devices may comprise a communication module, such like an interface, by way of which treatment- related or device-configuration-related data can be exchanged with additional devices, such like personal computers or smartphones. The various components of such portable medical devices may be rather susceptible to mechanical impact and may affect the general operability of such devices when exposed to mechanical impact above a certain threshold.

Objects of the invention

It is therefore an object of the present invention to provide a medical device protection assembly by way of which the susceptibility of the medical device against mechanical impact can be reduced and by way of which the mechanical resistivity of the medical device against mechanical impact or comparable hazards can be improved. It is a particular aim to provide a medical device protection assembly, which is adaptable to existing medical devices and which can be retrofitted. Moreover, the medical device protection assembly should comprise a rather simple and intuitive structure. Furthermore, it should automatically activate.

Summary of the invention

In a first aspect, a medical device protection assembly is provided which is connectable to a medical device, in particular to a portable medical device. The medical device protection assembly comprises at least one impact-protection member, which is operable to deploy an expandable shock-absorbing structure upon detection that an impact-event will occur or that an impact-event is likely to occur. By means of expanding a shock-absorbing structure, rather sensitive components of the medical device can be protected against mechanical impact and mechanical shock-effects.

Preferably, the expandable shock-absorbing structure is plastically or elastically deformable when deployed or expanded in order to absorb mechanical impact impinging on the medical device. Additionally or alternatively, the expandable shock-absorbing structure may mechanically reinforce the medical device and/or a housing thereof in the event of an impact.

In particular, rather shock- or impact-sensitive components, e.g. electronic components of a medical device, such like a display, a storage- and/or a communication module can be effectively protected in order to ensure, that at least general functionalities of the medical device stay intact even when a hazardous impact occurs. By keeping at least electronic components of the medical device substantially intact, a final read out or a transfer of data stored in the device may still be possible even if other components or functionalities of the device became substantially inoperable.

Moreover, if the medical device comprises a drug delivery device or an injection device having a container arranged therein which is filled with a medicament, the medical device protection assembly may also serve to protect the container against mechanical impact. For instance, a vitreous and breakable cartridge filled with a liquid medicament can be effectively protected by means of the expandable shock-absorbing structure. Even if the device should become substantially inoperable, protection of the cartridge may effectively impede a breaking thereof and may thus prevent an uncontrolled release of the medicament to the environment.

Especially with comparatively expensive or comparatively hazardous medicaments, such an impact-protection might be rather valuable. Even in case the medical device becomes inoperable due to an impact-event, the medicament contained therein can be in general retrieved and may be consumed and used up by making use of another medical device.

In a further embodiment, the impact-protection member is operably connected to or comprises at least one sensor to detect and/or to determine an impact-event. In typical situations, occurrence of an impact-event is due to a falling down of the medical device. Consequently, the sensor is adapted to detect and/or to determine an acceleration or deceleration, a velocity, a distance to a surface or a mechanical contact with another object. Moreover, the sensor may be adapted to determine or to at least estimate a magnitude of a mechanical impact.

In typical embodiments, the afore-mentioned parameters to be measured or to be detected by the sensor are processed by a processor in order to determine whether an impact- event is likely to occur or not. Therefore, the measurable parameters, acceleration, velocity, distance to a surface as well as magnitude of a mechanical impact are compared with pre-defined values which are indicative of an impact-event. Measurement of an acceleration close to the gravitational acceleration may be treated as an indicator, that the medical device, to which the impact protection member and/or the sensor is attached to, actually is subject to a free-fall. In the event that for instance an acceleration above a predefined threshold is detected by the sensor, also the time interval the acceleration is above the given threshold can be determined. From these parameters, an actual velocity of the impact-protection member and the medical device to which the impact-protection member is connected can be at least estimated.

Apart from estimating or deriving a velocity, the sensor may also be operable to measure and/or to determine the velocity of the medical device and/or of its impact-protection member. From the actually measured or estimated velocity, a magnitude of a

corresponding impact can be at least derived or calculated. In case a measured, calculated or estimated impact is above a pre-defined threshold, the impact-protection member is operable to deploy the expandable shock-absorbing structure. Deployment or release of the expandable shock-absorbing structure typically occurs on a very short time- scale, preferably on a scale of milliseconds or even less.

By means of a comparatively fast and instant deployment of the expandable shock- absorbing structure, the medical device or selected components thereof may be effectively protected against an impact even prior an impact-event occurs.

The impact-protection member is not only operable to estimate that an impact-event will occur. Moreover it is conceivable that the impact-protection member is adapted to detect an actually occurring impact-event. Reaction times of the expandable shock-absorbing structure may be as short, that deceleration detection in the course of an impact-event may be sufficient to deploy and/or to release the expandable shock-absorbing structure.

In a further embodiment, the shock-absorbing structure comprises an inflatable bag, an expandable foam and/or a gel-like substance. Depending on the implementation of the impact-protection member and/or the sensor for detecting the impact-event, different kinds of expandable shock-absorbing structures can be implemented. If the shock-absorbing structure comprises an inflatable bag, the impact-protection member and the sensor operably connected therewith can be implemented as a kind of airbag control, which is operable to detect an impact-event when the magnitude of a measured, detected or estimated acceleration or deceleration is above a predefined threshold.

Instead or additional to an inflatable bag, which may be inflated by means of pressurized and respectively releasable gas or air it is also conceivable that the shock-absorbing structure comprises an expandable foam, by way of which externally applied impact can be absorbed and/or damped. Similarly, the impact-protection member may release or deploy a gel-like substance, which may be highly viscous and which may provide a comparative shock-absorbing or damping effect. In a further embodiment, the impact-protection member is fastened to a housing of the medical device. This way, even the housing of the medical device can be effectively protected against mechanical impact. The impact-protection member may be fastened to an outside facing portion of the housing. Furthermore, the impact-protection member may serve as an impact receiving structure which is adapted to face an impact-inducing object, such like a ground surface, e.g. in the event of a free-fall.

In a further aspect, the expandable shock-absorbing structure is expandable outside and/or is expandable inside the housing of the medical device to at least partially embrace the housing and/or to at least partially embrace at least one component of the device arranged inside or at the housing. By arranging the shock-absorbing structure inside the housing, the outer appearance of the medical device may remain completely unaffected by the implementation of the medical device protection assembly. Only in the event of an impact or a predicted impact, the shock-absorbing structure may deploy and expand inside the housing to provide mechanical support and/or impact protection to various device components assembled inside the housing.

In this way, particular device components, e.g. electronic device components, can be effectively protected for maintaining at least some basic functionalities thereof in the event of a damaging impact.

Here, it is also conceivable, that the impact-protection member is arranged inside the housing but that the shock-absorbing structure expanding from the impact-protection member spreads and expands also or exclusively outside the housing of the device. For instance, the impact-protection member might be arranged near or in direct vicinity of a scoring line or a predetermined breaking area of the housing, which, in case of a detected or predicted impact-event is adapted to be broken by the expanding shock-absorbing structure extending through a ruptured portion of the devices' housing.

Alternatively or additionally it is also conceivable that the impact-protection member is assembled to or at an outside facing portion of the housing. The expandable shock- absorbing structure may then particularly expand outside the housing for protecting the medical device and/or at least some of its components against mechanical impact.

Moreover, the impact-protection member may be located in a through opening or in a receptacle of the housing of the medical device. It is even conceivable, that the impact- protection member is arranged to the housing of the medical device in such a way, that the expandable shock-absorbing structure expands inside as well as outside the housing simultaneously. In a further preferred embodiment, the impact-protection member is replaceably fastenable to the housing either outside the housing but also inside the housing.

Depending on the particular mutual fastening of the medical device protection assembly and the medical device, replacement of a deployed or expanded impact-protection member may require to open the housing of the medical device. In embodiments, where the impact-protection member is assembled outside the housing of the medical device and wherein the expandable shock-absorbing structure expands outside the housing of the device, a replacement of a deployed impact-protection member simply requires to exchange the deployed impact-protection member by a new one.

In embodiments, wherein the impact-protection member is located inside the housing and/or wherein the shock-absorbing structure extends into the housing, replacement of the impact-protection member may require to open and/or to re-configure the medical device. In another aspect, a medical device and in particular a portable medical device is provided. The device comprises a housing and at least one functional component which is either arranged inside the housing or which is fastened to the housing. Moreover, the medical device comprises a medical device protection assembly as described above. This way, the medical device can be effectively protected against mechanical impact. In such events, where electrical signals received from the sensor of the protection assembly indicate that an impact-event occurs or that a likelihood that an impact-event is to occur shortly, hence, when a respective measureable parameter is above a predefined threshold, the impact-protection member may immediately start to deploy the expandable shock-absorbing structure to protect particular impact sensitive components of the medical device.

According to another embodiment, the shock-absorbing structure is expandable into the inner volume of the housing to at least partially embrace and/or to mechanically support the at least one functional component of the medical device. When expanding into the inner volume of the housing, a free space inside the housing can be sufficiently filled with the shock-absorbing structure. This may particularly counteract an uncontrolled loosening or separation of particular device components. In case the shock-absorbing structure expands between medical device components, which for instance may be located on opposite sidewall portions of the device's housing, a kind of mutual abutment or mutual damping of such device components can be provided across the expanded shock-absorbing structure. Moreover, by at least partially embracing selected components of the medical device by means of the shock-absorbing structure said components can be effectively protected against mechanical impact.

However, expansion of the shock-absorbing structure into the inner volume of the housing of the medical device may disable particular functions of the medical device or may even render the entire device substantially unusable. Since a malfunctioning medical device may expose a serious health risk to a patient, such an intentional disabling of device functions obliges the patient to bring the device to a customer service in order to check its operability. The medical device protection assembly may therefore implement an additional security mechanism, which imposes a maintenance or check up of the device in the event that the device has been exposed to extreme mechanical load or other potentially damaging events.

In a further aspect, the expanded shock-absorbing structure substantially fills a free space between functional components and/or between the at least one functional component and an inside facing wall of the housing. This way, the functional components may either mutually support or may be supported by a portion of the housing of the medical device.

For instance, a rather large-scaled display component, which may be embedded in the housing or which may even form part of a housing can be supported by the expanded shock-absorbing structure in such a way that the entire free space underneath the display is substantially filled with the shock-absorbing structure. This way, the rather large and eventually fragile display component can be supported, structurally stabilized or even reinforced by the expanded shock-absorbing structure, which may itself reach against a portion of the housing located opposite the display component.

In a further aspect, the medical device comprises a drug delivery device, in particular an injection device, such like a pen-type injector. According to other embodiments, the medical device may comprise an analysis device, such like a blood glucose monitoring device. In still another aspect a method of protecting a medical device is provided by making use of the above described medical device protection assembly. Said method comprises the steps of detecting that an impact-event will occur and deploying an expandable shock- absorbing structure by means of an impact-protection member in response to the detection or prediction of the impact-event.

In this context it is to be noted that all features and embodiments as described herein are to be understood to equally apply to the medical device protection assembly, to the medical device and to the method of protecting the medical device. In particular, a mentioning of a component being configured or arranged to conduct a particular operation is to be understood to disclose a respective method step and vice versa.

The term "drug" or "medicament", as used herein, means a pharmaceutical formulation containing at least one pharmaceutically active compound, wherein in one embodiment the pharmaceutically active compound has a molecular weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a vaccine, a DNA, a RNA, an enzyme, an antibody or a fragment thereof, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound, wherein in a further embodiment the pharmaceutically active compound is useful for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis, wherein in a further embodiment the pharmaceutically active compound comprises at least one peptide for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, wherein in a further embodiment the pharmaceutically active compound comprises at least one human insulin or a human insulin analogue or derivative, glucagon-like peptide (GLP- 1 ) or an analogue or derivative thereof, or exendin-3 or exendin-4 or an analogue or derivative of exendin-3 or exendin-4. Insulin analogues are for example Gly(A21 ), Arg(B31 ), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28- B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

Insulin derivates are for example B29-N-myristoyl-des(B30) human insulin; B29-N- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-

ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-Y-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; Β29-Ν-(ω- carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(u)-carboxyheptadecanoyl) human insulin.

Exendin-4 for example means Exendin-4(1 -39), a peptide of the sequence H-His-Gly-Glu- Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-lle-Glu- Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2. Exendin-4 derivatives are for example selected from the following list of compounds:

H-(Lys)4-des Pro36, des Pro37 Exendin-4(1 -39)-NH2,

H-(Lys)5-des Pro36, des Pro37 Exendin-4(1 -39)-NH2,

des Pro36 Exendin-4(1 -39),

des Pro36 [Asp28] Exendin-4(1 -39),

des Pro36 [lsoAsp28] Exendin-4(1 -39),

des Pro36 [Met(0)14, Asp28] Exendin-4(1 -39),

des Pro36 [Met(0)14, lsoAsp28] Exendin-4(1 -39),

des Pro36 [Trp(02)25, Asp28] Exendin-4(1 -39),

des Pro36 [Trp(02)25, lsoAsp28] Exendin-4(1 -39),

des Pro36 [Met(0)14 Trp(02)25, Asp28] Exendin-4(1 -39),

des Pro36 [Met(0)14 Trp(02)25, lsoAsp28] Exendin-4(1 -39); or des Pro36 [Asp28] Exendin-4(1 -39),

des Pro36 [lsoAsp28] Exendin-4(1 -39),

des Pro36 [Met(0)14, Asp28] Exendin-4(1 -39),

des Pro36 [Met(0)14, lsoAsp28] Exendin-4(1 -39), des Pro36 [Trp(02)25, Asp28] Exendin-4(1 -39),

des Pro36 [Trp(02)25, lsoAsp28] Exendin-4(1 -39),

des Pro36 [Met(0)14 Trp(02)25, Asp28] Exendin-4(1 -39),

des Pro36 [Met(0)14 Trp(02)25, lsoAsp28] Exendin-4(1 -39),

wherein the group -Lys6-NH2 may be bound to the C-terminus of the Exendin-4 derivative; or an Exendin-4 derivative of the sequence

des Pro36 Exendin-4(1 -39)-Lys6-NH2 (AVE0010),

H-(Lys)6-des Pro36 [Asp28] Exendin-4(1 -39)-Lys6-NH2,

des Asp28 Pro36, Pro37, Pro38Exendin-4(1 -39)-NH2,

H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1 -39)-NH2,

H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-NH2,

des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-(Lys)6-N H2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-(Lys)6-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-(Lys)6-NH2,

H-(Lys)6-des Pro36 [Trp(02)25, Asp28] Exendin-4(1 -39)-Lys6-NH2,

H-des Asp28 Pro36, Pro37, Pro38 [Trp(02)25] Exendin-4(1 -39)-N H2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-N H2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-N H2, des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-(Lys)6-des Pro36 [Met(0)14, Asp28] Exendin-4(1 -39)-Lys6-NH2,

des Met(0)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1 -39)-N H2,

H-(Lys)6-desPro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-NH2, des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Lys6-des Pro36 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1 -39)-Lys6-N H2,

H-des Asp28 Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25] Exendin-4(1 -39)-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-N H2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1 -39)- NH2,

des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(S1 -39)- (Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1 -39)- (Lys)6-NH2; or a pharmaceutically acceptable salt or solvate of any one of the afore-mentioned

Exendin-4 derivative.

Hormones are for example hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists as listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.

A polysaccharide is for example a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra low molecular weight heparin or a derivative thereof, or a sulphated, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and/or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium.

Antibodies are globular plasma proteins (~150kDa) that are also known as

immunoglobulins which share a basic structure. As they have sugar chains added to amino acid residues, they are glycoproteins. The basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only one Ig unit); secreted antibodies can also be dimeric with two Ig units as with IgA, tetrameric with four Ig units like teleost fish IgM, or pentameric with five Ig units, like mammalian IgM.

The Ig monomer is a "Y"-shaped molecule that consists of four polypeptide chains; two identical heavy chains and two identical light chains connected by disulfide bonds between cysteine residues. Each heavy chain is about 440 amino acids long; each light chain is about 220 amino acids long. Heavy and light chains each contain intrachain disulfide bonds which stabilize their folding. Each chain is composed of structural domains called Ig domains. These domains contain about 70-1 10 amino acids and are classified into different categories (for example, variable or V, and constant or C) according to their size and function. They have a characteristic immunoglobulin fold in which two β sheets create a "sandwich" shape, held together by interactions between conserved cysteines and other charged amino acids. There are five types of mammalian Ig heavy chain denoted by α, δ, ε, γ, and μ. The type of heavy chain present defines the isotype of antibody; these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively. Distinct heavy chains differ in size and composition; a and γ contain approximately 450 amino acids and δ approximately 500 amino acids, while μ and ε have approximately 550 amino acids. Each heavy chain has two regions, the constant region (CH) and the variable region (V_H). In one species, the constant region is essentially identical in all antibodies of the same isotype, but differs in antibodies of different isotypes. Heavy chains γ, a and δ have a constant region composed of three tandem Ig domains, and a hinge region for added flexibility; heavy chains μ and ε have a constant region composed of four immunoglobulin domains. The variable region of the heavy chain differs in antibodies produced by different B cells, but is the same for all antibodies produced by a single B cell or B cell clone. The variable region of each heavy chain is approximately 1 10 amino acids long and is composed of a single Ig domain.

In mammals, there are two types of immunoglobulin light chain denoted by λ and κ. A light chain has two successive domains: one constant domain (CL) and one variable domain (VL). The approximate length of a light chain is 21 1 to 217 amino acids. Each antibody contains two light chains that are always identical; only one type of light chain, κ or λ, is present per antibody in mammals.

Although the general structure of all antibodies is very similar, the unique property of a given antibody is determined by the variable (V) regions, as detailed above. More specifically, variable loops, three each the light (VL) and three on the heavy (VH) chain, are responsible for binding to the antigen, i.e. for its antigen specificity. These loops are referred to as the Complementarity Determining Regions (CDRs). Because CDRs from both VH and VL domains contribute to the antigen-binding site, it is the combination of the heavy and the light chains, and not either alone, that determines the final antigen specificity.

An "antibody fragment" contains at least one antigen binding fragment as defined above, and exhibits essentially the same function and specificity as the complete antibody of which the fragment is derived from. Limited proteolytic digestion with papain cleaves the Ig prototype into three fragments. Two identical amino terminal fragments, each containing one entire L chain and about half an H chain, are the antigen binding fragments (Fab). The third fragment, similar in size but containing the carboxyl terminal half of both heavy chains with their interchain disulfide bond, is the crystalizable fragment (Fc). The Fc contains carbohydrates, complement-binding, and FcR-binding sites. Limited pepsin digestion yields a single F(ab')2 fragment containing both Fab pieces and the hinge region, including the H-H interchain disulfide bond. F(ab')2 is divalent for antigen binding. The disulfide bond of F(ab')2 may be cleaved in order to obtain Fab'. Moreover, the variable regions of the heavy and light chains can be fused together to form a single chain variable fragment (scFv).

Pharmaceutically acceptable salts are for example acid addition salts and basic salts. Acid addition salts are e.g. HCI or HBr salts. Basic salts are e.g. salts having a cation selected from alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion

N+(R1 )(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1 -C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10- heteroaryl group. Further examples of pharmaceutically acceptable salts are described in "Remington's Pharmaceutical Sciences" 17. ed. Alfonso R. Gennaro (Ed.), Mark

Publishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia of Pharmaceutical Technology. Pharmaceutically acceptable solvates are for example hydrates.

It will be further apparent to those skilled in the pertinent art that various modifications and variations can be made to the present invention without departing from the spirit and scope of the invention. Further, it is to be noted, that any reference signs used in the appended claims are not to be construed as limiting the scope of the present invention.

Brief Description of the Drawings

In the following, preferred embodiments of the invention will be described by making reference to the drawings, in which:

Fig. 1 schematically illustrates a medical device prior to deploying an expandable shock-absorbing structure, Fig. 2 shows the medical device according to figure 1 after deploying of the shock- absorbing structure, Fig. 3 shows another embodiment of the medical device protection assembly, wherein the shock-absorbing structure extends outside the housing of the device and

Fig. 4 is illustrative of another embodiment with a replaceable impact-protection member.

Detailed Description In Fig. 1 a medical device 10 is schematically illustrated. The device 10 comprises a housing 20 and a number of device components 12, 14, 15, 16. The device component 12 may provide a configuration and control means, such like control and operation buttons, knobs, dials or comparable operating elements. The device component 16, which is of rather elongated and flat shape may comprise an input/output means such like a display, by way of which device specific information can be visually and/or audibly provided to a user. Moreover, the device component 16 may comprise a touch screen, by way of which a user may select particular functions and configurations of the device.

The medical device 10 may further comprise a device component 14 acting as a communication module, by way of which treatment- or analysis-related data can be stored and/or communicated or transferred to other devices, such like personal computers. By way of a communication module 14, an application history of the medical device 10 can for instance be transferred to such other devices and can be for instance analyzed by a physician. Additionally, the medical device 10 may comprise a device component 15 which contains a medicament to be administered to a patient. In embodiments, where the medical device 10 comprises a drug delivery device, the device component 15 may comprise a cartridge, such like a vitreous ampoule or carpule comprising a liquid medicament to be dispensed. The various device components 12, 14, 15, 16 but also the housing 20 of the device 10 may be rather sensitive and susceptible to mechanical impact. In order to protect the medical device 10 and its device components 12, 14, 15, 16 a medical device protection assembly 1 1 is implemented, comprising an impact-protection member 18. The impact protection member 18 further comprises or at least communicates with a sensor 26, which is operable to detect and/or to determine an acceleration, a velocity, a distance to a surface, a mechanical contact with another object and/or the magnitude of a mechanical impact. The sensor 26 may be implemented as an optical sensor adapted to transmit and to receive electromagnetic radiation for e.g. distance- or velocity measurement purpose. The sensor 26 may also be implemented as a magnetic sensor arrangement, by way of which an acceleration or orientation of the medical device 10 can be measured, detected and/or at least estimated. The sensor 26 may be integrated in the impact-protection member 18 but may also be arranged separately inside or at the housing 20 of the medical device 10.

Even though not particularly illustrated here, the impact-protection member 18 comprises some kind of processor or controller to evaluate and/or to process signals received from the sensor 26. In the event, that at least one of the above mentioned parameters, acceleration, velocity, distance and the like exceeds a predefined threshold, the sensor signal is then indicative that an impact-event occurs or is very likely to occur within shortly. Consequently, an impact-event is detected.

In response to a detection of an impact-event, the impact-protection member releases or deploys an expandable shock-absorbing structure 22 as illustrated in Fig. 2. The expanded shock-absorbing structure 22 extends into the inner volume 24 and into the free space between the various device components 12, 14, 15, 16 and provides a mechanical shock-absorbing functionality. In the event, that the medical device 10 drops down to a ground surface, the mechanical impact impinging on the housing 20 of the device 10 can be at least partially absorbed by the expanded shock-absorbing structure 22. The impact can be therefore at least damped. The shock-absorbing structure 22 may comprise an inflatable bag, comparable to an airbag, which is to be deployed by means of a pressurized gas. Alternatively, the shock- absorbing structure 22 may comprise an expandable foam and/or a gel-like substance. Irrespective of its particular embodiment, the shock-absorbing structure might be elastically or plastically deformable to absorb mechanical impact and respective mechanical energy.

As illustrated in Fig. 2, the expanded shock-absorbing structure 22 may provide

mechanical support for the device components 12, 14, 16. By covering an entire inward facing portion of device components 12, 14, 16, these components 12, 14, 16 can be effectively protected against loosening or uncontrolled separation from their position with respect to the housing 20. Furthermore, by means of the expanded shock-absorbing structure 22 device components 12, 16 and device components 16, 14 may experience pairwise mutual mechanical support, by way of which the device components 12, 14, 16 may securely remain in their position with respect to the housing.

As further illustrated in Fig. 2, the expanded shock-absorbing structure 22 may substantially fill the entire free space of the inner volume 24 of the housing 20 of the medical device 10. This may incur that interaction and interoperation of various device components 12, 14, 15, 16 gets disturbed or disrupted. Consequently, the medical device 10 may become at least partially inoperable. The end user is then obliged to seek a customer support to resurrect the device and/or the check in how far the device 10 as a hole or particular components thereof 12, 14, 15, 16 require replacement.

In this context it is even conceivable, that the impact-protection member 18 is replaceably arranged in or at the housing 20 of the medical device. Here, it is beneficial when the expanded shock-absorbing structure 22 removably expands inside the housing 20 which allows its easy and intuitive removal when the impact-protection member 18 is replaced.

Depending on the location of the device components 12, 14, 15, 16 inside or at the housing 20, the shock-absorbing structure 22 may also entirely embrace and enclose a device component 15 in order to provide a maximum of impact protection. When the device component 15 comprises a cartridge filled with a rather expensive and valuable medicament, it may be rescued from a broken or destroyed medical device 10 and may be further used up with another medical device 10.

In the embodiment according to Fig. 3, the impact-protection member 28 is located inside the housing 20 in such a way, that the expandable shock-absorbing structure 32 extends outside the housing 20 when an impact-event is detected. In this way, the housing 20 can be effectively protected against mechanical impact. Here, the shock-absorbing structure 32 may cover only a selected portion of the housing 20 or even the entire housing 20. Additionally, but not illustrated, the impact-protection member 18 according to Fig. 3 may be further operable to expand another shock-absorbing structure 22 into the inner volume 24 of the housing 20 as already illustrated and explained with respect to Fig. 2.

In the embodiment according to Fig. 3 it is of particular benefit, when the portion of the housing 20 to which the impact-protection member 18 is assembled either comprises a through opening or some kind of structurally weakened structure, which may break away when the shock-absorbing structure deploys. In this way, a release of the shock-absorbing structure outside the housing 20 of the device 10 can be effectively provided. In the further embodiment according to Fig. 4, the impact-protection member 38 providing a kind of a separate impact-protection module is releaseably and/or replacably arranged at an outside facing portion of the housing 20 of the medical device 10. Here, the shock- absorbing structure 42 expands around the outside facing portion of the housing 20 and may at least partially or even entirely enclose or embrace the housing 20. In the event of an impact and after deploying the expandable shock-absorbing structure 42, the impact- protection member 38, hence the entire medical device protection assembly 1 1 can be removed from the housing 20 of the device 10 and can be exchanged and replaced by a new one.

The embodiment as illustrated in Fig. 4 is therefore particularly applicable to retrofit existing medical devices 10 with a medical device protection assembly 1 1 . The inner structure of the medical device 10 remains completely unaffected by the medical device protection assembly and its impact-protection member 38.

List of Reference Numerals

10 medical device

1 1 medical device protection assembly

12 device component

14 device component

15 device component

16 device component

18 impact-protection member

20 housing

22 shock-absorbing structure

24 inner volume

26 sensor

28 impact-protection member

32 shock-absorbing structure

38 impact-protection member

42 shock-absorbing structure

Claims

A medical device, comprising:

a housing (20),

at least one functional component (12, 14, 15, 16) arranged inside the housing

(20) or fastened to the housing (20), and

a medical device protection assembly (1 1 ) connectable to the medical device (10) and comprising at least one impact-protection member (18; 28; 38), which is operable to deploy an expandable shock-absorbing structure (22; 32; 42) upon detection that an impact-event will occur.

The medical device according to claim 1 , wherein the impact-protection member (18; 28; 38) is operably connected with at least one sensor (26) to detect and/or to determine an acceleration, a velocity, a distance to a surface, a mechanical contact with another object and/or the magnitude of a mechanical impact.

The medical device according to claim 1 , wherein the impact-protection member (18; 28; 38) comprises at least one sensor (26) to detect and/or to determine an impact-event, wherein parameters to be measured or to be detected by the sensor (26) are processed by a processor in order to determine whether an impact-event is likely to occur.

The medical device according to any one of the preceding claims, wherein the shock-absorbing structure (22; 32; 42) comprises an inflatable bag, an expandable foam and/or a gel-like substance.

The medical device according to any one of the preceding claims, wherein the impact-protection member (18; 28; 38) is fastened to a housing (20) of the medical device (10).

The medical device according to claim 5, wherein the expandable shock-absorbing structure (22; 32; 42) is expandable outside and/or inside the housing (20) of the medical device (10) to at least partially embrace the housing (20) and/or to at least partially embrace at least one component (12, 14, 15, 16) of the device (10) arranged inside the housing (20). The medical device according to anyone of the preceding claims, wherein the impact-protection member (18; 28; 38) is replaceably fastenable to the housing (20) of the medical device (10).

The medical device according to any one of the preceding claims, wherein the shock-absorbing structure (22) is expandable into the inner volume (24) of the housing (20) to at least partially embrace and/or to mechanically support the at least one functional component (12, 14, 15, 16).

The medical device according to any one of the preceding claims, wherein the expanded shock-absorbing structure (22) substantially fills a free space between functional components (12, 14, 15, 16) and/or between the at least one functional component (12, 14, 15, 16) and an inside facing portion of the housing (20).

The medical device according to anyone of the preceding claims, comprising a drug delivery device, an injection device or an analysis device.

The medical device according to claim 10, further comprising a cartridge (15) being at least partially filled with a medicament.

A method of protecting a medical device (10) by making use of a medical device protection assembly according anyone of the preceding claims 1 to 6, the method comprising the steps of: detecting that an impact-event will occur,

deploying an expandable shock-absorbing structure (22; 32; 42) by means of an impact-protection member (18; 28, 38) in response to the detection of the impact-event.