Specially adapted apparatus, instruments, devices, or processes for the following types of therapy:

Components having specialized structural features that limit their use to the apparatus, instruments, or devices for the types of therapy appropriate for this subclass.

Several subclasses provide for subject matter that is used for therapy. The relationship between these subclasses in regard to the type of therapy covered by each is as follows:

Subclass A61N provides for medical treatment-type therapy by apparatus or methods utilizing forms of energy other than direct mechanical energy when they are not used for surgical purposes and they are intended to either

In particular, subclass A61N covers implanted devices, when the implanted device is not a replacement or supplementation of an actual portion of the organ or part, utilizing forms of energy other than direct mechanical energy to stimulate organs or body parts in a manner that facilitates, regulates, or improves their normal functioning.

Subclass A61H provides for massage and physical-type therapy apparatus or methods for the treatment of disease or disability (i.e., an abnormal condition of the body) by utilization of direct mechanical energy. The apparatus or methods appropriate for this subclass do not surgically alter any portion of the bodies during treatment. Usually, the massage and therapy apparatus and methods of this subclass are intended to facilitate the healing of diseases, reduce the impact of injuries, or beneficially influence the condition of disabled body parts by physically moving a part of a body (e.g., devices for exercising a passive body member) solely by direct physical contact with, or stimulation of, external surfaces of the body or naturally occurring cavities in the body. However, stimulation of internal organs or body parts, such as artificial respiration and stimulation of the heart, when it is done by direct mechanical energy is also considered proper for this subclass.

Subclass A61K and Subclass A61P provide for drug-type therapy using chemical compounds or medicinal preparations specially adapted for use in healing, benefiting, or destroying abnormal conditions of the body (e.g., diseases, birth defects) and the specific therapeutic activities that the chemical compounds and medicinal preparations are used for.

Subclass A61B provides for surgery and surgical-type therapy that alters or repairs organs and body parts. It also provides for any surgical or diagnostic apparatus or methods that would otherwise be proper for subclass A61H or A61N when the apparatus or methods are used for both purposes or combined together. In particular, subclass A61B provides for surgical instruments, devices, or methods for transferring non-mechanical forms of energy to or from the body (e.g., electromagnetic radiation surgery) to alter or repair it.

Details about electric fields which directly provide a therapeutic effect or which render the delivery of therapeutic substances possible; details about (components of) apparatuses which generate these electric fields.

Additional information could be either

Documents with such information should be given an Indexing Code.

Details about the electrodes and their associated leads specially adapted for delivering electrical therapeutic stimulation.

Details about the stimulating device as such, about the therapeutic signal and/or about the stimulating algorithm should be classified in A61N 1/36-A61N 1/3712.

Protecting the functioning of electrical therapeutic stimulation devices, especially against MRI.

This group only relates to protection (especially against MRI) for electrical therapeutic stimulation devices and not for other types of medical devices such as drug pumps. The purpose of this protection is to protect the functioning of the medical device.

Protecting the functioning of the medical device constitutes the difference with A61N 1/16, which relates to protecting the human body. E.g. pacemaker circuitry protecting the pacemaker from the field of a TV antenna should go to A61N 1/08 whereas as special building arrangement for protecting a person from the same field to A61N 1/16.

Leads (both implantable and external) having features that mitigate the effects of unwanted electric currents induced by a Magnetic Resonance Imaging [MRI] device or field.

Screening or neutralising atmospheric or terrestrial radiation or fields with the purpose of protecting the human body. The purpose of this protection is to protect the human body.

Protecting the human body constitutes the difference with A61N 1/08, which relates to protecting the functioning of the medical device. E.g. pacemaker circuitry protecting the pacemaker from the field of a TV antenna should go to A61N 1/08 whereas as special building arrangement for protecting a person from the same field to A61N 1/16. A61N 1/08 takes precedence over A61N 1/16.

Details about the therapeutic signal and/or about the stimulation algorithm, constructional and/or circuitry details, telemetry details.

Covers devices (both implanted and external to the body) that treat cancer by electrical stimulation.

Covers features of control systems used by electrical stimulation devices that are external to the body (e.g. switches/buttons used for controlling TENS devices, control displays for pain relief devices, controlling modes of operation for muscle stimulators, algorithms/flow charts for controlling external stimulation devices, etc.).

Device control systems under A61N 1/3603, which adjust therapeutic electrical stimulation based upon at least one sensed physiological parameter.

Device control systems under A61N 1/3603, which are characterised by their stimulation parameters (e.g. frequency, amplitude, pulse width, multiphasic, combination of waveforms, etc.).

Covers therapeutic devices that electrically stimulate portions of a patient's outer, middle, or inner ear.

Devices under A61N 1/36036 that electrically stimulate a patient's cochlea.

Devices and methods used for fitting a patient with a cochlear stimulation device or setting a cochlea stimulation parameter (as described in A61N 1/36038) (This subgroup is intended for devices having more than a general mention of fitting or stimulation parameters).

Electrical stimulation devices used for correcting spinal deformities.

Includes implantable neurostimulation devices and associated methods used to perform spinal stimulation (as described in A61N 1/3605).

Control systems for implantable neural stimulation devices (under A61N 1/3605) which measure impedance (This subgroup is intended for devices having more than a general mention of impedance).

Heart stimulation devices (e.g. pacemakers) under (A61N 1/362) which also include an additional non-electric therapy to the heart or other body area (e.g. drug therapy, nanotherapy, gene therapy, etc.).

Heart stimulation devices under A61N 1/368, which include dual chamber pacemakers (e.g. pacers using DDD modes of operation) and pacing devices that electrically stimulate multiple sites within the 4 chambers of the heart.

Covers heart stimulation devices under A61N 1/3684 having more than one stimulation site within the same heart chamber (e.g. two stimulation electrodes in the right ventricle that deliver separate and/or different stimulation to each electrode, etc.).

Covers heart stimulation devices which stimulate both the right ventricle [RV] and the left ventricle [LV].

Specifications going beyond the implantable medical device in isolation, such as communicating with, delivering power to, or testing of the implantable medical device.

Structural details of (parts of) the implantable medical device, e.g. casing or feedthrough.

Devices and methods used to provide security (both programming and physical) for electrical stimulation devices (in particular pacemakers and defibrillators) to combat hackers and other unauthorised persons from accessing/re-programming electrical stimulation devices.

Covers device features related to the construction of pacemakers (i.e. housings/can details, material, shape, etc.).

Covers device features related to the construction of brain implants (i.e. housing or can details, material, shape, etc.).

Covers device features related to the construction of intravascular implants (i.e. housing details, material, shape, etc.).

Covers anchoring/fixation details of electrical stimulation devices.

Covers external heart defibrillators (e.g. Automatic External Defibrillators [AEDs], semi-automatic external defibrillators, manual) and methods for constructing and using them.

External defibrillators and methods for using them for performing or assisting in cardiopulmonary resuscitation [CPR] therapy.

External defibrillators which include features that protect a user or patient from an accidental or unwanted shock.

Implantable defibrillator which in addition to electrical shock therapy, also provides another form of heart therapy (e.g. drug therapy, gene therapy, nanotherapy, etc.).

Implantable defibrillators under A61N 1/3962 which apply pacing therapy in addition to defibrillation shocks.

Implantable defibrillators under A61N 1/3962 which apply electrical stimulation therapy for pain reduction.

Use of static or dynamic magnetic fields for treating humans or animals, where the magnetic field itself provides the therapeutic effect.

Therapeutic treatment of the human or animal body with electromagnetic or particle radiation.

Therapy implies the curing of a disease or malfunction of the body and includes prophylactic treatment like killing of germs, bacteria in or on the body by means of radiation as well as treatment of symptoms like pain (anaesthesia) by means of radiation.

The IPC group A61M36/00 is not used: these devices are instead classified in A61N 5/10, since their purpose is therapeutic.

Surgery vs. Therapy

In contrast to the therapeutic applications covered by this group, surgery is characterized by the immediate and direct destruction or transformation of the tissue (ablation, vaporization, coagulation...). For therapy, the effect in the tissue is induced with rather lower intensity and power levels and/or longer pulse durations (photothermal, photochemical reactions, biostimulation...). Thus, for instance, cell destruction by photoactivation of an agent is to be classified in A61N 5/062. Some devices may be used for both applications depending on the operation mode.

Note that A61N 5/1084 covers focussed radiotherapy applications like "gamma knife" and stereotactic radiotherapy which are sometimes also called "radiosurgery", which is not to be confused with surgery in the sense of A61B 18/00.

Light therapy (A61N 5/06)

The scheme in A61N 5/06 contains several independent classification trees covering different aspects of a light therapy apparatus.

The therapeutic application is meant to be classified in A61N 5/0613 and lower hierarchical groups thereof for external treatments or A61N 5/0601 and lower hierarchical groups thereof for internal treatments.

Further aspects are then classified in codes according to the area of treatment (subgroups of A61N 2005/0635), the type of light source used (subgroups of A61N 2005/065), and the wavelength of therapeutic light (subgroups of A61N 2005/0658).

Aspects like coherence of the therapeutic light (A61N 5/067) and polarisation (A61N 2005/073) are also to be coded.

For some aspects, no suitable code is available and in such cases, sometimes the scheme of a neighbouring field is used: subgroups of A61B 2018/00773 or A61B 2017/00022 (feedback at the treatment site), A61B 2018/2255 (features at the distal end of a light guide, e.g. diffusers).

Note: devices of A61N 5/0614 (tanning) do not need to be classified in A61N 2005/0661 since the ultraviolet light is there by necessity.

Particle and X-ray therapy (A61N 5/10)

In the A61N 5/10 part, there is a similar aspect coded in A61N 2005/1085 (type of particles, e.g. ions, electrons, neutrons, low energy photons etc.). This code is obligatory for the particles specified in the subgroups of A61N 2005/1085. Only normal energy (MeV) photons are not coded in this tree, since it concerns the default situation.

The group A61N 5/01 should not be used for radiotherapy gantries, since a rotating gantry is common and not worth to classify.

Ultrasound therapy of the human or animal body. Also included is the thermal destruction of tissue in the focal point of a high intensity ultrasound beam.

A61N 7/00

Ultrasound therapy with negligible thermal effect. Treatment area not reduced to a focal point. E.g. devices for bone fracture healing.

A61N 2007/0004

The subgroups define various application areas on the body to be treated or therapeutic applications. Headgroup A61N 2007/0004 not to be used for classification.

A61N 7/02

Localized ultrasound hyperthermia, high intensity focused ultrasound (HIFU). The effect is primary a thermal one of substantially heating tissue above the normal temperature or even above the point of tissue destruction. Mechanical percussion to destroy calculi is to be classified in A61B 17/22004 or A61B 17/225 in case of external shockwaves.

A61N 7/022

Intracavitary localized hyperthermia. The probe or transducer is located within a body cavity.