Surgery – Instruments – External pressure applicator
Reexamination Certificate
2000-05-10
2003-03-11
Reip, David O. (Department: 3731)
Surgery
Instruments
External pressure applicator
C601S024000
Reexamination Certificate
active
06530941
ABSTRACT:
This invention relates to an apparatus and a method for fixing bodies/body parts, especially of the human body or human body parts.
In many fields of human medicine or medical research and technology secure fixing of the patient or a person under investigation is necessary. This is of greatest importance especially in the field of diagnostic use (radiology), radiotherapy or in operative/surgical interventions (neurosurgery, ENT, etc.) but also during (acute or permanent) pre- or post-operative care of wounds/injuries. The requirements on accuracy and reproducibility, both in determining a stereo-tactical frame system in or on the human body and also in fixing the body itself, have been increased by the introduction of computer technology in diagnosis and therapy.
The following fixing methods are known as the state of the art:
a) fixing the body with adhesive tapes or cuffs: The body of the patient lies on a foam material pad. Tapes tensioned transversely over the body fix the patient on this pad. The following points are disadvantageous:
indentation, pressure points, displacements and/or swelling of the skin can arise from the strong pull of the adhesive tapes;
after removal of the retaining elements (adhesive tapes) it is hardly possible to effect repositioning in exactly the same position again, which is a disadvantage particularly in stereo-tactical operations and in radiotherapy;
the body cannot be fixed adequately; movement in the sideways direction in particular (laterally) cannot be restricted or defined adequately.
b) fixing the body by screwing into the bone: The body of the patient is screwed to a metal frame at various places. The following are disadvantages:
screwing to the bone is an invasive procedure and is thus only possible and justified for particular indications;
the physical stress on the patient is substantial;
the method can only be used for specific positions of the patient and impedes the operator;
fixing of the soft parts (muscles, ligaments, connective tissue) is hardly possible at all.
c) fixing by formworks: The patient is placed on a kind of “air mattress”, which is filled with foam material balls. By sucking the air out of this mattress, this becomes solid through the foam material balls lying against one another. The vacuum mattress is thus matched to the body in the first step and is sucked out in the second step. An impression of the body is obtained by this method. Disadvantages in this are:
the “mattresses” usually employed do guarantee immobilisation but not fixing with uncooperative or anaesthetised patients adequate immobilisation is hardly possible at all;
an inadequate impression of the patient often results, since the mattress can hardly bear exactly on all body parts;
pressure points often result from formation of folds or too strong pressure, which can lead to pressure points and damage to tissues, especially with anaesthetised patients.
Other moulding materials, such as rails, thermoplastic material or plastics moulds, gypsum, etc. exhibit similar disadvantages. In addition, these methods involve substantial expenditure in money or time and are therefore only used for long-term applications.
The invention is therefore based on the object of providing an apparatus and a method for fixing/making moulds/compressing the human body or body parts, which avoids the cited disadvantages, is of simple structure and simple to use and kind to the patient to a high degree. The apparatus should moreover facilitate the exact application of calibration points (so-called markers) and optimal accessibility to operation regions.
This object is met by an apparatus according to the features described with reference to the present invention and the associated method.
In contrast to the apparatuses and procedures initially described, the fixing of the human body is effected in the proposed apparatus or method essentially by vacuum force. A blanket-like outer element is placed over a body support surface (flexible or rigid) with suction openings and is sucked at least substantially airtight on to the body support surface in its edge region projecting beyond the body (of the patient) A closed vacuum chamber thus results, so that the body is fixed relative to the support surface exactly and immovably in all directions.
The patient simply lies on the body support surface in the preferred arrangement and is “covered up” with the ox-like outer element. The patient or his body part(s) is/are now surrounded by this bag-like structure. Parts of the body (arms, legs, head, back) can emerge from the air or vacuum chamber through “peepholes” and thus remain unfixed, these openings being bounded by airtight arrangements, e.g. rubber bands or airtight cuffs. The air is now sucked out of the space between the body support surface and the outer element and the patient is fixed in the vacuum chamber thus resulting.
The described outer element or the body support surface is formed in the preferred embodiment from structurally reinforced, easily stretched plastics material or a metal foil and can accordingly adapt accurately to the anatomical structure of the body. By suitable choice of the material thickness and/or the level of the vacuum in the vacuum chamber an enhanced fixing or even compression of the body (of the patient) can be realised, so that the foil-like outer element lies like a second skin taut over the body (part).
By virtue of this fixing by means of vacuum it can be ensured that fixation which is always firm, exact and remaining constant is made possible, in particular after repeated use of the apparatus.
Vacuum pumps with adjustable degree of suction, hose connections and shut-off valves can be used as means for creating a vacuum. These devices can also be controlled/regulated in their vacuum action. In order to assist the vacuum action, shallow hollow spaces or vacuum channels can be formed by the creation of pores/channels on the outer element or the body support surface, which ensure uniform sucking out, for example by means of an air-bubble film with bumps known for protective packing. The previously described closed system can thereby also be operated as a semi-open system with constant sucking out of air, especially to facilitate the skin breathing during long operations. A further method of achieving the described effect is to overlay and/or underlay between the outer element and the patient with a net/fleece/foam material or similarly structured material. Such materials ensure optimal flow of the air in all body regions, through the number of their air channels/pores in this application. Other media than air can also be used to create the vacuum. Possible “air-flow barriers” which are created by the suction or affect this are thus prevented. Pressure measuring devices serve to control a comparatively constant pressure on the body regions.
With a safety button the patient himself (e.g. in case of sickness or panic) or the operator (e.g. in case of complications during the intervention) can interrupt the vacuum (or even convert the vacuum briefly into a raised pressure) and thus release the body of the patient from the fixing very rapidly and without complication, since the outer element is then lifted “at a stroke” from the support surface.
The blanket-like outer element, preferably in the form of a heat protective aluminium foil known per se, can be packed sterilely as a disposable article but is also easy to clean and sterilise, so that the operating costs remain small, since all essential parts can be reused.
In addition to the pure fixation/compression/making moulds, auxiliary apparatuses (such as guide devices, optical apparatus, target devices, etc.) can be fitted by means of mechanical/pneumatic or magnetic anchorage, since the blanket-like outer element takes up hardly any additional space. Reproducible application with high accuracy is therefore possible through scaling or similar devices.
The body (part) can be so placed that practically any body region is completely accessible to the treating doctor or other treating person, especially fo
Müller Christian
Vogele Michael
Perkins Coie LLP
Reip David O.
Woo Julian W.
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