Surgery – Means for introducing or removing material from body for... – Material introduced into and removed from body through...
Reexamination Certificate
2000-03-22
2002-07-23
Walberg, Teresa (Department: 3742)
Surgery
Means for introducing or removing material from body for...
Material introduced into and removed from body through...
C604S021000
Reexamination Certificate
active
06423027
ABSTRACT:
The present invention concerns a pressurized liquid dissection apparatus enabling simultaneous pressurized spraying of a treatment product, as well as the procedure implemented in such an apparatus.
The use of a pressurized liquid jet is known in the medical and surgical field and enables to advantageously realize all types of incisions, dissections, ablations, or disaggregations. Numerous pressurized liquid pulsed or continuous jet apparatuses, with or without aspiration, have been described within the framework of patent applications. Examples which may be cited in this regard include the applications WO 97/03713, FR 2,780,268 and FR 2,779,734 in the name of SAPHIR MEDICAL or the application EP 0,636,345 in the name of SENTINEL MEDICAL.
Pressurized liquid jet surgical apparatuses advantageously enable replacement, for certain delicate medical or surgical interventions, of the conventional mechanical cutting tools such as scalpels, which are not very precise and are particularly traumatizing, or lasers, which make a particularly fine, precise, incision, but by means of burning tissues, resulting in necrosis of adjacent tissues, both undesirable and difficult to heal, as well as ultrasonic bistouries offering reduced efficacy and necessitating frequent and precise adjustments.
In contrast, pressurized liquid jet apparatuses enable the realization of a clean, precise, incision without damaging tissues adjacent to the target. Moreover, their cost is moderate, in any event clearly less, for example, than that of laser or ultrasonic apparatuses, and they are particularly flexible to use. In fact, many operational parameters, such as the pressure of the working liquid, the force or frequency of aspiration, and the pulse duration, if a pulsed jet is used, may be modified in order to optimize the effect obtained. Depending on the value of these parameters, it is possible to obtain a more or less incisive tissue cutting action and a more or less extensive dissection effect, resulting, for example, in incision of the softest tissues and leaving the other tissues intact.
Pressurized liquid jet surgical apparatuses are thus particularly appropriate to realize, for example, the ablation of soft tissues, because they are capable of emulsifying these tissues without damaging the adjacent tissues. The emulsified tissues are then easily removed from the operative site by aspiration.
In order to increase the benefits of the surgical intervention for the patient, it would often be desirable to be able to inoculate the patient with a treatment product at the time of the operation. This product may have any therapeutic activity associated with the patient's pathology or with the course of the surgery. It could be, for example, a preparatory agent for the surgery, useful in its course, increasing its beneficial effects, limiting the risks of postoperative complications, or combating secondary effects associated with surgical trauma. It could also be any therapeutic agent useful in the treatment of the problem or of the disease of the patient in question.
However, with the surgical instruments known in the prior art, the direct and simultaneous application of a treatment product is not possible. The application of a treatment product usually occurs before or after the operation and/or by means of an injection not made at the site of the operation, which is most often inaccessible. The therapeutic agent must, consequently, circulate within the blood system of the patient until it reaches its target. This circulation may cause a reduction in the efficacy of the treatment product and provoke undesirable secondary effects by also affecting tissues other than those targeted.
If carried out during the operation, the application must be effected with an instrument other than the dissection instrument, a situation which implies a loss of time and concentration for the surgeon, who must change instruments during the course of the operation. This is all the more complicated when the intervention is non-invasive, i.e., is performed percutaneously by means of instruments carried by or integrated into a catheter advanced to the site of the intervention.
The object of the invention is to enable application of a treatment product directly at the site of the surgical or medical intervention simultaneously with its realization and to do so with the same apparatus.
To solve this technical problem, the pressurized liquid dissection apparatus according to the invention includes means of switching or mixing a treatment product with the working liquid or multiplexing means in the case of a pulsated system of pressurized pulsed jets.
Thus, the surgeon may, using the apparatus according to the invention, make the incision directly with the treatment product using it as the working liquid. Since the therapeutic agent is usually rather expensive, it is also possible to use a mixture of conventional working liquid, preferably physiological serum, and treatment product.
Starting from this basic principle, it is possible to conceive of numerous other variants of the apparatus according to the invention. This may, for example, include a control means enabling the person performing the operation to trigger, to stop, and/or to modify the parameters of the pressurized working liquid jet and that of the treatment product, based on his needs, with the two liquids possibly leaving the apparatus through two different orifices or through a single discharge orifice connected by a switching or mixing element with two separate or with one mixed pressurized supply.
A preferred embodiment of the apparatus according to the invention provides a pulsed pressurized liquid jet. It may then have a multiplexer enabling combining the pulses of the working liquid and the treatment product within the discontinuous pulse train constituting the pulsed jet. The parameters of the various pulses, their nature, and their succession may be modified and programmed depending on the needs of the surgeon, of the patient, and of the type of surgery performed, in order to optimize the result of the intervention.
The apparatus and the procedure according to the invention afford very significant advantages compared to the known systems. Thanks to them, the treatment liquid may be sprayed directly under pressure onto the operative site itself. The product thus arrives directly at its site of action with maximum efficacy. The risks of the application affecting organs or tissues not involved are greatly reduced.
The application of the treatment product occurs at the time of the incision and simultaneously during the course of the intervention, at the most appropriate time to ensure maximum efficacy of the treatment product. The force of the pressure of the liquid jet also enables better penetration and diffusion of the treatment product deep into the tissues where it diffuses rapidly and extensively, a situation which further reinforces its efficacy.
Moreover, the application of the therapeutic agent is simple and rapid and takes place without changing the apparatus and without interfering with the concentration of the surgeon.
The medical or surgical intervention procedure according to the invention enables realization of a surgical and therapeutic act on the body of a living being, in a single intervention, and with a single surgical or medical apparatus of which the working fluid is a pressurized biocompatible liquid. To accomplish this, during the intervention, and with this same apparatus, a treatment product, mixed or not with the working liquid, is sprayed under pressure, thus improving its penetration and diffusion into the tissues. The treatment product preferably is in liquid form.
In a variant, it is possible to also spray a therapeutic agent before surgery in preparation therefor or an agent to complete the surgical task after the surgery.
The apparatus and procedure according to the invention may be suitable for a large variety of medical or surgical interventions on all the organs of the body of a living being, of which only a few examples will be
Patel Vinod D.
Saphir Medical Products GmbH
Walberg Teresa
LandOfFree
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