The invention relates to an applicator for a water jet separating apparatus especially for treating wounds and abscesses.
Wounds and abscesses are injuries to the skin and heal best when: an adequate blood flow is present for self cleaning; the bacteria, which have developed in the ulcer, are destroyed or are removed; and, the upper epidermis of the tissue is configured to have sharp edges to facilitate better healing. For smaller wounds, it is only necessary to clean and disinfect in order to satisfy these conditions.
Larger wounds and ulcers have, as a rule, irregular wound edges and ulcers have a greater proportion of necrotic tissue. The necrotic tissue mostly extends over a large area and often extends deeply which hinders the healing process and greatly increases the danger of an infection. An especially dangerous and treatment intensive ulcer is the leg ulcer or lower leg ulcer (ulcus cruris).
Ulcers are, as a rule, mechanically treated in that the necrotic tissue is scraped out or cut away with the aid of a curette or a scalpel. Penetration extends into healthy tissue to improve bleeding.
This method is, however, not very pleasant for the physician conducting the procedure and is not adequately free of pain for the patient.
For this application, there exists the need for a water jet separating technology which has been already widely introduced in medical technology.
This water jet separating technology basically includes: a pressure generating unit having a discharge nozzle for a separating liquid jet; a vacuum generating unit having one or several suction openings for a suction flow; and, an applicator which is adapted to the special case at hand. In this applicator, the discharge nozzle for the separating liquid jet and the suction openings for the suction flow are configured and arranged in a special manner. This water jet separating technology is used successfully and invasively always where body cavities are present wherein the separating liquid can locally collect so that it can be drawn away by suction with the separated tissue parts. This condition is not present for the treatment of wounds in general and especially not for the treatment of ulcers. The use of conventional water jet separating technology is therefore not suitable in these cases because the separating liquid and the pathogenic microorganisms from the ulcer could flow uncontrolled into the surroundings of the area of surgery. This endangers the patient and the personnel.
U.S. Pat. No. 5,941,859 discloses a wound irrigation apparatus having a liquid feedback and having a bell-shaped protective shield. Within this protective shield, there is a discharge nozzle for a liquid medication and a suction stub for the exited liquid medicine. The protective shield covers the wound during the treatment and thereby protects, the surgeon from liquid enriched with bacteria. This protection is, however, only slight because no adequate covering of the work region is present. Furthermore, the wound irrigation apparatus is only provided for irrigating and cleaning a wound and a surgical intervention for treating the wound is not possible.
In the publication of Guthke et al entitled “Wundreinigung bei Ulcus cruris-eine Indikation für den Hochdruckwasserdissektor”, Zentralblatt Haut 1994:164; pages 181 and 182, a treatment tent, which shields against the surroundings having a discharge lock of the Medaxis Company is described which encloses the entire work area for the surgery and prevents an uncontrolled propagation of microorganisms. This discharge lock does not correspond to present day requirements because it greatly limits the manipulability of the surgeon and because it requires an unusually high suction power in order to withdraw by suction the content of the large-volume discharge lock, this content comprising air, water and tissue parts. The drive units must be designed correspondingly large and powerful and therefore it is not possible to use this water jet separating apparatus for the outpatient treatment of wounds.
There are a series of applicators known wherein the discharge nozzle of the pressure line and the inlet opening of the suction line are so arranged toward each other that the exiting water jet together with the separated tissue parts enter directly into the suction opening.
U.S. Pat. No. 6,290,670 discloses an applicator wherein the discharge nozzle is configured as a nozzle ring having a peripherally-extending nozzle slit directed radially. This slit is so directed and the pressure of the liquid jet and the suction flow are so matched to each other that a liquid membrane is formed which dips into the suction tube with this liquid membrane separating the tissue.
U.S. Pat. Nos. 6,375,635, 6,960,182 and 7,122,017 describe an applicator wherein the discharge nozzle of the water jet and the inlet opening of the suction line are positioned at a specific distance relative to each other. The distance is so selected that an additional suction force is generated in accordance with the venturi principle and this suction force improves the removal of the separated tissue. In special cases, a separate suction unit is not needed.
In contrast, German published patent application 40 18 736 discloses an applicator which, at the distal end of the suction tube, has a nozzle ring having two discharge nozzles for the separating fluid which are directed radially and into the interior of the suction tube.
All these applicators do avoid an uncontrolled scattering of the exiting separating liquid because of the direct proximity of the discharge nozzle and the suction opening; however, they have in common the disadvantage that they define a very narrow work area. The distance between the discharge nozzle and the suction opening is, however, narrow and related to function and an increase of this distance is only possible to a limited extent because the size of the suction opening and the intensity of the suction flow can then no longer ensure a trouble-free take-up of the entire liquid flow. These applicators are exclusively provided for the invasive use and therefore are unsuitable for a debridement of open and large area wounds and ulcers.
It is an object of the invention to provide an applicator which ensures the largest possible work area and shields the surroundings while at the same time being suitable for mobile use.
The applicator of the invention is for a water jet separating apparatus including an apparatus for treating a wound or an ulcer. The applicator includes: a handpiece; a protective cover connected to the handpiece and being provided for placement on a body part of a patient over the wound or ulcer; a pressure line having a discharge nozzle arranged in the protective cover; a suction line having an opening likewise arranged in the protective cover; the protective cover and the body part conjointly defining a vacuum-closed work chamber; and, a vacuum sensor for monitoring the vacuum in the work chamber.
The new applicator eliminates the above-mentioned features of the state of the art. With the invention, all the known advantages of the water jet separation are effected with these advantages being especially that a cut can be made deep into the healthy tissue in a protected manner which can be tolerated by the patient. These advantages include, for example, the following: the use of a dynamic and pulsed water jet; the use of an abrasive separating means; the use of an antibiotic, antiseptic medium; or, the use of a temperature-controlled separating means. Here, it is especially advantageous when a vacuum is generated in the protective cover via the suction line which vacuum is preferably pulsating and stimulates the tissue. This facilitates the healing process. The special advantage of the new applicator lies in that the intervention takes place in a work chamber closed off with a vacuum therein. This draws the tissue parts by suction into the work chamber and prepares the tissue parts in an advantageous manner for the separating operation. The vacuum, however, ensures also that the blood flow of the wound or the ulcer is increased which advantageously affects the cleaning of the wound or ulcer. A special advantage, however, is that the propagation of pathogenic microorganisms is reliably prevented for the protection of the surgeon and the surroundings. This protection takes place because of the vacuum-conditioned sealing of the work chamber during the surgical procedure. The protection results, however, in that the separating liquid is controlled by the vacuum and can only discharge when the sealing of the work chamber is ensured. An additional shield is provided during the switch-off phase by a special sealing element having a novel catch flap.
The new applicator also provides a work area of increased size because the protective cover can be dimensioned, configured and arranged independently of the arrangement of the discharge nozzles and the suction openings. In this way, larger wounds or ulcer surfaces can be treated. Should a repositioning nonetheless be required, this is easily realized by the surgeon with the control of the vacuum via the bypass opening in the suction flow.
The invention will now be described with reference to the drawings wherein:
The applicator 1 belongs to a surgical water jet separating apparatus which comprises a liquid separating unit for separating a biological structure and a corresponding suction unit. This water jet separation apparatus is generally well known in medical technology and therefore needs no further description. The water jet separating apparatus accordingly comprises a supply vessel for a sterile liquid, a pressure pump and an injection line and the suction unit comprises a collecting vessel for the liquid and the separated tissue parts as well as a suction pump and an suction line. The injection line of the water jet separating apparatus and the suction line of the suction unit open in common in the applicator 1.
The applicator 1 of all embodiments shown except for
In a first embodiment as shown in
As shown in
As shown in
In the embodiment of
At the distal end, the suction line 4 has an end face suction opening 12 and, selectively, additional suction openings 12 which can be arranged distributed over the periphery. Correspondingly, the suction line 4 ends in its length at a predetermined distance above the sealing edge 7 of the protective cover 6″ in order to maintain the end face suction opening 12 open. The pressure line 3 has a discharge nozzle 11 which is arranged at the outermost distal end and is arranged radially and is directed in a direction away from the suction line 4.
The modified work probe 5″ of the third embodiment is shown in
In the present embodiment, the end of the protective cover 6″ is beveled so that an oval sealing edge 7 is formed. A special sealing element 16 is seated on this sealing edge 7. The sealing element 16 is made of a flexible material and therefore is adaptable to different body shapes of the patient.
This sealing element 16 has a proximal holding ring 17 which ensures the connection to the cylindrical protective cover 6″ and a distal sealing lip 18 which lies on the body surface of the patient. In a special manner, the distal sealing lip 18 is equipped with a catch flap 19 movable in the axial direction in the region of the suction openings 12 of the suction line 4. The catch flap 19 is movable between an unfolded position in the rest position as shown in
In the region of the handpiece 2, the protective cover 6″ likewise has a first bypass opening 13 which is held open or closed by the hand of the surgeon and is so dimensioned that, in the open state, the suction flow is conducted via the bypass opening 13 and therefore a build up of suction forces at the distal end is prevented. A second bypass opening 20 is disposed in the vicinity of the first bypass opening 13. The second bypass opening is so dimensioned to match with the power of the vacuum pump that a defined suction flow having a specific suction force adjusts for a complete sealing at the sealing element 16 and a closed bypass opening 13.
In the handpiece 2 of the applicator 1, a vacuum sensor 21 is also provided which, on the one hand, is connected via a pressure sensor line 22 to the work chamber 8 and, on the other hand, via a signal line 23 to the liquid conveying pump. The vacuum sensor 21 is so configured and so coupled to the liquid conveying pump that the liquid conveying pump is only capable of pumping at a predetermined vacuum pressure range. A pumping of liquid and therefore a discharge of liquid from the discharge nozzle 11 are not possible outside of this vacuum pressure difference.
According to
The distal ends of the pressure line 3 and the suction line 4 are, in turn, equipped with a radial discharge nozzle 11, which is directed away from the suction line 4, and an end face suction opening 12 and, selectively, further radial suction openings 12.
According to
During operation of the water jet separating apparatus, a predetermined water pressure adjusts in the pressure line 3 which forms a corresponding preferably flat water separating jet in combination with the exit nozzle 11. The suction line 4 is first without pressure because the bypass opening 13 is opened and so generates an ancillary suction flow. With the closure of this bypass opening 13 by the surgeon, an underpressure builds up in the work chamber 8 of the protective cover (6, 6′, 6″, 6′″) which lifts the tissue disposed in the region of the work probe 5, 5′, 5″, 5′″, 5″″ and presses it against the sealing edge 7 of the protective cover 6, 6′, 6″, 6′″. In this way, the work area is hermetically sealed with respect to the surroundings so that no water and therefore no bacteria can exit from the work area. At the same time, the tissue to be separated by the force of the suction flow within the protective cover 6 is lifted and stretched and is brought into a favorable position for the separating operation. The water jet does its work in that it penetrates in an intelligent manner between the tissue cells and expands these cells and further tensions and separates the cells one from the other. Tissue cells are hardly damaged thereby. The suction flow entrains the separated tissue cells together with the collected water and moves the same through the suction openings 12 to the collecting vessel.
In the first embodiment of
The applicator 1 of the second embodiment of
In the third and fourth embodiments of
After the successful removal of devitalized tissue, the pressure generation for the water jet is switched off and the bypass opening 12 is opened by the surgeon so that the suction flow relaxes and the tissue is again exposed which was drawn by suction onto the sealing edge 7 of the protective cover (6, 6′, 6″, 6′″). Thereafter, the applicator 1 is moved into the next work area and the applicator 1 is taken into service anew.
This repositioning of the applicator 1 within the wound or the ulcer is rendered essentially unnecessary in the embodiment of
The modified applicator 1 in the third embodiment of
After the successful removal of devitalized tissue, the surgeon opens the bypass opening 13 so that the vacuum relaxes and the sealing element 16 releases from the surface of the body. The vacuum sensor 21 detects this pressure change in the work chamber and issues a control signal to the liquid pump in order to immediately permit the same to be switched off. This control signal simultaneously initiates a short reversal of the pumping direction in order to minimize an afterrunning of the liquid pump and therefore a limited further pumping action. The surgeon therefore lifts the applicator 1 from the body surface of the patient directly after the opening of the first bypass opening 13 in order to be able to seat the same at the next body location. Because of the sensor-supported on and off switching of the liquid pump, an uncontrolled exiting of liquid laced with bacteria into the ambient is prevented. An additional protection against the unwanted exiting of contaminated liquid occurs via the special function of the sealing element 16. Because of the natural movement of the surgeon, the upper portion of the sealing edge 7 with the discharge nozzle 11 first releases when the applicator 1 is lifted while the lower portion of the region of the suction openings 12 still remains on the surface of the body. In this way, the catch flap 19 opens with this flap taking up a pressure liquid jet which is present for a short time against expectation and is deflected into the interior of the work chamber 8. An exiting of the pressure liquid jet from the region of the work chamber 8 in the proximity of the surgeon is thereby prevented. After the repositioning of the applicator 1, this function repeats at another body location.
It is understood that the foregoing description is that of the preferred embodiments of the invention and that various changes and modifications may be made thereto without departing from the spirit and scope of the invention as defined in the appended claims.
Number | Date | Country | Kind |
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20 2006 018 986.6 | Dec 2006 | DE | national |
This application is a continuation application of international patent application PCT/DE 2007/002057, filed Nov. 14, 2007, designating the United States and claiming priority from German application 20 2006 018 986.6, filed Dec. 16, 2006, and the entire content of both applications is incorporated herein by reference.
Number | Date | Country | |
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Parent | PCT/DE2007/002057 | Nov 2007 | US |
Child | 12457581 | US |