Abstract:
The present invention relates to a puncture method and a puncture system. More specifically, the objective of the present invention is to carry out the aspiration of a sample from a human organ or an animal organ and the inner examination thereof, without the outward leak of the fluid and the like in the organ. 
     The puncture method and puncture system of the present invention is in the following structure; making a parasol part arranged on a reservoir adhere through an adhesive to the site to be punctured, inserting a needle body through a sealing part of the reservoir into the site to be punctured to draw out the inner fluid, the leak of the fluid can be prevented by the reverse operation of the sealing part.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the invention 
     The present invention relates to a puncture method and a puncture system. More specifically, the present invention relates to a novel modification thereof to carry out the aspiration of a sample from an organ and the examination of the inner conditions of the organ without the outward leak of the fluid and the like in the organ of human bodies and animals. 
     2. Description of the Prior Art 
     A puncture method generally comprising puncturing a site to be punctured in an organ with an injection needle and aspirating the inner fluid and the like for pathological examination of the fluid and the like, has been employed conventionally. 
     Because the conventional puncture method has been conducted as described above, the following problems have been remarked. 
     When an injection needle is inserted into a site to be punctured to aspirate and then withdraw the fluid and the like, an opening remains at the site punctured so that the fluid and the like may leak into bodies, eventually causing the metastasis of the fluid into other organs if the fluid is malignant. 
     SUMMARY OF THE INVENTION 
     The object of the present invention is to provide a puncture method and a puncture system for aspirating a sample from an organ and examining the inner conditions of the organ without leaking fluid and the like from the organ of human bodies and animals. 
     In accordance with the present invention, a medical instrument for use in puncturing an organ of interest within a body cavity is disclosed having a first tubular body with a first end for being inserted into a body cavity and a second end. The first tubular body has a severable portion proximate the first end. A seal is provided within the severable portion. A resilient parasol with a normally opened and a closed position extends from the first end, as well. A second tubular body contains the first tubular body and parasol, compressing the parasol and maintaining the parasol in the closed condition when the parasol is within the second tubular body. When the parasol is advanced out of the second tubular body, the parasol deploys into its normally opened condition. The severable portion is preferably defined by a circumferential groove around the tubular body. A reservoir within the first tubular body sealed with a removable plug, or a cuttable bag which depends from the first end of the tubular body, may be provided for delivering adhesive to between the parasol and the organ of interest. 
     A system is also disclosed including the medical instrument described above and adhesive for connecting the opened parasol to the organ, a needle for puncturing the organ after the parasol is connected to the organ and cutting means for cutting the severable portion of the first tubular body. A kit of parts is disclosed, as well. 
     By the puncture method and the puncture system in accordance with the present invention, the puncture system is inserted through an opening formed on the wall of a human body or an animal body to push in only the first tubular body. The parasol part and the reservoir are then sprung out from the second tubular body, whereby the parasol part is opened from the compact folded shape into the original parasol shape. The surface of a site to be punctured is dried by a drying means inserted from another direction and thereafter adhesive is fed by cutting of the bag part, removal of the plug or other adhesive feeding jigs onto the site to be punctured or the parasol part to a final film thickness of about 0.1 to 0.2 mm. 
     At the state described above, pushing inwardly the whole system, the parasol part gets in close contact with the site to be punctured, so that the two are integrated by means of the action of the adhesive. 
     Inserting the needle body into the first tubular body then punctures the sealing part and passes through the site to be punctured. Drawing out only the bar-like needle part from the tubular needle part and inserting the aspirator into the head of the tubular needle part for aspiration, the fluid and the like in the site to be punctured can be aspirated and drawn out. Cutting the tubular body immediately after completion of such aspiration, the parasol part and a part of the tubular body remain on the site to be punctured, along with the compaction of the sealing part to recover the original shape, so that the opening made during puncturing with the needle body disappears and the opening formed on the site to be punctured is completely occluded with the sealing part, whereby the outward leak of the inner fluid can be prevented. Thus, the metastasis of a malignant cancer via such leak to other organs can be prevented. 
     By inserting a camera or a sample collector instead of the aspirator described above, the inside of the site to be punctured can be observed or a biological sample can be collected. 
    
    
     BRIEF DESCRIPTION OF DRAWINGS 
     FIG. 1 depicts the sectional view of the principal part of the puncture system in accordance with the present invention; 
     FIG. 2 depicts the enlarged sectional view of the sealing part of FIG. 1; 
     FIG. 3 depicts the sectional view showing another example of FIG. 2; 
     FIG. 4 depicts the sectional view showing still another example of FIG. 2; 
     FIG. 5 depicts the structurally decomposed view of the system of FIG. 1, for arranging a first tubular body; 
     FIG. 6 depicts the structural view showing a second tubular body; 
     FIG. 7 depicts the sectional view showing the tubular needle part of the needle body; 
     FIG. 8 depicts the sectional view showing the bar-like needle part; 
     FIG. 9 depicts the sectional view of the needle body; 
     FIG. 10 depicts the compositional view of a woman&#39;s abdomen showing a step in a puncture method for use in the treatment of ovarian cancer, wherein a trocar is being inserted into the abdomen; 
     FIG. 11 depicts the compositional view of the women&#39;s abdomen after insertion of the trocar; 
     FIG. 12 depicts a next step in the puncture method, wherein the puncture system is inserted into the trocar; 
     FIG. 13 depicts the longitudinal sectional view of the abdomen after insertion of the puncture system; 
     FIG. 14 depicts the transverse sectional view of the abdomen after insertion of the puncture system through the trocar; 
     FIG. 15 depicts the longitudinal sectional view of the abdomen after deployment of the parasol; 
     FIG. 16 depicts the transverse sectional view of FIG. 15, showing the drying means in phantom; 
     FIG. 17 depicts the longitudinal sectional view of the abdomen during hooking of the bag part; 
     FIG. 18 depicts the transverse sectional view of FIG. 17, further illustrating the hooking means; 
     FIG. 19 depicts the longitudinal sectional view of the abdomen showing the parasol part in adhesion to the site to be punctured; 
     FIG. 20 depicts the transverse sectional view of FIG. 19; 
     FIG. 21 depicts the longitudinal sectional view of the abdomen immediately prior to puncturing; 
     FIG. 22 depicts the transverse sectional view of FIG. 21; 
     FIG. 23 depicts the longitudinal sectional view of the abdomen, wherein the site of the cancer is punctured; 
     FIG. 24 depicts the transverse sectional view of FIG. 23; 
     FIG. 25 depicts the longitudinal sectional view of the abdomen during aspiration; 
     FIG. 26 depicts the transverse sectional view of FIG. 25; 
     FIG. 27 depicts the longitudinal sectional view of the abdomen after aspiration when the needle body is removed; 
     FIG. 28 is a view of a portion of the tubular body prior to cutting; 
     FIG. 29 depicts the transverse sectional view of the abdomen showing the cutting means; 
     FIG. 30 depicts the longitudinal sectional view of the abdomen after the puncture system is removed; 
     FIG. 31 depicts the transverse sectional view of FIG. 30; 
     FIG. 32 depicts the transverse sectional view of the abdomen showing an embodiment using a camera; 
     FIG. 33 depicts the transverse sectional view of the abdomen showing an embodiment using a sample collector, 
     FIG. 34 is a structural view of another embodiment; 
     FIG. 35 is a sectional view of another embodiment; 
     FIG. 36 is a sectional view of a further embodiment; 
     FIG. 37 is a sectional view of a still further embodiment; and 
     FIG. 38 depicts the sectional view of the abdomen during surgery condition. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The puncture method and puncture system of the present invention will now be explained in detail below with reference to the drawings. 
     FIG. 1 shows the principal part of the puncture system of the first embodiment; &#34;1&#34; represents a parasol part in a parasol shape composed of urethane rubber; a tubular body 3 containing an adhesive reservoir 2 is integrally formed (may be also formed separately) at the position of the axial center of the parasol part 1; and the reservoir 2 is composed of stopper 1A and sealing part 3A, arranged in a sealing fashion on the tubular body 3. Herein, the tubular body 3, the parasol part 1 and the sealing part 3A may be integrally molded, or they may be composed of separate parts and then integrally connected together. The stopper 1A is composed of rubber and the like, arranged in a removable manner on the tubular body 3. By pulling wire 1Aa connected with the stopper 1A, the stopper 1A can be removed from the tubular body 3. As shown in FIG. 2, the sealing part 3A is composed of first and third films 3Aa and 3Ac arranged at the both ends in the axial direction and second film 3Ab positioned intermediately between them, and a cross-cut 3B is formed on the second film 3Ab so that the needle and the like described below might readily pass through the sealing part 3A. Furthermore, the structure of the sealing part 3A comprises not only such three layers but also a single layer or two layers. Further, there may be provided the sealing part 3A as shown in FIGS. 3 and 4. 
     On the tubular body 3, there is arranged screw body 5 of a tubular form comprising corrosion-resistant aluminium and the like. Adhesive 7 such as surgical Allon-alfa and the like (other adhesives may be used as well) is injected into the reservoir 2 by means of injector 6, immediately prior to use. Without using the injector 6, adhesive 7 may be fed into the reservoir 2 after removing the stopper 1A. Incidentally, it is preferable to set an amount of this adhesive to 0.1 cc through 2.0 cc. 
     A tubular body 9 of nearly the same outer diameter as that of the screw body 5, comprising corrosion-resistant aluminium and the like and having also first holder 8, is helically connected in series connection with the screw body 5. Furthermore, the tubular body 9 may be directly or indirectly connected with the tubular body 3, integrally or in a separate fashion. 
     As shown in FIG. 6, the tubular body 9 connected with the screw body 5 has a second holder 10, and is inserted along the coaxial direction into a second tubular body 11 comprising corrosion-resistant aluminium and the like. Thus, the puncture system 20 in accordance with the present invention is depicted in the state of completion in FIG. 6. In this state, the parasol part 1 is closed into a more compact shape and is contained in the second tubular body 11. As shown in FIG. 1, the parasol body 1 is composed of urethane rubber and the like; and the tubular body 3 is composed of silicone rubber, a resin and the like. 
     FIGS. 7 to 9 depict the structure of a needle body 30 to be used in the puncture system 20 shown in FIG. 6 described above; FIG. 7 depicts a tubular needle part 31; and FIG. 8 depicts a bar-like needle part 32 to be inserted into the tubular needle part 31. Taper-like insertion part 33 is formed on the rear end of the tubular needle part 31, and by inserting the bar-like needle part 32 through the insertion part 33 into the tubular needle part 31, a guide hole 30a inside the tubular needle part 31 is occluded. By forming a diameter D1 of a expanded part 32a formed on the rear part of the bar-like needle part 32 far larger than the bore diameter of the insertion part 33, the insertion part 33 can be occluded structurally by means of the expanded part 32a. Furthermore, the needle body 30 is entirely coated with silicone coating. 
     Description of puncturing a human organ or an animal organ by means of the structure described above, follows human ovarian cancer. 
     As shown in FIGS. 10 to 14, a laparascope 41 is inserted into the wall body 40 for expansion under gas supply, to stand up tubular first trocar 42. As shown in FIGS. 13 and 14, inserting the puncture system 20 of the present invention through the first trocar 42 into the wall of the body 40 to push in only the tubular body 9 as shown in FIG. 15, parasol part 1 is pushed outside from the inside of the second tubular body 11. Then, the parasol part 1 is opened from the compact shape into the original parasol shape. 
     As shown in FIG. 16, using drying means 44 for supplying dry air or gas through second trocar 43 inserted into the wall body 40 from the other direction, the surface of an ovarian cancer site to be punctured 45, for example, is dried. Subsequently, the drying means 44 is withdrawn from the second trocar 43 and a hooking means 46 is inserted through the second trocar 43 and the wall body 40, for pulling wire 1Aa, as shown in FIGS. 17 and 18. Stopper 1A is removed by the hooking means to supply adhesive 7 onto the site to be punctured 45. Additionally, the adhesive 7 should be injected primarily into the reservoir 2, immediately prior to surgery. 
     As shown in FIGS. 19 and 20, pushing the puncture system 20 through the wall body 40, the parasol part 1 is fixed through the adhesive 7 onto the surface 45a of the site to be punctured 45. As shown in FIGS. 21 and 22, needle body 30 is then inserted into the puncture system 20. As shown in FIGS. 23 and 24, then, the needle body 30 is passed through sealing part 3A, so that the tip of the needle body 30 can be inserted into the site to be punctured 45. 
     Drawing only the bar-like part 32 from the tubular needle part 31 while in such state, inserting aspirator 50 into insertion part 33 of the tubular needle part 31 for carrying out aspiration, as shown in FIGS. 25 and 26, the fluid and the like in the site to be punctured 45 are aspirated into the aspirator 50, whereby sampling is completed. 
     After completion of the aspiration and drawing out the tubular needle part 31, a cutting means 46A composed of a scissor is inserted into the wall body 40, as shown in FIGS. 28 and 29, to cut recessed groove part 3c of the tubular body 3 while the parasol part/is fixed to the site to be punctured 45. Only a part of the tubular body 3 and the parasol part 1 are left fixed to the site to be punctured 45. In such case, the shape of the site to be punctured 45 is in the compact shape compared with the original shape. Furthermore, because the opening left on the sealing part 3A after drawing out the needle body 30 is occluded by means of the shrinking action of the elastic body, the leak of the fluid and the like in the site to be punctured 45 to the outside (namely, endoabdominal region) can be prevented. 
     Then, it should be determined whether or not the fluid and the like in the site to be punctured 45 is malignant and which operative technique should be adopted. When it is diagnosed that the sample is benign, the site to be punctured 45 should be resected. Concurrently with the resection of the site 45, the remaining parasol part 1 and the like should be removed from the body, as shown in FIGS. 30 and 31. When the fluid and the like are malignant, alternatively, the site to be punctured 45 is resected while being enclosed by a bag (not shown) to prevent the spread of the fluid and the like into the endoabdominal region. Thus, the metastasis of a malignant cancer, if any, to other organs can be prevented. Furthermore, coating the tip of the needle body 30 with silicone coating so as to avoid the adhesion of an adhesive, the needle body 30 is advantageously passed through the sealing part 3A. 
     In another example, by inserting camera 60 instead of the aspirator 50 into the site to be punctured 45, as shown in FIG. 32, the inside can be examined by means of monitor TV 61 for establishing the diagnosis. 
     As shown in FIG. 33, furthermore, inserting a well known sample collector 70 instead of the camera 60 and controlling the sample collector 70 by means of a remote controller 71, a biological specimen may be drawn out from the site to be punctured 45. 
     The above example describes the surgery of a human body. It is needless to say that the above example may be applied also to animals, with no specific limitation to humans. The above example describes the surgery by means of laparascope 41. If such laparascope 41 is not used, however, the system does not require the second tubular body 11 but requires the tubular body 3 and the first tubular body 9, as shown in FIG. 5. The present invention is not limited to the foregoing embodiment, but may be applicable to the following embodiments, as well. 
     Instead of the reservoir 2 employing the plug 1A in the above-mentioned first embodiment, as shown in FIG. 34 illustrating a second embodiment, an adhesive feeding jig 100 containing the adhesive may be inserted into the peritoneal cavity to feed the adhesive 7 onto the puncture site or the parasol part 1, without use of the reservoir 2 and the plug 1A. In the embodiment of FIG. 34, the sealing part 3A of the tubular body 3 includes a pair of sealing plates 101. Ethyl alcohol can be contained within the region 102 between the sealing plates 101. Further, in a third embodiment illustrated in FIG. 35, a tubular body 4 made of corrosion-resisting aluminum or the like is fitted to an outer periphery of the elastic holder body 3b, so that pressure is applied to the elastic holder body 3b from its outer peripheral side by the tubular body 4 to squeeze and shrink a port 3a formed after the puncture by the needle body or the like for restoration to its original state. A tubular threaded body 5a made of corrosion-resisting aluminum or the like is disposed at the lower end of the elastic holder body. Incidentally, the adhesive, such as surgical Allon-alfa is injected into the bag part 2a, which may be substituted for the reservoir 2, by an injection appliance 6 immediately prior to usage. Accordingly, the bag part 2a is constructed as shown in FIG. 36 and 37. For practical surgery, as shown in FIG. 38, the bag part 2a is broken within the peritoneal cavity by using cutting means 46a to feed the adhesive 7 for bonding the parasol part 1 to the site to be punctured, so that the procedure similar to that of the first embodiment can be performed. 
     Because the puncture method and puncture system in accordance with the present invention are composed as described above, the following advantages may be brought about. 
     Because a parasol part adheres through an adhesive to a site to be punctured and a needle body is then inserted through the sealing part, the opening of the sealing part is shrunk and occluded after drawing out the needle body, to prevent the outward leak of the fluid and the like in the site to be punctured. 
     The insertion of a camera and a sample collector can be done through the needle body, whereby a wide variety of the applications can be achieved in medical fields.