KR20050105272A - Insufflator and method of use - Google Patents

Abstract

A surgical device and method for endoscopic surgical procedures capable of preventing injuries to internal organs during insertion. The surgical device can include one or more of the following: a multiple system of sharp blade edges or a single blade, a mechanical tissue protection device that includes a series of thin plastic guards sliding along the sides of the planar knives and having an angle between their edges smaller than that of the cutting knife edges, one or more fixed conical deflectors to expand the cut tissue passage leaving the guards to contact tissue contact only at their tips, an insufflation passage configured to transport fluid into the body cavity during penetration, a locking system for the guards that prevents accidental reuse of the cutting features, and/or an ergonomic design which facilitates handling.

Description

Blower and How to Use {INSUFFLATOR AND METHOD OF USE}

This application has priority in Provisional Application No. 60 / 140,409, filed Jun. 22, 1999, incorporated by reference herein in all respects, and filed Mar. 6, 2003, respectively, by Blanco. Currently granted in a continuation of application number 09 / 598,453, issued as U.S. Patent No. 6,497,687, which also prioritizes Provisional Application No. 60 / 452,040 and Provisional Application No. 60 / 494,122, filed August 12, 2003. It is a partial consecutive application of US Patent No. 10 / 324,050, filed October 20, 2002, with priority.

A blower is a needle-like device in which gas or other fluid can be injected into a space or potential space at a location in the body. The device and its method of use are not limited to human use. The apparatus also applies to many unrelated areas where precise penetration of buried spaces is desired.

Most existing trocar or blower needles used in endoscopic surgical procedures cannot very effectively prevent injury to internal organs upon insertion and manipulation of the trocar. Despite strong efforts to improve existing trocar designs, the results are still poor. Existing procedures frequently injure internal organs, and the resulting injuries are sometimes serious or even fatal. Thus, the need for safer trocar and blower needles is essential, especially because endoscopic surgical procedures will become more extensive in the future.

Endoscopic or minimally invasive surgery offers the opportunity to improve current surgical procedures and instruments that can only be compared to the innovative impact of the introduction of anesthesia in the 19th century.

Recently, trocars use a tip "shield" or cover for the incision edge, which usually develops immediately after penetration of the body cavity. This penetration carries the risk of injury to internal organs. The surgeon may be careful when penetrating the body cavity, but the resistance to penetration falls at the last minute before damaging the internal organs. This sudden drop in penetration resistance is called the "plunge effect" and occurs throughout the safety profile development. In some trocars, penetration is controlled in some form, with a small increase or in the form of approximately direct observation, evaluation or monitoring. In all cases, however, the design results in many piercing tips, which are inserted to dangerous depths before any protective devices are deployed. This is perhaps not surprising since after all, a hole must be formed before any protection can be deployed.

In most cases, because the delicate tissue is very close to the inside of the pierced skin layer, penetration is performed after the internal cavity is filled with carbon dioxide to minimize the risk of accidental injury due to contact with the sharp piercing tip or incision edge of the instrument. It is reasonable to do. In most cases, however, the force necessary for piercing and the elastic nature of the muscle layer cause severe pressure on the surgical site, thus resulting in a penetrating tip of the instrument proximate to the internal organs. In some of these cases, the sudden penetration of the steel wall and the rapid drop in resistance are driven deeper than the mechanism is desired or controllable. In addition, friction between the tissue wall and any protective device retards the deployment of the protective device, and injury almost occurs.

Thus, one object of the present invention is to ensure that these phenomena are avoided through a surgical device in which the penetrating tip or incision edge of the instrument is always kept sufficiently spaced from the delicate tissue. Thus, even under dynamic conditions, the likelihood of injury will be reduced. As mentioned in US Pat. No. 6,497,687, invented by the inventor of the present invention, most existing trocars used in endoscopic surgical procedures cannot effectively prevent injury to internal organs upon insertion and manipulation of the trocar. Despite strong efforts to improve existing trocar designs, the results are still poor. Existing Surgical Procedures Frequent injuries to internal organs and the resulting injuries are sometimes serious or even fatal. Therefore, the need for a safer trocar is essential, especially if the endoscopic surgical procedure becomes more extensive in the future.

1 is a perspective view of a trocar described in the background of the present invention.

2 is a cut away view of the penetrating end of an exemplary trocar with a guard with the tip knife back removed to illustrate the shape of the embodiment more clearly;

3 shows the same end of an exemplary trocar with a guard that retracts when the penetration of the exemplary embodiment begins, with the knife edges exposed and ready for incision.

4 shows the tip of the guard with the incision tip protruding forward when the tip begins to penetrate the abdominal cavity.

5 shows the tip of an exemplary trocar with a guard extending up to cover the knife edge when the tip has completely penetrated the abdominal cavity.

6 shows the moment when the trocar tip reaches the epidermis, then the guard tip begins to pressurize the skin and retracts into the penetrator.

FIG. 7 is a diagram illustrating the point at which the guard is pushed completely to the retracted position and the knife tip begins to incise the tissue in an exemplary embodiment.

8 illustrates, in an exemplary embodiment, that a knife tip completes a passage across tissue and exits the abdominal cavity across the endothelium, then away from an area where a powerful jet of pressurized carbon dioxide gas has just penetrated the fine internal tissue. The figure shows the point at which the guard tip begins to push into the initial opening at the same time.

9 shows that in the exemplary embodiment, the guard tip passes through the opening, then the exposed knife edge continues the cutting operation behind the opening and the pressurized carbon dioxide gas continues to expand to maintain fine tissue from the cutting area, At the same time, it is a view showing the timing of preventing any contact between the knife tip and the surrounding internal tissue.

FIG. 10 is a diagram showing a continuous penetration in which the guard is nearly fully penetrated, while in the exemplary embodiment, the edge still exposed behind the guard continues the cutting operation and continues the passage of gas.

FIG. 11 is a diagram illustrating a point in time when penetration is complete, in an exemplary embodiment, with the knife edge fully covered by the guard and the tissue opening being the passage of the cannula until completion and the penetrator assembly can be removed. Is a view showing the timing at which blowing is continued.

12 is a plan view of an exemplary trocar handle with a portion cut away to show the interior in detail.

13 is a longitudinal cross-sectional view along the 13-13 horizontal line shown in FIG. 12 to illustrate the interior of an exemplary trocar handle in more detail.

Figure 14 is a plan view of the distal end of an exemplary handle with a grasping horn for ease of handwriting.

Figure 15 shows a partial cutout for the flap valve pivot and lever while showing the interior of the distal end of the exemplary handle as seen from the right.

Figure 16 is a partial isometric view of an exemplary locking mechanism for the guard stem while showing most of the elements in the tip of the handle.

Figure 17 is an enlarged view of most elements of the guard stem locking mechanism in space relationship.

18 illustrates an example locking mechanism in the locked position.

19 illustrates an example locking mechanism that is released and ready to begin penetration.

Figure 20 shows how the pushing of the guard against the epidermis forces the stem of the guard to the right.

Figure 21 shows the position of the stem where the guard is fully retracted and the knife edge is fully exposed for incision.

FIG. 22 shows the position of the locking mechanism after the guard is fully released into the abdominal cavity and the lock of the stem is retracted to the initial position of the guard shown in FIG.

Figure 23 is a top plan view of a guard for the blower of the present invention.

Fig. 24 is a top plan view showing, in cross section, a portion of the top of the incision blade of the blower;

FIG. 25 is a top plan view of the incision blade shown in FIG. 23. FIG.

Fig. 26 is a plan view showing a part of the guard tip.

Fig. 27 is a side view showing a part of the guard tip.

Figure 28a is a top plan view of the assembled distal tip when the guard first contacts the epidermis.

Figure 28B is a top plan view of the assembled distal tip when pressing the epidermis.

Fig. 28C is a top plan view of the device when (for example) penetrates the tissue layer of the abdominal cavity wall.

FIG. 28D is a top plan view showing the device in the initial penetrating stage of the final tissue layer of the abdominal wall with gas / liquid selectively provided at the moment of penetrating. FIG.

FIG. 28E is a top plan view showing the distal tip in the extended position of the guard after continued penetration of the tissue layer. FIG.

Figure 29 is a partial cross sectional view of the locking mechanism used in accordance with the present invention.

30 is a cross-sectional view of FIG.

FIG. 31 is an enlarged side view of part of FIG. 29; FIG.

Figure 32 is a top plan view of the locking mechanism with the locking mechanism of Figure 29 removed.

Figure 33 is a side sectional view of another embodiment of the present invention.

Figure 34 is a top plan view of the inner guard sliding in the embodiment of Figure 33;

35 is an end view of the sliding inner guard tip.

36 is an axial side view of another embodiment assembled.

Figure 37 illustrates another embodiment of the present invention.

FIG. 38 is a view showing the distal end of the sleeve of the third embodiment, including the blade; FIG.

Figure 39 is a top plan view of the sleeve end with a tapered flange.

40 is a top plan view of the guard positioned in the sleeve.

Figure 41 is a side view of another embodiment of the present invention.

42 is a side view of the cannula and its blades.

Thus, one object of the present invention is to ensure that these phenomena are avoided through a surgical device in which the penetrating tip or incision edge of the instrument is always kept sufficiently spaced from the delicate tissue. Thus, even under dynamic conditions, the likelihood of injury will be reduced.

Another object of the present invention is to provide a surgical device (a trocar, a blowing needle, or a structurally equivalent device), wherein the blowing fluid can be driven into a patient upon penetration of the body cavity by the surgical device, so that surgery It can drive internal organs away from the device. Blown fluid of the present invention may be supplied from an external pressurized reservoir or pressurized (and collected) upon penetration of the body cavity by a surgical device.

It is yet another object of the present invention to provide a surgical trocar or blowing needle that includes one or more incision edges that provide low friction between the incision edge and the tissue upon penetration of the body cavity, thereby providing the necessary force to drive the surgical device into the body cavity. To save money.

It is yet another object of the present invention to provide a surgical device comprising a protective device that substantially extends out of contact with tissue, thereby reducing friction with the protective device and ensuring advantageous control of deployment.

Still another object of the present invention is to provide a surgical device comprising a protective device such as a safety guard, the guard element having apex and the angle formed at the vertex by the blade or incision element of the surgical device. Smaller than the angle formed, it ensures a gradual covering of the blade or of the cutting element upon deployment of the protective device.

It is another object of the present invention to provide a surgical device having a gripping mechanism that allows for convenient gripping and twisting of the surgical device upon penetration of the body cavity.

It is a further object of the present invention to provide a surgical device comprising a locking system that prevents accidental reuse of the incision element after the tip is used.

Accordingly, the present invention seeks to substantially improve surgical safety.

The above and other objects of the present invention include a set of thin and flat arrow-shaped sharp cutting blades coupled at a cutting tip coaxial with a hollow cylinder penetrator and a blade type having a cutting edge convergence at the cutting angle at the cutting tip. Achieved by a surgical device such as a needle, a trocar tissue penetrator, or blowing. In addition, a single flat blade can be used as needed. The rear outside of the set of incision blades may be secured on the inside of the hollow cylindrical penetrator while fully protruding the incision edges. The hollow cylinder may have a front end, which is slotted, each segment is sharply formed in a triangular shape, curved to fit between the blades, and between the moving guards inside and the outer tissue. It has edges that are generally parallel to the edges of the protruding blades to function as a tissue dilator to prevent contact of the axially indented behind it. The slots between the triangular shaped curved tissue expanders at the end of the hollow cylindrical penetrator can be widened at least as thick as the blades to allow passage between the slots and the sides of the incision blade of the guard seat. . The at least one axially extending curved seat guard freely slides in the space between the sides of the incision blade and the triangular curved segment of the hollow cylinder, and has a tip angle profile that is generally sharper than the adjacent angle of the blade edges. It can be set to have a front end that ends with a very small blunt round tip. The angled front edge of the curved seat guard may have shallow angular ends that are gently curved towards the edge, so that the angle never exceeds the angle of adjacent incision edges. An extended curved seat guard inserted between the incision blades and the triangularly curved segments of the hollow cylinder may be attached at the opposite end to the stem pressed against the front incision edge by a coil spring.

Advantageous features of this surgical device include, for example:

Multiple systems of sharp planar knife edges that substantially eliminate lateral friction and provide reduced resistance to penetration, thereby reducing penetration "plunge effect" and tissue springback.

A series of thin plastic guards that slide along the sides of the flat knives and in a preferred embodiment the mechanical tissue protection device wherein the angle between the edges is smaller than the incision knife edges. These plastic guard edges can then be appropriately contoured to provide complete protection between the incision edges and the surrounding tissues from the actual beginning of penetration, and do so in a gradual manner without jerks or discontinuities. It can be seen that. The gradual protective action caused by the angle between the sides of the guards being smaller than the angle between the edges of the incision blades allows the guard to penetrate into the micro-opening formed by the incision tip and immediately surrounding it, thereby providing the most Allows to prevent damage to internal organs during critical moments. Thus, when the incision blades continuously expand the micro initial opening, the guards progressively advance, with the incision edge always covered outside of the penetration site and isolated from the internal organs until the penetration is complete and the cannula is fully inserted.

One or more fixed conical deflectors that isolate the guard from friction against tissue at the side of the penetration point by extending the incised tissue passageway while allowing the guard to contact tissue only at its tip. Therefore, even if a minute opening is formed in the tip by the incision blades, the guards are immediately punctured into the opening and prevent any contact with the internal organs of the blade tip. Thus, the use of a tissue expander outside the guard prevents friction between the guard and the tissue, which can delay dispersal action. The use of a tissue expander allows the safety device to operate without limitation, thereby eliminating one of the major deficiencies of conventional trocars. That is, the dynamic response of the guard is inherently much faster than the penetration rate of the blade. As a result, the incision edges are never dangerously exposed to the blowing passages configured to transport fluid into the body cavity during penetration, while contacting internal organs but with a fast penetration rate. The blowing passage can be pressurized by using an external reservoir or by pressurizing the gas contained within the passage during penetration. Once the initial penetration of the epithelium has been formed, fluid from the intake passage will cause internal organs to fall away from the incision edge (s). In the case of a carbon dioxide gas reservoir, the carbon dioxide gas valve is opened, thereby pressurizing the penetrator tubular body. In this pressurization, because the anterior is surrounded by the tissue, the incision tip penetrates the tissues while preventing outgassing, but as soon as the most minute opening appears at the tip, the guard tips are driven by the spring. Simultaneously pushing through the opening, the gas suddenly diffuses into the opening and forces the sensitive internal organs to deflect away from the tip of the incision surface. The use of a pressurized fluid (or gas) tissue deflector then creates an organ-free area in front of the incision blade tip at the moment of initial penetration, even before the guard tip is stuck into the opening. In addition, it must be pointed out that as the flow occurs where the guard lies exactly between the incision blades and the conical diffusers, the sudden expansion as well can also promote the dispersion of the guard. It may also be generally mentioned that the guards are ejected by fluid flow. This improves its speed of dispersion and thus improves the overall safety of the surgical device.

A guard locking system located at the tip of the instrument to prevent accidental reuse of the incision after the tip is safely introduced for the first time. The locking system for trocar guard includes a locking cylinder attached to a locking button which is supported by the leaf spring and inserted into the socket. The cylinder has a conical tip and a peripheral groove at the bottom, can be pressed by a button, and is held downward by allowing sliding motion until the U-shaped spring comes out and returns to its initial position and is ready to be locked. Can be joined by a groove in. If a reset action is required, it is essential to press it down strongly against the lock button and carefully reset it for another cycle. Since the lock button is located deep within the recess of the leading end section of the handle, it requires some effort to access and operate, and therefore is difficult to accidentally reset.

Ergonomic design for easy handling. When the forefinger and forefinger hold the side horn to control rotation, the tip hemisphere handle is easily hidden into the hollow of the hand, allowing pushing, pulling, rotating, and tilting in a very natural and comfortable manner. do.

Thus, a surgical device having the features noted above may include a trocar, a blowing needle, or any other surgical / penetrating device having a similar function.

The blower according to one embodiment of the invention comprises a needle-like device through which gas or fluid can be injected through any space or potential space in the body of a patient. The device is not limited to use for humans. It can also be applied in many unrelated areas where precise penetration of the buried space is required.

Referring now to the drawings, in which the same reference numerals indicate identical or corresponding parts in the several figures, in particular with reference to FIG. 1, the cannula 2 corresponding to the background of the present invention is provided with a handle consisting of two segments. It is firmly attached to the distal section, and the distal end 6 has a hemispherical handle shape that allows easy grip with the grip horn 6a, the blowing device 11, the flap valve lever 12, and the palm of the hand. It includes the tip handle section 5 to the outside. In addition, this section is provided with an indentation 9 having a flat bottom 9a and a button inserted to slide in the slot 8 to observe and control the position of the safety guard at the end of the cannula 2. And an external appliance comprising 7). The safety mechanism protruding away from the cannula 2 comprises a conical tissue expander 4 and a safety guard 3 adapted to cover a set of knives (not shown in FIG. 1). These are the shapes of the invention seen from the outside.

2 shows details of the penetrating distal end of the trocar. As shown in FIG. 1, the hollow outer cylinder 2 is a cannula which is firmly attached to the distal section of the handle 6. In the cannula 2 there is another hollow cylinder 13 which is a penetrator. This is a removable part attached to the tip section of the handle 5 and can be removed after the penetration is complete to allow the introduction of surgical instruments. The cannula 2 has an inclined distal end, indicated at 2a, to facilitate its introduction through the tissue opening with minimal resistance. The penetrator cavity cylinder 13 has a distal end formed by a plurality of conical segment expanders 4 spaced apart by slots 4a to enable the projection of a thin similar arrowhead coupled at the center and a pointed flat knife coupled at the center of the instrument. Have As shown in Fig. 2, the knives are positioned into the penetrator cavity cylinder 13 to the depth shown in 14a. The knife edge outer slot 4a between the cone segment expanders protrudes a considerable distance to ensure sufficient incision. The set of knives is assembled to the penetrator cylinder by spot welding 15 or other similar mechanism. Immediately after the intersection of the knife blades a plastic guard tip 3a is provided. In Figure 2, the guard is shown removed from the knife to aid in understanding the relationship between the shape and the knives. The subassembly of the guard 3 is part of the support disk 16 which is part of the protective cavity stem 17 which connects the subassembly to the support disk 16 and locks the instrument at the tip of the handle (not shown). In the actual instrument, the guard tip 3a is inserted around the knife blade which fits into the narrow space 3b between the guards. The guard is then assembled by pressing forward until it protrudes between the conical expander slot 4a and the blade side, as can be seen below in FIG. In Figure 3, the tip of the guard is barely visible because the guard is retracted, such as when the trocar is first pressed against the skin.

4 shows the tip 3a of the guard projecting forward of the tip of the knives to cover the knives. The short distance behind the edge of the tip 3a of the guard and the knife 14 is exposed and can be cut. 4 shows the configuration of the trocar incision tip immediately after the start of penetration across the abdominal tissue. At this time, the small tip 3a of the guard is inserted across the starting point of the opening and quickly covers the sharp incision tip, and the exposed knife edge continues inside the skin until the penetration is completed as shown in FIG. Make an incision. 5 shows how the anterior end of an exemplary trocar looks after completion of insertion into the abdominal cavity. At this time, all edges of the incision knife are covered by the fully extended guard and the entire penetrator assembly can be pulled to the tip of the handle.

In one embodiment, as shown hereafter, after the first penetration of the abdominal cavity wall is made, a powerful jet of carbon dioxide gas is ejected across the penetration to deflect the delicate gut near the knife tip, while at the same time the guard tip is An opening is entered to cover the tip of the knife edge. The above-described surgery will be shown through a series of figures in FIGS. 6-11 as specific portions of the present invention. However, the present invention can function without the blowing treatment occurring because the blade is protected.

6 shows an exemplary trocar guard tip 3a when it begins to contact the skin layer 20. Intestines are shown to the left with 25. At this time, the skin outer layer is deflected under the force of the guard tip pushed forward by the spring. When the trocar is pressed forward, the guard is pressed into the penetrator 13 to displace the base disk 16 and the guard stem 17 to the right against the force of the spring.

7 shows the guard 3 fully retracted into the penetrator 13 and the knife edge 14 fully exposed. At this time, the tip of the knife is cut into the outer tissue layer and begins to penetrate. As shown in Figure 7, the incision path of the incision tip / knife edge has a diameter smaller than the inner diameter of the cannula, so that the incision performed by the blade produces a lumen or bore smaller than the cannula. At this time, the carbon dioxide gas may be pressurized inside of the penetrator 13 and some gas may initially leak out, but the tissue around the tip will continue to flow until the incision tip begins to exit across the inner abdominal wall. Seal.

8 shows the start of penetration. At this time, the incision tip tip 14b creates a very fine through 23, and due to the presence of the guard tip 3a, the fluid flow (shown as the gas jet 24) flows out and the internal tissue 25a Sufficient space is provided to cause displacement near), while at the same time the guard tip 3a extends the pressurized opening by spring pressure at 17 and enters through the penetrating to effectively cover the incision tip 14b.

9 shows the result of the above-described action. The gas jet 24 continues to erupt to guide the viscera 25a farther and the guard tip 3a completely surrounds the incision tip 14b. All risks to the intestines are eliminated. The very fast flow of gas and the action of the guard tip make it possible to safely and easily master the operating elements of the trocar. The force or speed of the penetrating action is of little importance for this reason.

10 shows a through process. The cannula 2 is partially introduced across the tissue 27, with portions of the edge not yet covered by the guard 14a incising the remainder of the opening in front of the cannula and the tissue dilator 4 being the tissue. While protecting the guard from friction to facilitate penetration, the guard tip 3a continues to advance to protect the internal tissue from the knife edge. At this penetrating point, the flow of carbon dioxide gas 24 is not disturbed and a blow treatment step of the process is performed to move the viscera 25a away from the trocar portal.

11 shows the trocar after all insertions and at the end of the blowout treatment. The knife edge is now fully covered by the guard and the cannula 2 is shown fully inserted across the tissue. The blowout therapy continues until the penetrator 13 is removed to allow insertion of surgical instruments across the cannula after completion.

Insertion, Protection and Blown Therapy Therapies and the parts of the instruments that perform them have been described in a series of detailed descriptions, but additional explanations remain on how to complete all of these. An instrument that makes this possible is located on the handle of the instrument.

12 is a plan view of a trocar showing some external components, and is a partial cutaway view of some internal components. The body of the handle is made of plastic and has two main segments. The tip segment 5 is designed to fit the palm and has a hemispherical tip with an indentation of a precise profile 9 at the top which terminates in the plane 9a where the guard stem control is located. These controls include double slots with vertical slots 8, 8a recessed with flat indentations 9a and inserted into buttons 7 and rectangular guide bag 7a to prevent unwanted operation. The button 7 is movable vertically and horizontally, the horizontal movement being limited between arrows 7b and 7c, as will be explained later. The tip segment 5 is assembled as an integral part of the penetrator system. The distal end 51 forms a boundary between two segments of the handle.

The distal segment 6 of the handle has two side protruding horns 6b to facilitate manipulation during penetration and orientation. The two handle segments 5 and 6 are locked together in use by the bayonet studs 29 and the slots 29a. During insertion, the studs 29 on the part 5 align with the slots 29a on the part 6 and are pressed clockwise to rotate, and the horns and knobs of the five phases until the studs securely lock the two segments. 6b) provides good phage for surgery. The slot 29a extends slightly away from the boundary 51 to incline in the transverse direction so that the rotational locking motion ensures a firm and stable connection. This will be explained with reference to FIG.

The partial left incision section of the upper end segment 16 is intended to illustrate the operation of the flap valve 32 which acts as a check valve in the illustrated embodiment. The valve has a shaft 34 pivoted between the upper part 6 and the lower part 6a of the handle and is pressed to rotate counterclockwise by a torsion spring 33 located around the shaft 34. The shaft of the flap valve is firmly attached to the valve and can be rotated from outside the body segment 6 as shown in FIG. The outer lock allows the valve to remain open during desufflation when rotated to the stop position 32 shown in dashed lines. As shown in the embodiment shown in FIG. 12, the valve is opened by the insertion of the penetrator 13. In other cases, the valve may be open for surgical or visualization instruments. With respect to its left side the valve rotates counterclockwise and the snap is closed against the surface of the seal 35 which functions as a surface seal for the valve and a lip seal for the penetrator 13. The left end of FIG. 12 shows how cannula 2 is attached to handle segment 6 by flange 37 to prevent leakage by " O " ring 36. FIG. Likewise, FIG. 12 shows how the carbon dioxide gas stopper manual valve 11 is mounted on one side of the top of the segment 6.

Figure 13 is a longitudinal vertical section along the "A-A" plane to show details in the handle. As can be seen, the two segments of the handle comprise an upper part and a lower part divided along the horizontal plane for manufacturing, one being 5 and 5a and the other being 6 and 6a, each segment being internal After the parts are fitted, the halves of each segment are permanently attached to each other. Each of the two segments is assembled separately because they must be removed and attached during use. It should be emphasized that the through segment is only used to make the entryway, but such a step carries a great risk.

The end segment made of parts 6, 6a houses the cannula 2 and all gas injection and valves. Connecting the cannula to the segment part 6 has been described above. Fig. 13 shows the gas connector and the layer 11a to which the gas line is fixed. The valve system is attached to the boss on the plane 10 via the conical stem 11b so that the entering gas flows in the direction of the arrow 30 and compresses the space between the inlet and the seal 35, the seal 35. ) May enter the opening 38 around the tile penetrator 13 to fill the space between the lip seals 40, 41. Since the lip seal is pointing forward, the pressure opens the lip seal 40 but not the lip seal 41, while the gas fills and pressurizes the entire space along the penetrator 13 so that the trocar tip is It is not possible to escape when inserted into the valve, but if a minimum opening is created by the point of the blade, the gas escapes like a jet and deflects the internal organ around the inlet away from the entrance. The lip seal 40 is intended to prevent backflow from the penetrator in case of accidental openings or leaks across the gas valve during the process. In this case, the pressurized gas volume in the penetrator 13 is sufficient to ensure safe deflection of nearby tissue even before the tip 3a of the guard enters the opening. The guard stem 17 is completely sealed at the front by the disk 16 so that the interior thereof can be at atmospheric pressure. However, since the stem must slide forward and backward with the guard, it must be supported at the tip and slide over a stationary hollow steel stud 44 inserted to a minimum depth of four diameters. The tip of the stud 44 is enlarged to fix between the parts 5, 5a of the central hemispherical handle. Holes 56 on the hollow studs 44 provide air passages into and out of the studs when the guard stem moves back and forth like the piston pump. The hole 56 is of a diameter that penetrates the studs and does not block flow and should mitigate the sliding motion of the stems of the guards. A compression coil spring 47 mounted around the stud 44 serves to provide the force required to press the guard stem in the proximal end direction. The tip of the penetrator 13 outside the cylinder is expanded at 43 to be fixed on the tip handle segment parts 5, 5a. Since the expanded tubular assembly 43 is not a reliable seal, it is sealed from the front by the " O " ring 42 so that no leakage of gas occurs even if the seal 35 leaks.

The tip handle segment formed by the parts 5, 5a is attached to the penetrator 13 and includes all its functions and control elements. The guard stem 17 has a shallow cylindrical indentation at its tip to which the thin ring 45a, which is part of the leaf spring 45, is fixed. The exact shape of the locking system to which the spring 45 belongs is shown in Figures 16 and 17, the function of which can be seen in Figures 18-22. 17 is an exploded view of some elements of the locking system in proper relation. In assembly, the button 7 is inserted across the slot 8 into the upper surface 9a of FIG. 13 and the locking cylinder 48 having a peripheral groove 48a and a conical end 48c has a rectangular guide 7a. The button 7 is assembled to the slot 8a by being pushed upward along the stem 7b with respect to the bottom of the head. Subsequently, the lower tip of the stem 7b is pressed strongly against the punch hole 45d of the leaf spring until the groove 7c is gripped at 45d by the lateral tab, thereby completing the assembly of the button. Now when the open hollow cylinder 45a is snapped into the surface indent at the tip of the stem 17, the button 7 is axially coupled to the stem 17 and moved forward and backward in response to the coil spring 47. Follow the movement and press on the tip of the guard. 16 shows that the U-shaped spring 46 is assembled inside the lower part using the screw 50. Figure 16 does not show the button 7 for the sake of simplicity, but shows that the leaf spring 45 is pressed against the bottom of the U-shaped spring 46. If the assembly of the button 7 and the lock cylinder 48 is not shown here, the button is pushed upward and the lock cylinder 48 is press-inserted into the circular socket 8b so that the leaf spring 45 and the guard stem attached thereto ( It is apparent that the movement of 17) is prevented by the ring 45a. Figure 13 illustrates such a relationship.

Subsequently, FIGS. 18-22 illustrate the operation of the example locking system. Since the cylinder 48 is inserted into the circular socket 8b, the guard stem and the guard cannot move at all. Fig. 19 shows what happens when button 7 is pressed downward. When pressed downward, the conical end 48c of the cylinder 48 opens the U-shaped spring 46, which springs snaps into close contact with the groove 48a to release the locking cylinder from the circular socket 8b. Thus the system is unlocked. A trocar is called "armed" and moves the guard backwards, exposing the incision blades for penetration of the skin. 6 shows such a position. The following description relates to the embodiment shown in FIG. Penetration to the skin presses the guard and the guard stem 17, and the connecting leaf spring 45 moves the button 7 to the tip. The rectangular slide section 7a enters the space between the guides 8a, and after a while the locking cylinder groove 48a is released from the open end of the U-shaped spring 46, and the spring presses the stem groove 7c upward. 45 presses the upper portion of the locking cylinder to snap to the lower portion of the groove 8a. In that position, the lock cylinder 48 continues to slide freely along the lower side of the groove 8a until initial penetration is made, as shown in Fig. 21, and the coil spring 47 force is applied with the guard stem 17. The leaf spring 45 causes the button 7 to return to its initial position, in which the locking cylinder passes freely over the U-shaped spring 46 and snaps back into the circular socket 8b so that the guard inadvertently guards the locking system. It is in the "safe position", which cannot be moved by hand. FIG. 22 returns to the initial form of FIG. 18 to show the completion of the cycle.

Looking at an example of such a locking system from the user's point of view, the actuation of the trocar “arms” the trocar until it “snaps” downward by pressing the button on the top of the handle down in the 7 'position as shown in FIG. Observe and listen to the position of the button that presses the trocar against the skin and slides towards 7 'to "snap" to its initial position 7'. This represents complete penetration. If for any reason the button 7 is accidentally pressed downwards, the button can simply be moved in the 7 'direction to reset to the "safe" position and then released. It is snapped at a high level in the 7 'position and cannot be moved without pressing downward.

Details of the example operation of the flap valve, its design, and the locking for deflation are shown in FIGS. 14 and 15. 14 shows a top view of the handle end segment, and FIG. 12 as a partially cutaway view shows an interior or detail. However, Figure 14 shows external operational control on the handle segment in terms of the user's benefit. The flap valve lever 12 is shown in the closed position as it should be closed when the penetrator is removed. The lever is attached to a shaft 34 whose opposite end is attached to the flap 32 as shown in FIG. Insertion of the internal trocar element is performed when the top 6 and bottom 6a of each handle segment are separated before being glued along the plate 6d.

Fig. 15 is an end view seen from the right side of the embodiment shown in Fig. 14 as described above. It shows what happens to the distal segment of the handle when the distal segment is removed. The flap valve outer lever handle 53 is provided with a small indent 54 at the bottom thereof such that the lever is rotated in the direction of the arrow 52 and then forced to engage the small handle 54a protruding from the plane 10. Is kept open. This is the exhaust position of the valve that allows the doctor to massage the blown up portion with both hands at the end of the surgery to release the gas in the patient. The lever is shown with the rotating arc 55 required to engage the protruding handle 54a. If the valve is opened by the insertion of the penetrator, the lock position is not reached by the lever. The locking of the valve must be performed carefully and strongly by the surgeon. The incineration 52 shown in the bayonet locking stud 29 is referred to as the preferred slope of the groove 29, which ensures a sufficient locking force to prevent accidental loosening between the leading and distal segments of the handle. The elasticity of the locking element determines the exact angle to be used such that it is approximately 2 to 5 degrees for error of tolerance. The injection valve 11, its lever 11c and its connector 11a are shown in FIG. In Fig. 15, the opening of the valve is indicated by arrow 11d. Figure 15 also shows the cutout of the valve shaft 34, its upper " O " ring seal 34a, and its torsion spring 33 inserted into the slot of the actuation bracket of the valve 32. Figs. 15 shows the seal 35 as well as the front face 51a of the distal handle segment in contact with the mating surface 51 of the leading segment.

In one embodiment, the fluid is transferred from tubing or syringe to the device via Luer lock coupler 101 and through the device, and flow control by a simple stopcock 102. Both items are generally well known in the industry.

The outer body portion of the device is a hollow cylinder 104 (which may be made of surgical steel), the cylinder being intended to have a diameter of 1.0 to 4.0 mm in the preferred embodiment, with the distal cutting blade 104a fixed thereto. In the outer body cylinder, there is a coaxial sliding spring pressurized cylinder 105 in which a blunt blade guard 105d is formed in the distal direction. The tip area of the sliding blade guard is formed by a spring mechanism consisting of a fixed tip block 103a attached to the outer body, an appropriate gauge spring 103b, and an attachment 103c to the sliding guard 105a. Is pressurized. Block 103a has a central opening formed therein for passage of the fluid. The spring mechanism may further include a locking mechanism that prevents retraction of the sliding guard after the guard has fully protruded in the distal direction (ie, after penetrating the tip of the predetermined space).

The distal incision of the outer guard consists of a thin, sharp securing blade 104a across the open end of the distal cylinder fixed in position 104f. On the flat side of the incision blade 104a, the cylinder wall 107 is inclined in the tip direction and terminates at the inclined edge 104b to facilitate penetration. The blade 104b has a centrally located opening 104b to facilitate fluid flow through this area of the blower and to the tip and main outlet port 105b. The angle 104c formed by the opposing blade edges is defined as the θ blade. The angle 104e formed by the imaginary line from the blade tip to the inner exposed edge of the outer cylinder perpendicular to the plane of the blade is defined as the θ tip.

Slidable inner guard mechanism 105 has a substantially conical tip 108 and an open lumen 105a that extends distal beyond the paired main outlet port 105b. The distal lumen of the inner guard mechanism may be recessed in a manner that maximizes fluid flow through the tip of the device and is not limited to the particular inner shape shown by reference numeral 105a. The slit 105c wide enough to accommodate the incision blade 104a is perpendicular to the outlet port. The slit 105c extends in a proximal direction to a position 105f far enough to allow distal deployment of the guard over the blade incision surface, and the guard has a blunt tip 105d as shown. The angle 105e formed by the tapered edge of the distal blade guard in the plane of the incision blade is defined as θ shield. For the shield to function properly, the θ shield needs to be smaller than the θ blade. The angle 105g formed by the end tape guard edge perpendicular to the plane of the blade is defined by the θ tip portion. The angles 104e and 105g should suitably be the same.

The blower is configured and the spring compression is adjusted so that the sliding blade guard retracts in the tip direction so that the distal blade is exposed when pressed against the skin or the outer surface of the penetrating area (FIGS. 28A, 28B). At the moment the end of the device penetrates the (potential) space, the blunt distal tip of the guard advances away from the sharp tip of the blade, and a certain amount of fluid is discharged from the distal tip of the instrument (FIG. 28D). Once the penetration of the space is complete, the sliding blade guard continues to advance over the blade, and the device is shown as shown in Figure 28E. Thus, the main fluid outlet port is fully open, allowing for maximum outflow. Further, the distal protruding of the sliding guard is prevented by the contact of the distal end of the guard slit 5c in contact with the distal end of the blunt side of the incision blade.

The blade 104c may have a slightly rounded or blunt tip as it has a shape similar to the blade used in the aforementioned patent publications and patent applications, and may have a guard and blade vertex relationship as disclosed herein.

Here, the guard locking mechanism (Figs. 29 to 32) is composed of a pair of bilateral lever arms 207a that are textured so as to be firmly gripped by a finger. A device having one or more lever and receiver slots is also possible. The spring allows disengagement of the locking pegs 207c due to the axial compression of the movable lever arm, and the needle can be pushed into the space due to the pressure on the more vertical end lever arm. The lever is attached and fixed through the hinge 207b at the lever base. The lever pegs 207c are compressed into corresponding holes in the outer sleeve 204 and corresponding receiver grooves 207d of the sliding inner guard 205. The peg end is circularly designed to slide in the receiver groove with minimal friction. The area of the lever arm around the peg has an outline that tightly fits with the peripheral outer surface of the outer sleeve to seal the hole and prevent fluid from escaping or entering through bilateral defects. The lever pegs 207c are bent to the radius of the pedestal to allow the pegs to pass smoothly through the holes or receiver grooves.

The receiver groove 207d (FIGS. 31 and 32) is inclined (deeper at the tip) so that compression from the bilateral lever arm through its pegs does not interfere with the movement of the sliding inner guard 205. FIG. Indeed, this geometric shape aids in the forward projection of the sliding guard and aids in the safe shape. At the top end of the receiver groove is a deeper peg seal 207f. When the lever arm peg is seated in this indentation in both directions, the distal protrusion of the sliding inner guard 205 is firmly fixed in place. At this time, the worker feels the movement to be seated through the fingers to ensure the activity of the guard. The depth and size of the receiver groove may vary but should not include the flow of fluid through the needle lumen. The axial length of the receiver groove slots corresponds to the length of movement of the sliding inner guard.

Another embodiment of the present invention is designed to increase the expansion force of the outer sleeve 204 by adding a wider surface at the distal end 210c (Figure 33). Such a wide surface can be made by thickening the wall of the outer sleeve. The tip range of this thick wall is given the reference number 210f. The inner guard lumen is slightly narrow but still suitable for the path of fluid 210e. The cutting edge 204a is of the same geometry as the sliding inner guard as in the first embodiment, but the cutting blade itself can be made of solid flat metal pieces without the inner window 204b. Line 201b (FIG. 39) shows the tip range of this incision blade. The blade may be firmly fixed to the outer sleeve in region 210d.

The sliding inner guard of the second embodiment is geometrically identical to the incision edge as already described herein. The end tip 212a of the guard may have a semiconical convex outward (FIG. 34). Guard tip 212a may be more square shaped depending on the application. The flow of fluid through the tip of the device is increased by significantly expanding the defects of the guard tip and reducing the support of the guard tip against the rail or post that is parallel in two bilateral directions. The wide communication between the inner guard lumen and the large guard flaw can be seen in the axial rotation side view of the sliding inner guard tip. The distal range of defects is represented by line 213a (Figure 35).

A side view of a further embodiment assembled is shown (FIG. 34). When the guard is fully extended, it is evident that there is a large space through the distal tip for the fluid flow 212b but a large area of the outer incision sheath 210c for generating expansion force separated from the sliding inner guard. The axially rotating side view (FIG. 37) of the expanded guard of this additional embodiment shows how the sliding inner guard 212a covers and protects the incision blade 210a and also how it extends from the expansion force generated by the outer sleeve surface 210c. It shows if it is separated.

Another embodiment of the present invention (Figure 38) increases the expansion force of the outer sleeve 204. The distal end of the sleeve has a plurality of flanges 216a (Figs. 38-40) tapered at the distal end to help protect the blade 210a. This flange is parallel to the incision blade 204a but provides adequate space for the discharge of the sliding inner guard. Such flanges generate substantially all of the expansion forces required for the entry of the device into the substrate (or other penetrating medium) of the tissue. This allows the sliding inner guard to be moved to the end without significant friction on the guard. Once the space or latent space is reached by the distal tip of the device, the sliding inner guard extends distal into the indicated position (Figure 40). This may expose guard defects 212b, creating a suitable channel for fluid to pass through the device. The axial rotation diagram of the assembled device (FIG. 41) shows the distal extent and the relationship of the elements of the inner guard fault channel 213a passing distal to the expansion flange.

A further embodiment of the device is shown (Figure 42). This embodiment incorporates the aspects of the second and third versions described above. In this version, the distal expansion flange thickens into a more conical shape 220a with a thicker base. This thickened and hardened flange terminates at 210f but is supported by the thickened wall of the outer sleeve 204 allowing flow of fluid through the lumen 10e. Flange 220a is perforated 220b in a manner that facilitates the flow of fluid through the tip of the device.

The needle device can be fitted with an additional guard lock mechanism (Figure 29). This lock keeps the slidable guard 205 in the extended blade covering position after penetration of space or latent space. The lock can be disengaged by holding the lever arm 207a firmly and allowing the guard to retract to the tip to allow the needle to travel through a deep, continuous layer of tissue. The operator has a tactile sense of the lever arm that closes when the lever peg 207c is seated in the peg seat 207f of the sliding inner guard 205 whenever the guard slides to the end and is locked in place. In this way, the worker can access a given space or latent space within the body (eg, epidural space, amniotic space, peritoneal cavity, intravascular space, etc.) in a step-by-step, controlled manner.

Modifications to each embodiment include a blade slightly wider than the diameter of the outer sleeve 204. This makes a major flaw in the tissue (or other medium that penetrates) and facilitates penetration through strong, dense tissue (eg ligaments). Such alterations may facilitate medical practices such as epidural anesthesia.

In the third and fourth embodiments, the shape of the tip portion of the guard slot 202c between the blade 210a and the expansion flange 220a is deformable. The slot may be terminated as indicated by reference numeral 202d (FIG. 42), or may be rectangular or circular, for example.

Various modifications and variations of the present invention are possible within the above teachings. It is, therefore, to be understood that within the appended claims the invention may be practiced.

Claims (51)

A main body configured to be gripped, A through portion having a main shaft and attached to the main body, A cutting blade located at the distal end of the penetrating portion; A guard located in said penetration and configured to be movable relative to said incision blade and to selectively expose said incision blade, Formed in one of the guard, the penetrating portion and the body, to discharge pressurized fluid while the incision blade is in body tissue and to transport the pressurized fluid to body tissue when the incision blade substantially penetrates the body tissue. Includes a configured blow passage, The guard having a vertex, the angle formed at the vertex of the guard to gradually cover the blade during deployment of the penetration is less than the angle formed by the blade. The surgical device of claim 1 further comprising an external reservoir configured to supply the pressurized fluid to the intake passage. 3. The surgical device of claim 2, wherein the surgical device further comprises a check valve positioned between the intake passage and the exterior of the surgical device, wherein the check valve is configured to prevent leakage from the intake passage. The surgical device of claim 1, wherein the blowing passage is configured to be pressurized during insertion of the incision blade into body tissue. The surgical device of claim 1 wherein the pressurized fluid comprises a gas. The surgical device of claim 1, wherein the blowing passage passes through the cylinder through portion. The surgical device of claim 1, wherein the incision tip comprises at least one substantially flat blade coupled to the through blade and configured to be positioned along a major axis of the through portion. The surgical device of claim 1, wherein the penetrating portion is hollow and has an inclined edge for deflecting tissue. The surgical device of claim 1 wherein the guard has slots formed therein, each aligned with the blade to allow at least partially covering the blade by the guard. 2. The surgical device of claim 1 including a biasing member positioned within the penetration to engage the guard and move the guard toward the incision tip. The surgical device of claim 1, wherein the incision tip is less than or equal to the inner diameter of the penetrating portion such that the incision formed in the tissue by the blade is smaller in lumen than by a cannula. The surgical device of claim 1 wherein the through portion comprises a cylindrical through portion and the blade has a central recess formed to allow increased flow of the pressurized fluid. A main body configured to be gripped, A through portion having a main shaft and attached to the main body, A cutting blade located at the distal end of the penetrating portion; A blowing passage for discharging the pressurized fluid while the incision blade is in body tissue and for transporting the pressurized fluid across the body tissue when the incision blade substantially penetrates the body tissue; An external reservoir for supplying the pressurized fluid to the blowing passage; A guard movable relative to the incision blade, The guard having a vertex, wherein an angle formed at the vertex of the guard to gradually cover the blade during deployment of the penetration is less than an angle formed by the blade. The surgical device of claim 13 wherein the penetrator comprises a hollow needle. The surgical device of claim 13 wherein the penetrator comprises a cylindrical needle. A needle body configured to be gripped, A penetrator having a main shaft and attached to the needle body; At least one incision blade located at the distal end of the needle body; A tissue expander located at the distal end of the penetrator for expanding the tissue incision by the incision blade to insert the penetrator; Moveable relative to the tissue expander, exposing the incision blade when the incision tip begins to incise the tissue layer, and when the at least one incision blade is within the tissue layer, the distal tip of the incision blade being the tissue layer A guard configured to gradually cover the end of at least one of the incision blades immediately after substantially passing therethrough, At least one said cutting blade comprises a blade extending substantially parallel to said major axis and having at least one blade edge, And the guard comprises at least one safety guard positioned substantially parallel to at least one of the blades. 17. The surgical device according to claim 16, wherein the penetrator includes an inclined end surface that biases tissue when penetrating the penetrator into tissue. 18. The surgical device of claim 17, wherein the guard includes a releasable locking mechanism that selectively locks and releases the position of the penetrator. 17. The surgical device of claim 16, further comprising a spring configured to allow translational movement of the guard in response to a force generated during actuation of the incision tip passing into the tissue layer. The surgical device of claim 16, wherein the tissue expander further comprises tissue expander faces positioned adjacent the incision tip. A needle body configured to be gripped, A penetrator having a main shaft and attached to the needle body; At least one incision blade located at the distal end of the cylindrical penetrator, A tissue dilator flange configured to expand tissue cut by the incision tip to insert the penetrator and positioned at the distal end of the penetrator; Moveable relative to the tissue dilator flange, exposing the incision tip when the incision tip begins to incise the tissue layer, and when the incision tip is in the tissue layer, the distal tip of the incision tip substantially subtracts the tissue layer. And a guard configured to gradually cover the end of the incision tip immediately after passing therethrough. A needle body configured to be gripped, A penetrator needle having a main shaft and attached to the needle body; At least one incision blade located at the distal end of the penetrator needle, A tissue expander configured to expand tissue cut by the at least one incision blade to insert the penetrator; Moveable relative to the tissue expander flange and configured to selectively expose at least one of the incision blades, the angle of the apex of the guard being at least one for gradually covering the at least one incision blade during placement of the penetrator Surgical device comprising a guard having a vertex smaller than the angle made by the incision blade of the. 23. The surgical device of claim 22 wherein the guard is slidably attached between the tissue dilator and the incision tip. 23. The device of claim 1, 16 or 22, wherein the incision blade comprises a blade having a first blade edge, wherein the blade edge is attached to the distal end of the penetrator needle, A surgical device directed substantially parallel to the major axis and configured to create an opening in the body tissue for inserting a surgical cannula. 25. The surgical device of claim 24 wherein the penetrator needle is hollow and has a passageway in communication with the isolation of the patient. 27. The surgical device of claim 25, comprising a locking mechanism that selectively locks the guard in place and unlocks the guard so that multiple layers of tissue can penetrate each tissue layer in a protected manner. 27. The surgical device of claim 25 wherein the blade is attached to the distal end of the penetrator and is oriented substantially parallel to the guard. A main body configured to be gripped, A penetrator having a main shaft and attached to the main body, At least one incision blade located at the distal end of the penetrator needle, A guard configured to slidably cover and open at least one said incision blade, A locking mechanism configured to selectively prevent accidental opening of at least one of the incision blades by the guard, The guard is movable relative to the tissue expander and configured to selectively expose at least one of the incision blades, And the guard has a vertex and the angle formed at the vertex of the guard to gradually cover the at least one incision blade during deployment of the penetrator needle is smaller than the angle formed by the at least one incision blade. 29. The surgical device of claim 28 wherein the body comprises a needle cannula. Means for gripping the surgical device, Needle means mounted to the means for gripping the surgical device to pass the object through the hole in the tissue member, Means for extending a tissue member mounted to the means for passing an object into a hole in the tissue member; Cutting means mounted to the needle member for passing the object into the hole of the tissue member to cut a hole for inserting the means for passing the object into the hole of the tissue member; Means for selectively stopping said cutting means, The means for cutting out the hole of the tissue member is movable relative to the means for expanding the tissue member, The stopping means comprises means for protecting the cutting means, The means for protecting the incision means is movable relative to the means for expanding the tissue member, The means for protecting the incision means has a vertex, wherein the angle formed at the apex of the protection means for gradually covering the incision means during deployment of the means for expanding the tissue member is smaller than the angle formed by the incision means . 31. The surgical device according to claim 30, wherein the means for protecting the incision means comprises at least one guard. 31. The surgical device according to claim 30, wherein said stop means comprises means for blowing tissue under said incision means. A main body configured to be gripped, Penetrator needle means comprising a main shaft and attached to the main body, Body tissue dissection means located at the distal end of the penetrator needle means; A tissue expander means extending at the distal end of the penetrator needle means for expanding the tissue cut by the tissue cutting means; Blowing passage means configured to release pressurized fluid while the tissue cutting means is in body tissue and to transport the pressurized fluid to body tissue when the cutting blade means substantially penetrates the body tissue; Guard means for selectively protecting and unprotecting said tissue dissection means, Said guard means being movable relative to said tissue and configured to unprotect said dilator means and to selectively expose said tissue dissection means, The means for protecting the tissue cutting means has a vertex, wherein an angle formed by the tissue cutting means is formed at an apex of the means for protecting the tissue cutting means to gradually cover while the means for expanding the tissue member is deployed. Surgical device smaller than an angle. 34. The surgical device of claim 33, wherein the surgical device further comprises an external reservoir configured to supply the pressurized fluid to the blowing passage means. 35. The surgical device of claim 34, wherein the surgical device further comprises a plurality of blades. 39. The surgical device according to claim 38, wherein the blowing passage means is configured to press while the incision tip is inserted into body tissue. A main body configured to be gripped, A needle penetrator including a main shaft and attached to the main body, A cutting blade located at the distal end of the needle penetrator; A tissue expander extending at the distal end of the needle penetrator to expand the tissue incised by the incision blade, A blowing passage configured to release pressurized fluid while the incision blade is in body tissue and to transport the pressurized fluid to body tissue when the incision blade substantially penetrates the body tissue; And a guard selectively moveable between the incision blade and the dilator, moveable relative to the tissue dilator, and configured to selectively expose the incision blade. A main body configured to be gripped, A needle penetrator including a main shaft and attached to the main body, A cutting blade located at the distal end of the needle penetrator; A tissue expander extending at the distal end of the needle penetrator to expand the tissue incised by the incision blade, A blowing passage configured to release pressurized fluid while the incision blade is in body tissue and to transport the pressurized fluid to body tissue when the incision blade substantially penetrates the body tissue; And a guard configured to selectively move relative to the tissue expander and to selectively expose and cover the incision blade, the guard including a substantially flat portion extending substantially parallel to the incision blade. A main body configured to be gripped, A needle penetrator including a main shaft and attached to the main body, An incision tip located at the distal end of the needle penetrator, A tissue expander positioned at the distal end of the needle penetrator for expanding the tissue incision by the incision tip such that the penetrator is inserted therein; Exposing the incision tip while the incision tip is beginning to incise the tissue layer and while the incision tip is in the tissue layer, and immediately after the distal tip of the incision tip substantially passes through the tissue layer A guard progressively covering the end of the tip, reexposing the incision for subsequent recovery, and selectively movable relative to the tissue dilator, The incision tip comprises at least one blade substantially parallel to the major axis and having at least one blade edge, the guard being positioned substantially parallel to the at least one blade, And the safety guard further comprises a safety guard edge having a guard edge angle smaller than the blade edge angle defined by the at least one blade edge intersecting the major axis. A method of inserting a protected, bladed surgical needle into an individual, Using the incision tip of the bladed needle to incise a hole suitable for insertion of the cannula body of the needle into the body tissue layer of the individual, Simultaneously pressurizing the pressurized fluid into the aperture for inserting the pressurized fluid under the body tissue layer; Stopping the incision by projecting the guard over the incision tip of the bladed needle. 41. The method of claim 40, wherein the pressurized fluid comprises a gas. 41. The method of claim 40, wherein the incision tip comprises at least one incision blade edge. A method of inserting a protected, bladed surgical needle through an individual's tissue using a penetrator needle, incision blade and guard, Shaping the guard, having a vertex, such that the angle formed at the vertex of the guard is progressively smaller than the angle formed in the incision blade to gradually cover the incision blade tip while the penetrator needle is deployed; Connecting the incision blade to the distal end of the penetrator needle to incise the tissue, Selectively covering and exposing the incision blade and movably positioning the guard within the penetrator to gradually cover the blade with the guard while the penetrator needle is deployed. 44. The method of claim 43, comprising positioning a tissue dilator at the distal end of the penetrator needle to expand a portion of tissue incised by the incision blade. 44. The method of claim 43 including connecting the penetrator needle to the body for manipulating the penetrator needle during incision of the tissue. 46. The method of claim 45 including providing a blow passage through the penetrator to release pressurized fluid when penetrating the tissue by the incision blade. 47. The method of claim 46 including positioning a valve between the intake passage and the outside of the penetrator needle to prevent leakage of pressurized fluid from the penetrator needle. 44. The method of claim 43 including using a selectively unlockable and relockable locking mechanism to prevent accidental exposure of the incision blade. The method of claim 46, wherein the fluid comprises a gas. 44. The method of claim 43 including forming the distal end of the blade to be one of a substantially blunt tip and a substantially circular tip. 41. The method of claim 40, comprising shaping the guard, having a vertex, such that an angle formed at the vertex of the guard to cover the incision blade tip gradually while the guard is deployed is less than an angle formed in the incision blade.