EP1605812A2 - Insufflateur et procede d'utilisation - Google Patents

Insufflateur et procede d'utilisation

Info

Publication number
EP1605812A2
EP1605812A2 EP04717923A EP04717923A EP1605812A2 EP 1605812 A2 EP1605812 A2 EP 1605812A2 EP 04717923 A EP04717923 A EP 04717923A EP 04717923 A EP04717923 A EP 04717923A EP 1605812 A2 EP1605812 A2 EP 1605812A2
Authority
EP
European Patent Office
Prior art keywords
tissue
penetrator
cutting
guard
surgical device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP04717923A
Other languages
German (de)
English (en)
Other versions
EP1605812A4 (fr
Inventor
Ernesto E. Blanco
Gilbert B. Wilshire
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Erblan Surgical Inc
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP1605812A2 publication Critical patent/EP1605812A2/fr
Publication of EP1605812A4 publication Critical patent/EP1605812A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
    • A61B17/3496—Protecting sleeves or inner probes; Retractable tips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3474—Insufflating needles, e.g. Veress needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B2017/3454—Details of tips
    • A61B2017/346—Details of tips with wings

Definitions

  • An insufflator is a needle-like device through which a gas or other fluid can be injected into a space or potential space somewhere within the body.
  • the device and the method of use thereof is not limited to use in humans. Indeed, the device could find applications in numerous unrelated fields where precise penetration of embedded spaces is desired.
  • trocars utilize a tip "shield", or cover, for the cutting edges which is usually deployed immediately after penetration of the body cavity has taken place.
  • a penetration is fraught with danger of injury to internal organs.
  • careful a surgeon may be during penetration of the body cavity, the resistance to penetration drops at the last instant prior to damage to the internal organs. This sudden drop in the resistance to penetration is called a "plunge effect" and occurs prior to any safety feature deployment.
  • the penetration is controlled in some fashion, either taking place in small increments or under some form of approximate direct observation, estimate, or monitoring. In all cases, however, the designs result in much of the piercing tip being inserted to a dangerous depth before any protecting devices is deployed.
  • one object of this invention was to insure that such events be avoided through a surgical device in which a penetrating tip or cutting edge(s) of the instrument be kept, at all times, sufficiently distant from delicate tissues.
  • a surgical device in which a penetrating tip or cutting edge(s) of the instrument be kept, at all times, sufficiently distant from delicate tissues.
  • the probability of injury will be reduced.
  • most existing trocars used for endoscopic surgical procedures are incapable of truly effective prevention of injuries to internal organs during insertion and manipulation of the trocar.
  • Present procedures frequently injure internal organs, and the resulting wounds are sometimes serious or even fatal.
  • the need for safer trocars is thus imperative, especially given that endoscopic surgical procedures are likely to become more widespread in the future.
  • one object of this invention is to insure that such events be avoided through a surgical device in the form of a trocar or insufflation needle in which a penetrating tip or cutting edge(s) of the instrument be kept, at all times, sufficiently distant from delicate tissues.
  • a surgical device such as a trocar or insufflation needle in which a penetrating tip or cutting edge(s) of the instrument be kept, at all times, sufficiently distant from delicate tissues.
  • a further object of this invention is to provide a surgical device (trocar, insufflation needle or structurally equivalent device) wherein insufflation fluid can be driven into a patient during penetration of the body cavity by the surgical device to drive the internal organs away from the surgical device during penetration.
  • the insufflation fluid of the present invention can either be supplied from an external pressurized reservoir, or compressed (and hence gathered) during penetration of the body cavity by the surgical device.
  • a further object of the invention is to provide a surgical trocar or insufflation needle that contains one or more cutting edge that provides low fiictional forces between the cutting edge and tissue during penetration of the body cavity, thus reducing the force needed to drive the surgical device into the body cavity.
  • a further object of the invention is to provide a surgical device that includes a protective device that deploys while remaining substantially out of contact with tissue, thus reducing frictional forces between the protective device and ensuring a controlled and advantageous deployment.
  • a further object of the invention is to provide a surgical device that includes a protective device such as safety guards, wherein he guarding elements have an apex and the angle subscribed at the apex is smaller than the angle subscribed by the blades or cutting elements of the surgical device, thus insuring progressive coverage of the blades or cutting elements during deployment of the protective device.
  • a protective device such as safety guards
  • a yet further object of this invention is to provide a surgical device with a grip mechanism that allows convenient gripping and twisting of the surgical device during penetration of the body cavity.
  • An additional object of this invention is to provide a surgical device that includes a locking system that prevents accidental reuse of he cutting elements after the tip has been used. It is therefor desired that this invention, in general, improve surgical safety.
  • a surgical device such as a trocar tissue penetrator or insufflation, bladed needle including a set of thin planar arrow- pointed cutting blades joined at a cutting point coaxial and within a hollow cylinder penetrator and having the cutting edges converge at a cutting angle at the cutting point.
  • a single flat blade can also be used if desired.
  • the back outside of the set of cutting blades can be fixed o the inside of the hollow cylinder penetrator with the cutting edges fully protruding.
  • the hollow cylinder can have its front end slotted and each segment pointed in a triangular shape and bent to fit between the blades and having its edges substantially parallel to the edges of the protruding blades but axially recessed behind such edges to act as a tissue expander to prevent contact between inside moving guards and the outside tissue.
  • the slots between the triangularly shaped bent section tissue expanders at the end of the hollow cylinder penetrator can be wide enough to permit the passing between them and the sides of the cutting blades of a guard sheet at least as thick as the blades.
  • One or more elongated axially bent sheet guards can be set to slide freely within the space between the sides of the cutting blades and the triangular bent segment of the hollow cylinder and having their frontal end with a tip angle profile substantially more acute than the adjacent angle of the blade edges and terminating in a very small dull round tip.
  • the angular frontal edges of the bent sheet guards can have shallow angle ends and curving slowly toward the edges so that at no time their angle exceeds that of the adjacent cutting edges.
  • the elongated bent sheet guards inserted between the cutting blades and the triangularly bent segments of the hollow cylinder can be attached at their opposite end to a stem which is urged toward the frontal cutting edges by a coil spring.
  • this surgical device includes, e.g., the following: a multiple system of sharp planar knife edges that practically eliminate lateral friction and provide a reduced resistance to penetration, thereby reducing the penetration "plunge effect" and tissue springback.
  • a mechanical tissue protection device that includes a series of thin plastic guards sliding along the sides of the planar knives and, in a preferred embodiment, having an angle between their edges smaller than that of the cutting knife edges. It can then be shown that, with proper contouring of such plastic guard edges, it is possible to provide complete guarding between the cutting edges and the surrounding tissues from the very start of the penetration, and to do so in a truly progressive manner, without jerks or discontinuities.
  • guarding action that results from the smaller angle between the sides of the guards than the angle between the edges of the cutting blades allows the guards to plunge into the tiny opening made by the cutting tip and instantly surround it, thereby preventing injury to internal organs during the most crucial instant of the trocar insertion. Therefore, guarding action takes place in a truly progressive manner in which, as the cutting lades continue expanding the tiny initial opening, the guards progressively advance keeping the cutting edges constantly covered outside the penetrating region and isolated from internal organs until the penetration is completed and the cannula fully inserted; one or more fixed conical deflectors to expand the cut tissue passage leaving the guards to contact tissue only at their tips, thus isolating the guards from friction against the tissue at the sides of the point of penetration.
  • the guards instantly plunge into the opening and prevent the blade tip from any contact with internal organs.
  • tissue expanders outside the guards prevents friction between the guards and the tissue, which would retard the deployment action.
  • the use of this tissue expander allows the safety device to function without restriction, thereby eliminating one of the major deficiencies of existing trocars.
  • the dynamic response of the guards is inherently much faster than the rate of penetration of the blades.
  • cutting edges are never dangerously exposed to, contact with internal organs, however fast the penetration rate may be; an insufflation passage configured to transport fluid into the body cavity during penetration.
  • the insufflation passage can be pressurized either using an external reservoir or by compressing gas contained in the passage during penetration. Once an initial penetration of the epithelium has been made, fluid from the insufflation passage will drive the internal organs away from the cutting edge(s).
  • a carbon dioxide gas valve is opened, hereby pressurizing the penetrator tubular body. Under such pressurization, since the front is enclosed by tissue, the cutting tip penetrates the tissues while the gas is prevented from exhausting, but as soon as the most minute opening starts to appear at the tip, the gas expands suddenly into the opening and forcibly deflects delicate internal organs away from the tip of the cutting surface while simultaneously the guard tips are forced through the opening by their spring.
  • a pressurized fluid (or gas) tissue deflector thus creates an organ-free zone in front of the. cutting blade tips at the instant o the incipient penetration, even before the guard tips plunge into the opening. It must also be pointed out that a sudden as expansion can also aid the deployment of the guards since the flow occurs between the cutting blades and the conical expanders, precisely where guards may be located. It could almost be said that the guards are spit out by the fluid flow. This increases the velocity of their deployment and hence the overall safety of the surgical device; a locking system for the guards, which is located at the proximal end of the instrument, prevents accidental reuse of the cutting features after the tip has been safely introduced for the first time.
  • the locking system for the trocar guards includes a locking cylinder attached to a locking button supported by a leaf spring and inserted into a socket.
  • the cylinder has a conical tip and a circumferential groove at the bottom and can be depressed by way of the button and engaged by the groove into a U shaped spring that will hold it down permitting it sliding motion until it comes out of the U shaped spring and is ready for locking again on its return to the initial position. If a reset action is desired it is necessary to push hard downward against the locking button and deliberately reset it for another cycle. Since the locking button is located deep within a recess at the proximal section of the handle, it demands some effort to reach and actuate, and thus it is difficult to accidentally reset. an ergonomic design which facilitates handling.
  • the proximal hemispherical knob nestles easily into the hollow of the hand while the index and middle fingers control rotation by gripping the side horns, thereby permitting push, pull, rotation, and tilting in a very natural and comfortable manner.
  • the surgical device having the above-noted characteristics can thus comprise a trocar, an insufflation needle or any other surgical/penetration device having a similar function.
  • the insufflator in accordance with one embodiment of the present invention comprises a needle-like device through which a gas or other fluid can be injected into a space or potential space somewhere within the body of a patient.
  • the device is not limited to use in humans. Indeed, the device could find applications in numerous unrelated fields for precise penetration of embedded spaces is desired.
  • FIG. 1 wherein a cannula 2 corresponding to the background of the invention is firmly attached to a distal section of a handle which is formed from two segments, the distal one 6 externally containing gripping horns 6a, insufflation device 11, and flap valve lever 12, and a proximal handle section 5 in the shape of a hemispherical knob to facilitate its pushing with the palm of the hand.
  • This section also contains a depression 9 with a flat bottom 9a, and external mechanisms including a button 7 inserted for sliding into a slot 8 to monitor and control the position of safety guards at the extreme distal en of cannula 2.
  • the safety mechanisms protruding distally from cannula 2 include conical tissue expanders 4, and safety guards 3 intended to cover a set of knives (not visible in this FIG. 1). Those are the externally visible features of this invention.
  • FIG. 2 shows details at the penetrating distal end of the trocar.
  • a hollow outside cylinder 2 is the cannula which is firmly attached to the distal section of the handle 6 as was described in FIG. 1.
  • Inside of the cannula 2 there is another hollow cylinder 13 which is the penetrator. This is the removable part which is attached to the proximal section of the handle 5, and can be removed after the penetration is completed to allow for the introduction of surgical instruments.
  • the cannula 2 has its distal end beveled as shown by 2a to facilitate its introduction across the tissue opening with minimal resistance.
  • the penetrator hollow cylinder 13 has its distal end formed as a plurality of conical segment expanders 4 which are spaced by slots 4a to allow for the protrusion of pointed flat knives 14 joined at the center of the instrument and resembling thin arrowheads joined at a center. As shown in FIG. 2, the knives are positioned into the penetrator hollow cylinder 13 to a depth shown at 14a. The knife edges outside the slots 4a between the conical segment expanders protrude a substantial distance to insure adequate cutting. The set of knives is assembled into the penetrator cylinder 13 by spot welds 15, or by other similar mechanism. Right behind the crossing of the knife blades can be seen the plastic guard tips 3a. In FIG.
  • the guards are shown as removed from the knives so as to facilitate the understanding of their shapes and relations .lip to the knives.
  • the subassembly of the guards 3 is part of a support disk 16 which in turn is part of the guards hollow stem 17 connecting them to an actuator spring and locking mechanism at the proximal section of the handle (not shown here).
  • the guard tips 3a are inserted around the knife blades which fit into the narrow spaces 3b between the guards.
  • the guards are then assembled by being pushed forward until they protrude between the blade sides and the conical expander slots 4a as can be shown in FIG. 3 below.
  • the tips of the guards are barely visible because the guards are retracted as when the trocar is first pushed against the skin.
  • FIG. 4 shows the tips of the guards 3 a protruding ahead of the tip of the knives and covering them. A short distance behind the tips of the guards 3a the edges of the knives 14 are exposed and capable of cutting.
  • FIG. 4 shows the configuration of the trocar cutting tip right after initiation of the penetration across the abdominal tissue. At that instant, the guard's tiny tips 3a plunge across the start of the opening and quickly cover the sharp cutting point while the exposed knife edges continue cutting inside the skin until the penetration is complete as shown in FIG. 5.
  • FIG. 5 shows how the front end of the example trocar looks after the penetration into the abdominal cavity has been completed. At that time all edges of the cutting knives are covered by the fully extended guards and the whole penetrator assembly can be pulled out with the proximal sector of the handle.
  • FIG. 6 represents the example trocar guard tips 3a as they begin to contact the skin layer 20.
  • the internal organs are shown at the left side as 25.
  • the skin outside layer is deflected under the force of the guard tips which are urged forward by their spring.
  • the guards will be forced into the penetrator 13 and displace the base disk 16 and guard stem 17 toward the right against the force of their spring.
  • FIG. 7 shows the guards 3 already completely retracted into the penetrator 13, and the knife edges 14 completely exposed. At that instant, the point of the knives begins to cut and penetrate at 21 into the outside tissue layer. As shown in FIG. 7, the cutting pathway of the cutting tip/knife edge is of a smaller diameter than the inner diameter of the cannula 2 such that the cutting bade by the blade results in a smaller lumen or bore than that of the cannula. At that time, the carbon dioxide gas is allowed to pressurize the inside of the penetrator 13, and while some gas may escape at first, the tissues around the tip will seal the flow until the cutting tip starts to emerge across the internal abdominal wall.
  • FIG. 8 shows the onset of penetration.
  • the cutting tip point 14b has made a very minute perforation 23 and, because of the presence of the guard tips 3 a, there is enough space to allow a fluid flow (shown here as a gas jet 24) to issue out and cause the displacement of nearby internal organ tissues 25a, while simultaneously the guard tips 3a expand the opening urged by their spring pushing at 17 and plunge through the perforation effectively covering the cutting tip 14b.
  • FIG. 9 shows the result of the action described above.
  • the gas jet 24 continues issuing and driving internal organs 25 a farther away while the guard tips 3 a completely enclose the cutting tip 14b. All danger to internal tissues has passed.
  • the extremely quick flow of the gas and the action of the guard tips make the manipulation factors of this trocar the safest to master easily.
  • the force or speed of the penetration action are, within reason, almost immaterial.
  • FIG. 10 shows the penetration process.
  • the cannula 2 is partly introduced across the tissue 27 and the guard tips 3 a continue advancing and protecting the internal tissues from the knife edges while the portions of the edges not yet covered by the guards 14a are seen cutting the remainder of the opening ahead of the cannula, and the tissue expanders 4 facilitate penetration by protecting the guards from tissue friction.
  • the flow of carbon dioxide gas 24 is fairly unimpeded and performs the insufflation stage of the process, driving internal organs 25a farther away from the trocar portal.
  • FIG. 11 shows the trocar after full insertion and in the last stage of insufflation. The knife edges are now fully covered by the guards, and the cannula 2 is seen fully inserted across the tissue. The insufflation continues until completed and then the penetrator 13 is removed to allow the insertion of surgical instruments across the cannula.
  • FIG. 12 is a top view of the trocar showing some of the external parts as well as a partial broken view of some interior parts.
  • the body of the handle is made out of plastic and has two main segments.
  • the proximal segment 5 is designated to fit into the palm of the hand and has a proximal end of hemispherical shape with a depression of arcuate profile 9 at the top terminating at a flat surface 9a where the guard stem controls are located.
  • Those controls are recessed into the flat depression 9a to prevent unwanted actuation, and include a double slot with vertical slots 8 and 8a into which is inserted a button 7 and its rectangular guiding shank 7a.
  • the button 7 is capable of vertical and horizontal movement, the latter movement being limited between arrows 7b and 7c as will be described later.
  • the proximal segment 5 is assembled as an integral part of the penetrator system. Its distal end 51 forms the interface between the two segments of the handle.
  • the distal segment 6 of the handle has two lateral protruding horns 6b to facilitate its manipulation during penetration and orientation.
  • the two handle segments 5 and 6 are locked together during usage by way of a bayonet stud 29 and slot 29a.
  • the stud 29 on part 5 is aligned with the slot 29a on part 6, pushed, and turned clockwise, until the stud locks the two segments firmly, the knob on 5 and the horns 6b provide a good grasp for that operation.
  • the slot 29a is slanted in the transversal direction running slightly away from the interface 51 so as to insure that the turning-locking motion will assure a firm and stable connection. This will be discussed further in reference to FIG. 14.
  • the partial broken section at the top left of the distal segment 6 is intended to show 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 6 and lower 6a portions of the handle and is urged to rotate counterclockwise by a torsi onal spring 33 located around the shaft 34.
  • the shaft of the flap valve is fi ⁇ nly attached to the valve and can be rotated from outside the body segment 6 as will be shown later on FIG. 14.
  • An external lock allows the valve to remain open during desufflation if turned hard to its stop position 32a shown in dotted lines.
  • the valve has been opened by the insertion of the penetrator 13. In other cases, the valve could be opened for surgical or visualization instruments.
  • FIG. 12 shows how the cannula 2 is attached to the handle segment 6 by way of a flange 37, and prevented from leaking by an "O" ring 36.
  • FIG. 12 is shown how the carbon dioxide gas spigot manual valve 11 is mounted at one side of the top of segment 6.
  • FIG. 13 s a longitudinal vertical cross section along a plane "A—A" to show the internal details of the handle.
  • the two segments of the handle include a top and a bottom part split along a horizontal plane for fabrication, one becoming 5 and 5 a, and the other 6 and 6a, and after each segment has been fitted with the internal parts at assembly the two hales of each segment are permanently bonded together.
  • Each of the two segments is assembled separately since they must be detached and attached during usage.
  • the penetrator segment is only used to make the entry portal, but it must be emphasized that it is such step that involves the greatest risk.
  • the distal segment made of parts 6 and 6a houses the cannula 2 and all the gas infusion and valving.
  • FIG. 13 shows the gas connector or layer 11a to which the gas line is a fixed.
  • the valve system is bonded via a conical stem 1 lb into a boss on plane 10 so the incoming gas flows in the direction of arrow 30 and pressurizes the space between the inlet and the seal 35 from where it can enter the openings 38 around tile penetrator 13 walls and fill the space between lip seals 40 and 41.
  • Lip seal 40 is intended to prevent back flow from the penetrator in case of accidental opening or leakage across the gas valve during a procedure. In such a case, the pressurized volume of gas within the penetrator 13 will suffice to insure the safe deflection of nearby tissues even before the tips of the guards 3a plunge into the opening.
  • the guards stem 17 is completely sealed at the front by disk 16 and thereby its interior can be at atmospheric pressure. However, since it must slide back and forth with the guards it must also be supported at the proximal end and must be guided over a stationary hollow steel stud 44 inserted into it to a minimal depth of four diameters.
  • the proximal end of stud 44 is flared to provide fixation between parts 5 and 5a of the proximal hemispherical knob.
  • a hole 56 on the hollow stud 44 serves to provide air passage in and out of the stud when the guards stem moves back and forth acting as a piston pump. The hole 56 should pass through the stud and be of a diameter such as not to impede flow and dampen the sliding action of the guards' stem.
  • Compression coil spring 47 mounted around stud 44 serves to provide the required force to urge the guards stem in the distal direction.
  • the proximal end of the penetrator outside cylinder 13 is flared at 43 for fixation onto the proximal handle segment parts 5 and 5a. It is also sealed at the front by an "O" ring 42 to insure that no leakage of gas would occur even if seal 35 should leak: flared tubular assemblies like 43 are not reliable seals.
  • the proximal handle segment formed by parts 5 and 5 a is attached to the penetrator 13 and contains all its functional and control elements.
  • the guards stem 17 has at its proximal end a shallow cylindrical depression into which a thin ring 45a which is part of leaf spring 45 is affixed.
  • the exact configuration of the locking system to which the spring 45 belongs can be seen in FIGS. 16 and 17, and its function in the sequence of FIGS. 18 through 22.
  • FIG. 17 is an exploded view of some of the elements of the locking system in their proper relationship.
  • the button 7 is inserted across slot 8 on the top surface 9a on FIG.
  • FIG. 16 shows the assembly of the U spring 46 to the lower inside of 5 by the use of screw 50.
  • FIG. 16 does not show button 7 for the sake of clarity, but it shows flat spring 45 pushing up against the bottom of the U spring 46. If the assembly of the button 7 and the locking cylinder 48 was shown there, it would be evident that the button would be pushed upwards and the locking cylinder 48 would be forcibly inserted into the round socket 8b, thereby preventing any motion of the flat spring 45 and the guards stem 17 attached to it by ring 45a. That is the situation depicted on FIG. 13.
  • FIGS. 18 through 22 describe an operation of an example locking system in detail, as follows. In the position illustrated in FIG. 18, the system is locked.
  • FIG. 19 shows what happens when button 7 is pushed down.
  • the conical end 48c of cylinder 48 opens the U spring 46 and the spring then snaps close into the groove 48a thereby disengaging the locking cylinder from the round socket 8b.
  • the system is then unlocked.
  • the trocar is said to be "armed”, and able to permit the motion of the guards backwards, exposing the cutting blades for penetration of the skin. That is the position depicted on FIG. 6.
  • the following discussion is directed to the embodiment shown in FIG. 20.
  • FIG. 22 shows the completion of the cycle back to the initial configuration of FIG. 18.
  • buttons 7 were pushed down accidentally, it could be reset to the "safe” condition by merely moving it in the direction to 7 and then releasing it. It should then get snap-locked at a high level in position 7, and could not be moved without first pushing it down.
  • FIGS. 14 and 15 show the top view of the handle distal segment, previously presented in FIG. 12 as a partial broken section to show the inter or details.
  • FIG. 14 is intended to show the external operative controls on this segment of the handle in the interest of the user.
  • the flap valve lever 12 is shown in the closed position as it should be when the penetrator is removed.
  • the lever is attached to a shaft 34 whose opposite end is attached to the flap 32 as seen in FIG. 15.
  • the insertion of the internal trocar elements is performed when the top 6 and bottom 6a of each handle segment are separated prior to their being bonded along plane 6d.
  • FIG. 15 is the end view of the example embodiment previously illustrated in FIG. 14 as seen from the right side. That is how the distal segment of the handle will appear when the proximal segment is removed.
  • the flap valve external lever knob 53 is provided with a small depression 54 at its bottom to allow it to be held open when the depression is forcibly made to engage a small knob 54a protruding from the flat surface 10 after the lever has been turned in the direction of arrow 52. That is the desufflation position of the valve which allows the surgeon to use both hands to massage the insufflated region and expel the gas retained by the patient at the end of the procedure.
  • the arc of rotation needed for the lever to engage the protruding knob 54a is labeled as 55.
  • This locking position is not reached by the lever when the valve is opened by the insertion of the penetrator.
  • the locking of the valve has to be done by the forceful and deliberate action of the surgeon.
  • the small angle 52 shown at the bayonet locking stud 29 refers to the desirable slant for the groove 29 so as to insure that the locking force increases sufficiently to prevent accidental loosening between the proximal and the distal segments of the handle.
  • the elasticity of the locking elements determines the exact angle to be used, which should be somewhere between 2 and 5 degrees to account for tolerance errors.
  • the infusion valve 11, its lever l ie, and its lever connector 1 la are shown on FIG. 14. In FIG. 15, the opening of the valve is indicated by arrow l id.
  • valve shaft 34 also shows a broken section of the valve shaft 34, its top "O" ring seal 34a, and its torsion spring 33 inserted into a slot in he operating bracket of valve 32.
  • the seal 35 is seen, as well as the front surface 51a of the distal handle segment, which contacts the mating surface 51 of the proximal segment.
  • FIG. 1 shows a general view of the trocar described in the background of the invention in isometric pictorial form
  • FIG. 2 illustrates a partial broken view of the penetrating end of the example trocar with guards removed to behind the tip knives to illustrate a shape of this embodiment more clearly;
  • FIG. 3 shows the same end of the example trocar with the guards installed but retracted as when penetration of an example embodiment starts, and thus, the knife edges are exposed and ready to start cutting;
  • FIG. 4 shows the tip of the guards protruding ahead of the cutting tip as when the tip had just started to pierce the abdominal cavity;
  • FIG. 5 shows the tip of the example trocar with the guards fully extended and covering the knife edges as when completely inside of the abdominal cavity
  • FIG. 6 shows the example trocar tip at the moment it approaches the skin layer, and thus the guard tips are beginning to push against the skin and be retracted into the penetrator;
  • FIG. 7 illustrates the point when, in an example embodiment, the guards are completely pushed into the retracted position and the knife tips start to cut into the tissue;
  • FIG. 8 illustrates the point when, in an example embodiment, the knife tips have completed the passage across the tissue and begins to emerge across the endothelial layer into the abdominal cavity, and thus the tips of the guards begin to push into the incipient opening while a forceful jet of pressurized carbon dioxide gas pushes delicate internal tissues away from the immediate penetration region;
  • FIG. 9 illustrates the point when, in an example embodiment, the tips of the guards have penetrated the opening and prevent any contact between the knife tips and the surrounding internal tissues while the exposed knife edges behind the opening continue the cutting action, and the pressurized carbon dioxide gas expansion continues to hold delicate tissues away from the cutting region;
  • FIG. 10 illustrates, in an example embodiment, the continuing penetration, and thus the guards have penetrated almost completely, while behind them the still-exposed edges continue the cutting action and the passage of gas continues;
  • FIG. 11 illustrates the point in an example embodiment when the penetration has been completed. The knife edges are fully covered by the guards and the tissue opening allows for the passage of the cannula and the insufflation continues until completed and the penetrator assembly can be removed;
  • FIG. 12 shows the top view of an example trocar handle with a portion broken away to show some internal details;
  • FIG. 13 illustrates a longitudinal section along the horizontal plane 13-13 in FIG. 12 to exhibit most of the internal details of an example trocar handle
  • FIG. 14 illustrates a top view of the distal section of an example handle with the grasping horns to facilitate manipulation
  • FIG. 15 illustrates an end view of the distal section of an example handle as seen from the right showing also a partial broken section detail of the flap valve pivot and lever;
  • FIG. 16 illustrates a partial isometric view of the example locking mechanism for the guards stem showing some of the element within the proximal section of the handle;
  • FIG. 17 illustrates an exploded view of some of the example elements of the guards stem locking mechanism in an example spatial relationship;
  • FIG. 18 illustrates an example locking mechanism in a locked position
  • FIG. 19 illustrates an example locking mechanism having been unlocked and ready for the start of penetration
  • FIG. 20 illustrates how pushing the guards against the skin has forced their stem towards the right
  • FIG. 21 illustrates a position of the stem where the guards are completely retracted and the knife edges fully exposed for cutting
  • FIG. 22 illustrates a position of the locking mechanism after the full release of the guards into the abdominal cavity and the locking of their stem back to its initial position shown in FIG. 18.
  • FIG. 23 is a top plan view of a guard for the insufflator of the present invention.
  • FIG. 24 is a top plan view partially in cross section of the cutting blade top portion of the insufflator;
  • FIG. 25 is a side elevational view of the cutting blade tip portion shown in FIG. 23;
  • FIG. 26 is a top plan view of the tip portion of the guard
  • FIG. 27 is a side elevational view of the tip portion of the guard
  • FIG. 28a is a top plan view of the assembled distal tip shown when the guard is initially in contact with the skin
  • FIG. 28b is a top plan view of the assembled distal tip when pressed against the skin
  • FIG. 28c is a top plan view showing the device when penetrating tissue layers of the abdominal wall (for example);
  • FIG. 28d is a top plan view showing the device in an early stage of penetration of a final tissue layer of the abdominal wall with an option of gas/fluid provided at the moment of perforation;
  • FIG. 28e is a top plan view showing the distal tip in an extended position of the guard after puncture of the contiguous tissue layers.
  • FIG. 29 is a partial cross sectional view of the locking mechanism utilized in accordance with the present invention.
  • FIG. 30 is a cross-sectional view of FIG. 29.
  • FIG. 31 is an enlarged side elevational view of a portion of FIG. 29.
  • FIG. 32 is a top plan view of the lock mechanism shown in FIG. 29 with the lock mechanism removed.
  • FIG. 33 shows a side view of an additional embodiment of the invention in cross sectional.
  • FIG. 34 shows a top plan view of the sliding inner guard of the embodiment of FIG. 33.
  • FIG. 35 shows a side elevational view of the sliding inner guard tip.
  • FIG. 36 is a side axial view of the assembled additional embodiment.
  • FIG. 37 illustrates a further embodiment of the present invention.
  • FIG. 38 shows the distal end of the sleeve of the third embodiment, including the blade.
  • FIG. 39 discloses a top plan view of the distal end of the sleeve having a tapered flange.
  • FIG. 40 is a top plan view showing the guard when in position in the sleeve
  • FIG. 41 shows a side view of an additional embodiment of the present invention.
  • FIG. 42 shows a side view of the cannula and blade thereof. DESCRIPTION OF THE PREFERRED EMBODIMENTS
  • fluid is delivered into and through the device from an appropriate tubing or syringe via a Luer lock coupler 101 and is flow controlled with a simple stopcock mechanism 102, both items being common and well-known in the industry.
  • the outer body of the device is a hollow cylinder 104 (possibly made of surgical steel) and which is contemplated as being of a diameter of 1.0 - 4.0 mm in the preferred embodiment, to which is fixed a distal cutting blade 104a.
  • Within the outer body cylinder resides a coaxial sliding spring-loaded cylinder 105 with a blunt blade guard 105d fashioned distally.
  • the proximal extent of the sliding blade guard is compressed with a spring mechanism comprised of a fixed proximal block 103 a attached to the outer body, an appropriate gauge spring 103b, and an attachment 103c to the sliding guard 105a.
  • the block 103 a has a central opening formed therein for passage of the fluid therethrough.
  • the spring mechanism may additionally contain a locking mechanism that prevents retraction of a sliding guard after the guard fully protrudes distally (i.e., after tip penetration of the desired space).
  • the distal cutting end of the outer guard is comprised of a thin pointed fixed blade 104a across the open end of the distal cylinder, fixed at position 104f. Lateral to the flat aspect of the cutting blade 104a, the cylinder walls 107 slant proximally away and terminate in a beveled edge 104b to facilitate penetration.
  • the blade 104b has a centrally located opening 104b to facilitate flow of fluid through this region of the insufflator and into the tip and primary exit ports 105b.
  • the angle 104c subtended by the opposing blade edges is defined as #blade.
  • the angle 104e subtended 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 #tip.
  • the sliding inner guard mechanism 105 has a substantially conical tip 108 and an open lumen 105a that extends distally past the paired primary exit ports 105b.
  • the distal lumen of the inner guard mechanism may be hollowed out in such a way as to maximize fluid flow through the tip of the device, and is not restricted to the specific internal shape portrayed by reference numeral 105a.
  • Perpendicular to the exit ports is a slit 105c that is just wide enough to accommodate the cutting blade 104a.
  • the slit 105c is extended proximally to a position 105f far enough to allow distal deployment of the guard over the blade cutting surfaces and the guard has a blunt tip 105d as shown.
  • the angle 105e subtended by the tapered edges of the distal blade guard in the plane of the cutting blade is defined as ⁇ shield .
  • the proper functioning of the shield requires that 0 shield be less than ⁇ blade.
  • the angle 105g subtended by the distal tapering guard edges perpendicular to the plane of the blade is defined as 0tip.
  • the angles 104e and 105g should be approximately equal.
  • the insufflator is constructed, and the spring compression is adjusted, so as to allow the sliding blade guard to retract proximally and expose the distal cutting blade when pressed against the skin or outer surface of the area to be penetrated (Figs. 28a, 28b).
  • the distal blunt tip of the guard advances beyond the sharp tip of the blade and a puff of fluid discharges from the distal tip of the instrument (Fig. 28d).
  • the sliding blade guard continues to advance over the blade and the device appears as shown in Fig. 28e.
  • the primary fluid exit ports are thus fully exposed and maximum outflow can proceed.
  • the blade 104c has features similar to the blade utilized in the above-noted patent publication and patent application and thus can include a slightly rounded or blunt tip and also has a guard and blade apex relationship as described therein.
  • the guard lock mechanism ( Figures 29-32) here is constructed from paired, bilateral lever arms 207a which are textured to allow firm digital grip. A device with one or more levers and receiver slots is also possible. Axial compression of the spring-loaded lever arms allows disengagement of the locking pegs 207c, whereas pressure on the more perpendicular, distal lever arms allows the needle to be pushed into the desired space.
  • the levers are anchored via hinges 207b at the lever fulcrum.
  • the lever pegs 207c are compressed into corresponding holes in the outer sleeve 204 and corresponding receiver grooves 207d in the sliding inner guard 205.
  • the peg ends are rounded and designed to slide within the receiver grooves with a minimal amount of friction.
  • the area of the lever arm around the peg is contoured to tightly fit the surrounding outside surfaces of the outer sleeve so as to seal the holes and prevent escape or ingress of fluids through the bilateral defects.
  • the lever pegs 207c are curved to the radius of the fulcrum to allow smooth passage of the pegs through the holes and receiver grooves.
  • the receiver grooves 207d are slanted (deeper at the proximal end) so that compression from the bilateral lever arms via their pegs does not impede the movement of the sliding inner guard 205. Indeed, this geometry aids in the forward protrusion of the sliding guard and assists the safety features.
  • a deeper peg seal 207f At the most proximal extent of the receiver grooves is a deeper peg seal 207f.
  • a further embodiment of the invention is designed to increase the dilating forces of the outer sleeve 204 by the addition of a larger surface area at the distal end 210c (Figure 33).
  • This larger surface area may be created by thickening the wall of the outer sleeve.
  • the proximal extent of this thickened wall is denoted as 21 Of.
  • the cutting edge 204a is of the same relative geometry to the sliding inner guard as the first embodiment, but the cutting blade, itself, may be made as a solid, flat piece of metal without an internal window 204b.
  • the line denoted 210b (Fig. 39) shows the proximal extent of this cutting blade.
  • the blade may be securely fixed the outer sleeve at the area denoted 210d.
  • the sliding inner guard of the second embodiment retains the same relative geometry to the cutting edge as described earlier in the invention.
  • the most distal tip 212a of the guard may have a semi-conical shape, convex to the outside ( Figure 34).
  • the guard tip 212a may also be of a more squared shape, depending on its application.
  • the flow of fluid through the tip of the device is augmented by greatly enlarging the defect in the guard tip and reducing the support of the guard tip to two bilateral, parallel rails or posts.
  • the ample communication between the inner guard lumen and large guard defects is demonstrated in the rotated axial side view of the sliding inner guard tip.
  • the distal extent of the defect is denoted by the line 213a ( Figure 35).
  • a side axial view of the assembled an additional embodiment is shown ( Figure 34).
  • FIG. 37 A rotated axial side view of the extended guard of this additional embodiment ( Figure 37) demonstrates how the sliding inner guard 212a covers and protects the cutting blade 210a, and is separated from the dilating forces created by the outer sleeve surface 210c.
  • a further embodiment (Figure 38) of the invention further augments the dilating forces of the outer sleeve 204.
  • the distal end of the sleeve has plurality of distally tapering flanges 216a ( Figures 38-40) to help shield the blade 210a. These flanges parallel the cutting blade 204a, yet provide adequate space for the egress of the sliding inner guard. These flanges create virtually all the dilating forces required for entry of the device into the substance of the tissue (or other medium being penetrated). This allows the sliding inner guard to move distally without any significant frictional forces on said guard. Once a space or potential space is reached by the distal tip of the device, the sliding inner guard extends distally into the position denoted ( Figure 40).
  • FIG. 41 An axially rotated view of the assembled device ( Figure 41) further shows the relationship of the components and the distal extent of the inner guard defect channel 213a distally past the dilating flanges.
  • FIG. 42 An additional embodiment of the device is shown ( Figure 42). This embodiment combines aspects of both the second and third versions described above.
  • the distal dilating flanges are thickened into a more conical shape 220a with a thicker base. This thickened, stronger flange would be supported by the thickened walls of the outer sleeve 204 that terminate at 21 Of, yet allow for fluid flow through the lumen lOe.
  • the flanges 220a may be perforated 220b in a manner that facilitates flow of fluids through the tip of the device.
  • the needle device may be fitted with an optional guard locking mechanism (Figure 29).
  • This lock maintains the sliding guard 205 in its extended, blade-covering position after penetration of a space or potential space.
  • the lock may be disengaged by squeezing the lever arms 207a, allowing the guard to retract proximally, which then allows the needle to be advanced through deeper, successive layers of tissue.
  • the operator will have a tactile sensation of the lever arms closing as the lever pegs 207c seat in the peg seats 207f in the sliding inner guard 205 each time the guard slides distally and locks in position. In this manner, the operator can access a desired space or potential space within the body (e.g., the epidural space, amniotic cavity, peritoneal cavity, intravascular space, etc.) in a safe, step by step, controlled manner.
  • a desired space or potential space within the body e.g., the epidural space, amniotic cavity, peritoneal cavity, intravascular space, etc.
  • a modification to each embodiment includes a blade which is somewhat wider than the diameter of the outer sleeve 204. This will cut a larger defect in the tissue (or other medium being penetrated) and facilitate penetration through strong, dense tissues (e.g., ligaments). This modification may ease the performance of medical procedures such as epidural anesthesia.
  • the shape of the proximal end of the guard slot 202c between the blade 210a and dilating flange 220a can be variable.
  • the slot may terminate as indicated 202d ( Figure 42) or may be squared or rounded, for example.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Vascular Medicine (AREA)
  • Pathology (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un dispositif et un procédé chirurgicaux pour mettre en oeuvre des interventions chirurgicales endoscopiques permettant de prévenir des lésions aux organes internes lors de l'insertion du dispositif. Ce dispositif peut comprendre un ou plusieurs des éléments suivants : système à tranchants multiples ou à une seule lame, dispositif de protection mécanique de tissu qui comprend une série de gardes en plastique mince glissant sur les côtés de couteaux plans et dont les bords forment un angle inférieur à celui formé par les arêtes de coupe, un ou plusieurs déflecteurs coniques fixes qui agrandissent le passage dans le tissu coupé et ne laissent que les extrémités des gardes en contact avec le tissu, passage d'insufflation conçu pour permettre le transport d'un fluide dans la cavité corporelle pendant la pénétration, système de verrouillage des gardes qui empêche une réutilisation accidentelle des éléments coupants, et/ou conception ergonomique facilitant la manipulation.
EP04717923A 2003-03-06 2004-03-05 Insufflateur et procede d'utilisation Withdrawn EP1605812A4 (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US45204003P 2003-03-06 2003-03-06
US452040P 2003-03-06
US49412203P 2003-08-12 2003-08-12
US494122P 2003-08-12
PCT/US2004/003370 WO2004080274A2 (fr) 2003-03-06 2004-03-05 Insufflateur et procede d'utilisation

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EP1605812A2 true EP1605812A2 (fr) 2005-12-21
EP1605812A4 EP1605812A4 (fr) 2006-07-26

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EP (1) EP1605812A4 (fr)
JP (1) JP2006519670A (fr)
KR (1) KR20050105272A (fr)
AU (1) AU2004220625A1 (fr)
CA (1) CA2518043A1 (fr)
MX (1) MXPA05009572A (fr)
WO (1) WO2004080274A2 (fr)

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US20070093697A1 (en) * 2005-10-21 2007-04-26 Theranova, Llc Method and apparatus for detection of right to left shunting in the cardiopulmonary vasculature
US8911463B2 (en) * 2008-06-10 2014-12-16 Covidien Lp Bladed/bladeless obturator for use in a surgical trocar assembly
KR101840551B1 (ko) * 2016-07-08 2018-03-20 운스메디칼 주식회사 보호캡을 구비한 생체검사용 바늘 조립체
CN107744401B (zh) * 2017-11-14 2024-05-07 北京水木天蓬医疗技术有限公司 超声骨刀刀头
KR20210056630A (ko) * 2019-11-11 2021-05-20 고려대학교 산학협력단 양막 파막 장치

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US5797943A (en) * 1994-05-06 1998-08-25 Endoscopic Concepts, Inc. Shielded trocar and trocar shield
WO2000078387A1 (fr) * 1999-06-22 2000-12-28 Blanco Ernesto E Trocart de securite pourvu de protections de tete de coupe et d'un deflecteur a jet de gaz dans les tissus.

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US5984941A (en) * 1997-02-13 1999-11-16 Endoscopic Concepts, Inc. Trocar

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Publication number Priority date Publication date Assignee Title
US5797943A (en) * 1994-05-06 1998-08-25 Endoscopic Concepts, Inc. Shielded trocar and trocar shield
WO2000078387A1 (fr) * 1999-06-22 2000-12-28 Blanco Ernesto E Trocart de securite pourvu de protections de tete de coupe et d'un deflecteur a jet de gaz dans les tissus.

Non-Patent Citations (1)

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Title
See also references of WO2004080274A2 *

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MXPA05009572A (es) 2005-11-17
WO2004080274A3 (fr) 2006-03-16
EP1605812A4 (fr) 2006-07-26
AU2004220625A1 (en) 2004-09-23
JP2006519670A (ja) 2006-08-31
KR20050105272A (ko) 2005-11-03
WO2004080274A2 (fr) 2004-09-23
CA2518043A1 (fr) 2004-09-23

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