WO2013163708A1 - Micro-incision instrument - Google Patents
Micro-incision instrument Download PDFInfo
- Publication number
- WO2013163708A1 WO2013163708A1 PCT/BR2013/000144 BR2013000144W WO2013163708A1 WO 2013163708 A1 WO2013163708 A1 WO 2013163708A1 BR 2013000144 W BR2013000144 W BR 2013000144W WO 2013163708 A1 WO2013163708 A1 WO 2013163708A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- blade
- instrument
- button
- instrument according
- micro
- Prior art date
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
- A61B17/32—Surgical cutting instruments
- A61B17/3209—Incision instruments
- A61B17/32093—Incision instruments for skin incisions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00008—Vein tendon strippers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3209—Incision instruments
- A61B17/3211—Surgical scalpels, knives; Accessories therefor
- A61B2017/32113—Surgical scalpels, knives; Accessories therefor with extendable or retractable guard or blade
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0814—Preventing re-use
Definitions
- the present invention relates to a micro-incision instrument with high degree of safety against accidents, graduated, with intended but not limited use in surgeries and micro-surgeries of varicose veins of the lower limbs, having the function of making incisions by (removal of varicose veins) and incisions for safenectomy (surgical treatment of the saphenous vein, with access by the inguinal region), with the lowest possible trauma to the skin.
- the instrument of the present invention further includes, in some of its variations, safety devices to minimize the risk of work accidents with contaminated puncturing material.
- veins that by different processes have become dilated, elongated and tortuous.
- the 40 x 12 needle having a cylindrical shape and its blade almost completely accompanying this shape, eventually performs a "puncture" on the skin, associated with a micro-biopsy of the skin (taken from a micro-fragment), resulting in an irregular, oval incision, with the consequent loss of a small fragment of skin (Figs. 1 to 4, 29 and 33), culminating with a slightly larger scar due to the trauma caused.
- Fig. 32 primary healing - first intention
- Fig. 33 secondary healing - second intention, verified when the surgical wound has irregular and distant edges, evolving with slower healing and with greater formation of fibrous tissue, worse aesthetic result.
- the puncture-wound accident in addition to the injury itself, carries with it the risk of contamination by blood-borne pathogens, in particular the AIDS virus, Hepatitis B and Hepatitis C, thus exposing the medical staff and auxiliaries to serious risks, in addition to large financial costs.
- Both the 40 x 12 needle and the No. 11 knife were adapted to this function (perform the micro-incisions) and not developed for this function, resulting in limitations and technical problems that may compromise to a lesser or greater degree the result end of the surgical procedure, in its aesthetic and safety aspect, both with potential risk of causing work accidents, and with a not insignificant risk of contamination for the team.
- the instrument of the present invention consists of its basic configuration in a surgical instrument in steel or plastic, disposable (Fig. 31), ergonomic, approximately 37 mm in length, 23 mm in width and with a thickness of 1 to 4 mm and with its rounded edges, further comprising a v-shaped ultra-thin blade at its end, with cutting edge limited by the minor edge of the apparatus.
- the instrument of the present invention has various grades (micro-incision blade sizes) and, alternatively and in addition, an automatic safety system.
- the graduations regarding the cutting area of the blade allow incisions that fit the surgical needs of each segment, that is, allow the performance of micro-incisions graduated for the segmental extraction of microvarices, and surgical incisions for safenectomy (Fig. 34).
- the safety system due to a device for automatic retraction of the blade, makes the instrument safer and makes concealment of the blade natural and independent of the action of the operator.
- the inclusion of safety devices in the design of surgical instruments is mentioned in the available literature as the best way to reduce puncture-shear injuries, and may make unintentional injury to the medical staff or the patient unlikely (see Tan al., 2001).
- the functional concept of the device developed is very intuitive, with a simplified use, both with regard to its central function, which is the performance of micro-incisions, as well as the protection against puncture-sharp accidents, thus dispensing with specific training for its use .
- the ergonomic concept applied led to the development of a small, light weight device with negligible weight, a shape that resembles the human thumb (Fig. 21 and 57) and with an anti-slip area (Figs 21 and 31).
- the instrument of the present invention enables the micro- - minimally traumatic linear incisions in the skin, without subtracting skin fragments (ie, without biopsy), in a controlled and graduated manner, adapting to the needs of each varicose segment to be treated, and without the need for the use of digital artifices by part of the surgeon to control the extent of his incision, thus resulting in a smaller and more discreet scar, contributing to an even more satisfactory aesthetic result; in addition to providing safety and comfort in the handling of surgical instruments, avoiding accidents because it has a safety device that optionally or automatically recovers the whole piercing area when not in use, allowing its handling
- the instrument of the present invention presents, in one of its embodiments, a "shared" level of security of responsibility in which the user of the apparatus is responsible for monitoring and triggering the shield that protects the blade (Fig. 15).
- the instrument of the present invention has an "improved" device, with more complex construction, which eliminates the need for monitoring and activating the security system.
- the device automatically assumes the safe position, with retraction of the blade and its perforating-cutting area, immediately after the end of its use, thus conferring a higher level of protection ( Figures 40 and 52).
- Figures 1 to 4 represent the prior art, with the use of a syringe needle
- Figures 5 to 9 represent the prior art, with the use of a scalpel
- Figures 10 and 11 show the prior art application with the use of a syringe needle
- Figures 12 and 13 represent the application of the prior art, with the use of a scalpel
- Figure 14 is a perspective view of the preferred embodiment of the invention, with a protective shield
- Figure 15 is a perspective view of the preferred embodiment of the invention with the protective shield activated
- Figure 16 is a cross-sectional view of the preferred embodiment of the invention, with a protective shield
- Figure 17 is an exploded view of the preferred embodiment of the invention, with a protective shield
- Figure 18 represents an illustration of the protective shield
- Figure 19 is a cross-sectional view of the protective shell
- Figure 20 is a schematic view showing the operating principle of the invention.
- FIG. 21 is an illustration of the use of the invention.
- FIG. 22 is an illustration of the use of the invention.
- Figure 23 is a perspective view of the variation of the invention with retractable blade
- Figure 24 is a schematic illustration showing the actuation of the variation of the invention with retractable blade
- Figure 25 is a perspective view of the variation of the invention with retractable blade showing the side of the apparatus having anti-slip texture
- Figure 26 represents an exploded view of the 1st variation of the invention, with retractable blade
- Figure 27 is a cross-sectional view of the variation of the invention with retractable blade
- Figure 28 shows a side view of the variation of the invention with retractable blade, showing the minimum thickness of the cable
- Figure 29 represents an illustration of the five possible positions of the blade in I the variation of the invention, with retractable blade: four different possibilities of exposed blade and one with the blade sheltered;
- Figure 30 is an illustration of the use of the variation of the invention with retractable blade
- Figure 31 represents a schematic view demonstrating performing micro-incision on the skin
- Figure 32 is an illustration showing the linearity and uniformity of the micro-incisions carried out with the invention.
- Figure 33 represents an illustration demonstrating the shape and size variation of the needle micro-incisions
- Figure 3 represents an illustration showing the shape and size variation of the micro-incisions made with a scalpel blade
- Figure 35 represents an illustration of the invention
- Figure 36 represents a schematic view showing a minimally traumatic linear micro-incision on the skin
- Figure 37 represents a schematic view showing a micro-incision with subtraction of skin fragments (i.e., with biopsy);
- Figure 38 shows an illustration of the blade outlet platform, in the variation of the invention, with retractable blade
- Figure 39 is an illustration of the use of the blade outlet platform in the variation of the invention with retractable blade
- Figure 40 represents a perspective of the 2nd variation of the invention with the concealed blade
- Figure 41 represents a perspective of the 2nd variation of the invention with the two buttons engaged and the exposed blade;
- Figure 42 is a side view of the variation of the invention, supported on a surface and with the blade secured;
- Figure 43 is a cross-sectional view of the variation of the invention without the drive and the blade secured;
- Figure 44 represents an illustration of the mechanism of the second variation of the invention, without the buttons being engaged, and with the blade guarded;
- Figure 45 shows a cross-sectional view of the 2nd variation of the invention with the two buttons engaged and with the exposed blade;
- Figure 46 is an illustration of the drive mechanism of the invention, with the buttons engaged, and with the blade exposed;
- Figure 47 is a front view of the variation of the invention.
- Figure 48 is a side view of the variation of the invention.
- Figure 49 represents a top view of the variation of the invention.
- Figure 50 represents a rear view of the 2nd variation of the invention.
- Figure 51 represents a schematic illustration of the transmission of the vertical movement to the horizontal movement, through a larger ramp, with the simplification of the mechanism;
- Figure 52 represents a schematic illustration of the transmission of vertical movement to horizontal movement, via a smaller ramp, with the addition of a lever;
- Figure 53 represents a perspective of the variation of the invention, with the blade hidden
- Figure 54 is a perspective view of the variation of the invention, with the blade exposed
- Figure 55 configuration of the third variation of the invention in neutral position, with hidden blade
- Figure 56 configuration of the third variation of the invention with the selected blade, hidden;
- Figure 57 configuration of the third variation of the invention with exposed blade, in use situation
- Figure 58 illustrations of the use of the 3rd variation of the invention.
- Figure 59 represents an illustration explaining the components of the mechanism of the variation of the invention.
- Figure 60 illustration of the central button of the third variation of the invention.
- the preferred embodiment comprises an ultrasonic blade of specific width and length for performing customized incisions in varice removal surgeries, added with a widening for the surgeon's handling and with the blade arranged in such a way as to limit its insertion in the patient, as shown in the schematic of Figure 20, where measurements x and z are accurately reached at all incisions.
- Figures 14, 15, 16, 17, 18, 19, 20, 21 and 22 show the preferred embodiment of the instrument of the present invention comprised of a cable 1 with anti-sliding protrusions and an ultra- carefully dimensioned.
- the cable 1 increases in thickness as it approaches the blade 2, as shown in Figure 16, thereby enabling the minimum thickness of the anti-slip cable at the opposite end.
- the preferred embodiment of the invention is composed of three elements: the cable (1), the blade (2) and the shield (6).
- the cable (1) we can see the instrument in the safe position, with the shield (6) advanced, protecting the blade (2) from unwanted contacts with the user.
- Figure 17 is a schematic illustration where it is possible to visualize the three components of this embodiment of the invention.
- the shield (6) engages the blade (2) by means of its protuberance (8) which runs on the rail (7).
- FIG 16 shows that with this drawing it is possible for the thickness of the cable (1) to be as thin as the thickness of the ultrafine blade (2).
- the shield 6 has two protrusions 8, as shown in Figure 19, which run within the rail 7 and have its movement limited thereto. Moreover, the side piece (6) slides along the cable (1), as seen in Figure 13.
- Figures 23 to 31, 38 and 39 show the 2nd embodiment of the invention, with graduation of the blade.
- the variation in question is justified by the peculiarity of each clinical case. As explained earlier, each patient requires a different depth and incision width. This variation contains two blades aiming at bringing together in the same instrument three or four variations of width and length of incision.
- the system uses two slides with a specific shape that allows up to four qualities of incisions with them to be made.
- the instrument has two outputs at the opposite ends of the apparatus. At one end a larger blade, the other a narrower blade.
- the four incision measurements are obtained with the positioning of each blade partially or fully exposed. In this way for each blade - with its profile designed specifically for the function - there are two use positions, totaling four types of incision, with the widths (s), (t), (q) and (r) and different lengths regulated through of a button running on a tear in the body of the instrument.
- the instrument can only be in one of these positions at a time, since the joined assembly (formed by the components 34 and 33) operates in such a way that one position makes the other inexorably unfeasible.
- This movable assembly has lateral recesses where protrusions (36) engage when the assembly moves longitudinally and return to rest when they encounter another recess in the relief of the blade (34). From this motion results a tactile sensation signaling the change of position.
- the recesses can be directly on the blade or the plastic support that supports it, which can generate changes in the manufacturing cost.
- the movable assembly comprised of the blade 34 and the button 33 runs through the rails 37 and the groove contained in the body 32a.
- the body 32b contains a shoulder 36 which engages the recesses of the movable assembly 34 and 33 according to the principle explained above.
- the body (32a) contains markings (35) indicating in which position the moving assembly found. Likewise, the width of the blade is signaled at each end (28).
- the instrument is inexorably thicker.
- a prolongation (83) of the body (32a) toward the blade outlet forms a platform allowing the surgeon to maintain full view of the blade at the time of the micro (Figs. 38 and 39).
- Figures 40 to 52 show the 2nd variation of the invention, with an automatic safety system.
- the blade retracts automatically by a spring that, in rest situation, keeps the blade inside the body of the apparatus.
- the instrument can only be used by continuous pressure on the drive buttons (65 and 59) located on both sides of the device, thus minimizing the occurrence of perforating-cutting accidents resulting from exposure without the need for the blade.
- the system of this mode uses two central buttons (59 and 65), on the front and back of the device, which must be simultaneously the blade to be exposed (Figs 40 and 41).
- the back button of the device 59 has an inverted “L” shaped extension (Fig. 44, item 66) which latches the blade or the plastic component containing the blade (68) while not being depressed.
- the front button 65 is connected to a lever 64, which transmits its movement to the cartridge with the blade 68, causing it to slide out of the body.
- Figures 43, 44, 45 and 46 depict the operation of this embodiment.
- Figures 43 and 44 show the instrument in the resting state, with the blade guarded
- Figures 45 and 46 show the use situation, with the blade exposed.
- the surgeon presses with the thumb and forefinger simultaneously the mentioned center buttons causing the back button of the device to unlock the cartridge (68) while the front button fires the lever 64, which in turn transmits the action to the cartridge 68, causing it to slide horizontally, exposing the blade 63, and assuming the use configuration (Figures 45 and 46).
- the design of the blade 63 with a stopper and the small aperture in the body of the device 62 ensures accuracy as they determine the portion of the exposed blade and consequently the size of the micro-incisions made by the surgeon during the act operative.
- the vertical movement of the button (Fig. 44 - item 65) in horizontal movement of the cartridge (68) can operate in two ways: through a larger ramp, a and simplification of the mechanism (Fig. 51); or through a smaller ramp, a lower knob and an internal lever to achieve the same horizontal displacement with less vertical displacement (Fig. 52).
- Fig. 51 when depressed - vertical movement - the ramp 69 located below the button directly pushes the blade 70, causing it to slide - horizontally.
- the ramp 71 located below the button moves a lever 73, which rotates, causing the blade to slide and be exposed.
- Figures 53, 54, 55, 56, 57, 58, 59 and 60 show the variation of the invention, with automatic safety system and choice of various blade sizes.
- the blade automatically retracts by means of a spring 76 which, in rest state, holds the blade within the body of the apparatus and the instrument can only be used by continuous pressing on the drive button 78, .
- this mode In order not to accidentally trip the blade, this mode has a "neutral" position in which no blade is selected. The surgeon then engages the selector gear (81) to bring the instrument into the "active" position, depending on the blade size desired. It minimizes the occurrence of perforating injuries and allows the micro-incision to be graded.
- the 3rd variation of the invention contains a plate-shaped three - pointed star (Fig. 54, item 72), to meet the same incision instrument three qualities (length and width variations).
- the risk of puncture-sharp accidents to which the health team is subject has also been mentioned.
- the The blade retracts automatically after use (Fig. 55) and is placed in a safety position, ie the 3-prong star (73) goes to a "neutral" position where no blade is aligned with the appliance outlet.
- Figures 55, 56 and 57 illustrate the 3 configurations that the improved mechanical device acquires during its use: In the first, figure 55, the blade in neutral position; In the second, figure 56, selecting the blade size through the rotation of the gear (79); and in the third, figure 57, the exposed blade, in use situation. When the surgeon releases the instrument, it automatically returns to the first setting, in a neutral position (Fig. 55).
- the cartridge where the blade is secured but free to rotate 75 moves forwardly, leading the blade 73 and exposing it for use (Fig. 57).
- the lever 80 rotates under the effect of the protrusion 78c, leaving the gear 81 free.
- the latch 78e descends, preventing the gear from moving by the spring 82.
- the compression spring 77 causes the button to raise to the initial position, enabling the cartridge 77 to slide backward, bringing the blade (73) into the device, securely.
- the latch 78e rises together with the button releasing the gear 81, which, by force of the gear spring 82, returns to the neutral position by rotating with it the small gear attached to the blade 74.
- the shoulder 83 on the gear 81 touches the lever 80 by moving it to its original position, thereby preparing the device to be used again.
- the device is arranged in such a way that when pressing the external button (Fig. 58, item 78) accidentally or without the previous selection of size, the blade can not be expelled.
- the use is therefore made in two steps: the rotation of the gear for the choice of the blade and the drive of the central central button (78) for the ejection of the blade. If the external button is activated without prior selection of the blade, the cartridge (75) will advance in a neutral position, not allowing blade exposure (Fig. 54). When it automatically returns to the neutral position (Fig. 54), the instrument will again need two steps to expel the blade.
- the way to perform the conversion of the vertical movement of the horizontal movement displacement of slide button 3 and the 2nd variation of the invention is not limited to the shape shown in the respective descriptions.
- the manufacturer can change the solutions, opting for the direct system (Fig. 51) which is simpler but requires a larger ramp; or by the indirect system, with a more complex lever (Fig. 52), however, it requires a smaller ramp on the outer knob, resulting in a smaller total thickness.
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
BRBR102012010633-7A BR102012010633A2 (en) | 2012-05-04 | 2012-05-04 | MICRO-INCISION INSTRUMENT |
BRBR102012010633-7 | 2012-05-04 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2013163708A1 true WO2013163708A1 (en) | 2013-11-07 |
Family
ID=49514122
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/BR2013/000144 WO2013163708A1 (en) | 2012-05-04 | 2013-05-03 | Micro-incision instrument |
Country Status (2)
Country | Link |
---|---|
BR (1) | BR102012010633A2 (en) |
WO (1) | WO2013163708A1 (en) |
Citations (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3905101A (en) * | 1974-04-19 | 1975-09-16 | Becton Dickinson Co | Disposable surgical scalpel |
WO1990011725A1 (en) * | 1989-04-06 | 1990-10-18 | Stuart Dolgin | Surgical scalpel with retractable blade guard |
US5207696A (en) * | 1992-04-30 | 1993-05-04 | Medical Sterile Products, Inc. | Surgical scalpel |
US5319853A (en) * | 1992-11-02 | 1994-06-14 | Great Neck Saw Manufacturing, Inc. | Scraper |
US5370654A (en) * | 1993-06-18 | 1994-12-06 | Leonard Bloom | Disposable guarded finger scalpel for inserting a line in a patient and method of use thereof |
US5868771A (en) * | 1997-07-25 | 1999-02-09 | Pabban Development, Inc. | Scalpel blade cover |
US6623499B1 (en) * | 2002-02-21 | 2003-09-23 | Michael Andreini | Retractable safety scalpel |
US20040243161A1 (en) * | 2003-05-30 | 2004-12-02 | Ribbel International Limited | Disposable guarded surgical scalpel |
WO2010065508A1 (en) * | 2008-12-03 | 2010-06-10 | Shackelford Howard L Sr | Scalpel with removable blade assembly |
-
2012
- 2012-05-04 BR BRBR102012010633-7A patent/BR102012010633A2/en not_active IP Right Cessation
-
2013
- 2013-05-03 WO PCT/BR2013/000144 patent/WO2013163708A1/en active Application Filing
Patent Citations (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3905101A (en) * | 1974-04-19 | 1975-09-16 | Becton Dickinson Co | Disposable surgical scalpel |
WO1990011725A1 (en) * | 1989-04-06 | 1990-10-18 | Stuart Dolgin | Surgical scalpel with retractable blade guard |
US5207696A (en) * | 1992-04-30 | 1993-05-04 | Medical Sterile Products, Inc. | Surgical scalpel |
US5319853A (en) * | 1992-11-02 | 1994-06-14 | Great Neck Saw Manufacturing, Inc. | Scraper |
US5370654A (en) * | 1993-06-18 | 1994-12-06 | Leonard Bloom | Disposable guarded finger scalpel for inserting a line in a patient and method of use thereof |
US5868771A (en) * | 1997-07-25 | 1999-02-09 | Pabban Development, Inc. | Scalpel blade cover |
US6623499B1 (en) * | 2002-02-21 | 2003-09-23 | Michael Andreini | Retractable safety scalpel |
US20040243161A1 (en) * | 2003-05-30 | 2004-12-02 | Ribbel International Limited | Disposable guarded surgical scalpel |
WO2010065508A1 (en) * | 2008-12-03 | 2010-06-10 | Shackelford Howard L Sr | Scalpel with removable blade assembly |
Also Published As
Publication number | Publication date |
---|---|
BR102012010633A2 (en) | 2014-03-25 |
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