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EP0162836A1 - Bistouri a profondeur de coupe fixe - Google Patents

Bistouri a profondeur de coupe fixe

Info

Publication number
EP0162836A1
EP0162836A1 EP83903658A EP83903658A EP0162836A1 EP 0162836 A1 EP0162836 A1 EP 0162836A1 EP 83903658 A EP83903658 A EP 83903658A EP 83903658 A EP83903658 A EP 83903658A EP 0162836 A1 EP0162836 A1 EP 0162836A1
Authority
EP
European Patent Office
Prior art keywords
blade
cut
depth
handle
scalpel
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Withdrawn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
EP83903658A
Other languages
German (de)
English (en)
Inventor
Ronald P. Jensen
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.)
Individual
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 EP0162836A1 publication Critical patent/EP0162836A1/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Withdrawn legal-status Critical Current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
    • 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
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/013—Instruments for compensation of ocular refraction ; Instruments for use in cornea removal, for reshaping or performing incisions in the cornea
    • A61F9/0133—Knives or scalpels specially adapted therefor
    • 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
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin

Definitions

  • This invention relates to scalpels which include means to control the depth of cut. More particularly, this invention relates to scalpels for use in radial keratotoirty.
  • radial keratotomy This procedure corrects myopia (nearsightedness) by altering the curvature of the cornea of the eye. The curvature is altered by making a series of radial incisions in, but not through, the cornea itself.
  • the depth of cut into the cornea must be accurately determined and controlled.
  • the incisions must have sufficient depth, usually just greater than three-quarters of the depth of the cornea, but should not 1 penetrate the cornea itself. Penetration of the cornea would release fluid from the anterior chamber of the eye, increase the likelihood of infection, and detract from the predictability of the results of '5 the procedure.
  • the thickness of the cornea varies from patient to patient and accordingly, must be accurately determined by known means prior to surgery.
  • the appropriate depth of cut can be selected.
  • adjustable scalpels have several drawbacks.
  • One drawback relates to the predictability of the depth of the cut.
  • To set the depth of cut the surgeon must, by hand and using a scale or a gauge, adjust depth of' cut of the scalpel.
  • One type of adjustable scalpel is one type of adjustable scalpel
  • a blade coupled with an adjustable micrometer ⁇ like knob on the handle.
  • Another type uses a depth gauge separate from the scalpel and provides for adjustment of the depth of cut by movement of a guard relative to the scalpel blade cutting edge, the
  • 25 guard being positionally fixed to the scalpel handle by a thumbscrew after determination of the desired cut depth.
  • OMPI 1 Another problem of scalpels having an adjustable depth of cut occurs in setting the depth of cut after - * - * --- r p- ⁇ -.djustment has been ascertained by use of a gauge. The fixing of the adjustable member may '5 alter the setting, thereby again detracting from the accuracy of the depth of cut setting. Still another drawback is that adjustable scapels tend to be expen ⁇ sive. Yet another drawback is that reusable scalpels must be sterilized and their blades tend to dull with
  • the scalpel particularly adapted for radial keratotomy.
  • the scalpel includes a handle which mounts a blade at one end, the blade having a suitable cutting edge.
  • a sleeve is fixed to
  • the handle near its one end and includes an outwardly projecting mount.
  • the mount in cooperation with the handle and the sleeve, enables the surgeon to securely and comfortably grip the scalpel between the index finger, middle finger, and thumb, and with the cutting 5 edge consistently oriented in a proper position.
  • a foot is provided.
  • the foot is preferably metallic to resist bending and twisting which would effect the depth of cut and has one end attached to the sleeve. Additionally, the 0 metallic foot can be made relatively narrow so as not to interfere with the surgeons view while still resis ⁇ ting deflection. From the sleeve, the foot projects toward the blade to define, remote from the sleeve, a bifurcated guard defined by a pair of arms which run 5 parallel to and straddle the blade cutting edge.
  • the arms are adapted to bear against the cornea, the extension of the cutting edge past the guard determining the depth of cut.
  • the position of the guard relative to the cutting edge is accurately preset, thereby accurately determining the depth of cut to within 10 microns.
  • kits including a plurality of
  • FIG. 1 is a perspective side view of an adjustable scalpel according to the prior art
  • FIG. 2 is a side elevation view of a scalpel according to the present invention.
  • FIG. 3 is an enlarged side elevation view of the tip of the scalpel shown in FIG. 2;
  • FIG. 4 is a front end view of the scalpel shown in
  • FIG. 2
  • FIG. 5 is a partial top view of the scalpel shown in FIG. 2;
  • FIG. 6 is a partial side view of the scalpel as held in the hand
  • FIG. 7 is a front end view of the scalpel as held in the hand.
  • FIG. 8 is a graphical depiction of the distri ⁇ bution of the required depth of cut based upon emperical data with the ordinate representing depth of cut and the abscissa representing number of occurrences in which a particuliar depth of cut was required in a radial keratotomy procedure.
  • the scalpel 10 has a handle 12 which may be fashioned from plastic or the like. At one end of the handle is fixed a blade 14 having a suitable cutting edge 16. The cutting edge 16 is adapted to make incisions into the cornea of the patient during the surgical procedure known as radial keratotomy.
  • a sleeve 18 is adjustably mounted to the handle 12. As can be appreciated from FIG. 1, the sleeve 18 passes over the handle 12 and can be fixed relative thereto by a set screw 20.
  • the sleeve 18 includes a foot 22 which projects toward the blade 14 to define a guard shown generally as 24.
  • the guard 24 is bifurcated to define a pair of parallel arms 26 spaced apart by a gap 28, the arms 26 straddling and extending parallel to the blade and normal to the length of the scalpel handle at the anterior end of the scalpel. As can be seen, the blade cutting edge 16 extends through the gap 28 and past the arms 26. During radial keratotomy, the anterior surfaces of the arms 26 bear against the cornea to prevent the cutting edge 16 from cutting too deep into or penetrating the cornea.
  • the extent to which the cutting edge 16 protrudes through the gap 28 outwardly (anteriorly) of the guard 24 can be determined.
  • the amount to which the cutting 16 protrudes past the guard 24 defines the depth of cut of the scalpel 10.
  • adjustable scalpel 10 involves the setting of the depth of cut.
  • a separate depth gauge is used to determine the position of the guard 29 relative to the tip of the blade cutting edge 16.
  • a surgeon or technician is required to compare the depth of cut as set on the scalpel 10 with the gauge and adjust the position of the sleeve 18 accordingly.
  • the setting of the depth of cut is not exact. Misperception, inaccuracy of the gauge, or other factors noted above, either acting in combination or acting independently, can detract from the overall accuracy of the depth of cut setting.
  • the tightening of the set screw 20 may in and of itself tend to alter the position of the sleeve 18 along the handle 12 and thereby the location of the arms 26 relative to the cutting edge 16. This in turn, causes a deviation in the depth of the cut setting. Furthermore, since the scalpel 10 is adapted to be used repeatedly, the tightening of the set screw 20 may produce dimples in the handle 12. In setting the depth of cut, the set screw 20 may tend to seek an adjacent dimple thereby altering the position of the sleeve 18 along the handle 12 and the setting of the depth of cut.
  • the scalpel 30 includes a handle 32 preferably molded from plastic or the like.
  • '5 handle 32 is cylindrical having a longitudinal axis and having one end tapered to define a forward tip 34.
  • a blade 36 having a surgical cutting edge 38.
  • the tip 34 is provided with an axial aperture 40 which
  • 10 may mount the blade 36 by an interference fit.
  • the blade may be secured to the handle by insert molding of the blade 36 into the handle 32 or the blade 36 may be bonded into the aperture 40 and handle 32 by a suitable glue. Accordingly, the
  • blade 36 is securely affixed to the handle 32 and is prevented from moving axially and angularly relative to the handle 32.
  • the scalpel 30 includes a sleeve 42, preferably of molded plastic, adapted to set a depth of cut.
  • the sleeve 42 is semi-cylindrical having a forward end 43 and having an internal diameter adapted to mate with the outside diameter of the handle 32.
  • the sleeve 42 is precisely positioned along the handle 32 and is thereafter fixed to the handle 32 by sonic welding, by a suitable adhesive, or by other means. Accordingly, the sleeve 42 once fixed to the handle 32 is prevented from moving relative thereto.
  • the sleeve 42 holds and supports a gauge member or foot 44 which preferably is fashioned from metal to prevent deflection such as by bending and twisting during the surgical procedure. Deflection of the foot 44 would tend to unpredictably alter the depth
  • the foot 44 can be made relatively narrow so as not to obscure the surgeon's vision.
  • the sleeve 42 includes a radially outwardly projecting mount 46.
  • the mount 42 is preferably rectangular and extends longitudinally along the sleeve 42 at approximately the circumferential midpoint from the forward end 43 to a point repre ⁇ senting approximately one-half the longitudinal length of the sleeve 42. It is to be understood, however, that the mount 46 can have other configura ⁇ tions and orientations suitable for operation of the scalpel 30 as herein set forth.
  • the foot 44 may be insert molded into the mount 46, or the mount 46 may be provided with a receptacle to receive the foot which is thereafter bonded into the recepticle by a suitable glue or the like. Accordingly, the foot 44 and sleeve 42 are positioned and fixed along the handle 32 as a unit.
  • the foot 44 projects from the mount 46 substan ⁇ tially parallel to the taper of the handle tip 34 to a point spaced posteriorly from but near the tip of the blade cutting edge 38. At the aforementioned point, the foot 44 is bent to define an elbow 48 and, as shown in the drawings, particularly at FIG. 3, an upwardly extending guard 50. The angle of the bend of the elbow 48 is such that the guard 50 is substan ⁇ tially transverse to the longitudinal axis of the handle 32.
  • the surgeon places and maintains the guard 50 against the cornea to, as described below, produce the desired incision having the proper depth of cut.
  • the guard 50 is bifurcated to define a pair of parallel arms 52 spaced apart by a gap 54.
  • the arms extend to either side of or "straddle” and are positioned transversly of the blade cutting edge 38.
  • the blade 36, and more particularly the cutting edge 38 extends through the guard 50, and more particularly the gap 54, to define the depth of cut shown as "d" in FIG. 3.
  • the arms 52 have a length adequate to project past the blade 36 so that the cutting edge 38 can freely pass through the gap 54.
  • the longitudinal axis of the foot 44 lies in the plane defined by the cutting edge 38. Additionally, the mount 46 is oriented to have its longitudinal axis coplanar with the axis of the foot 44. Therefore, the mount 46 has a longitudinal axis coplanar with the cutting edge 38.
  • the sleeve 42 is precisely positioned along the handle 32 such that the relative position of the guard 50 to the cutting edge 38 establishes the depth of cut "d" to within 10 microns of the selected setting.
  • the selected depth of cut typically falls between 0.435mm and 0.755mm. Since the positioning of the sleeve 42 along the handle 32 is done during manufacture rather than in the hospital operating room or the like, precise positioning to within 10 microns can be obtained. After the sleeve 42 has been located at the selected position, it is fixed to the handle 32 by sonic welding, glue, or the like.
  • the scalpel 30 is relatively inexpensive since both the handle 32 and sleeve 42 are molded- from plastic. The only metallic parts are the foot and blade. Due to the inexpensive nature of the scalpel 30, it is disposable. Since the scalpel 30
  • OMPI is disposable, the problem of dull blades encountered by repeated use of scalpels, such as the adjustable scalpel 10, is not encountered. Furthermore, since the setting of the sleeve on the handle is done at the factory, the depth of cut "d" can be accurately determined. As an added advantage, the scalpel 30 can be sterilized and prepackaged, dispensing with the need for sterilization.
  • FIGS. 6 and 7 a further advantage of scalpel 30 is shown.
  • the surgeon grasps it between the index and middle fingers and the thumb.
  • the fingers and thumb could only support the scalpel at basically three points around its circumference. Accordingly, the scalpel would be subject to rotation within the surgeons hand which, in turn, disorients the blade.
  • the surgeon cannot determine by feel in which direc- tion the cutting edge is oriented.
  • the mount 46 By providing the sleeve 42 with the mount 46, it has been found that the scalpel 30 can be more securely and comfortably held and that the direction of orientation of the cutting edge 38 can easily be determined by feel when the scalpel is picked up. As shown in FIG. 7, the mount 46, sleeve 42, and handle 32 cooperate to approximate a triangular periphery which securely and comfortably mates with the index and middle finger and thumb during the normal grasp of the scalpel 30. The mount also provides means for easily determining by feel the direction of cut by virtue of having its longitudinal axis oriented coplanar with the cutting edge 38.
  • OMPI While individual pre-set scalpels may be separately provided, the present invention also contemplates providing a number of sets of scalpels 30 in a kit, the scalpels of each set having the same depth of cut and the depth of cut varying from set to set.
  • the kit may include the same number of scalpels in each set. However, this would not be cost effective since some required depths of cuts are rarely encountered whereas others are frequently used simply due to the normal distribution of variances of cornea thicknesses and other pertinent factors determination of desired depth of cut.
  • the number of scalpels provided in each set is based upon the probability that a particuliar depth of cut will be required. It has been found, based upon empirical data from 533 cases that due to variations in the thicknesses of corneas from patient to patient and other pertinent factors, the probable depth of cut varies from between 0.435mm and 0.755mm. It has further been found that the population distribution of required depths of cut is not random, but approxi ⁇ mates a Gaussian or normal distribution as shown in FIG. 8. For example, for any particular patient, the probability or likelihood that the required depth of cut will be 0.60mm is extremely more likely than that the required depth of cut will be 0.45mm.
  • the kit of scalpels will contain sets of scalpels, all of the scalpels of each set having a particular depth of cut and the number of scalpels in any one set being determined by the probability that that particular depth of cut will be required. In other words, the number of scalpels in any particular set in the kit is based, approximately the probability distribution of required use.

Landscapes

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

Abstract

Bistouri jetable (30) possédant une profondeur de coupe fixe et conçu notamment pour la kératotomie radiale, possédant un manche (32) à l'extrémité duquel est fixée une lame (36). Egalement fixé au manche (32) se trouve un manchon (42) comprenant une monture (46) faisant saillie vers l'extérieur et servant à retenir et à supporter un pied (44). La monture (46), de concert avec le manche (32) et le manchon (42), permet au chirurgien de saisir le bistouri (30) de manière sûre et confortable. Pour permettre de déterminer la profondeur de coupe, le pied (44) fait saillie sur la monture (46) et définit une garde fourchue (50) à califourchon sur la lame (36). Pendant l'intervention chirurgicale, la garde (50) s'appuie contre la cornée afin de limiter la profondeur de coupe de la lame (36). La lame (36) fait saillie au travers de la garde (50) pour définir la profondeur de coupe. En fixant avec précision le manchon (42) et par conséquent le pied (44) sur le manche (32) lors de la fabrication, on peut déterminer une profondeur de coupe précise du bistouri (30). On décrit également une trousse de groupes de bistouris, les bistouris de chaque groupe ayant la même profondeur de coupe, la profondeur de coupe variant d'un groupe à l'autre. Le nombre de bistouris dans chaque groupe est déterminé par la distribution normale des probabilités d'utilisation d'une profondeur de coupe particulière (figure 8).
EP83903658A 1983-10-05 1983-10-05 Bistouri a profondeur de coupe fixe Withdrawn EP0162836A1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US1983/001575 WO1985001431A1 (fr) 1983-10-05 1983-10-05 Bistouri a profondeur de coupe fixe

Publications (1)

Publication Number Publication Date
EP0162836A1 true EP0162836A1 (fr) 1985-12-04

Family

ID=22175479

Family Applications (1)

Application Number Title Priority Date Filing Date
EP83903658A Withdrawn EP0162836A1 (fr) 1983-10-05 1983-10-05 Bistouri a profondeur de coupe fixe

Country Status (2)

Country Link
EP (1) EP0162836A1 (fr)
WO (1) WO1985001431A1 (fr)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4602630A (en) * 1985-05-16 1986-07-29 Anis Aziz Y Radial keratotomy knife
US4682597A (en) * 1985-07-15 1987-07-28 Myers William D Scleral dissector
JPH07108300B2 (ja) * 1989-02-20 1995-11-22 株式会社貝印刃物開発センター 皮膚切除具
GB9121937D0 (en) * 1991-10-16 1991-11-27 Kabukoba Josaphat J Surgical instruments and parts therefore
WO1995009573A1 (fr) * 1993-10-06 1995-04-13 Mcadams John B Instruments et procede de chirurgie refractive de la cornee
TW200509851A (en) * 2003-04-22 2005-03-16 Becton Dickinson Co Surgical knife safety handle
GB2411840A (en) * 2004-03-09 2005-09-14 Barbara Spours-Idun Surgical handles with finger grip
TWI369970B (en) 2004-10-20 2012-08-11 Beaver Visitec Int Us Inc Surgical knife safety handle having user operable lock
US7267124B1 (en) 2006-02-07 2007-09-11 Roberson Jr Travis Hubert Emergency tracheostomy kit
RU2481794C1 (ru) * 2012-03-14 2013-05-20 Николай Павлович Шастин Способ лечения вросшего ногтя и хирургический нож для его осуществления
CA2967150A1 (fr) 2017-05-15 2018-11-15 Stanley Michael Karl Valnicek Dispositif d'elevateur de volet de peau a profondeur fixe et methode d'utilisation associee

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US137404A (en) * 1873-04-01 Improvement in channeling and edging tools
US1195169A (en) * 1916-08-22 Masvin e
GB194892A (en) * 1922-02-11 1923-03-22 Frederick Merry Improvements in or relating to hand knives with adjustable blades
US2743523A (en) * 1955-06-27 1956-05-01 Honey Robert Carton opening knife
US3670733A (en) * 1970-09-14 1972-06-20 Richard S Carlisle Precise depth cutter
US3945117A (en) * 1973-02-15 1976-03-23 Rudolph Beaver, Inc. Surgical blade with adjustable blade guard
US3898735A (en) * 1973-05-09 1975-08-12 Conde Kk Knife for cutting out clippings
US3892038A (en) * 1973-06-25 1975-07-01 Phillip J Novak Single sheet paper slitter
US4180075A (en) * 1977-04-05 1979-12-25 Marinoff Gerald P Ophthalmological surgical instrument
US4324044A (en) * 1980-08-04 1982-04-13 Shahinian Jr Lee Surgical knife for precise depth of cut control
US4373263A (en) * 1980-12-17 1983-02-15 Eli Lilly And Company Molded implant removal knife
US4408396A (en) * 1982-03-15 1983-10-11 Scholl Albert S Trim knife

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO8501431A1 *

Also Published As

Publication number Publication date
WO1985001431A1 (fr) 1985-04-11

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