Patent Application
20120245610
The invention relates to scalpels for surgery and other procedures, in particular a blade unit cartridge that can be attached to a scalpel handle, that comprises a scalpel blade and a retractable blade cover to protect the blade from dulling and to protect against injury to the user.
The scalpel is a basic tool for surgeons. Scalpels are generally available in either fully disposable or re-usable forms. The most common form of reusable (non-disposable) scalpel includes an elongate metal handle, with a blade mount projecting from an end of the handle. The conventional type of blade mount consists of a finger projecting from an end of the handle, configured to fit into a slotted opening in a blade. A disposable surgical blade (referred to as a “sharp”) is provided, usually in a foil package, which includes a slot configured to lock onto the finger. In order to mount the blade, the user must carefully remove the blade from its packaging and clip the blade onto the finger. In order to protect the user from contact with the blade during this procedure, the blade can be handled with forceps or other handling tool. Care must be taken to avoid dropping the blade, since if the blade strikes a sterile tray or bowl, the blade can be dulled and rendered unsuitable for further use. Removal of the blade after use also presents particular risks, since at this point the blade is contaminated. Manipulation of the blade at this point presents a risk of injury with potentially serious consequences to the user's health and safety. As well, careful and deliberate manipulation of the blade takes up valuable time in the operating theatre.
Replacement of the blade is required with each new surgical procedure and in some cases the blade may be replaced during the procedure itself if it has become dulled.
In order to reduce the risk of injury, various means have been proposed to provide a removable or retractable cover for the blade. In some cases, the cover consists of a sheath that slips over the blade during installation and removal of the blade, and which may be removed when the blade is to be used. However, the act of removing or installing the cover itself presents risks. Other proposed solutions have involved a scalpel with a retractable blade. For example, U.S. Pat. No. 7,101,382 to George et al. discloses a retractable-blade scalpel with two releasable latching elements. When the scalpel blade is in an extended position, each releasable latching element is accessible for depression by finger pressure to cause retraction of the extended blade.
Another device is disclosed in U.S. Pat. No. 5,827,309 to Jolly et al., relating to a surgical scalpel having a movable blade guard that can be retracted to expose the blade and that can be extended to cover the sharp cutting edge of the blade. The guard is mounted inside the blade handle.
Systems that include a retractable guard as disclosed above generally require a specialized handle that is specially configured and adapted for use with the blade guard. In general, such systems are not adapted for use with conventional, commonly-available scalpel handles. This tends to add to the cost of such systems and requires hospitals to stock multiple handle types.
More importantly, it can be difficult to overcome the reluctance of surgeons to use a new type of handle with which they are unfamiliar. There is thus a need to provide a system for protecting a blade which avoids drawbacks of conventional removable blade covers, and which is adapted for use with a conventional scalpel handle. Such a system thereby provides an increased level of comfort and familiarity to the surgeon, and permits hospitals to continue to use their supply of existing scalpel handles.
The present applicant's prior application no. PCT/CA2010/000703 discloses a removable blade cartridge for mounting to a conventional scalpel handle, thereby addressing the above need. The present invention relates to improvements in a scalpel having a removable cartridge.
An object of the present invention is to provide an improved scalpel having a detachable blade cartridge, wherein the blade cartridge includes a retractable cover that protects the blade during storage, installation and disposal. A further object is to provide a blade cartridge for mounting to a scalpel handle, wherein the blade cartridge includes a body which can be mounted to a scalpel handle prior to use. A scalpel blade and a blade cover are mounted to the body, wherein the cover can slide relative to the body to selectively cover or expose the blade.
In an aspect of the present invention, a blade cover is incorporated in a removable blade cartridge that can be mounted to a conventional scalpel handle. The invention further relates to a kit consisting of a scalpel handle and a removable blade cartridge.
One aspect of the invention relates to a blade cartridge for attachment to a scalpel handle of the type that includes a blade mount comprising an elongate finger which projects forwardly from an end of the handle. Preferably, the scalpel handle is a conventional non-disposable handle that conforms to ISO standard configurations. The blade cartridge comprises a body having a mount configured to releasably engage the finger, a scalpel blade attached to the body and protruding forwardly therefrom and a blade cover slideably engaged to the body. The cover is configured to be moved between a forward, protective position fully covering the blade and a retracted position wherein the blade is exposed for use and the cover at least partially covers the body.
The blade cartridge may be provided as a disposable unit, intended for one-time use. The blade cartridge may be supplied in a sterile package or alternatively in unpackaged form for autoclaving or other form of sterilizing prior to use. An advantage of the present invention is that the blade cartridge is safe for handling when it is in its pre-use configuration with the cover extended over the blade and does not have to be supplied in an individual package, thereby saving on costs as well as eliminating waste and the step of opening and disposing of the package.
The blade cartridge can accommodate various types and sizes of blades, such as various industry standard blades. These include, for example, blade size nos. 11, 12 and 22. The blade cartridge can also fit the ISO Standard Fitting features of surgical scalpels, such as the ISO small fitting feature (No. 3) and large fitting feature (No. 4), and is adaptable to accept other fitting features as these become available. Alternatively, according to another aspect, the handle may have a non-standard blade mount, with the blade cartridge being configured to attach to the non-standard mount. For example, for certain applications it may be desirable to provide a unique mounting configuration of the handle and blade cartridge.
In one aspect, the invention relates to a detachable blade cartridge comprising:
The releasable catch may comprise at least one user-actuated detent associated with said cover and first and second recesses within said body corresponding to said open and closed positions respectively of the cover. The user-actuated detent is associated with a release member. The detent is biased for engagement with a selected one of said recesses upon alignment therewith for selectively positioning the cover in the open or closed position and may be released from said detent by depression of said release member. The body may comprise at least one ledge comprising a ledge surface downwardly stepped from the upper surface and extending laterally outwardly from said sidewall, wherein said first and second recesses are within said ledge. In one aspect, the ledge surface faces downwardly and said user-actuated detent is biased upwardly to engage said surface from below and move upwardly into a selected one of said recesses when aligned therewith. The cartridge may comprise two of said ledge surfaces on opposing sides of said body, each with respective first and second recesses, and two of said user-actuated detents for engagement with said opposed ledge surfaces.
In another aspect, the release member for the user-actuated detent(s) may comprises a flexible segment of said cover for vertical travel relative to the cover and at least one arm depending from said segment, wherein said user-actuated detent protrudes from said arm and is urged by said flexible portion into engagement with said detent. In this aspect, the release member comprises a portion of said flexible segment configured for depression by a user to disengage said detent from a corresponding one of said recesses. The cover may comprise an upper surface and the sidewalls include a cutaway region. The flexible segment of said cover comprises a portion of an upper surface of the cover protruding over said cutaway region.
According to another aspect, the cartridge body has at least one axially-extending groove and said cover comprises at least one groove-traveller configured to slide within said groove to guide said cover along said body.
In another aspect, the user-actuated detent and recesses of the cartridges generate an audible and/or tactile signal when brought into engagement, to signal to the user that the cover is properly positioned in either of the open or closed positions.
In another aspect, the body further comprises a window opening to at least one side of said body. The mount for fastening the cartridge to the handle includes a plate embedded within said body, said plate having a slot therein configured to engage said finger. The window exposes said slot for mounting the handle to the body. In one aspect, the body is laterally flexible in the region of said window wherein lateral flexing of said body causes said plate to flex laterally to permit release of said handle from said cartridge.
According to another aspect, the invention relates to the combination of a scalpel handle and the blade cartridge as described above, supplied as a kit. The scalpel and blade cartridge may be configured for medical/surgical use, or any other use where a scalpel-type cutting implement may be usefully employed, such as for home hobbyists.
The invention will now be further described by a description of non-limiting detailed embodiments. It will be understood that the particular elements, means, components, methods and the like described herein are presented merely by way of example, and may be varied by persons skilled in the art while remaining within the scope of the invention. As well, any directional references used herein are merely for convenience of description, and do not limit the scope of the invention, which of course may be used in any orientation. In general, directional references herein are from the reference of a scalpel in a horizontal position with the sharp edge of the blade facing downwardly. Although the present specification refers to surgical uses of scalpels, it will be evident that the present invention relates to scalpels intended for any suitable use.
Ail prior art cited herein is incorporated into this application in its entirety, if and to the extent permitted. References herein to prior art are not intended as an admission in any form that such references constitute prior art for purposes of determining the validity of any of the claims of this application, nor that such art is material to the patentability of the invention.
The invention relates to a scalpel system that includes a conventional scalpel handle 10, such as a Finger™ or Spectrum™ handle, as particularly shown in
Finger 16 is configured to normally engage a conventional surgical blade, not shown. In normal use of handle 10, a disposable blade may be clipped onto finger 16. A conventional blade of this type includes a slot configured to clip the blade to finger 16 in a manner that securely holds the blade to the handle but that may be released by flexing the blade in the region of the slot. The respective configurations of a conventional finger and blade slot meet recognized international standards (usually an ISO standard) for compatibility. Handle 10 further comprises a pair of opposed sloping shoulders 19 where the fingers join with the body portion of handle 10. Handle 10 is usually provided with ridges or other tactile features to improve the user's grip.
According to the invention, a separate disposable blade cartridge 30 is provided that is releasably attachable to handle 10. Blade cartridge 30 may be moulded from rigid plastic such as polycarbonate or polyester, which is capable of withstanding hospital autoclaving and other various sterilization methods (such as radiation, ionization, ETO). Blade cartridge 30 is radio-opaque to aid in localization in the event it is left behind postoperatively within the patient's body.
Blade cartridge 30 includes a body 24 and a sliding cover 60 which is coupled to and slides over body 24 to selectively shield the scalpel blade 15. Body 24 comprises an elongate generally flat structure, configured for mounting at its proximal end to handle 10. Body 24 comprises opposing sidewalls 2a and 2b, an upper surface 4 and an opposed lower surface 6. Body 24 further includes a mount at a proximal end region thereof to releasably fasten body 24 to handle 10. The mount comprises a shallow groove 17 recessed into sidewall 2b, configured to receive finger 16 therein to permit body 24 to clip onto finger 16. Groove 17, seen in more detail in
As seen in
The distal end of body 24 includes a recessed portion of sidewall 2a. Surgical blade 15 is mounted to sidewall 2a within this recessed portion. Blade 15 can be permanently fixed to body 24 by melt-fastening or other permanent fastening means and protrudes forwardly therefrom. Alternatively, as seen in
Button 7, which protrudes laterally from one side of body 24, includes a contact surface 80 configured to contact a corresponding face 82 of the blade cover 60 when in the open position to prevent over-retraction of cover 60.
It will be seen that with modifications, body 24 may be configured to mount to a scalpel handle having a finger with a non-standard configuration or a configuration which differs from that described herein. It is foreseen that mounting systems other than that described and depicted herein may by employed for certain scalpels and other cutting implements, and in most such cases it would require only a routine modification to adapt the invention to mount to such a handle.
As seen in
Cover 60 is configured to shield blade 15 when extended distally relative to body 24; it will be seen that the configuration of cover 60 may vary depending on the size and configuration of blade 15 in order to fully shield blade 15. In the first embodiment described herein, blade 15 is a conventional single-edged triangular scalpel blade. Cover 60 slides axially along body 24 to travel between a storage position wherein blade 15 is covered and a retracted position.
Sidewalls 62 of cover 60 each include a proximal cut-away region 70 at the proximal end thereof, configured to expose slot 17 when cover 60 is extended to cover blade 15. This arrangement ensures that blade cartridge 30 is in a configuration to be engaged to handle 10 or disengaged therefrom only when cover 60 is extended and blade 15 is covered, thereby permitting safe handling of the device when attaching or detaching cartridge 30 to a scalpel handle 10.
Cover 60 has a gap 69 within its upper surface 66 which exposes a portion of body 24. Gap 69 is continuous with cutaway regions 113 within sidewalls 62a and b. As discussed below, these cutaway regions are configured to accommodate and permit movement of flexible portions of the cover and associated arms 122, to permit these portions to flex downwardly.
In the closed position, wherein cover 60 is extended in the distal direction, blade 15 is fully covered such that the cartridge can be safely transported, stored and handled by the user. During normal use, an inadvertent retractive force will not dislodge cover 60 from this covered position. Cover 60 can be retracted only with a deliberate force to expose blade 15, as described below. When the device is in the retracted position, blade 15 protrudes through open end 62 of cover 60 and the scalpel may be used in a conventional fashion. Rearward travel of cover 60 past the retracted (use) position is limited by contact between shoulder 82 of cover 60 and stopper 80 which prevents over-retraction of cover 60.
As seen in
Cartridge 30 includes a one-way catch that is configured to restrict movement of cover 60 relative to body 24 in a distal direction past a limit position while permitting movement in an opposed proximal direction. For this purpose, cover 60 incorporates a detent 89 located adjacent its distal end that projects downwardly from the end of a flexible, resilient arm 91. Arm 91 extends rearwardly from the forward (distal) edge of gap 69 and partially bridges this gap. Detent 89 is configured to engage a recess 90 which is within the upper surface body 24 and adjacent to the distal end of body 24. Recess 90 comprises a transverse groove spanning the upper surface of body 24, having opposed distal and proximal sidewalls and essentially the same cross sectional configuration as detent 89. Arm 91 urges detent 89 downwardly to engage recess 90 when aligned therewith. Detent 89 provides a one-way stop for cover 60. When detent 89 is engaged within recess 90, cover 60 is effectively prevented from sliding along body 24 in the distal direction, thereby preventing inadvertent separation of cover 60 from body 24. For this purpose, the respective distal faces 95 and 96 of detent 89 and recess 90 are configured to limit distal travel of cover 60 along body 24 past a predetermined “limit” position when these surfaces are in contact. In order to provide a secure and essentially non-releasable catch, faces 95 and 96 are essentially flat and either vertical or sloping upwardly and rearwardly such that when in contact and mutual engagement with each other, further distal travel of cover 60 is highly resisted. As well, arm 91 is relatively short and stiff to minimize the risk that it will flex upwardly to inadvertently release detent 89 from recess 90. The opposed, proximal, faces 97 and 98 respectively of detent 89 and recess 90 slope and/or curve in the proximal direction, wherein sliding cover 60 in a proximal direction to expose blade 15 easily urges detent 89 upwardly to be released from recess 90 as arm 91 is flexed upwardly. When detent 89 is released from recess 90, cover 60 may freely slide along body 24.
Upper surface 66 of cover 60 further comprises a recessed region 92 adjacent to the proximal end thereof. Region 92 is configured to receive detent 89 when the cover is locked in the open position. This permits arm 91 to depress into a position that is essentially flush with surface 66 to prevent hindrance to a user when gripping the scalpel.
Upper surface 66 of cover 60 includes an unsupported segment 112 that projects forwardly towards gap 69 and towards arm 91. Segment 112 is defined by cutaway portions 113 within sidewalls 62a and b of cover 60 whereby it may freely flex vertically independently of sidewalls 62. The free end of segment 112 terminates in an upwardly-projecting tab 121 and downwardly-projecting arms 122a and b. Cutaway portions 113 dip downwardly to accommodate arms 122, with sufficient space being provided beneath arms 122 to accommodate their downward movement when flexed downwardly to release detents 110. Arms 122a and b each terminate at their lower edges with inwardly-projecting detents 110a and 110b respectively. Detents 110 are configured to contact and slide along ledge surfaces 40. Ledge surfaces 40 thus effectively form a track for detents 110 whereby detents 110 slide along these surfaces as the cover is retracted or extended.
At the rear portion of body 24, detents 110a and b enter into and slide within grooves 41. Arms 122 are configured to position detents 110 to be in contact with and bear against ledge surfaces 40. When detents 110 are in contact with ledge surfaces 40, segment 112 is flexed upwardly to urge detents 110 upwardly to bear against these surfaces. As a result, when detents 110 are brought into alignment with first (distal) recesses 44, detents 110 move upwardly and enter into recesses 44 to lock cover 60 in the closed position. Cover 60 remains locked in this position until detents 110 are released by a downward force on tab 121. When cover 60 is locked in the closed position, detent 89 is also engaged within recess 90 to prevent further forward movement of cover 60 even if detents 110 are released. In this fashion, cover 60 is prevented from sliding forwardly off body 24. Detent 89 can only be released from recess 60 by a rearward movement of cover 90 when detents 110 are released. Cover 60 may thus be unlocked from the closed position by pressing tab 121 downwardly and urging the cover rearwardly to slide it into the open position to expose blade 15.
In a fashion similar to the above, when cover 60 is slid rearwardly, detents 110 are brought into alignment with second (rear) recesses 46 when cover 60 is located in the appropriate position to fully expose blade 15. At this point, upward bias exerted by segment 112 urges detents 110 upwardly to lock into rear recesses 46. Detents 110 may be released from the respective recesses by depressing segment 112 downwardly by pressing against tab 121. At the proximal end of body 24, lower recesses 48 provide spaces to receive respective detents 110 as these are pushed downwardly to release them from recesses 46. At the distal end of body 24, detents 110 are unopposed when urged downwardly out of recesses 44, and can thus be freely released when segment 112 is urged downwardly.
Preferably, an audible and/or tactile click is generated when detents 110 move into either of the front or rear recesses, to clearly indicate that to the user that the cover is locked into the open or closed position.
As seen in
In an alternative embodiment, features of which are shown in
Body 224 has a region that is less resistant to lateral flex where shelf regions 39 and shoulders 42 are absent resulting in less structure within body 224 that resists such flex. A user may flex body 224 in this region by applying a lateral force on button 7. A retractive force, away from the midline of body 224, will cause insert 226 to flex, which when sufficiently flexed will permit release of finger 16 from slot 228 to detach cartridge 200 from handle 10.
It will be seen that the cartridges described herein can be scaled up or down in size, and the configuration of the respective components thereof altered, to accommodate different sizes and configurations of blades. As well, different materials can be employed to serve various requirements and other alterations may be made to the embodiments described herein.
A scalpel according to the present invention may be supplied to the user as a kit which includes a variety of blade cartridges with a variety of blade sizes and types. Such a kit may include one or more handles.
Although the present invention has been described in part by way of a detailed description of embodiments thereof, it will be seen by those skilled in the relevant art that the invention is not limited to the particular embodiments described above. Rather, the full scope of the present invention is defined by the present patent specification as a whole, including the claims, which should be given the widest interpretation permissible by law.
This application claims the benefit of U.S. application No. 61/467,129, filed on Mar. 24, 2011. The contents of said application are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 61467129 | Mar 2011 | US |
