U.S. patent application number 11/577768 was filed with the patent office on 2009-08-13 for safety scalpel.
Invention is credited to Timothy J. Maxwell.
Application Number | 20090204137 11/577768 |
Document ID | / |
Family ID | 36202721 |
Filed Date | 2009-08-13 |
United States Patent
Application |
20090204137 |
Kind Code |
A1 |
Maxwell; Timothy J. |
August 13, 2009 |
SAFETY SCALPEL
Abstract
A scalpel enabling both safe blade engagement or disengagement
and safe passing among personnel during surgical procedures. The
blade arm assembly of the scalpel is positionable in three
positions, including a retracted position, an operational extended
position and a fully extended position for engagement and
disengagement of the blade.
Inventors: |
Maxwell; Timothy J.;
(Stittsville, CA) |
Correspondence
Address: |
JOHN S. PRATT, ESQ;KILPATRICK STOCKTON, LLP
1100 PEACHTREE STREET, SUITE 2800
ATLANTA
GA
30309
US
|
Family ID: |
36202721 |
Appl. No.: |
11/577768 |
Filed: |
October 21, 2005 |
PCT Filed: |
October 21, 2005 |
PCT NO: |
PCT/IB05/03151 |
371 Date: |
November 19, 2007 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
60621146 |
Oct 22, 2004 |
|
|
|
Current U.S.
Class: |
606/172 ; 30/164;
606/167 |
Current CPC
Class: |
A61B 17/3213 20130101;
A61B 17/3211 20130101; A61B 2017/32113 20130101 |
Class at
Publication: |
606/172 ;
606/167; 30/164 |
International
Class: |
A61B 17/3211 20060101
A61B017/3211 |
Claims
1. A scalpel handle assembly for use with a replaceable scalpel
blade, the assembly comprising: (a) a handle comprising an
elongated body, and (b) a blade carrier assembly comprising: (i) a
blade arm comprising a blade tang positionable relative to the
handle alternatively: 1. with the blade withdrawn entirely into the
handle, 2. with the blade projecting from the handle with a
proximal blade end within the handle thereby retaining the blade on
the tang, or 3. with the blade entirely outside the handle.
2. A scalpel handle assembly for use with a replaceable scalpel
blade, the assembly comprising: (a) a handle comprising an
elongated body penetrated by a first longitudinal slot open to the
outside of the handle, and a pair of opposed longitudinal slots
transverse to the first slot, and (b) a blade carrier assembly
comprising: (i) a blade arm comprising a blade tang attached to an
arm body positionable within the first slot, and (ii) a spring
associated with the blade arm to secure the blade arm in a selected
one of two positions with the blade projecting from the handle for
use or retracted into the handle for safety.
3. The scalpel handle assembly of claim 2, wherein a pin is
received in a first detent when the blade arm is in the blade
projecting position and in a second detent when the blade arm is in
the safety position.
4. The scalpel handle assembly of claim 2, wherein a button or knob
facilitates manipulation of the pin.
5. The scalpel handle assembly of claim 2, wherein the pin is
secured to the spring and is received in one of two detents in the
handle.
6. The scalpel handle assembly of claim 3, wherein a transition
between the second detent and a side of the slot is more gradual
than the transition between the first detent and a side of the
slot, requiring an increased lateral force to disengage from the
blade projecting position to a fully projected position.
7. A surgical scalpel comprising: (a) a blade arm assembly that
slides within a handle, (b) the handle comprising a transverse slot
that receives the blade arm assembly so that when a portion of a
blade attached to the blade arm assembly is located in the slot the
blade is secured to a blade arm assembly; the blade arm assembly
comprising three positions within the handle, including: (i) a
fully retracted position, (ii) a protruding operational position,
and (iii) a fully extended position for engaging and disengaging a
blade.
8. The scalpel of claim 7, wherein the blade arm assembly further
comprises a blade arm, a button assembly and a spring.
9. The scalpel of claim 8, wherein the spring is a bi-cantilever
element.
10. The scalpel of claim 7, wherein the wherein the handle further
comprises: (a) a first detent that captures the button assembly to
lock the blade carrier in a retracted position and (b) a second
detent that captures the button assembly to lock the blade carrier
in an extended operational position and wherein extending the blade
carrier beyond the second detent extends the blade arm sufficiently
to allow disengagement or engagement of a blade.
11. The scalpel of claim 8, wherein depression of the button
assembly permits advancement of the blade arm assembly from a
retracted position to an extended position.
12. The scalpel of claim 10, wherein engagement of the button
assembly with either the first or second detent produces an audible
sound.
13. The scalpel of claim 7, wherein the handle further comprises
ridges.
14. The scalpel of claim 9, wherein a free end of a section of the
bi-cantilever element is shaped to fit around a curved end of a
second cantilever section, thereby allowing for a spring-like
action limited in its inward travel by the contact of the two
cantilever sections and as they are squeezed toward each other.
15. The scalpel of claim 8, wherein the button assembly further
comprises a button and pin.
16. The scalpel of claim 15 wherein the button and pin are integral
to the cantilever spring.
17. The scalpel of claim 7, wherein the scalpel is formed from
materials comprising aluminum, stainless steel, titanium or
plastic.
18. The scalpel of claim 10, wherein a transition between the
second detent and a side of the slot is more gradual than the
transition between the first detent and a side of the slot,
requiring an increased lateral force to disengage from the blade
projecting position to a fully projected position.
Description
FIELD OF THE INVENTION
[0001] This invention relates to surgical scalpels and, in
particular, to surgical scalpels that have disposable, retractable
and ejectable blades.
BACKGROUND OF THE INVENTION
[0002] Surgical scalpels have long been available. However, there
is need for a scalpel with better ergonomic features while meeting
rigorous occupational health and safety requirements for sharps
used in medical practice. More specifically, there is need for
scalpels that facilitate scalpel blade engagement and disengagement
(ejection). It is desirable to minimize the need to exert pressure
with fingers when mounting the blade to the blade tang and to
eliminate entirely the need for direct contact with the blade to
disengage it from the scalpel handle. In addition, for safe passing
of scalpels among surgical personnel, it is desirable for the blade
to be retracted into the handle and preferably to minimize the need
for visual confirmation that the blade is retracted.
SUMMARY OF THE INVENTION
[0003] The scalpel assembly of this invention incorporates two key
features enabling safe blade engagement or disengagement and safe
passing among personnel during surgical procedures. For scalpel
blade loading, the blade is readily positioned on the blade with
one hand, and a simple retraction motion by the other hand
positions the blade in a horizontal manner for entry into a guiding
channel slot within the scalpel handle. During use the blade is
held in the handle in a stable manner to allow for highly
controlled surgical incisions without any undesirable blade
mobility. For disengaging the scalpel blade, a simple extension of
the blade arm, beyond the locked operational position, to a fully
extended position permits the blade to disengage from its firmly
fixed engagement with the blade holder, thereby enabling hands-free
blade disengagement.
[0004] During use of the scalpel assembly, it may be safely passed
from one person to another because the blade may be easily
retracted within the handle with one hand. In addition to distinct
tactile indications of positioning of the blade (in a retracted or
extended position), there is a distinct auditory cue.
[0005] The scalpel assembly includes a handle and a blade arm
sub-assembly for easy disassembly for cleaning, reassembly and
subsequent sterilization for re-use.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] FIG. 1 is a top view of a blade arm assembly of a scalpel of
this invention.
[0007] FIG. 2 is a side view of the assembly shown in FIG. 1.
[0008] FIG. 3 is a side view of a scalpel assembly of this
invention with the blade assembly retracted.
[0009] FIG. 4 is a top view of the scalpel assembly of FIG. 3, with
the blade assembly retracted.
[0010] FIG. 5 is a top view of the scalpel assembly of FIG. 3, with
the blade assembly extended to the position in which it is
used.
[0011] FIG. 6 is a front view of the scalpel of FIG. 3 without the
blade.
[0012] FIG. 7 is a bottom view of the bi-cantilever element of FIG.
1.
DETAILED DESCRIPTION
[0013] A scalpel assembly of this invention includes a handle and a
blade arm assembly that cooperate to provide both safe blade
engagement or disengagement and safe passing during surgical
procedures. The blade arm assembly, an embodiment 35 of which is
shown in FIGS. 1 and 2, slides within longitudinal slots in the
handle, an embodiment 20 of which is shown in FIG. 3, and may be
positioned in either a blade retracted position (FIG. 4), a blade
extended operational position (FIG. 5), or a fully extended blade
engagement and disengagement position.
[0014] As may be seen in FIGS. 3-6, the handle 20 is an elongated
body 22 preferably having a generally uniform, more or less oval
cross section (best seen in FIG. 6) with a longitudinal central
channel slot 24 that penetrates the handle body and two opposed
internal transverse slots 29 oriented perpendicular to the central
channel slot 24. All of the slots 24 and 29 extend fully from the
proximal end 21 to the distal end 23 of the handle, making it
relatively easy to manufacture handle 20 from a section of aluminum
extrusion.
[0015] Slots 24 and transverse slots 29 together provide a T-shaped
or X-shaped slot within the handle 20 within which the blade arm
assembly 35 and blade 32 slide. The leading edges of slot 29 may be
beveled, rounded over or otherwise eased to facilitate entry of the
back end 31 of the blade into the slots 29.
[0016] A scalpel blade 32 is held on a blade holder 44 extending
from one end of a blade arm 36 that slides within the central slot
24. Blade arm 36 carries a bi-cantilever element 52 (shown in FIGS.
1, 2 and 7 and further described below) that functions as a spring,
and a button 38 is attached to the bi-cantilever element 52 by a
pin 42. Button 38 travels within a recessed region 39, visible in
FIGS. 4 and 5.
[0017] The bi-cantilever element 52 is generally flat and extends
from the blade arm 36 on either side so that portions of it can be
received in transverse slots 29 while the element 52 more or less
surrounds a portion of blade arm 36, as may be appreciated by
reference to FIGS. 1 and 2. Pin 42 projects from hole 63 (shown in
FIG. 7) bi-cantilever element 52 and through central slot 24, but
pin 42 is urged toward one side 25 (shown in FIGS. 5 and 6) of that
slot 24 by the spring action of bi-cantilever element 52 thereby
urging pin 42 to seat in one of detents 26 or 28 when it reaches
those detents, thereby locking blade arm 36 in a blade extended
position (with pin 42 in detent 26) or a blade retracted position
(with pin 42 in detent 28). In an alternative embodiment, a face of
the slot channel that opposes the detents may have a slight
indentation so that the slot width is slightly wider in that
region. This alternative allows additional lateral movement of the
button and pin prior to movement of the blade arm, thereby
providing a more distinct lateral shift of the button and pin and
increasing the tactile feel of the device.
[0018] By sliding blade arm 36 so that pin 42 travels beyond detent
26 (i.e., further from detent 28), the base 31 of blade 32 will
move out of transverse slot 29, thereby permitting it to lift off
of tang or blade holder 44 and release from blade arm 36. With
blade arm 36 in the same position, a blade 32 can easily be
positioned on the blade holder 44 and then secured by sliding the
blade arm 36 into the handle until pin 42 reaches at least detent
26, at which point the base 31 of blade 32 will be captured in
transverse slots 29, thereby preventing it from disengaging from
tang or blade holder 44.
[0019] The position of blade arm 36 in handle 20, and thus the
position of blade 32 is easily manipulated with one hand by finger
contact with button 38 to disengage pin 42 from the detent 26 or 28
within which it is seated and by then sliding the blade arm 36
relative to handle 20 by contact with either or both of button 38
and ridges 66. The shapes and relative positions of the components
of the scalpel of this invention permit all of these manipulations
to be done with one hand. Simple reversal of the scalpel blade and
blade tang accommodates both left and right handed scalpel
users.
[0020] As explained above, the blade arm assembly 35 consists of
several components: the blade arm 36, the button 38 and pin 42, and
the planar bi-cantilever element 52. The function of the
bi-cantilever element 52, shown in FIG. 7, in cooperation with the
button 38 and pin 42, is to control movement of the blade arm 36
within the handle 20, and to provide positively locking positions
(together with audible confirmation of achievement of those
positions) with the blade 32 in an extended for use or a retracted
for safety position. Element 52 functions as a spring but in a
planar structure that travels and functions partially within the
transverse slots 29 that also serve to receive and retain blade 32
on tang or blade holder 44. Moreover, the geometry and material of
element 52 is durable, capable of sterilization and otherwise
highly functional in this application.
[0021] In the embodiment shown in FIG. 7, the crook 60 of one arm
54 of bi-cantilever element 52 is shaped to fit around the head 56
of the second cantilever arm 58, thereby allowing for a spring-like
action limited in its inward travel by the contact between the two
cantilever arms 54 and 58 as they are squeezed toward each other.
The head 56 and crook 60 of the bi-cantilever element 52 align
edge-to-edge in the horizontal plane (coming out of the page in
FIG. 2), which restricts the lateral inward movement of the
assembly 35 and provides for definitive control of the motion of
button 38. In other words, the crook 60 cradles the head 56 when
the element 52 is compressed. In an alternative embodiment, inward
or outward motion of the button is restricted by the physical
contact of the button pin with the edge of the channel slot. In
this embodiment, it is not necessary for the fixed portion of the
cantilever element to interact with the non-fixed section of the
cantilever element to control the extent of lateral motion. As a
result, the fixed cantilever portion may be shorter in length.
[0022] The assembly of button 38 and pin 42 may be permanently
joined to the distal end of the bi-cantilever element 52. In
another embodiment, the button 38 and pin 42 may be fastened to
blade arm 36 in a manner similar to that of a semi-tubular rivet.
In this manner, the scalpel assembly may be formed so that either
of the arms 54 or 58 may act as the flexible member of the spring
element. In yet another embodiment, both arms 54 and 58 are
flexible and free to move.
[0023] The bi-cantilever element 52 may be inserted or removed from
the main blade arm 36, if required, but it is normally maintained
assembled to the blade arm 36. Notch 53 (shown in FIGS. 1 and 7) of
bi-cantilever element 52 is adapted to receive the blade arm
36.
[0024] As shown in FIG. 2, a step-like feature 64 is located at the
junction of the blade holder 44 and the rest of the blade arm 36 to
allow for a ramping up motion as the blade arm 36 moves toward the
distal end 23 of holder body 22, thereby positioning the scalpel
blade 32 for alignment with the traverse slots 29, facilitating
retraction of scalpel blade 32 into the proximal end 21 of the
handle body 22. This motion of the blade arm 36 generally requires
a relatively loose fit between the blade arm 36 and the
bi-cantilever element 52. The ramping up motion is partially guided
by a channel 61 (shown in FIG. 2) in the blade arm 36 while the
bi-cantilever element 52 remains captured in the traverse slot 29.
If, as an alternative to the separate blade arm 36 and element 52
assembly shown in the Figures, a one-piece molded assembly is used
for arm 36 and bi-cantilever element 52, the inherent properties of
the materials (such as plastics or plastic composites) could allow
for a similar flexible motion to permit for horizontal blade
alignment with the slots 29. Alternatively, any other suitable
structure may be used to create this ramping motion. For example,
the inner topmost portion of the opening of the proximal end of the
handle may be slightly beveled (e.g. 30 degrees), providing a
ramping force to gently push the distal end of the scalpel blade
downwards and onto the blade tang.
[0025] Engagement of the button pin 42 with the detents 26 or 28
produces an audible sound, confirming the tactile sense of detent
engagement with the button 38 and pin 42. The need for visual
confirmation of either blade retraction or extension may be
minimized by the combined tactile and auditory cues.
[0026] In the embodiment shown in the Figures, the transition area
33 (shown in FIG. 4) between the proximal detent 26 and a side of
the slot includes a steeper, almost perpendicular, rise requiring
an increased lateral force on the button 38 followed by a forward
motion along the handle channel to allow the blade arm 36 to travel
from the operational, blade extended position (with button pin 42
in detent 26) to the further extended position (in which pin 42 is
located proximally to detent 26) allowing for blade disengagement.
The transition area 34 (shown in FIG. 5) between the distal detent
28 and a side of the slot may be more gradual, requiring less force
to travel from a retracted position to an operational position.
[0027] Uni-directional blade arm loading occurs from the distal end
23 with the detents 26 and 28 engaging the button 38 and pin 42 on
the blade arm 36, automatically locking in place at either the
fully retracted or extended blade positions.
[0028] The handle 22 may be easily separated from the inner
components (blade arm 36, bi-cantilever element 52, pin 42 and
button 38) for cleaning. During such separation, the button 38
position is maintained essentially along the axis of the channel 24
for pulling the blade arm assembly back and out from the handle
body 22.
[0029] The blade-securing structures of tang or blade holder 44 on
the blade arm 36 are generally the same as those disclosed in U.S.
patent application Ser. No. 09/937,542 filed Sep. 26, 2001 for
Scalpel Assembly, Michael S. G. Bell, et al, inventors
(PCT/1800/00426, WO 00/61014) which is incorporated herein by this
reference. A scalpel handle body of this invention can accommodate
in its standard configuration essentially all scalpel blades
complying with ISO 7740-1985 (E) standards except for those that
have a hooked or curved surface which would require a larger
opening adaptation at the proximal end of the handle. As shown in
FIG. 6, shallow notches 61 located on the upper inner surface of
transverse slot 29 may be included in order to accommodate
rib-backed scalpel blades, which are designed to prevent snapping
of the blade during surgery.
[0030] For improved control and to facilitate gripping of the
handle body 22, ridges 46 are positioned across the width of the
handle body 22 top-most and bottom-most edges on the proximal
portion 48. These ridges may be about 0.6 mm deep, or any other
suitable size. Ridges 46 may cover approximately 1/4-1/3 of the
handle length.
[0031] Handle body 22 may include ruler markings (not shown in the
Figures) imprinted or stamped on the non-slotted broad face 50
(shown in FIG. 10) of the handle body 22. In addition, the handle
22 can be made of different lengths to provide industry standard
scalpel assemblies, such as #3, #3L, #4, #4L. Handle 22 may also be
weighted if desired depending upon the materials used.
[0032] The top-most surface of the blade arm 36 may include ridges
66 (shown in FIG. 2) to provide adequate contact area for
one-finger induced motion, either forward or backwards, of the
blade arm 36.
[0033] The button 38 can be colored differently to indicate
different scalpel types.
[0034] The inner assembly of blade arm 36, bi-cantilever element
52, button 38 and pin 42 can be produced as individual components
and then assembled or it can be produced as a single entity by, for
instance, metal injection molding or machining, or molding or
otherwise fabricating of plastics or a plastic composite.
[0035] The handle body 22 and inner blade arm 36 assemblies can be
produced from materials such as aluminum, stainless steel, titanium
or plastic allowing for a full-range of sterilization techniques to
be used (e.g. steam, gas, E-beam or gamma irradiation
sterilization).
[0036] The scalpel assembly of this invention can be produced for
reusable (non-disposable) or disposable systems.
[0037] As will be understood by those skilled in the art,
variations in materials or manufacturing techniques and numerous
other variations in the details of the protected blade scalpel
handle of this invention can be made without departing from the
scope and spirit of this invention as described above and in the
accompanying Figures and the following claims.
* * * * *