U.S. patent application number 12/794165 was filed with the patent office on 2010-09-23 for suture needle retention device.
Invention is credited to Todd O'BRIEN.
Application Number | 20100241143 12/794165 |
Document ID | / |
Family ID | 38140410 |
Filed Date | 2010-09-23 |
United States Patent
Application |
20100241143 |
Kind Code |
A1 |
O'BRIEN; Todd |
September 23, 2010 |
SUTURE NEEDLE RETENTION DEVICE
Abstract
An improved suture needle retention device suitably adapted to
be removably attached to the end of a surgical instrument for
convenient placement proximate to the surgical field yet out of the
way of the surgeon, said device having a needle pervious retention
member to accept the sharp end of a suture needle, with said
retention member encased by a needle impervious protective
sheathing to prevent inadvertent pass-through of the suture
needle.
Inventors: |
O'BRIEN; Todd; (Orono,
ME) |
Correspondence
Address: |
ANTHONY D. PELLEGRINI RUDMAN & WINCHELL, LLC
84 HARLOW STREET, P.O. BOX 1401
BANGOR
ME
04402-1401
US
|
Family ID: |
38140410 |
Appl. No.: |
12/794165 |
Filed: |
June 4, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11298372 |
Dec 9, 2005 |
7763038 |
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12794165 |
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Current U.S.
Class: |
606/148 |
Current CPC
Class: |
A61B 17/062 20130101;
A61B 17/0493 20130101 |
Class at
Publication: |
606/148 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1. A suture needle retention device comprising a retention member,
said retention member being needle pervious, said retention member
suitably adapted to be pierced by a suture needle such that a
portion of the suture needle is embedded within said retention
member, said retention member suitably adapted to retain an
embedded suture needle securely, and said retention member suitably
adapted to release an embedded suture needle when a sufficient
extraction force is applied to the suture needle; a protective
sheathing, said protective sheathing being needle impervious, said
protective sheathing being substantially hollow, said protective
sheathing having an interior, said protective sheathing having an
open end providing access into the interior, said protective
sheathing having a closed end substantially opposite the open end,
and said protective sheathing suitably adapted to contain at least
a portion of the retention member within its interior while
exposing another portion of the retention member, whereby the
retention member is at least partially contained within the
protective sheathing; and an attachment component, said attachment
component being integrated with the protective sheathing, and said
attachment component being suitably adapted to removably attach the
suture needle retention device to a surgical instrument without the
use of adhesives.
2. The suture needle retention device of claim 1 wherein the
retention member is comprised of a resilient closed-cell foam
having negligible friability.
3. The suture needle retention device of claim 1 wherein the
attachment component comprises a slot, said slot formed into the
protective sheathing proximate to the closed end of the protective
sheathing and providing access into the interior of the protective
sheathing, said slot having a length, said length of said bottom
slot oriented substantially parallel with the closed end of the
protective sheathing, and said slot suitably adapted to accommodate
an end of the surgical instrument such that the end of the surgical
instrument is inserted through the slot into the interior of the
protective sheathing; whereby the surgical instrument protrudes
through the bottom slot of the protective sheathing with the end of
the surgical instrument located within the interior of the
protective sheathing.
4. A suture needle retention device comprising a retention member,
said retention member being needle pervious, said retention member
suitably adapted to be pierced by a suture needle such that a
portion of the suture needle is embedded within said retention
member, said retention member suitably adapted to retain an
embedded suture needle securely, and said retention member suitably
adapted to release an embedded suture needle when a sufficient
extraction force is applied to the suture needle; a protective
sheathing said protective sheathing being needle impervious, said
protective sheathing being substantially hollow and having an
interior and an interior surface, said protective sheathing having
an open end providing access into the interior, said protective
sheathing having a closed end that is substantially planar, and
located substantially opposite the open end, said protective
sheathing having a top side and a bottom side, and said protective
sheathing suitably adapted to contain at least a portion of the
retention member within its interior while exposing another portion
of the retention member, whereby the retention member is at least
partially contained within the protective sheathing; and an
attachment component, said attachment component comprising a bottom
slot, said bottom slot formed into the bottom side of the
protective sheathing proximate to the closed end of the protective
sheathing and providing access into the interior of the protective
sheathing, said bottom slot having a width and a length, said
length of said bottom slot oriented substantially parallel with the
closed end of the protective sheathing, and said bottom slot being
suitably adapted to accommodate an end of the surgical instrument
such that the end of the surgical instrument is inserted through
the bottom slot into the interior of the protective sheathing, and
a top slot, said top slot formed into the top side of the
protective sheathing proximate to the closed end of the protective
sheathing and providing access into the interior of the protective
sheathing, said top slot having a width and a length, said width of
the top slot being less than the width of the bottom slot, said top
slot oriented substantially in alignment with the bottom slot, said
top slot being suitably adapted to accommodate the end of the
surgical instrument such that the end of the surgical instrument is
inserted through the top slot from the interior of the protective
sheathing, said attachment component being integrated with the
protective sheathing, and said attachment component being suitably
adapted to removably attach the suture needle retention device to a
surgical instrument without the use of adhesives; whereby the
surgical instrument protrudes through the bottom and top slots of
the protective sheathing with the end of the surgical instrument
protruding from the top slot.
5. The suture needle retention device of claim 4 wherein the
retention member is comprised of a resilient closed-cell foam
having negligible friability.
6. The suture needle retention device of claim 4 wherein the
protective sheathing further comprises a retention lip, said
retention lip located circumferentially about the open end of the
protective sheathing, and said retention lip suitably adapted to
retain the retention member within the interior of the protective
sheathing.
7. The suture needle retention device of claim 4 wherein the entire
retention member is inserted into the interior of the protective
sheathing through the open end of the protective sheathing.
8. The suture needle retention device of claim 7 wherein the
protective sheathing further comprises a retention lip, said
retention lip located circumferentially about the open end of the
protective sheathing, and said retention lip suitably adapted to
retain the retention member within the interior of the protective
sheathing.
9. The suture needle retention device of claim 7 wherein the
protective sheathing further comprises a plurality of engagement
barbs, said engagement barbs located within the interior of the
protective sheathing on the interior surface of the protective
sheathing, with each said engagement barb protruding into the
interior of the protective sheathing from the interior surface of
the protective sheathing and oriented towards the closed end of the
protective sheathing; whereby the engagement barbs are suitably
adapted to hold the retention member securely within the interior
of the protective sheathing.
10. The suture needle retention device of claim 9 wherein the
protective sheathing further comprises a retention lip, said
retention lip located circumferentially about the open end of the
protective sheathing, and said retention lip suitably adapted to
retain the retention member within the interior of the protective
sheathing.
11. A suture needle retention device comprising a retention member,
said retention member being needle pervious, said retention member
suitably adapted to be pierced by a suture needle such that a
portion of the suture needle is embedded within said retention
member, said retention member suitably adapted to retain an
embedded suture needle securely, and said retention member suitably
adapted to release an embedded suture needle when a sufficient
extraction force is applied to the suture needle; a protective
sheathing said protective sheathing being needle impervious, said
protective sheathing being substantially hollow and having an
interior and an interior surface, said protective sheathing having
an open end providing access into the interior, said protective
sheathing having a closed end that is substantially planar, and
located substantially opposite the open end, said protective
sheathing having a top side and a bottom side, said protective
sheathing suitably adapted to contain at least a portion of the
retention member within its interior while exposing another portion
of the retention member, whereby the retention member is at least
partially contained within the protective sheathing, and said
protective sheathing having a plurality of engagement barbs, said
engagement barbs located within the interior of the protective
sheathing on the interior surface of the protective sheathing, with
each said engagement barb protruding into the interior of the
protective sheathing from the interior surface of the protective
sheathing and oriented towards the closed end of the protective
sheathing, whereby the engagement barbs are suitably adapted to
hold at least a portion of the retention member securely within the
interior of the protective sheathing; and an attachment component,
said attachment component comprising a bottom slot, said bottom
slot formed into the bottom side of the protective sheathing
proximate to the closed end of the protective sheathing and
providing access into the interior of the protective sheathing,
said bottom slot having a width and a length, said length of said
bottom slot oriented substantially parallel with the closed end of
the protective sheathing, and said bottom slot being suitably
adapted to accommodate an end of the surgical instrument such that
the end of the surgical instrument is inserted through the bottom
slot into the interior of the protective sheathing, and a top slot,
said top slot formed into the top side of the protective sheathing
proximate to the closed end of the protective sheathing and
providing access into the interior of the protective sheathing,
said top slot having a width and a length, said width of the top
slot being less than the width of the bottom slot, said top slot
oriented substantially in alignment with the bottom slot, said top
slot being suitably adapted to accommodate the end of the surgical
instrument such that the end of the surgical instrument is inserted
through the top slot from the interior of the protective sheathing,
said attachment component being integrated with the protective
sheathing, and said attachment component being suitably adapted to
removably attach the suture needle retention device to a surgical
instrument without the use of adhesives; whereby the surgical
instrument protrudes through the bottom and top slots of the
protective sheathing with the end of the surgical instrument
protruding from the top slot.
12. The suture needle retention device of claim 11 wherein the
retention member is comprised of a resilient closed-cell foam
having negligible friability.
13. The suture needle retention device of claim 11 wherein the
protective sheathing further comprises a retention lip, said
retention lip located circumferentially about the open end of the
protective sheathing, and said retention lip suitably adapted to
retain the retention member within the interior of the protective
sheathing.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation in part of U.S. Ser. No.
11/298,372, filed Dec. 9, 2005 and currently pending, entitled
Suture Needle Retention Device, by O'Brien, Todd, which is hereby
incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Technical Field
[0003] The invention relates generally to the field of surgical
instruments and accessories. More specifically, the invention is
directed to an improved suture needle retention device to be used
during the suturing procedure to provide a temporary safe location
for a suture needle while the surgeon ties off the suture or
performs other activities.
[0004] 2. Description of Prior Art
[0005] Injuries resulting from accidental contact with a sharp
medical instrument are fairly common in surgical procedures. These
so-called "sharps" injuries present a high risk to surgeons,
physicians assistants, nurses, and other medical personnel in light
of the prevalence of infectious blood-borne diseases, such as HIV
and hepatitis B. The danger is so serious that OSHA has promulgated
regulations directed to the safe handling of sharps.
[0006] A common source of sharps injuries are suture needles. It is
estimated that twenty percent of all sharps injuries are from
suture needles, representing more than 100,000 injuries each year
in the United States. The Center for Disease Control reports that
approximately twenty percent of all cases of HIV infection from
needle sticks arise specifically from suture needles.
[0007] Suture needles are typically curved needles attached to the
end of a length of suture material. A surgical instrument known as
a needle driver is used to hold the end of the suture needle
closest to the suture, and the surgeon, manipulating the needle
driver, maneuvers the sharp end of the suture needle into and
through skin or other tissue, pulling the suture material along
with it. The surgeon then ties off the suture with a secure knot,
cutting the excess suture material. The process is repeated for as
many sutures are needed. During the tying and cutting phase of the
procedure the suture needle is not used by the surgeon. It is
typically held between the surgeon's fingers, left to hang from the
excess suture material, or set down upon the surgical field, or
otherwise placed out of the way. As such it becomes a danger to all
persons in close proximity to it.
[0008] A suture needle retention device lessens the danger of an
accidental sharps injury from a suture needle during the tying and
cutting phase of suturing by providing a secure place to embed the
sharp end of the suture needle. However, the suture needle
retention devices known in the art are deficient in many respects.
Some are designed to be simply placed on a flat surface, where they
may be inconvenient to the surgeon or in danger of being knocked to
the floor. Others are designed to be worn on the surgeon's wrist or
held in the surgeon's hand. These configurations present the danger
of a surgeon attempting to place the suture needle into the device
but then missing and sticking him- or herself. This is clearly
unacceptable. Other devices are designed to be affixed to a
surgical instrument. This is an improvement, as it places the
device in a useful location, but attachment means comprising
adhesives tend to leave a residue upon the instrument, making
cleanup and/or sterilization more difficult, and attachment means
comprising magnets tend not to hold the devices securely
enough.
[0009] Following are examples of surgical needle retention devices
known in the art. Cramer, U.S. Pat. No. 4,380,292 (Apr. 19, 1983),
"Parenteral Needle Receptacle", discloses a foam block needle park
encased in a plastic container having a top aperture. Needles are
passed through the aperture into the foam block. The container
retains the foam block and has a means for attaching the device to
a surface, such as by adhesive tape or a magnet. The container
comes apart to permit disposal of the needle-filled foam block and
insertion of a fresh foam block. It is intended primarily as a
disposal device for needles, as opposed to device for temporarily
securing a suture needle during the suturing procedure. The
attachment means are inferior, as the use of an adhesive leaves a
residue behind when the device is removed, making it difficult to
sterilize the surface onto which the device was attached. The use
of magnetic attachment means is also inferior, as the device is
easily dislodged even during ordinary use. Moreover, the device is
not intended to be attached to a surgical instrument by any
attachment means.
[0010] Swor, U.S. Pat. No. 4,969,893 (Nov. 13, 1990), "Disposable
Suture Cutter and Needle Holder", discloses a suture cutting device
having a foam needle park to temporarily receive the suture needle.
It may be laid upon a flat surface or attached to a surface, such
as a surgical drape, or to the surgeon's hand or wrist. It is not
intended to be attached to a surgical instrument.
[0011] Shuter, U.S. Pat. No. 5,490,858 (Feb. 13, 1996), "Method and
Apparatus for Handling Suturing Needles", discloses, though does
not claim, a needle retention device comprised of a needle pervious
retaining material with a needle impervious cap provided over a
portion of the retaining material to prevent penetration of the
needle completely through the retaining material. The Shuter device
is intended to be held by the hand of the user. Shuter suggests the
device can be attached to an instrument by hook and loop fasteners
or magnetic means, but discloses no integrated means for securely
attaching the device to a surgical instrument. Further, Shuter
specifically teaches away from any kind of attachment component
which removably attaches the suture needle retention device to a
surgical instrument.
[0012] The above-cited prior art is easily distinguished from the
present invention. The present invention is directed to a suture
needle retention device which integrates easily and securely with a
surgical instrument, such as a forceps, typically used by the
surgeon to hold tissue during the suturing procedure. Attachment of
the present invention to the surgical instrument keeps the device
out of the way when not in use but allows it to be immediately
accessible when needed. More importantly, it directs the temporary
placement of suture needles away from the surgeon's hand. Its novel
attachment component allows for simple interchangeability between
instruments, if needed, and easy removal and disposal without
compromising the surgical instrument. It is not, however, a
permanent needle disposal device nor a device intended to store,
cut, or retain sutures or multiple needles.
[0013] These and other features of the present invention, described
below, disclose a novel and useful invention.
[0014] It is an objective of the present invention to provide an
improved suture needle retention device to receive and temporarily
hold a suture needle during a suturing procedure to keep the suture
needle safely out of the surgeon's way while the surgeon completes
tying the suture or performs some other task.
[0015] It is a further objective to provide an improved suture
needle retention device that increases the safety to the surgeon by
locating the device away from the surgeon's hand during use.
[0016] It is a further objective to provide an improved suture
needle retention device that increases the safety to the surgeon by
directing the path of the suture needle away from the surgeon's
hand when used to retain the suture needle.
[0017] It is a further objective to provide an improved suture
needle retention device that integrates easily and securely with a
surgical instrument, thereby keeping the device out of the way when
not in use but immediately accessible when needed.
[0018] It is a further objective to provide an improved suture
needle retention device that is removably attachable to a surgical
instrument by means providing secure attachment thereto and easy
removal therefrom.
[0019] It is a further objective to provide an improved suture
needle retention device that comprises an attachment means which
does not compromise the surgical instrument to which it is attached
during use.
[0020] It is a further objective to provide an improved suture
needle retention device that allows for simple interchangeability
between instruments, if needed.
[0021] It is yet a further objective to provide an improved suture
needle retention device that is simple and cost effective to
manufacture.
[0022] Other objectives of the present invention will be readily
apparent from the description that follows.
SUMMARY OF THE INVENTION
[0023] The invention comprises an improved suture needle retention
device suitably adapted to be removably attached to the end of a
surgical instrument held in the nondominant hand of the surgeon.
The suture needle retention device accepts the sharp end of a
suture needle and holds it securely, until such time as a
sufficient forced is applied to extract the suture needle from the
device.
[0024] The suture needle retention device is comprised of a
retention member, a protective sheathing, and an attachment
component. The retention member is constructed of a needle pervious
material, such as closed cell foam. The protective sheathing is
constructed of a needle impervious material, such as a rigid
plastic, and encloses most of the retention member, leaving a
portion of the retention member exposed so as to receive the sharp
end of the suture needle. A suture needle inserted too deeply into
the retention member will strike the protective sheathing and be
prevented from penetrating through the protective sheathing to the
exterior of the device. The protective sheathing may also comprise
structures within its interior to better secure the retention
member within the protective sheathing. The attachment component is
integrated with the protective sheathing and comprises one or more
slots formed into the end of the protective sheathing opposite the
exposed retention member. These slots are suitably adapted to
accommodate the end of a surgical instrument. The attachment
component may comprise additional structures to more firmly attach
the device to the surgical instrument, such as a flexible flap that
frictionally engages with the end of the surgical instrument.
[0025] The above configuration aligns the suture needle retention
device substantially perpendicular to the end of the surgical
instrument, such that movement of the suture needle towards the
device is not towards the surgeon's hand holding the
instrument.
[0026] The attachment component allows the suture needle retention
device to be easily placed onto and taken off the end of the
surgical instrument. It can be quickly swapped onto different
instruments if needed. If it becomes unusable during a suturing
procedure it can be easily removed and disposed of and a
replacement placed onto the surgical instrument.
[0027] Other features and advantages of the invention are described
below
DESCRIPTION OF THE DRAWINGS
[0028] FIG. 1 is a perspective view of the present invention
depicting the invention attached to the end of a forceps.
[0029] FIG. 2 is an exploded view of the present invention depicted
in FIG. 1.
[0030] FIG. 3 is a perspective front view of the protective
sheathing of the present invention.
[0031] FIG. 4 is a cut-away side view of the protective sheathing
of the present invention depicting the integrated attachment
component.
[0032] FIG. 5 is a cut-away side view of the protective sheathing
of the present invention depicting the retention flap being
displaced against the retention member by the surgical instrument,
resulting in the surgical instrument being held securely between
the retention flap, the retention ridges, and the edges of the top
and bottom slots of the attachment component.
[0033] FIG. 6 is a perspective view of the present invention being
used by a surgeon, depicting the surgeon directing the suture
needle towards the retention member of the device.
[0034] FIG. 7 is a perspective view of the present invention being
used by a surgeon, depicting the suture needle embedded in the
retention member of the device.
DETAILED DESCRIPTION OF THE INVENTION
[0035] The present invention is an improved suture needle retention
device 1 to be used by a surgeon during a suturing procedure. See
FIG. 1. The device 1 is suitably adapted to be removably attached
to the end 32 of a surgical instrument 30, such as a forceps, held
in the nondominant hand 50 of the surgeon. See FIG. 6. The surgeon,
holding a suture needle 10 with a needle driver 40 held in the
dominant hand of the surgeon, directs the sharp end of the suture
needle 10 into the device 1, such that the sharp end of the suture
needle 10 becomes embedded within the device 1 so that the device 1
holds the suture needle 10 securely and safely while the surgeon
ties off and cuts the suture 20 or performs some other function.
See FIG. 7. When the surgeon again requires use of the suture
needle 10, it is withdrawn from the device 1 by the surgeon and
used to continue with the suturing procedure.
[0036] The suture needle retention device 1 is comprised of a
retention member 100, a protective sheathing 200, and an attachment
component 300. The retention member 100 is contained substantially
within the protective sheathing 200, and the attachment component
300 is formed into and integrated with the protective sheathing
200.
[0037] The retention member 100 is needle pervious. When used as
intended, the retention member 100 is pierced by a suture needle 10
such that at least the sharp end of the suture needle 10 becomes
embedded within the retention member 100, with the remaining
portion of the suture needle 10 being exposed exterior to the
retention member 100. Placed as such, the suture needle 10 is
retained securely by the retention member 100 and the potentially
dangerous sharp end of the suture needle 10 is not exposed. The
retention member 100 is also suitably adapted to release the suture
needle 10 embedded therein when a sufficient extraction force is
applied to the suture needle 10. The retention member 100 is
preferably constructed of a resilient, deformable material, to
allow it to be placed within the protective sheathing 200 of the
device 1. The retention member 100 should be constructed of a
material having negligible friability, so that the retention member
100 resists shedding portions of its material upon being pierced by
a suture needle 10. It should also be sufficiently durable to
withstand multiple insertions and extractions of a suture needle
10. The retention member 100 may be constructed of any material
having the foregoing characteristics, with the preferred material
being a closed cell foam. In the most preferred embodiment, the
retention member 100 is constructed of low density polyethylene #2
medical grade closed cell foam.
[0038] The protective sheathing 200 is constructed of a needle
impervious material. The protective sheathing 200 should be
substantially rigid and light weight. It may be constructed of any
suitable material, with the preferred material being a rigid
plastic. In the most preferred embodiment, the protective sheathing
is constructed of ABS plastic. This allows for cost effective
manufacture using well known injection molding techniques.
[0039] The protective sheathing 200 must be suitably adapted to
enclose most of the retention member 100, leaving at least a
portion of the retention member 100 exposed so as to receive the
sharp end of the suture needle 10. The protective sheathing 200 is
substantially hollow and has an interior 210, and has an open end
230 providing access into the interior 210. See FIG. 3. Opposite
the open end 230, the protective sheathing has a closed end 240. At
least a portion of the retention member 100 is inserted into the
interior 210 of the protective sheathing 200. See FIG. 2. In the
preferred embodiment the entire retention member 100 is enclosed by
the protective sheathing 200, with one surface of the retention
member 100 exposed through the open end 230 of the protective
sheathing 200. See FIG. 1. To use the device 1, a suture needle 10
is inserted into the retention member 100 through the open end 230
of the protective sheathing 200. See FIGS. 6 and 7. Even if the
suture needle 10 is attempted to be inserted too deeply into the
retention member 100, it cannot pass through the protective
sheathing 200 and thus the sharp end of the suture needle 10 is
prevented from penetrating through to the exterior of the device
1.
[0040] The protective sheathing 200 may be of any shape suitable to
enclose the retention member 100 while leaving at least a portion
of the retention member 100 exposed. It can be of any size as well,
though in practical application the protective sheathing 200 should
be between one half inch to two inches long from its open end 230
to its closed end 240, and between one half inch and one inch
across its open end 230. The retention member 100 should have a
shape conforming substantially to the shape of the interior 210 of
the protective sheathing 200, to provide for a snug fit within the
protective sheathing 200. As such, the retention member 100 is
frictionally secured within the protective sheathing 200. In one
embodiment the protective sheathing 200 is semi-spherical in shape.
In another embodiment the protective sheathing 200 is cylindrical.
In the preferred embodiment the protective sheathing 200 is a
flattened cylinder. See FIG. 3. In this embodiment the protective
sheathing 200 has a top side 250 and a bottom side 260, and the
closed end 240 of the protective sheathing 200 is substantially
planar and oriented substantially parallel to the plane of the open
end 230 of the protective sheathing 200.
[0041] The protective sheathing 200 may also comprise structures
within its interior 210 to better secure the retention member 100
within the protective sheathing 200. See FIG. 4. In one embodiment,
the protective sheathing 200 comprises a plurality of engagement
barbs 270. The engagement barbs 270 are located within the interior
210 of the protective sheathing 200 on the interior surface 220 of
the protective sheathing 200. Each engagement barb 270 protrudes
into the interior 210 of the protective sheathing 200 and is
oriented towards the closed end 240 of the protective sheathing
200. When the retention member 100 is inserted into the interior
210 of the protective sheathing 200, the retention member 100
deforms around the engagement barbs 270 and the rearward
orientation of the engagement barbs 270 prevents the retention
member 100 from slipping out of the open end 230 of the protective
sheathing 200.
[0042] In another embodiment, the protective sheathing 200
comprises a retention lip 280. The retention lip 280 is located
circumferentially about the open end 230 of the protective
sheathing 200 and extends into the open end 230. As such, the
retention lip 280 assists in retaining the retention member 100
within the interior 210 of the protective sheathing 200. In yet
another embodiment both the engagement barbs 270 and the retention
lip 280 are present. In yet a further embodiment at least a portion
of the interior surface 220 of the protective sheathing 200 is
textured, providing enhanced frictional means for retaining the
retention member 100 within the protective sheathing 200. The above
described structures may be formed into the protective sheathing
200 during manufacture, for example by using injection molding
techniques, resulting in a monolithic component with integrated
interior structures.
[0043] The above configurations of the protective sheathing 200 are
suitably adapted to allow for easy insertion of at least a portion
of the retention member 100 into the interior 210 of the protective
sheathing 200. Final assembly of the device 1 is simplified by
merely directing the retention member 100 into the interior 210 of
the protective sheathing 200 with sufficient force to cause the
retention member 100 to deform past and around the various
structures present. No adhesive is needed to retain the retention
member 100 within the protective sheathing 200. Moreover, if
desired, the retention member 100 may be removed from the
protective sheathing 200, for example by grasping it with tweezers
and then extracting it through the open end 230 of the protective
sheathing 200, thereafter to be replaced by a new retention member
100.
[0044] The attachment component 300 of the device 1 is integrated
with the protective sheathing 200. The attachment component 300 is
suitably adapted to permit the device 1 to be removably attached to
a surgical instrument 30 without the use of adhesives or straps. It
secures the device 1 to the surgical instrument 30 sufficiently to
prevent accidental detachment during use as well as aligns the
device 1 with the surgical instrument 30 such that during use the
suture needle 10 is never directed towards the surgeon's hand
50.
[0045] The attachment component 300 comprises at least one slot
formed into the protective sheathing 200. The slot is located
proximate to the closed end 240 of the protective sheathing 200,
formed into the bottom side 260 of the protective sheathing 200,
and oriented such that its length is substantially parallel to the
plane of the closed end 240 of the protective sheathing 200. The
slot is suitably adapted to accommodate an end 32 of a surgical
instrument 30, whereby the end 32 of the surgical instrument 30 may
be inserted into and through the slot into the interior 210 of the
protective sheathing 200. The device 1 is frictionally secured to
the surgical instrument 30 by the sides of the slot surrounding the
instrument 30 and the end 32 of the instrument 30 being pressed
between the closed end 240 of the protective sheathing 200 and the
rear portion of the retention member 100.
[0046] In the preferred embodiment, the attachment component 300
comprises a bottom slot 310 and a top slot 320. The bottom slot 310
is located proximate to the closed end 240 of the protective
sheathing 200, formed into the bottom side 260 of the protective
sheathing 200, and oriented such that its length is substantially
parallel to the plane of the closed end 240 of the protective
sheathing 200. The top slot 320 is formed into the top side 250 of
the protective sheathing 200 proximate to the closed end 240 of the
protective sheathing 200, and is oriented substantially in
alignment with the bottom slot 310. The width of the top slot 320
is less than the width of the bottom slot 310. See FIG. 4. The
bottom slot 310 and the top slot 320 are suitably adapted to
accommodate the end 32 of a surgical instrument 30, whereby the end
32 of the surgical instrument 30 may be inserted into and through
the bottom slot 310 into the interior 210 of the protective
sheathing 200 and then into and through the top slot 320 from the
interior 210 of the protective sheathing 200 and out of the
protective sheathing 200. This results in at least a portion of the
surgical instrument 30 being contained within the interior 210 of
the protective sheathing 200, the end 32 of the instrument 30
protruding from the top slot 320, and the remainder of the
instrument 30 protruding from the bottom slot 310. Because the
width of the top slot 320 is less than the width of the bottom slot
310, and the end 32 of the surgical instrument 30 is typically
tapered, the end 32 of the surgical instrument 30 can pass only a
short way through the top slot 320 before becoming wedged therein.
The device 1 is therefore secured to the surgical instrument 30 by
the sides of the bottom and top slots 310,320 surrounding the
instrument 30. In certain configurations the portion of the
instrument 30 contained within the interior 210 of the protective
sheathing 200 is also pressed between the closed end 240 of the
protective sheathing 200 and the rear portion of the retention
member 100. In one embodiment the interior surface 220 of the
closed end 240 of the protective sheathing 200 is textured,
enhancing the ability of the device 1 to be frictionally secured to
the instrument 30.
[0047] With the bottom and top slots 310,320 of the attachment
component 300 formed into the protective sheathing 200 as described
above, the device 1 attaches to the surgical instrument 30 in a
substantially perpendicular orientation. That is, the longitudinal
axis of the device 1, running through the open and closed ends
230,240 of the protective sheathing 200, is substantially
perpendicular to the longitudinal axis of the surgical instrument
30. So oriented, the exposed portion of the retention member 100
lies in a plane substantially parallel to the surgical instrument
30. See FIGS. 6 and 7. Thus, when a surgeon directs the suture
needle 10 towards the device 1, the suture needle 10 does not move
towards the hand 50 holding the instrument 30. This is in contrast
to other devices known in the art, such as those worn on a wrist
band or held in the surgeon's hand. In those configurations the
suture needle 10 is directed towards the surgeon's hand 50; if the
suture needle 10 misses the device, it is likely to strike the hand
50, causing injury. The present invention avoids this undesirable
risk. If the surgeon misses the retention member 100, the suture
needle 10 is likely to strike either the surgical instrument 30 or
nothing at all. This configuration also enhances the security of
the attachment of the device 1 to the instrument 30. This is
because the forces necessary to insert the suture needle 10 into
the retention member 100 and to extract the suture needle 10 from
the retention member 100 are applied perpendicular to the
directions of force needed to attach or detach the device 1 to the
instrument 30, so that normal use of the device 1 does not tend to
loosen the device 1 from the instrument 30.
[0048] The attachment component 300 may comprise additional
structures to more firmly attach the device 1 to the surgical
instrument 30. One such structure is a flexible retention flap 330.
The retention flap 330 is substantially planar and has a top edge
332, a connection end 334 located opposite the top edge 332, and a
face 336. The retention flap 330 is located within the interior 210
of the protective sheathing 200 proximate to the bottom slot 310
and between the bottom slot 310 and the open end 230 of the
protective sheathing 200, such that the retention flap 330 is
located between the retention member 100 and the bottom slot 310.
The retention flap 330 is attached to the interior surface 220 of
the bottom side 260 of the protective sheathing 200 at its
connection end 334, with the face 336 of the retention flap 330
oriented towards and substantially parallel to the closed end 240
of the protective sheathing 200. The face 336 of the retention flap
330 may be textured. The retention flap 330 is angled towards the
closed end 240 of the protective sheathing 200 such that the top
edge 332 and at least a portion of the face 336 of the retention
flap 330 extend over at least a portion of the bottom slot 310. So
configured, the retention flap 330 is suitably adapted to flex and
to be displaced in a direction away from the closed end 240 of the
protective sheathing 200. When a surgical instrument 30 is inserted
into the bottom slot 310 and out through the top slot 320, as
described above, at least a portion of the instrument 30 contained
within the interior 210 of the protective sheathing 200 presses
against at least a portion of the face 336 of the retention flap
330 and displaces the retention flap 300 away from the closed end
240 of the protective sheathing 200 and against the retention
member 100. See FIG. 5. The retention flap 330 in turn presses back
against the portion of the instrument 30 contained within the
interior 210 of the protective sheathing 200 as a result of its
flexing and the counter force of the retention member 100 pressing
the retention flap 330 back against the instrument 30. In this
manner the device 1 is even more securely attached to the
instrument 30.
[0049] The attachment component 300 may also comprise at least one
retention ridge 340. Each retention ridge 340 is located on the
interior surface 220 of the closed end 240 of the protective
sheathing 200. Each retention ridge 340 is oriented substantially
horizontally and extends into the interior 210 of the protective
sheathing 200 from the interior surface 200 of the closed end 240
of the protective sheathing 200 such that at least a portion of the
retention ridge 340 is aligned over at least a portion of the
bottom slot 310. See FIGS. 4 and 5. The retention ridges 340
provide a greater surface area against which the surgical
instrument 30 is pressed when it is inserted through the bottom and
top slots 310,320.
[0050] The preferred embodiment uses both the retention ridges 340
and the retention flap 330, located on either side of the
instrument 30, respectively, to maximize the points of contact
between the instrument 30 and the device 1, thereby enhancing the
security of the attachment. This provides an improvement over the
prior art which might attach a suture needle retention device using
a magnet or a strap. A magnet small enough to be used with a
practically sized device will not have sufficient holding power to
retain the device securely to the instrument 30, but rather the
device will tend to slide along the instrument 30 and possibly be
pulled off the instrument 30 when extracting the suture needle 10
therefrom. Straps are not only awkward to use but may permit a
device to rotate about the instrument 30, taking the device out of
its desired alignment. Adhesives may hold a device more securely
than a magnet or straps, but then the device cannot be easily
removed from the instrument 30. Also, once the device is removed
from the instrument 30, a residue of the adhesive will remain
behind, making the instrument 30 harder to clean and sterilize. The
present invention overcomes all of these deficiencies by providing
a secure attachment that prevents the device 1 from moving in
relation to the instrument 30 when attached thereto, but also is
easily removed when no longer needed. This is especially important
if the surgeon needs to use different instruments during the
procedure; the device 1 can be easily swapped from one instrument
to another.
[0051] The device 1 configured in its most preferred embodiment,
with the protective sheathing 200 comprising a plurality of
engagement barbs 270, a retention lip 280, a retention flap 330,
and one or more retention ridges 340, may be manufactured with the
protective sheathing 200 and all said component structures being
formed as a monolithic unit in a single manufacturing step, such as
injection molding. Assembly of the device 1 is easily completed by
simply inserting the retention member 100 into the protective
sheathing 200 through the open end 230. As such, the present
invention represents an improvement over the more complicated
devices represented by the prior art with regard to cost and ease
of manufacture.
[0052] Other embodiments not specifically set forth herein are also
within the scope of the following claims.
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