Surgical needle abstract
A loop threaded needle-suture device is disclosed wherein a surgical
needle is provided with a pointed end and a drilled aperture extending
axially of the butt end, and a length of flexible suture material
is doubled upon itself to form a loop, both free ends of which are
attached to the needle in the butt end aperture. The blunt end of
the needle is deformed to form the aperture into an elliptical cross-section
and the length of the loop is substantially greater than the length
of the needle to facilitate insertion of the needle and suture material
into tissue to be sutured, and looping the needle through the suture
material prior to tieing the suture material. Thus, the loop functions
as a double suture. A method of forming the unique loop threaded
needle-suture is disclosed.
Surgical needle claims
What is claimed is:
1. In combination, a needle having a pointed end and a butt end,
said butt end having an aperture extending generally axially thereof
and having a substantially elliptical cross-sectional configuration
for reception of needle suture material, a suture loop formed from
flexible suture material, said flexible suture material having two
free ends positioned in engaged adjacent relation within said substantially
elliptical aperture of said needle such that the combined dimension
of said free ends of suture material corresponds generally to the
greater cross-sectional dimension of said aperture, said flexible
suture material being of length at least about 60 inches such that
said loop is about 30 inches in length to facilitate insertion of
said needle and at least a portion of said flexible looped suture
material into body tissue to be sutured, and looping said needle
through said lop to tie said suture material with respect to body
tissue, said needle being inwardly swaged at said butt end to provide
predetermined inward attachment force on said free ends of said
suture material sufficient to attach said suture material to said
needle.
2. The looped suture device according to claim 1 wherein said needle
is a surgical needle.
3. The looped suture device according to claim 2 wherein said needle
has an arcuate configuration.
4. The looped suture device according to claim 3 wherein said needle
is manufactured of 400 series surgical stainless steel.
5. The looped suture device according to claim 4 wherein said elongated
aperture has a substantially elliptical cross-sectional configuration.
6. The looped suture device according to claim 5 wherein said flexible
suture material is at least one of suture materials such as polypropylene,
silk, nylon, linen, cotton, polyester, stainless steel, natural
materials such as catgut, and synthetic polymers having glycolic
acid ester linkages subject to hydrolytic degradation to non-toxic,
tissue compatible absorbable components, including polyglycolic
acid.
7. The looped suture device according to claim 6 wherein said butt
end of said pointed needle is inwardly swaged in at least two directions
to provide inward forces directed at said flexible suture material
to attach said suture material to said needle.
8. The looped suture device according to claim 7 wherein said swaged
attachment at said butt end of said needle is controlled to provide
predetermined pull-out forces of said flexible suture material with
respect to said needle.
9. The looped suture device according to claim 8 wherein said pull
out forces average approximately 2.10 kilogram-force.
10. The looped suture device according to claim 1 wherein said
flexible suture material has a generally circular cross-sectional
configuration.
11. A method of manufacturing a looped suture device which comprises:
a) providing a surgical needle having a pointed end and a butt
end, said butt end having an elongated aperture extending axially
thereof and being of predetermined length;
b) providing a flexible suture material and looping said suture
material such that the two free ends thereof are in adjacent engaged
end to end relation, said flexible suture material being of sufficient
length to facilitate insertion of said needle and at least a portion
of said flexible material into body tissue to be sutured, and looping
said needle through said loop to tie said suture material with respect
to body tissue;
c) deforming said butt end of said needle such that said aperture
assumes a substantially elliptical cross-sectional shape having
a major dimension greater than a minor dimension substantially perpendicular
to said major dimension, said aperture of said needle being dimensioned
sufficient to receive a predetermined length of said free end portions
of said flexible suture material while maintaining said free end
portions in said end to end relation;
d) positioning a pair of dies about said butt end of said needle
and;
e) applying at least one inwardly directed force to said dies and
thereby to said butt end of said needle to cause said needle material
to become inwardly swaged sufficient to provide inward predetermined
attachment force on said suture material.
12. The method according to claim 11 wherein said flexible suture
material has a generally circular cross-sectional configuration.
13. The method according to claim 11 further comprising treating
the free end portions of said flexible suture material with a tipping
agent prior to positioning said free end portions within said aperture
of said needle.
14. The method according to claim 13 wherein said tipping agent
is a cyanoacrylate.
15. The method according to claim 14 further comprising providing
at least a second inwardly directed force on said butt end of said
needle in a direction generally perpendicular to said first provided
force to thereby cause said needle material to become further swaged
to provide predetermined attachment force on said flexible suture
material.
16. A method of manufacturing a looped suture device which comprises:
a) providing a surgical needle having a pointed end and a butt
end, said butt end having an aperture extending axially thereof
and of predetermined length;
b) providing a flexible suture material and looping said suture
material such that the two free ends thereof are in adjacent engaged
end to end relation;
c) deforming said butt end such that said aperture of said needle
assumes a cross-sectional shape having a major dimension greater
than a minor dimension substantially perpendicular to said major
dimension, said aperture of said needle being dimensioned sufficient
to receive a predetermined length of said free end portions of said
flexible suture material while maintaining said free end portions
in said end to end relation;
d) positioning a pair of dies about said butt end of said needle,
each die having a generally arcuate undulating surface portion facing
said butt end and including concave portions; and
e) applying inward force to said dies to cause said dies to strike
said needle butt end to transmit inward crimping forces thereto
so as to attach said flexible suture material to said needle while
permitting deformed material of said needle butt end to collect
within said concave portions so as to avoid distortion of said butt
end.
17. The method according to claim 16 wherein said flexible suture
material has a generally circular cross-sectional configuration.
18. A method of manufacturing a looped suture device which comprises:
a) providing a surgical needle having a pointed end and a butt
end, said butt end having an aperture extending axially thereof
and of predetermined length;
b) providing a flexible suture material and looping said suture
material such that the two free ends thereof are in adjacent engaged
end to end relation;
c) deforming said butt end such that said aperture of said needle
assumes a cross-sectional shape having a major dimension greater
than a minor dimension substantially perpendicular to said major
dimension, said aperture of said needle being dimensioned sufficient
to receive a predetermined length of said free end portions of said
flexible suture material while maintaining said free end portions
in said end to end relation;
d) positioning a pair of dies about said butt end of said needle,
each die having a pair of inner arcuate surface portions spaced
apart from each other to provide a material relief zone; and
e) applying inward force to said dies sufficient to cause crimping
of said needle butt end so as to attach said flexible suture material
to said needle while permitting portions of material forming part
of said butt end to be deformed and to collect within relief zones
between said pairs of arcuate surface portions.
19. The method according to claim 18 wherein said flexible suture
material has a generally circular cross-sectional configuration.
20. A method of manufacturing a looped suture device which comprises:
a) providing a surgical needle having a pointed end and a butt
end, said butt end having an aperture extending axially thereof
and of predetermined length;
b) providing a flexible suture material and looping said suture
material such that the two free ends thereof are in adjacent engaged
end to end relation, said flexible suture material being of sufficient
length to facilitate insertion of said needle and at least a portion
of said flexible suture material into body tissue to be sutured,
and looping said needle through said loop to tie said suture material
with respect to body tissue;
c) deforming said butt end such that said aperture of said needle
assembly assumes a substantially elliptical cross-sectional shape;
d) inserting a predetermined length of said free end portions of
said suture material into said substantially elliptical aperture
while maintaining said free end portions in end to end relation;
e) providing a first inwardly directed force in a first direction;
and
f) providing a second inwardly directed force in a second direction
different from said first direction to swage said butt end to said
suture.
21. The method of claim 20 wherein said first and second directions
are substantially perpendicular to each other.
22. A method of suturing body tissue with a looped suture device
having a needle having a pointed end and a butt end, said butt end
having an aperture extending generally axially thereof and having
a cross-sectional dimension greater in a first direction than the
cross-sectional dimension substantially perpendicular to said first
direction, a loop formed from a flexible suture material and having
both free ends positioned within said aperture and attached to said
needle, comprising inserting said needle into the body tissue until
at least a portion of said suture material penetrates the body tissue,
substantially reversing the direction of said needle and inserting
said needle through said looped suture material.
23. A method of manufacturing a looped suture device which comprises:
a) providing a surgical needle having a pointed end and a butt
end, said butt end having an elongated aperture extending generally
axially thereof and said aperture having a cross-section dimension
greater in a first direction than the cross-dimension substantially
perpendicular to said first direction;
b) providing a flexible suture material and looping said suture
material such that the two free ends thereof are in adjacent engaged
end to end relation, said flexible suture material being of sufficient
length at least about 60 inches such that the length of the resilient
loop is at least about 30 inches to facilitate insertion of said
needle and at least a portion of said flexible suture material into
body tissue to be sutured, and looping said needle through said
loop to tie said suture material with respect to body tissue;
c) inserting a predetermined length of said free end portions of
said suture material into said elongated aperture while maintaining
said free end portions in end to end relation; and
d) providing at least one inwardly directed force on said butt
end of said needle to cause said needle material to become inwardly
swaged sufficient to provide inward predetermined attachment force
on said suture material.
24. A method of repairing body tissue, comprising:
a) providing a looped suture device having a pointed end and a
butt end, said butt end having an aperture extending generally axially
thereof and having a cross-sectional dimension greater in a first
direction than the cross-section dimension substantially perpendicular
to said first direction, a loop formed from a flexible suture material
and having both free ends positioned within said aperture and attached
to said needle, said flexible suture material being of sufficient
length to facilitate looping said needle through said loop to tie
said suture material with respect to body tissue;
b) inserting said needle into the body tissue at a location and
in direction to effect a repair;
c) passing said needle and a substantial portion of said flexible
suture material through the body tissue;
d) inserting said needle through said looped portion of suture
material to tie said suture material with respect to said looped
portion and the body tissue.
25. A method of manufacturing a looped suture device which comprises:
a) providing a surgical needle having a pointed end and a butt
end, said butt end having an aperture extending axially thereof
and being of predetermined length;
b) providing a flexible suture material and having a generally
circular cross-sectional configuration;
c) treating the free end portions of said flexible suture material
with a tipping agent;
d) looping said suture material such that the two free ends thereof
are in adjacent engaged end to end relation, said flexible suture
material being of sufficient length to facilitate insertion of said
needle and at least a portion of said flexible material into body
tissue to be sutured, and looping said needle through said loop
to tie said suture material with respect to body tissue;
e) deforming said butt end of said needle such that said aperture
assumes a substantially elliptical cross-sectional shape having
a major dimension greater than a minor dimension substantially perpendicular
to said major dimension, said aperture of said needle being dimensioned
sufficient to receive a predetermined length of said free end portions
of said flexible suture material while maintaining said free end
portions in said end to end relation; and
f) providing at least one inwardly directed force to said dies
and thereby on said butt end of said needle to cause said needle
to become inwardly swaged sufficient to provide inward predetermined
attachment force on said suture material.
26. The method according to claim 25 wherein said tipping agent
is a cyanoacrylate.
Surgical needle description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a combined surgical needle-suture device
and more particularly to a drilled needle-suture device in which
a suture, in the form of a looped thread, is attached to the needle.
2. Description of the Prior Art
For many years, surgeons have employed needle-suture combinations
in which a suture or ligature is attached to the shank end of a
needle. Such needle-suture combinations are provided for a wide
variety of monofilament and multifilament braided suture materials,
both absorbable and non-absorbable, e.g., catgut, silk, nylon, polyester,
polypropylene, linen, cotton, and absorbable synthetic materials
such as polymers and copolymers of glycolic and lactic acids.
Needle-suture combinations generally fall into three classes: eyed,
with no suture attached; drilled end, i.e. with an aperture bored
down the long axis of the needle and a suture secured in the bore;
and channeled, i.e. with a U-shaped recess or channel with an end
of the suture secured in the channel. Examples of drilled and channeled
needles are provided by U.S. Pat. No. 3534740 while eyed needles
are disclosed, for example, in U.S. Pat. Nos. 1960117 and 4182341.
The last mentioned '341 patent incorporates a relatively short loop
of polymer strand to form the eye of the needle.
More recently, it has become increasingly desirable to reduce the
time required to suture a wound or opening and to tie the suture
satisfactorily. While threading the suture has become improved somewhat,
the last mentioned objective of quickly tieing the suture has not
been significantly improved. The present invention incorporates
a looped suture into a surgical needle to facilitate quick knotting
and tieing as needed during critical surgical procedures.
SUMMARY OF THE INVENTION
It has now been found that an improved loop threaded needle-suture
device can be provided by employing a drilled needle in place of
a channeled needle wherein the butt end of the needle is provided
with a looped flexible suture attached within a substantially elliptical
shaped bore. The loop functions as the actual suture material.
The invention relates to a looped suture device which comprises
a needle having a pointed end and a butt end, the butt end having
an aperture extending generally axially thereof and having a cross-sectional
dimension greater in a first direction than the cross-sectional
dimension substantially perpendicular to the first direction, a
loop formed from a suture material and having both free ends positioned
within the aperture and attached to the needle. The looped suture
device may include a curved surgical needle or a straight needle
manufactured of any surgically acceptable metal alloy such as 400
series surgical stainless steel.
By "Aperture" is meant an opening surrounded on all sides
by material forming the butt end of the needle, as compared to a
channel which is open on one side. With a channeled needle it would
be difficult to insert and retain both suture ends into the channel
during the swaging process. Further, swaging the open ends of the
channel without surface irregularities presents a separate and distinct
difficulty.
The suture material includes such suture materials as polypropylene,
silk, nylon, linen, cotton, polyester, stainless steel, natural
materials such as catgut, and synthetic polymers having glycolic
acid ester linkages subject to hydrolytic degradation to non-toxic,
tissue compatible absorbable components, including polyglycolic
acid. Monofilament and multifilament materials may be used.
Initially a needle is provided having an oversized drilled aperture
in the butt end. The butt end is swaged to form the aperture into
an elliptical shape. After inserting the two free ends of the looped
flexible suture material into the aperture, the butt end of the
pointed needle is inwardly swaged in at least one direction to provide
inward force directed at the flexible suture material to attach
the suture material to the needle. Alternatively, dies requiring
a single hit may be utilized.
The flexible suture material loop is of sufficient length to facilitate
looping the needle through the loop to tie the suture after passing
the needle and a portion of the loop through the body tissue.
Although the examples set forth hereinbelow are directed to standard
needle suture attachments, the invention is nevertheless applicable
to removable needle attachments. The minimum acceptable forces required
to separate a needle from a suture are set forth for various suture
sizes in the United States Pharmacopeia ("USP"). For example,
the USP prescribes minimum individual pull-out forces and minimum
average pull-out forces as measured for various representative needle-suture
combinations for both standard and removable needle/suture attachments.
The minimum acceptable pull-out forces for both standard and removable
needle-suture attachments set forth in the USP are hereby incorporated
by reference. However, in practicing the present invention, the
pull-out force for both standard and detachable sutures should be
comparable to the stated pull out force for a single strand of the
same size suture. Thus, the closure of the butt end of the needle
with respect to the doubled or "end to end" suture portions
positioned within the butt end of the needle as disclosed herein
can be modified appropriately by persons skilled in the art to accomplish
the same attachment (in Kgf) as with a single strand positioned
in the needle butt end. Examples of the present invention are set
forth hereinbelow for relatively large size suture strands having
standard needle/suture attachments of about 2.10 (Kgf). For the
size suture strand used, this attachment force is slightly greater
than the average force set forth in the USP Examples. Accordingly,
some variations of this force with the suture size listed are permissible
within the scope of the invention.
The looped suture device includes a flexible suture loop of length
sufficient to permit insertion of the needle into body tissue to
be sutured and thereafter, reversing the direction of the needle
and inserting it into the loop to facilitate tieing or knotting
the suture prior to releasing the suture from the needle. Essentially,
the provision of an elliptical opening at the butt end of the needle
facilitates insertion and attachment of the loop of suture material
to the needle aperture with the free ends of the suture material
in adjacent engaged relation in the elliptical aperture. However,
broadly any aperture having a major dimension and a lesser minor
dimension transverse to the major dimension is contemplated. The
loop is preferably at least 60 inches in total length, doubled to
form a loop of 30 inches.
A method is disclosed for manufacturing a looped suture device
which comprises taking a surgical needle having a pointed end and
a butt end, the butt end having an aperture extending axially thereof
and of predetermined length, providing a flexible suture material
and looping the suture material such that the two free ends thereof
are in adjacent engaged side-to-side relation. The method comprises
deforming the butt end such that the aperture assumes a cross-sectional
shape having a major dimension greater in length than a minor dimension
substantially perpendicular to the major dimension. The aperture
of the needle is dimensioned sufficient to receive a predetermined
length of the free end portions of the flexible suture material
while maintaining the free end portions in the end to end relation.
According to the method at least one inwardly directed force is
provided on the butt end of the needle to cause the needle material
to become inwardly swaged sufficient to provide inward predetermined
attachment force on the suture material. With standard needle suture
dies requiring at least two hits, the second and subsequent inwardly
directed forces are provided on the butt end of the needle in directions
generally perpendicular to the provided force to thereby cause the
needle material to become further swaged to provide predetermined
attachment force on the flexible suture material.
Particular improved dies are disclosed in application Ser. No.
431303 filed Nov. 3 1989 now U.S. Pat. No. 5046350 and Ser.
No. 431306 filed Nov. 3 1989 now U.S. Pat. No. 5099676 which
are incorporated herein by reference. With such improved dies, a
single hit may be used to attach the needle and the looped suture
material.
BRIEF DESCRIPTION OF THE DRAWINGS
Preferred embodiments of the invention are described hereinbelow
with reference to the drawings wherein:
FIG. 1 is a perspective view of a looped suture device constructed
according to the invention;
FIG. 2 is a perspective view of the looped suture device of FIG.
1 inserted into body tissue and looped upon itself;
FIG. 3 is a plan view, partially in cross-section, and partially
broken away, of the looped suture device shown in FIG. 1;
FIG. 4 is a cross-sectional view of a drilled needle butt end prior
to forming the aperture into an elliptical shape;
FIG. 5 is a cross-sectional view of the drilled needle butt end
shown in FIG. 4 after partially compressing the butt end such that
the aperture assumes an elliptical shape;
FIG. 6 is a cross-sectional view of the drilled needle butt end
of FIG. 5 with the free ends of the looped suture inserted into
the elliptical aperture prior to swaging; and
FIG. 7 is a cross-sectional view taken along lines 7-7 of FIG.
3 of the needle butt end of FIG. 6 after the needle/suture loop
attachment is completed by swaging the butt end of the needle.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring initially to FIG. 1 the looped suture device 10 constructed
according to the present invention is illustrated. The looped suture
device is formed of surgical needle 12 attached to flexible suture
material 14 as shown. The needle is preferably constructed of a
suitable surgical steel such as surgical stainless steel and has
pointed end 16 and butt end 18. Such materials as 300 and 400 series
surgical stainless steel are contemplated. However, any suitable
surgically approved metal alloy may be used. The actual suture is
in the form of a loop.
Referring now to FIG. 2 a significant feature of the looped suture
device is illustrated. The needle 12 is inserted into a portion
of body tissue (illustrated schematically at 20). Thereafter, the
suture device may be conveniently looped upon itself as shown, by
inserting the pointed end of the needle into the looped suture material
14 and forming an appropriate tie or knot to secure the device with
respect to the tissue. Tieing or knotting may not be required if
the suture is being applied only for the purpose of restraining
tissue during a surgical procedure.
In FIG. 3 the looped flexible suture material 14 is illustrated
with portions broken away, with both free ends 24 26 positioned
in adjacent end to end relation within an elongated elliptical aperture
which extends axially of the butt end 18 of the needle. The needle
is shown greatly enlarged in FIG. 3 for illustrative purposes. The
cross-sectional view shown in FIG. 4 illustrates the attachment.
The present invention may be utilized in numerous applications
including 1) starting a continuous stitch by tieing a knot with
the flexible suture material; 2) restraining tissue temporarily
during a surgical procedure; 3) inserting the suture device with
the flexible portion partially into the tissue and tieing a knot.
Clearly, other applications will readily come to the mind of a person
skilled in the art.
The preferred method of attaching the flexible suture material
14 to the butt end 18 of the needle 12 is best illustrated by FIGS.
4-7. Needle 12 is initially provided with an oversized drilled aperture
22 extending axially of the butt end and having a predetermined
length as shown in FIG. 3. The aperture is surrounded on all sides
by the material forming the needle butt as shown in FIG. 4. Moreover,
the expression "drilled aperture" contemplates a needle
drilled by mechanical means, laser or the like. However, any needle
having an elongated aperture as described is contemplated, regardless
of how the aperture is formed in the butt end of the needle. The
initial aperture is oversized with respect to the size of the flexible
suture material, i.e., capable of freely receiving both free ends
loosely. The butt end of the needle is first compressed inwardly
using a reduced swaging pressure with an appropriate die or tool
to cause the butt end 18 to assume an elliptical cross-section as
shown in FIG. 5. Both free ends 24 26 of the suture material are
placed in end to end contacting relation as shown and inserted into
the now elliptical aperture as shown in FIG. 6. Alternatively, a
needle having a substantially elliptical opening may be provided
in the first instance.
In certain applications it may be desirable to treat the ends of
the suture material with a suitable tipping agent such as a cyanoacrylate.
Most notable of such instances is where the suture material has
a tendency to become limp or where a multifilament material is subject
to a brooming effect. Thereafter, the butt end of the needle is
subjected to inward force by suitable dies to cause the butt end
to crimp so as to complete the attachment of the needle to the flexible
suture material.
The attachment process may be accomplished by standard dies utilized
for surgical needle/suture attachments utilizing a lap-overlap swaging
die at a reduced swaging pressure, whereby the bore may be swaged
under standard conditions to secure the flexible material to the
needle as shown in FIG. 7. A "double hit" technique may
be used whereby the needle suture attachment is accomplished by
sequential hits along mutually perpendicular directions. Depending
upon the intended application, any number of multiple hits may be
used, rotating the direction of hit with respect to the needle 90
degrees between hits.
Alternatively, the attachment may be accomplished utilizing such
apparatus as disclosed in the aforementioned commonly assigned U.S.
Pat. Nos. 5046350 and 5099676. Both of the last mentioned applications
are incorporated by reference herein and made a part of this disclosure.
In either case, with such improved devices as disclosed in the aforementioned
applications, the needle will be swaged by a single hit as disclosed
in these applications.
Also, the swaging action may be carefully and precisely controlled
to provide for controlled release of the needle from the suture
material by predetermined forces after the suture attachment on
the body tissue is completed.
The present invention combines a surgical needle with a looped
suture material wherein the length of the loop is substantially
greater than the length of the needle to facilitate tieing the suture
material in a knot or other tie. Thus, the combination of the attachment
disclosed herein and the unique relatively lengthy suture loop material
form significant features of the invention. Further, any type of
surgical needle is contemplated, including curved needles, straight
needles, etc., of various alternative surgically approved materials.
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