Note: Descriptions are shown in the official language in which they were submitted.
217~70
IMPT ~NT A~SIST APPAR~US
BACXGRqLTND OF TEIE INVi~NTION
This is a divisional application of co-pending
cAn l~;An Application Serial No. 2,049,103, filed August 13,
1991 .
1. ~ield of thç InYention
The present invention relates to a method and
apparatus for effectively joining and/or reinforcing separated
soft tissues in humans and animals. ~ore particularly, the
invention is directed to a method and apparatus for placement
of implants for reapproximating separations in or reinforcing
weakened or separated soft tissues normally subject to flexure
or strains such as for example, muscles, tendons or ligaments
without excessive abrasion.
2. I)escriPtisn of Related ~rt ~ -
Currently, end to end repair of elastic tissue such
as muscles, tendons and ligaments, separated either by surgical
procedure or injury, involves suturing the ends of the tissue
together for a time sufficient to permit normal healing. The
ends of the tissue are joined with a wide variety of both
absorbable and non-absorbable suture and implant materials.
With non-absorbable suture materials, the sutures are typically
removed within one or two weeks of implantation or left in
place .
Conventional curYed suture needles, with their small
radii, significantly limit the distance over which the suture
can be buried. This limitation requires that the sutures be
positioned proximal to the severed ends of the tissue.
Particularly, in the case of soft elastic tissue such as
muscles, tendons or ligaments, conventionally
~ ~ -2~ 7 ~
implanted sutures have a tendency to prematurely pull
through the joined ends of the tissue when it is flexed or
subject to slight strains. When this occurs, the tissue
ends separate and healing is arrested necessitating further
surgery to repair the damage. One particularly advantageous
suture for use in j oining ends of soft elas~ic tissue is a
braided suture. Braided sutures are well known in the art
and are more supple and workable than conventional
monofilament sutures for a given tensile strength. Braided
10 sutures, however, tend to abrade these types of soft tissue
as they are implanted. It is desirable to be able to
introduce a relatively rough-surfaced braided suture without
causing tissue damage because, once in place, this type of
suture may provide some frictional resistance to pull-out,
keep the two ends of the tissue being reapproximated from
pistoning and provide a scaffold for tissue ingrowth as
healing progresses thus reinforcing the repair.
It is also common to repair, reinforce or replace
tendons and ligaments with prosthetic devices, as for
20 example the anterior cruciate ligament. Prosthetic
ligaments such as the Gore-Tex cruciate ligament device are
generally implanted through tunnels and anchored at either
end. After the tunnels are drilled, it is generally viewed
as important to chamfer both the internal and external
surfaces to remove sharp edges in an attempt to prevent
damage to the prosthesis during placement.
Other common types of procedures involving the
reapproximation or reinforcing of tissue ends by implant
material include, ~; ~, patellar tendon
30 reconstruction, collateral ligament repair, knee repair,
rotato~ cuff, tendon suturing, muscle facia suturing, tendon
~ 2~7~0
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advancement, reattachment or grafting as well as muscle
transf er .
Therefore, it would be highly desirable to have a
method and apparatus which permits implant materials of all
types to be easily and efficiently positioned in soft or hard
tissue over an extended distance remote from ends of the tissue
to be joined without excessive abrasion.
In accordance with an embodiment of the present
invention there is provided an implant assist apparatus for
implanting material in tissue to bé approximated or reinforced
comprising: cannula means having a hollow body and an open
proxirnal and distal end; point means detachably fixed to the
open proximal end of the cannula means for penetrating tissue;
guide wire means attached to the point means and extending into
the open proximal end of the cannula means; and implant
material releasably attached to the guide wire means and
extending from the open distal end of the cannula means.
In accordance with another embodiment of the present
invention there is provided a method of implanting material in
tissue for reapproximating or reinforcing defects therein
comprising the steps of: providing cannula means having a
hollow body open at both ends and a detachable point at a
proximal end thereof, the detachable point having a guide wire
attached and extending into the hollow body; attaching a length
of implant material to the guide wire; passing the cannula
means with detachable point and implant material into the
tissue at an entry point remote from one side of the defect and
out of an exit point in an opposite side remote from the defect
such that a distal end of the hollow body extends from the
entry point and a distal end extends from the exit point;
removing the detachable point from the cannula means and
drawing the guide wire with implant material attached out of
the proximal end of the hollow body until the implant material
is exposed at both the distal and proximal ends of the hollow
body, withdrawing the cannula means from the tissue, leaving
2~ 7~70
-- 4 --
the implant material in place, and anchoring the implant
material to reapproximate or reinforce the defect.
In accordance with yet another embodiment of the
present invention there is provided an implant assist apparatus
for implanting material in tissue to be reapproximated or
reinforced comprising: a rigid cannula having an elongate
hollow body, an open proximal end, and an open distal end; and
a point detachably fixed to the open proximal end of the
cannula for penetrating tissue.
A still further embodiment of the present invention
provides an implant assist apparatus for implanting suture
material in tissue comprising: a rigid tubular cannula having
a hollow body and first and second ends; a point removably
attaclled to the first end of the tubular cannula for
penetrating tissue; and at least one surgical suture positioned
at least partially in the tubular cannula.
Features and advantages of the invention are set
forth in part herein and in part will be obvious therefrom, or
may be learned by practice with the invention, which is
realized and attained by means of instrumentalities and
combinations pointed out in the appended claims. The invention
consists of novel parts, constructions, arrangements, combi-
nations, steps and improvements herein shown and described.
SU;\~MAR~ QF ~TTF TNvENTIQN
According to the present invention, a method and
apparatus is provided for facilitating the reapproximation
and/or relnforcing of separated ends of soft or hard tissue of
human and animal bodies by placement of implant materials to
promote healing. The apparatus comprises a cannula with a
removable point releasably attached to one end. The cannula
is dimensioned in length, shape and diameter based upon,
alia, the type of implant material to be implanted, the length
of tissue through which the implant material is to pass and the
characteristics including shape, of the tissue. For example,
_ _ _ . . ... ..... . ... . _
21~
- 4a -
in the repair of small tendons or ligaments, a curved cannula
approximately four inches in length and 16 or 18 gage in
diameter would permit the implantation of a stay suture wherein
the suture would extend through the tissue defect and emerge
on either end approximately two inches remote from the defect.
The removable point serves to convert the cannula
into a hollow trocar to provide smooth passage of the
~5- 2~i78~7~
cannula through the tissue, particularly soft tissue, with
- minimal damage. Further support and guidance through the
tissue may be obtained by providing flutes or grooves
longi~ in~lly along the outer body of the cannula adjacent
the point.
once the hollow trocar is in position within the
tissue to be approximated or reinforced, the removable point
is detached, converting the hollow trocar back into a
cannula, open at both ends and ready to receive and guide an
10 implant material. The implant material is threaded through
the cannula until it is in position with an end of the
implant material extending from either end of the cannula.
}~ guide wire may be fixed to the removable point to aid in
threading of the implant material through the cannula. The
guide wire is attached proximal the base of the point and
extends through the cannula, terminating in a loop which is
accessible from the end of the hollow trocar.
Implant material ends may also be preattached to
the base of the point so that when the point is removed the
20 implant material is already in place. When the cannula is
removed, the implant material is embedded in the mid-
substance of the tissue. The number of implant ends
attached to the point can vary from one to any multiple
desired for a given procedure, with two ends being
preferred. Further, armed sutures (sutures with an attached
needle~ may be preattached to the removable point by a
variety of methods inrlllflin~ press fitting, adhesive, or
heat shrink tubing. ~lultiple armed sutures (sutures with
more than one attached needle) may be preat~ach~d ~o the
30 point by the~e methods w ~th the suture material extending
~ 217~Q
-
-- 6 --
into the cannula. These armed sutures include sutures with
needles disposed on either one or both ends.
Thereafter, the cannula is withdrawn from the tissue
leaving the implant material in place therein to securely
approximate and/or reinforce the separated ends of the tissue.
Final closure of the edges of the defect may be accomplished
by suitable means, e.g., small sutures, if necessary. Mowever,
the main implanted suture serves to support and distribute
fle~ure and strain forces applied to the ~oined tissue to
facilltate healing.
B~RT~l~ DEst~RTpTIoN OF 'I'M~ DR~INGs
The accompanying drawings, referred to herein and
constituting a part hereof, illustrate preferred embodiments
of the present invention and, together with the description,
serve to explain the principles of the present invention.
FIG. 1 is a side view of one embodiment having a
substantially linear cannula with removable trocar point
FIG. lA is an enlarged side view of one ' o~ir?rt
for implanting a braided tubular ligament prosthesis using a
linear cannula with the prosthesis attached to a removable
taper point;
FIG. 2 is a side view of another embodiment having
an arcuate cannula with removable cut taper point;
FIG. 3 is a side view of one embodiment of the
present invention having a partially linear and partially
arcuate cannula with a removable point having a guide wire
attached .
~7~ ~ ~8~0
FIG. 3A is a side view of an alternate embodiment
of the present invention having the implant material fixed
directly to the removable point.
FIG. 3B is a side view of an embodiment of the
present invention wherein the guide wire extends through the
canula and has the implant material attached to a loop
outside the cannula.
FIG. 4 is a side view of another embodiment of the
present invention having an arcuate fluted cannula with a
10 removable point and guide wire.
FIGS. 5-10 are perspective views of a tendon
repair using apparatus in accordance with the present
invention to implant a braided stay suture.
FIG. ll is a side view of an embodiment of the
present invention having two armed sutures preattached to a
removl able point .
FIG. 12 is an enlarged view of the removable point
of Figure 11.
20 D~TA~LE~ DES(~R~PTIQN OF THE ~ CI~'U l;MBQDIMl?N~5
FIGS. 1-4 show a variety of preferred embodiments
of the apparatus in accordance with the present invention.
FIG. 1 represents a substantially linear cannula 20 having a
removable point 22 detachably positioned in a proximal end
24 of linear cannula 20. ~emovable point 22 is press fit
with a slight interference into proximal end 24 to
facilitate secure attachment and easy removal. One skilled
in the art, however, would recognize that any releasable
attachment means would be appropriate including, threading,
30 twist on or break~way lines.
-8- 2~ 7~0
Point 22 is formed in the shape of a trocar to
- ease entry into soft tissue. Other shapes and
configurations are also useful including: conical, both
convex and concave; arcuate conical; tapered; reverse
cutting; side cutting; and flattened conical with a
plurality of sharpened edges. In order to ease entry of the
cannula into the tissue, the points are dimensioned at their
base to have approximately the same diameter as the cannula
to which they are attached.
Cannula 20 is dimensioned based on the particular
application and the type of approximating or rein~orcing
material to be implanted. For example, in hand tendon
repair, cannulas of 16 or 18 gage diameter in varying
lengths are particularly useful for implanting suture
material to join separated ends. For other applications
such as larger tendons, muscle, soft tissue or ligament
repair, size, shape, length and diameter may be varied as
required .
FIG. lA discloses an alternate embodiment of the
20 present invention for implanting a braided tubular ligament
prosthesis 21. A substantially linear cannula 23 encloses a
portion of the prosthesis Z1, one end of which is fixed
directly to removable taper point 25. This point 25 is
press fit in a similar manner to that described above with
respect to the Pmt~Orq; r-nt of FIG . 1.
FIG. 2 shows a substantially arcuate cannula 26
having a removable point 28 which is releasably attachable
to a proximal end 30 of cannula 26. In this embodiment,
point 28 is provided with internal threads 32 which are
30 threadably engagable with external threads 34 formed on
proximal end ~a of cannula 26. Alternatively, annu~ar rings
~9~ 217~7~
and grooves could be substituted for threads 32, 34 such
that point 28 interfits over cannula 26.
A cannula 3 6 having a partially linear and
partially arcuate shape is shown in FIG. 3. This embodiment
of the present inYention also includes a removable point 38
which i5 formed in the shape of an arcuate cone following
the curve of cannula 3 6 .
A guide wire 40 is affixed to the base of
removable point 38 and extends through cannula 36,
terminating in loop 42 at a distal end. This loop 42 may
either extend slightly beyond the distal end 44 of cannula
36 (FIG. 3~) or remain within the cannula to facilitate
attachment of an implant material (not shown) to be drawn
through cannula 36 by guide wire 40.
Alternatively, an implant material such as, for
example, a braided suture 41, may be fixed directly to
removable point 38 as shown in FIG. 3A. This configuration
would serve to pull the braided suture 41 directly into
position simply by removing point 38.
Another ' o~i~?~t of the present invention is
shown in FIG . 4 wherein a cannula 4 6 is formed with a
breakaway point 48. In this embodiment the entire assembly
(cannula 46 and breakaway point 48) is formed as a single
unit with a preformed breakaway line 50 to enable point 48
to be broken off after positioning, leaving cannula 46 in
place. This assembly can be formed using known techni~ues
such as, for example, extrusion, molding, etc. Appropriate
materials include, stiff or reinforced plastics, aluminum,
stainless steel, etc.
The breakaway point 48 of this embodiment is in
the shape of a flattened cone with sharp edges 52. Further,
-lo- 217~7~
flutes 54 are provided longit~ in~1 ly along cannula 46 to
aid and guide the assembly through the tissue.
FIGS. 5-10 illustrate the use of one embodiment of
the present implant assist apparatus to repair a defect in a
tendon using a braided type stay suture. FIG. 5 shows the
tendon, generally 56, separated into a first end 58
proximate muscle tissue 60 and a second end 62 proximate the
bone (not shown~.
Referring now to FIGS. 6-7, implant assist
70 apparatus 64, as shown 'q;'~ 5' '~led in FIG. 3, is used to
implant the braided stay suture 66 starting at the muscle
tissue 60, through first and second ends, 58 and 62,
respectively, to emerge from tendon 56 remote from second
end 6 Z .
Prior to initiating the repair procedure using
this embodiment of the present invention, the implant assist
apparatus is prepared by removing arcuate point 38 from
cannula 36 such that attached wire 40 and wire loop 42 are
exposed (not shown). A suitable length of suture
20 appropriate for the procedure is selected. Typically, a
length is selected such that when the suture is doubled
over, about six inches of suture are exposed on each end of
cannula 36. One end of the suture 66 is threaded through
loop 42 and pulled until approximately equal lengths of the
sut~re are disposed on either side of the loop 42. Both
ends of suture 66 are threaded into proximal end 41 until
the suture ends exit the distal end 44 of cannula 36. The
suture 66 is then pulled ~from the ends extending through
distal end 44) until loop 42 enters the cannula 36 (through
30 proximal end 41) and arcuate point 38 seats in the proximal
end 41 of cannula 36.
217~g7~
The implant assist apparatus 64 is now ready to be
passed into tissue across the site ~hich is being repaired.
Point 38 is inserted into muscle tissue 60 at location G8
remote from first tendon end 58. The apparatus 64 is guided
through the tissue, passing through both first and second
tendon ends, 58 and 62 respectively (Figure 7), until point
38 emerges from the tendon at exit site 70 (Figure 8). At
this stage, distal end 44 of cannula 36 should be exposed at
entry location 68 and point 38 should extend out of exit
10 location 70 a distance sufficient to expose proximal end 41
of cannula 36. See FIG. 8.
While holding cannula 36 near the exposed distal
end 44, point 38 is detached until loop 42 containing suture
66 is visible. Suture 66 is then pulled carefully until
approximately equal lengths are exposed from proximal and
distal ends of cannula 36. By gripping one end of suture 66
~in this case the end extending from exit location 70)
cannula 3 6 is pulled out of entry location 68 in the
direction of arrow 72 leaving the suture 66 in position.
20 See FIG. 9.
The ends of suture 66 are then tied off,
preferably using oblong tying buttons ?4 as shown in FIG.
10, to close the ends of the tendon defect to promote
healing. Where desired, whipping sutures 76 may be used to
close any unsatisfied ends of the tendon 56. Also, surgical
needles may be attached to the free ends of the exposed
suture and additional suturing and tying may be performed to
fully anchor the suture and complete the repair.
Referring to FIG. 11, there is shown an embodiment
30 of the present invention wherein a pair of double armed
suture~ (i.e. ~utures witL a needle at both ends), s ~own
--12--
2~ ~8~7~
generally at 80, extend through cannula 88 and are
preattached to removable point 82. As shown, the cannula 88
is arcuate, however, alternately the cannula 88 can be
linear as in Figure 1. In this particular embodiment, two
straight needles 86 are releasably preattached to point 82
by means of heat shrink tubing 84. The cannula is therefore
dimensioned to have an inside diameter of sufficient size to
receive adjacently aligned needles enveloped by shrink
tubing. As shown in Figure 12, heat shrink tubing 84 fits
10 around narrowed portion 83 of point 82 and tightly engages
f lange 8 5 .
Suture material go extends through proximal
opening 92 into cannula 88 and has a second pair of needles
94 attached to distal ends thereof. In this particular
embodiment shown in the drawings, straight needles are used
on both the proximal and distal ends of suture material 90.
~owever, one skilled in the art will appreciate that a wide
variety of needle types and shapes may be substituted.
In operation, after the pair of needles 86 are
~0 releasably preattached to removable point 82 by heat shrink
tubing 84, the removable point 82 is removably inserted into
the proximal opening 92 of cannula 88 as described above
with respect to other embodiments. The suture material may
be dimensioned such that the distal end thereof is retained
witllin cannula 88 or alterna~ively may extend outside the
distal opening 96 as shown in Figure 11. After the cannula
is emplaced within the subj ect tissue in the manner
described above, removable point 82 is separated from the
proximal opening 92 of cannula 88 exposing needles 86.
30 These needles are then separated from the heat shrink tubing
84 on ~movable point 82 (e.g. by pulling them out o~ the
-13~ 7 ~
end of the tubing). The cannula 88 may be withdrawn from
the tissue in a distal directlon leaving the pair of sutures
~ 0 with attached needles in place to be used in the surgical
procedure to be performed. This ~ ir?nt is particularly
useful in procedures wherein multiple sutures with attached
needles must be passed through tissue in close proximity to
ef ~ect j oining or repair.
To the extent not already indicated, it also will
be understood by those of ordinary sXill in the art that any
~0 one of the various specific embodiments herein described and
illustrated may be further modified to incorporate features
shown in other of the specific embodiments.
The invention in its broader aspects therefore is
not limited to the specific embodiments herein shown and
described but departures may be made therefrom within the
scope of the ~cc ~-nying claims without departing from the
principles o~ the invention and without sacrificing its
chief advantages.
