U.S. patent number 3,842,441 [Application Number 05/343,581] was granted by the patent office on 1974-10-22 for a temporary implant and method for tendon surgery.
Invention is credited to Anthony J. Kaiser.
United States Patent |
3,842,441 |
Kaiser |
October 22, 1974 |
A TEMPORARY IMPLANT AND METHOD FOR TENDON SURGERY
Abstract
A temporary implant for tendon surgery which comprises a
generally cylindrical tube of a continuous filamentary material,
said cylindrical tube having openings on the surface thereof
defined by said filamentary material; a generally flat planar
member composed of a resilient yieldable filamentary material,
which member can be used as a temporary implant in tendon surgery;
a generally cylindrical tube in the form of a continuous
filamentary material, which material runs in an undulating, sinuous
path, the apex and the nadir of the path of the filamentary
material being brought toward one another in a generally facing
relationship to define a substantially enclosed area having spaces
between the filamentary material; a transplant comprising a
substantially enclosed generally cylindrical object constructed of
a filamentary material, which filamentary material runs
continuously in an arcuate path from a point of said cylindrical
object to a point substantially 360.degree. away on the surface of
said object, at which point it reverses its direction and travels
in an arcuate path substantially 360.degree. away on the surface of
said object, at which point it reverses itself; an improvement in
surgically repairing broken tendons which comprises disposing about
the junction of the repaired tendon a temporary implant comprising
a generally cylindrical tube of a continuous filamentary material,
said cylindrical tube having openings on the surface thereof
defined by said filamentary material, and after the junction in the
tendon has substantially healed, removing said cylindrical tube by
pulling an end of said filamentary material to thereby sever
adhesions formed between the tendon and neighboring tissue
material; in a process for the surgical correction of at least one
severed tendon where the tendon is disposed close to but out of
contact relationship to a second tendon, the improvement for
surgically repairing said tendon which comprises disposing between
the severed tendon and the adjoining tendon a generally flat planar
member composed of yieldable filamentary material, allowing the
junction of the severed tendon to heal, and, thereafter, removing
said generally flat planar member by pulling an end of said
filamentary material.
Inventors: |
Kaiser; Anthony J. (East
Meadow, NY) |
Family
ID: |
26970003 |
Appl.
No.: |
05/343,581 |
Filed: |
March 21, 1973 |
Related U.S. Patent Documents
|
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
297145 |
Oct 12, 1972 |
|
|
|
|
Current U.S.
Class: |
606/217;
623/13.11 |
Current CPC
Class: |
A61F
2/08 (20130101) |
Current International
Class: |
A61F
2/08 (20060101); A61f 001/24 () |
Field of
Search: |
;3/1,DIG.1
;128/334R,335,335.5,1R |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Frinks; Ronald L.
Attorney, Agent or Firm: Burgess, Dinklage & Sprung
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATIONS
This is a continuation-in-part of application Ser. No. 297,145,
filed Oct. 12, 1972, entitled "A Temporary Implant for Tendon
Surgery", and now abandoned.
Claims
What is claimed is:
1. A temporary implant for tendon surgery which comprises a
generally cylindrical tube of a continuous yieldable filamentary
material, said cylindrical tube having openings on the surface
thereof defined by said filamentary material, said cylindrical tube
being in the shape of an alternating and reversing helix which has
a diameter between 1/8 and 1/4 inch and a length between 1 and 4
inches.
2. A temporary implant according to claim 1 wherein said
cylindrical tube has a circular cross section.
3. A temporary implant according to claim 1 composed of stainless
steel.
4. A temporary implant according to claim 1 wherein said continuous
filamentary material is serrated.
5. A temporary implant according to claim 4 wherein the serrations
have an amplitude between 0.0001 and 0.001 inch and there are
between 25 and 250 serrations per inch.
6. A temporary implant according to claim 1 wherein the filamentary
material is between 0.005 and 0.020 inch thick.
7. A temporary implant for tendon surgery according to claim 1
wherein the continuous filamentary material runs in an undulating,
sinuous path, the apices and nadirs of the path of the filamentary
material being brought toward one another in a general facing
relationship to define a substantially enclosed area having spaces
between the filamentary material.
8. A temporary implant according to claim 1 wherein the filamentary
material runs continuously in an arcuate path from a point on said
cylindrical tube to a point substantially between 270.degree. and
420.degree. away on the surface of said tube, at which point it
reverses its direction and travels in an arcuate path between
270.degree. and 420.degree. away on the surface of said tube, at
which point it again reverses its direction.
9. A temporary implant according to claim 8 wherein the continuous
filamentary material runs continuously in an arcuate path from a
point on the cylindrical tube to a point substantially 360.degree.
away on the surface of said tube, at which point it reverses its
direction and travels in an arcuate path substantially 360.degree.
away on the surface of said tube, at which point it again reverses
its direction.
10. A temporary implant for tendon surgery which comprises a
generally flat planar member composed of a yieldable filamentary
material having a thickness between 0.005 and 0.02 inch, said
generally flat planar member being in the form of a continuous sine
curve, the apices of which range from between 50 and 150 per linear
inch of said planar member.
11. A temporary implant according to claim 10 wherein said planar
member has a width between 1/8 and 1/4 inch.
12. A temporary implant according to claim 11 wherein said
filamentary material has serrations on the surface thereof such
that there are between 25 and 250 serrations per inch of
filamentary material.
13. A temporary implant according to claim 10 wherein the
filamentary material is stainless steel having a width between
0.008 and 0.012 inch and having between 50 and 150 apices per
linear inch of said implant.
14. An improvement in surgically repairing broken tendons which
comprises disposing about the junction of a repaired tendon the
temporary implant of claim 1, allowing the tendon to substantially
heal at the junction and thereafter removing said implant by
pulling an end of said filamentary material to thereby sever
adhesions formed between the tendon and neighboring tissue
material.
15. The process of claim 14, wherein the temporary implant is
carried on a generally tubular sheath material, said sheath
carrying said temporary implant is disposed over one severed end of
a tendon, said sheath material is removed thereby depositing said
temporary implant over said end of said tendon, said end is joined
to a sevred end and said implant is disposed over both ends of the
severed tendon.
16. An improvement in surgically repairing broken tendons which
comprises disposing about the junction of a tendon undergoing
repair the temporary implant of claim 7, allowing the tendon to
substantially heal at its junction and thereafter removing said
temporary implant by pulling an end of said filamentary material to
thereby sever adhesions formed between the tendon and the
neighboring tissue.
17. An improvement in surgically repairing broken tendons which
comprises disposing about the junction of a tendon undergoing
repair the temporary implant of claim 6, allowing the tendon to
substantially heal at its junction and thereafter removing said
temporary implant by pulling an end of said filamentary material to
thereby sever adhesions formed between the tendon and the
neighboring tissue.
18. In a process for the surgical correction of at least one
severed tendon where the tendon is disposed close to but in
out-of-contact relationship to a second tendon, the improvement for
surgically repairing said tendon which comprises disposing between
the severed tendon and the adjoining tendon the temporary implant
of claim 10, allowing the junction of the severed tendon to heal
and thereafter removing said implant by pulling an end of said
filamentary material.
19. In a process for the surgical correction of at least one
severed tendon where the tendon is disposed close to but in
out-of-contact relationship to a second tendon, the improvement for
surgically repairing said tendon which comprises disposing between
the severed tendon and the adjoining tendon the temporary implant
of claim 12, allowing the junction of the severed tendon to heal
and thereafter removing said implant by pulling an end of said
filamentary material.
20. In a process for the surgical correction of at least one
severed tendon where the tendon is disposed closed to but in
out-of-contact relationship to a second tendon, the improvement for
surgically repairing said tendon which comprises disposing between
the severed tendon and the adjoining tendon the temporary implant
of claim 13, allowing the junction of the severed tendon to heal
and thereafter removing said implant by pulling an end of said
filamentary material.
21. A process for the surgical correction of at least one severed
tendon which comprises disposing adjacent to said tendon a
temporary implant which comprises a continuous yielding filamentary
material having openings on the surface thereof defined by said
filamentary material, allowing the tendon to substantially heal and
withdrawing the implant and substantially simultaneous therewith
severing tenuous adhesions which are connected to said tendons by
impingement of said filamentary material.
22. A temporary implant according to claim 10 wherein said
generally flat planar member is disposed upon a generally flat
adhesive substrate.
23. A temporary implant according to claim 22 wherein the adhesive
substrate is transparent.
24. An improvement is surgically repairing a broken tendon which
comprises disposing about the junction of a repaired tendon the
temporary implant of claim 22, deforming said implant so that it is
in the form of a generally cylindrical object, removing said
adhesive substrate to thereby form a generally cylindrical tube,
and pulling an end of said filamentary material to thereby sever
adhesions formed between the tendon and neighboring tissue
material.
25. An improvement according to claim 24 wherein the filamentary
material is carried on a transparent adhesive substrate, said
transparent adhesive substrate is removed after the generally
cylindrical object of filamentary material is formed.
26. A temporary implant according to claim 1 wherein said
continuous filamentary material is notched.
27. A temporary implant according to claim 1 wherein said
continuous filamentary material has sharpened edges.
Description
BACKGROUND OF THE INVENTION
1. Field Of The Invention
This invention relates to the surgical repair of broken or severed
tendons. This invention is especially directed to a temporary
implant employed in the region of the tendon being surgically
repaired, which temporary implant can be wthdrawn to thereby sever
adhesions which occur either between the tendon and neighboring
tissue or between the tendon being repaired and an adjoining
tendon. This invention is also directed to the method of effecting
such surgical repair employing such temporary implant.
DISCUSSION OF THE PROBLEMS AND THE PRIOR ART
Tendon repair surgically presents considerable difficulty. When a
severed tendon is surgically repaired the severed ends initially
are brought together in end-to-end abutting relationship to permit
the same to heal and to rejoin one another. During the natural,
normal healing of a severed tendon, there is caused to grow fibrous
adhesions between the tendon undergoing healing and juxtaposed
tendons or adjacent tissues. The tendon undergoing healing
generally sets in a trough or enclosed in a sheath, especially in
respect to tendons in the hand.
When the severed tendon has healed at its junction, these fibrous
adhesions cement the healed tendon to its adjacent tissues and
thereby prevents the natural glide of the tendon which is necessary
for good function. For example, when the tendon in the hand is
repaired surgically, the surgeon initially joins the severed
tendon. Thereafter, the severed tendon, which sets in a trough
defined by neighboring tissues, becomes connected to the
neighboring tissues through fibrous adhesions. By the time the
healing of the tendon itself is complete, the fibrous adhesions
which grow into the injured tendon from the adjacent tissues to
bring nourishment, cause the healing tendon to stick to the
adjacent tissues. If the tendon adheres to the adjacent tissues it
is unable to glide in its trough and thereby loss of function of
the tendon occurs. For example, if a healed tendon in a finger is
adherent to the adjoining tissues, one cannot make a fist with this
finger because its tendon is unable to glide and thereby unable to
bend.
It has heretofore been suggested that the problems discussed above
can be avoided by completely ensheathing the tendon during surgical
repair. The purpose of completely ensheathing the tendon was to
avoid the creation or growth of these tendonous adhesions. However,
it was found that such means was unsuitable because the tendon was
insufficiently repaired by the natural healing process which
includes the above-described growth of fibrous adhesions from
adjacent tissues.
Therefore, it became desirable to provide a means which can be
disposed within the body which would enable the tendon itself to
heal normally and yet which could cope with the problems presented
by the creation of fibrous adhesions. Stated another way, it was
desirable to provide, for the first time, a surgical technique
which would allow the ready repair of tendons, especially in the
hand, while permitting the hand, after the tendon has been
repaired, to have the desired mobility. Thus it was desirable to
provide a means whereby the adverse effects of the fibrous
adhesions affecting movement in the region of the tendon could be
counteracted. This is achieved by the surgical implant of the
present invention which allows the naturally occurring adhesions to
form to facilitate the tendon repair while providing a means for
severing the same once they have served their purpose. Thus the
implant provides a simple technique of cutting the fibrous
adhesions and freeing the healed tendon to allow it to glide in its
trough. By severing the adhesions around the tendon, good mobility
of the body part, e.g., finger, can be achieved.
SUMMARY OF THE INVENTION
Broadly, this invention contemplates a temporary implant for use in
surgical tendon repair, which implant comprises a generally
cylindrical tube of a continuous filamentary material, said
cylindrical tube having openings on the surface thereof defined by
said filamentary material.
This invention further contemplates a temporary implant useful in
the surgical repair of tendons, which implant can be disposed
between a tendon being surgically repaired and an adjoining tendon
in out-of-contact relationship therewith, which implant comprises a
generally flat planar member composed of continuous filamentary
material.
This invention further contemplates an improvement in the surgical
repair of a severed tendon wherein the severed ends of the tendon
are joined together, which improvement comprises disposing about
said tendon a temporary implant of a generally cylindrical tube of
a continuous filamentary material, said cylindrical tube having
openings on the surface thereof defined by said filamentary
material, allowing said tendon to substantially heal, and
thereafter removing said generally cylindrical tube by pulling an
end of said filamentary material.
In another specific embodiment of this invention, there is
contemplated an improvement in the method of surgical repair of a
severed tendon, which severed tendon is disposed adjacent to but in
out-of-contact relationship with a second tendon, wherein the ends
of the severed tendon are joined together, which improvement
comprises disposing between said severed tendon and said second
tendon a generally flat planar member composed of a continuous
filamentary material, allowing said severed tendon to substantially
heal, and thereafter removing said generally flat planar member by
pulling an end of said filamentary material. Preferably said
filamentary material of said generally planar member runs in a
sinuous path with the peaks and troughs being formed on either side
of the generally planar member.
In a preferred embodiment of this invention, there is contemplated
a generally cylindrical tube in the form of a continuous
filamentary material, which material runs in an undulating, sinuous
path, the apices and the nadir of the path of the filamentary
material being brought toward one another in a generally facing
relationship to define a substantially enclosed area having spaces
between the filamentary material.
The above-stated generally cylindrical tube is useful as a
transplant in tendon repair. More specifically, the above-defined
cylindrical tube can be used to envelop a tendon being repaired or
it can be inserted between a tendon and a series of tendons. More
particularly, the generally cylindrical tube is suitably formed by
bending a generally flat planar member composed of a continuous
filamentary material, which filamentary material runs in a sinuous
path with the peaks and troughs being formed on either side of the
generally planar member, so that the peaks and troughs are brought
into facing relationship so as to convert the generally planar
member to one which is generally cylindrical. Accordingly, the
temporary transplant can be thought of as one which is a
substantially enclosed, generally cylindrical object constructed of
a filamentary material, which filamentary material runs
continuously in an arcuate path from a point on said cylindrical
object to a point substantially 360.degree. away on the surface of
said object, at which point it reverses its direction and travels
in an arcuate path substantially 360.degree. away on the surface of
said object, at which point it again reverses its direction.
From the above, it is seen that the surgical improvement provided
by the present invention involves the use of a temporary implant
which is positioned about or around the tendon being repaired. The
implant can have an overall cylindrical shape with openings on the
surface thereof to allow the creation of the aforementioned fibrous
adhesions. It has been found that the creation of these fibrous
adhesions is natural and, indeed, necessary in the proper surgical
repair of the tendon itself for, apparently, such tendonous
adhesions supply the needed body chemicals from the adjoining
tissue to the tendon being repaired. The generally tubular implant
is left in the region about the junction defined by the severed
ends of the tendon until the tendon itself has substantially
healed. An end of the implant protrudes slightly through the
exterior skin of the patent. When the tendon has substantially
healed, the protruding end of the temporary implant is pulled to
thereby unravel the temporary implant. As it unravels, it severs
the fibrous adhesions. By the time the filamentary material is
removed, substantially all of the fibrous adhesions are severed
without adversely affecting the healed tendon. The net result is
that the patient has a healed tendon without any adverse effects
due to the fibrous adhesions which would have affected the movement
of the body in the region of the tendon repaired.
It will be noted that a second embodiment of the present invention
is directed to an implant which is disposed between a tendon being
repaired and an adjoining tendon. It has heretofore been found that
when a tendon disposed near a second tendon is being repaired,
fibrous adhesions form between the tendons. These adhesions are so
strong that it is extremely difficult to separate the tendons.
Hence, they become virtually locked together and severely adversely
affect the movement of the body in the region of the tendon
repaired. Hence, in accordance with the invention, there is
disposed in the region between the tendons a generally flat planar
member composed of a continuous filamentary material. An end of the
filamentary material is allowed to protrude slightly from the
patient's skin. The tendon is allowed to heal and when healing is
substantially complete, the filamentary material is pulled at the
protruding end to thereby sever the fibrous adhesions between
tendons and unravel the filamentary material. When the same is
removed from the body, there is left a healed tendon which is
substantially free of fibrous adhesions which so severely affect
full movement in that region.
With respect to the embodiment of this invention wherein a
preformed generally tubular cylindrical member is placed around or
about the repaired and healing tendon, the filamentary material
preferably is wound to form the cylindrical tubular member in an
alternating or reversing helical pattern wuch that there is formed
a sinuous weave which reverses itself such that the apex of the
sinuous curve alternates, as will be more fully described below. It
has been found that this particular weave, especially when of a
yieldable material, functions ideally. Through use of such a wave
the portion of the filamentary material which extends from the body
can readily be pulled to effect an orderly severing of the fibrous
adhesions. Stated another way, through use of alternating reversing
tubular material, the filamentary material can be unwound without
substantial movement of the implant as a whole, as the same time
severing the fibrous adhesions which limited the gliding action of
the tendon. Such is shown in the attached figures to be discussed
below.
In the embodiment of this invention employed for use between
closely adjacent adhesions, it has been found that a flat planar
member composed of a continuous filamentary material in tightly
woven sine curve form is particularly suitable. Generally speaking,
the sinuous filamentary material will have between 50 and 150
apices per inch of length, preferably between 80 and 100 apices per
inch. Generally speaking, the overall dimensions of the flat planar
member will vary depending upon the length of the tendon being
repaired and the associated area. Similarly, the width of the
generally planar member will vary depending upon the size of the
tendon or tendons involved. However, it can be stated that, broadly
speaking, the temporary implant will be between one and four inches
in length, preferably between 11/2 and 2 inches, and will have a
width between 1/8 and 1/4 inches. Generally speaking, the width of
the material will be between 1/15 and 1/40 times that of the tendon
being repaired, preferably between 1/20 and 1/30 times the tendon
being repaired.
The above-described flat planar member has been found to be a
suitable object which can be formed into an implant around a
severed tendon. For instance, it is possible to take a yieldable,
generally flat planar member as described above and to wrap the
same around a severed tendon to segregate the severed tendon from
adjoining tissue. During such a wrapping operation the sides of the
generally flat planar member are brought in general facing
relationship to one another so that the planar member is in the
general form of a cylinder or other geometric form having a
circular or elliptical cross section whereby the implant
substantially encloses a given area. When so formed, there is
provided within the body itself a transplant which is a
substantially enclosed, generally cylindrical object constructed of
continuous filamentary material, which filamentary material runs
continuously in an arcuate path from a point on the surface of the
object to a point substantially on the other side thereof, say
about 360.degree. away on the surface of said object, at which
point it reverses its direction and travels in an arcuate path
substantially 360.degree. on the surface of said object, at which
point it again reverses itself in an ever reversing pattern.
The extent to which the generally flat planar member if formed into
a cylindrical shape will depend upon the specific application of
the implant within the body. It should be understood that the flat
planar member can be deformed from its planar shape into any
arcuate shape. Suitably, it is deformed to provide an enclosed
area. However, the generally planar member can be defomred into a
generally cylindrical form such that the lateral edges of the
planar member containing the apices of the sinuous curve of the
filamentary material define only a fraction of a circle, such as
two thirds of a circle. Stated differently, the generally flat
planar member can be deformed so that there if formed an enclosed
generally cylindrical object of filamentary material, which
filamentary material runs continuously in an arcuate path from a
point on said cylindrical object to a point substantially between
270.degree. and 420.degree. away on the surface of said object, at
which point it reverses its direction and travels in an arcuate
path substantially between 270.degree. and 420.degree. away on the
surface on said object, at which point it again reverses its
direction. For instance, if the filamentary material runs exactly
360.degree. to the other side of the cylindrical object and then
reverses its direction to run another 360.degree. there is formed a
perfect circle. If the filamentary material runs 320.degree. and
then reverses its direction for another 320.degree. there is
provided an object which is an incomplete circle, whereby
320.degree. of the path contain sinuous filamentary material, or
the circle is open for approximately 40.degree. or one-ninth of the
normal circular path. For that matter, the planar member can be so
deformed as to allow for a certain overlap of the edges of the
planar member. In such case, the filamentary material runs more
than 360.degree. in the arcuate path away from the first point,
then reverses its direction to run, for instance, 280.degree. away
from the point at which it first reversed its direction. It should
be understood that the transplant can also be formed such that
there is overlap at alternating apices. The determination as to
whether the temporary implant should define a complete circle, a
partial circle or should have overlap at the apices is left to the
surgeon and will be dependent at least in part upon the type of
adhesions which the surgeon expects may be created in the region of
the tendon repair.
The material of which the temporary implants of the present
invention are prepared is important. These materials should be
readily formable and yieldable so that they unravel from their
preformed shape during removal from the body. Preferably, they are
made of light-weight materials so that upon removal from the body,
they assume generally linear form. The filamentary material can
suitably be notched, serrated or sharpened at its edges to define
minute cutting surfaces which will assist in cutting the fibrous
adhesions upon withdrawal of the implant. Similarly, the number of
serrations per inch will be between 25 and 250, preferably between
50 and 100. It is to be understood that the number of serrations
per inch refers to the number of serrations per inch of filamentary
material, independent of the overall dimensions of the temporary
implant. These values apply to both the cylindrical tubular implant
and to the generally planar flat implant disposed between
neighboring tendons.
Preferably, the material of the temporary implants is made of a
metal wire, especially a stainless steel wire. However, it should
be understood that other metal wires can be used, notably those
made of metals such as iron, aluminum, magnesium, nickel, cobalt,
tin, copper, silver, gold, and the like, and alloys thereof. If the
specific composition of the metal itself might react with the body
chemicals or adjoining tissue adversely, it can be suitably coated
with an inactive substance, such as a polymeric material, notably
light-weight polymers of alpha olefins, polyvinyl chloride,
chlorinated polyethylene, polyvinyl alcohols, polyurethanes,
polyamides, polyimides, and other thermoplastic and thermosetting
resins.
Alternatively, the entire composition of the filamentary material
can be made of a polymeric material either in serrated or smooth
form. Suitable polymers include cellulosic materials, acetate
rayons, silk materials, nylon, orlon, polyesters, especially
phthalic acid derived polyesters, protein fibers, silk fibers,
rayon, wool, cotton, jute, hemp, floss and floss silk, Manila,
Manila hemp, binding twine, catgut, lace, polyolefins, phenolic
resins, phenylene oxide polymers, allyl resins, cellulosic molding
compounds containing reinforcing agents, and other thermoplastic
and thermosetting resins. Desirably, in its preferred form, the
filamentary material is made from a stainless steel having a
thickness between 0.005 and 0.02 inches, preferably between 0.008
and 0.012 inches. It will be appreciated that the thickness of the
filamentary material employed will be dependent upon the size of
the fibrous adhesions expected and the nature of the materials
employed. It should be further noted that the present invention can
be used employing a continuous thread which forms a generally
tubular cylindrical form having gaps therein defining openings or
perforations through which the fibrous adhesions grow during the
healing process. As indicated above, the existence of these fibrous
adhesions is important, as these fibrous adhesions apparently serve
as a vehicle for the proper nutrients from the body, being fed en
route to the healing tendon.
The present invention further contemplates an apparatus for use in
such tendon surgery employed to readily dispose about a free end of
a tendon to be repaired a cylindrical tube of the present invention
characterized by having openings in the periphery thereof. This
improvement comprises a generally continuous inner sleeve,
preferably constructed of a smooth plastic substance of the types
defined above, which sleeve carries said generally cylindrical tube
of continuous filamentary material. Such a sleeve can be used
during tendon repair wherein the sleeve carrying the generally
cylindrical tube is disposed over the freed end of a severed
tendon, the plastic tubing being removed to deposit the cylindrical
tube about the tendon to be repaired. After the tendon has been
repaired at the point of the broken joint or section, the generally
cylindrical tube is brought down so that it lies generally on
either longitudinal side of the joint of the healing tendon.
With respect to the sheathing material which carries the generally
tubular implant composed of filamentary material, it can be made of
any light-weight smooth material, such as polyamides, especially
nylon 6 and nylon 6,6, poly alpha olefins, especially polyethylene
and polypropylene, and polyesters, especially those based upon a
phthalic acid residue. Similarly, polyethers can be employed in
solid form. Additionally, it will be apparent that one can use
soluble materials of a smooth nature which dissolve under the
influence of the body chemistry and yet allow the temporary implant
to be disposed about the healing tendon. Especially suitable
materials include catgut and compressed "polysaccharides," i.e.,
glucose and cellulose.
BRIEF DESCRIPTION OF THE DRAWINGS
In order to more fully appreciate and understand the invention,
reference is made to the accompanying drawing, in which:
FIG. 1 is an expanded enlarged view of an alternating reversing
helically wound generally tubular temporary implant of the present
invention in serrated form;
FIG. 2 is an enlarged side view of a finger showing a skeletal
cross section of the bones of the finger and a single tendon under
repair with the generally cylindrical member of FIG. 1 in place
about a tendon during the process of healing. In this view there
can be seen the fibrous adhesions which grow radially outward from
the tendon itself;
FIG. 3 is an isometric view of a sleeve member adapted to carry and
insert into place the generally tubular member of FIG. 1;
FIG. 4 is an enlarged cross sectional elevation of a single tendon
about which is placed the sleeve member of FIG. 3 carrying the
tubular member of FIG. 1, the section being taken through the top
of the sleeve in FIG. 3 and taken before such time as the sleeve of
FIG. 3 is removed from a tendon, as more fully described below;
FIG. 5 is another embodiment of the present invention shown in
generally planar view, the same being for use between two
neighboring tendons. The device is at least partially serrated;
FIG. 6 shows in place the implants of FIGS. 1 and 5, the implant of
FIG. 5 being disposed between tendons, and the implant of FIG. 1
being disposed about the two tendons, the ends of each implant
extending outwardly toward the exterior of the patient;
FIG. 7 is a sectional view taken along the lines 7--7 of FIG.
6;
FIG. 8 is a view similar to FIG. 7 limited to the implants depicted
in FIG. 6;
FIG. 9 is an isometric view similar to FIG. 5 showing the
disposition of the generally planar transplant of FIG. 5 on a piece
of adhesive;
FIG. 10 shows the manner in which the temporary implant of FIG. 9
is disposed about a tendon to be repaired through the assistance of
the adhesive strip shown in FIG. 9;
FIG. 11 is an enlarged side view similar to FIG. 10 showing the
disposition of the various apices of the sinuous material whereby
they meet at a line such that the sinuous material travels
substantially about 360.degree. and reverses itself to travel about
360.degree. in the opposite direction before again reversing
itself;
FIG. 12 is an enlarged side view, similar to FIG. 11, showing an
overlap of the apices caused by the fact that the filamentary
material travels in excess of 360.degree. before it reverses
itself; and
FIG. 13 is an enlarged view similar to FIGS. 11 and 12 which shows
the generally planar member folded so as to define an enclosed area
only a portion of which contains filamentary material, such being
caused by the fact that the filamentary material travels less than
360.degree. before reversing itself.
DISCUSSION OF PREFERRED EMBODIMENTS
Preferred embodiments of the present invention are illustrated in
FIGS. 1 through 8 in which FIG. 1 is an enlarged isometric view of
the present invention. The embodiment shown therein is a reversing
or alternating helical wire member 2 having a first helix 4 which
reverses at 6 to form an oppositely directed helix which in turn
reverses once again to form a convolution or helix 8 of the same
configuration as helix 4. The alternating helical form of the
implant of FIG. 1 is continuous through its length from right to
left. The helical temporary implant of the present invention has a
protruding end member 10 adapted to extend through to the surface
of the patient, said member having a lip 12. In practice, this
minute member, generally made of a stanless steel wire having a
diameter between 0.008 and 0.012 inches, is placed, through the use
of the tubular sleeve 14 of FIG. 3, over one end of a severed
tendon. It must be remembered that tubular member 14 assists in
placing the implant 2 over the area to be healed. It is disposed
about a particular edge or end of the tendon under repair. The
sleeve 14 is withdrawn, leaving the implant 2 over a continuous
portion of tendon. The remaining helical tubular member is then
moved to overlay the joint formed by abutting ends of severed
tendon being repaired.
Referring to FIG. 4, there is shown the cross sectional elevation
of the sleeve 14 underlying and carrying the generally tubular
implant 2 disposed over an end 16 of a tendon. At this stage, the
sleeve 14 is withdrawn, and the helical member 2 is disposed so
that approximately half is on one side of the tendon suture
(repair) line and half on the other side, all as seen in FIG.
2.
In FIG. 2 there are also seen the adhesions 20 which grow radially
outward from the tendon of which portion 16 is proximate one end to
be joined to an opposing end 18. It can be seen that a natural
sheath envelops the tendon and it is between this sheath and the
tendon that the fibrous adhesive grows. Normally, the tendon rides
smoothly within this sheath. However, if there are lateral
adhesions present, the rideability during flexing is severely
inhibited.
After the healing is substantially complete, i.e., after the
surgeon has performed the usual surgical technique on the severed
tendon, the lip 12 is disposed slightly exterior of the patient, as
shown in FIG. 2. The wound is allowed to heal until the junction
between the ends of the tendon is substantially repaired.
Thereafter, the lip 12 is pulled, thereby unraveling the
filamentary material material which severs the fibrous adhesions as
it is removed.
In FIG. 5, there is illustrated an embodiment of the present
invention for use as s temporary implant between a healing tendon
and a neighboring tendon in out-of-contact relationship therewith.
This temporary implant generally is constructed of the same
material as the implant of FIG. 1 is constructed. This implant has
a tight sinuous curve with a protruding member 20 with a lip 22
adapted to be directed outwardly from the patient's body. FIG. 6
shows the same in position with its lip 22 disposed proximate lip
12 of the generally tubular implant 2.
Again, with respect to the assembly of FIG. 6, it should be noted
that generally speaking, after the same have been put in place,
immediately following the joining of the severed ends of the
tendon, the lips 12 and 22 are brought just slightly through the
surface of the patient. The patient's curing processes are allowed
to commence, which, indeed, cause fibrous adhesions between tendons
24 and 26. In fact, the tendons grow through the perforations or
slits defined by the sinuous curve of the generally flat member 19
of FIG. 5. After healing is substantially complete, the tip 22 is
pulled to unravel the flat member 19 while it severs adhesions
disposed between tendon 24 and tendon 26. Thereafter, the lip 12 is
pulled to unravel the alternating and reversing helical tubular
member 2 which severs the adhesions 20 disposed between the tissues
within the finger and the tendons 24 and 26. Only a small covering,
such as an adhesive bandage, need be applied over the minor opening
through which the filamentary material constituting the temporary
implants is removed.
A preferred form of the present invention is illustrated in FIGS. 9
to 13, inclusive. Referring to FIG. 9, there is shown a generally
continuous filamentary transplant of the type shown in FIG. 5
having apices 34 on one end thereof and nadirs 36 on the other. The
generally flat planar material designated by reference numeral 38
is disposed on an adhesive substrate 40. The generally planar
member has endpieces 42 and 44, at least one of which will be
disposed through the exterior skin of the patient.
The implant of FIGS. 9 and 13 is employed by wrapping the adhesive
material containing the sinuous continuous filamentary material
about a tendon 46 so that the adhesive is on the exterior side, as
shown in FIG. 10. The adhesive is thereafter removed after the
planar member is deformed to define a generally cylindrical
temporary implant. When removed, the implant takes the
configuration shown in FIG. 11 where the apices and troughs in
alternating sequence touch the same imaginary line drawn parallel
to the tendon 46. In FIGS. 10 and 11 the cylindrical temporary
implant substantially completely envelopes the tendon.
On the other hand, in FIG. 12 there is shown the configuration
provided if the planar member 38 of FIG. 9 is wrapped more tightly
around the tendon 46, the net result being that the apex of one
side becomes disposed within the open area on the opposite side
thereof between two troughs. The use of such temporary implant of
FIG. 12 is the same as that of FIG. 11. It should be recognized
that such an embodiment will insure the severing of virtually all
of the tendonous adhesions caused to grow between the tendon and
adjoining tissue. In certain instance, however, it is desirable to
dispose the planar member such that it only partially envelopes or
surrounds the tendon 46. Such configuration is depicted in FIG. 13.
It may well be that such a configuration will be provided around
one severed tendon which is adjacent an unsevered tendon. The
opening provided on the surface, owing to the fact that the
generally flat planar member does not define a full cylinder, may
allow for the disposition of a second flat planar temporary implant
of the type depicted in FIG. 5 in the region of the opening so that
intertendonous adhesions can be severed after the patient has
undergone the healing process.
In order to more fully illustrate the nature of the invention and
the manner of practicing the same, the following Example is set
forth:
EXAMPLE
An insertion was made in the surface of a dog which had revealed,
upon diagnosis, a severed flexor tendon of the second digit. The
area about the severed tendon was cleared of tissue. An alternating
reversing helical temporary implant having the configuration of
FIG. 1 was slid over one end of the tendon. The other end of the
tendon was placed in mating relationship with the first end of the
tendon and medically sutured to commence healing and joining of the
tendon longitudinally. The implant was then slid downward so that
it was half over each end of the severed tendon. The end or lip of
the tendon implant was permitted to protrude through the surface of
the dog which was covered by a suitable adhesive bandage or other
protective covering. The dog's exterior wound was repaired. Several
weeks later, after sufficient time had elapsed to permit healing of
the tendon, the lip of the implant was pulled so that it severed
fibrous adhesions which grew between the tendon under repair and
adjoining tissue. The entire filamentary material of the temporary
implant was withdrawn. The dog's tendon was completely repaired and
there were substantially no movement restrictions noted due to the
creation of fibrous adhesions, which occur in dogs as well as in
humans, during the healing of tendons. Without the severence of
these fibrous adhesions, the loss of function of the tendon and
therefore the body part occurs.
From the above, it is seen that the device of the present invention
improves the functional results after tendon repair. Desirably, the
device is a porous stainless steel temporary implant placed around
and between the tendons, the site of the suture line at the time of
repair. The implant remains in this position until sufficient time
is allowed for healing of the tendon to occur. After the tendon has
healed, the device is simply removed percutaneously as two lengths
of straightened wire, e.g., stanless steel wire. In the process of
removal, the implant acts as a cutter of adhesions which have grown
between the tendon and adjacent tissues and juxtaposed tendons.
This eliminates one of the major causes of poor functional results
after tendon repair due to the proliferation of fibrous adhesions
disposed between the tendon and adjacent tissues created during the
healing process. These adhesions can cement the tendon to the
adjacent tissues and thereby inhibit the gliding action of the
tendon so necessary for good functional results. To be able to
break the adhesions which cement the tendon in a fixed nongliding
position improves the functional results by improving the gliding
action and mobility of the tendon. The present invention provides a
simple, inexpensive means of breaking the peri- and inter-tendonous
adhesions which develop in the process of healing. Through use of
appropriately dimensioned implants, severed tendons in sensitive,
difficult-to-repair areas of the body, for example, the limbs and
especially the hands, can be repaired with substantially full
recovery of all movement. This is particularly suprising, as
surgical methods presently available do not adequately repair
severed tendons in many areas of the body. The use of such a device
is simple and can be performed by any orthopedic surgeon or the
like and does not require special training.
The above invention has been described with particular emphasis
upon the use of a stainless steel implant having a thickness
between 0.008 and 0.012 inch. Broadly speaking, however, the
implant can have a thickness between 1/8 and 1/4 inch, preferably
between 1/6 and 1/4 inch. The thickness will depend upon the nature
of the material, it being clear that the same must be able to
assume a shape, e.g., helical or flat planar, and yet be such that
when pulled, it assumes a generally straightened form.
Generally speaking, when the implant is in the form of a sinuous
continuous filament having apices at the edge thereof, the distance
between such apieces will be between 0.25 and 5 mm, preferably
between 1 and 2 mm. The cross section of the filamentary material
can have any suitable configuration such as triangular, elliptical,
rectangular, trilobal or circular. A triangular cross section for
the filament is particularly desired because such configuration
lends itself to a severing function. The cross section of the
entire implant generally assumes for the implant of FIG. 1 either a
circular, elliptical or triangular cross section.
* * * * *