U.S. patent application number 16/690752 was filed with the patent office on 2020-06-04 for high-strength bioabsorbable suture.
The applicant listed for this patent is Tornier, Inc.. Invention is credited to Kevin L. Ohashi, Dale R. Peterson, Corey R. Wilson-Wirth.
Application Number | 20200170640 16/690752 |
Document ID | / |
Family ID | 53403497 |
Filed Date | 2020-06-04 |
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United States Patent
Application |
20200170640 |
Kind Code |
A1 |
Wilson-Wirth; Corey R. ; et
al. |
June 4, 2020 |
HIGH-STRENGTH BIOABSORBABLE SUTURE
Abstract
A suture is provided having a multifilament sheath disposed
thereabout a monofilament core. The multifilament sheath includes a
plurality of yarns, and each of the plurality of yarns includes a
plurality of threads. Further, the suture includes
poly-4-hydroxybutyrate (P4HB).
Inventors: |
Wilson-Wirth; Corey R.;
(Bloomington, MN) ; Peterson; Dale R.;
(Bloomington, MN) ; Ohashi; Kevin L.;
(Bloomington, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Tornier, Inc. |
Bloomington |
MN |
US |
|
|
Family ID: |
53403497 |
Appl. No.: |
16/690752 |
Filed: |
November 21, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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15039167 |
May 25, 2016 |
10485535 |
|
|
PCT/US14/67760 |
Nov 26, 2014 |
|
|
|
16690752 |
|
|
|
|
61918083 |
Dec 19, 2013 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2250/0067 20130101;
A61B 2017/00893 20130101; A61F 2/08 20130101; A61B 17/0401
20130101; A61B 2017/044 20130101; A61B 2017/0409 20130101; A61B
2017/00004 20130101; A61B 2017/00526 20130101; A61F 2210/0004
20130101; A61L 17/105 20130101; A61B 2017/0414 20130101; A61B 90/92
20160201; A61B 17/06166 20130101 |
International
Class: |
A61B 17/06 20060101
A61B017/06; A61B 90/92 20060101 A61B090/92; A61L 17/10 20060101
A61L017/10; A61B 17/04 20060101 A61B017/04 |
Claims
1-20. (canceled)
21. A suture, comprising: a multifilament sheath including a
plurality of yarns, the plurality of yarns comprising
poly-4-hydroxybutyrate; and a monofilament core comprising
poly-4-hydroxybutyrate, wherein the multifilament sheath is
disposed thereabout the monofilament core, wherein the
multifilament sheath has between about 64.5 picks per inch and
about 70.5 picks per inch, wherein the monofilament core is about a
size 0, wherein the multifilament sheath comprises twelve
yarns.
22. The suture of claim 21, wherein the plurality of yarns includes
a plurality of threads, and each of the threads comprise
poly-4-hydroxybutyrate.
23. The suture of claim 21, where each of the twelve yarns
comprises about 60 threads.
24. The suture of claim 21, wherein each of the twelve yarns is
about 120 denier.
25. The suture of claim 21, wherein the suture has an elongation to
break between 34.8% and 50.9%.
26. The suture of claim 21, wherein the suture has an elongation to
break between 27.2% and 35.8% in a knotted configuration.
27. The suture of claim 21, wherein the suture has an ultimate
tensile strength between 139.9 Newtons and 195.7 Newtons.
28. The suture of claim 21, wherein the suture has an ultimate
tensile strength between 79.0 Newtons and 113.8 Newtons in a
knotted configuration.
29. The suture of claim 21, wherein the suture is about a size
2.
30. The suture of claim 21, wherein the suture includes an enlarged
portion disposed between a first end and a second end of the
suture.
31. The suture of claim 30, wherein the enlarged portion includes
poly-4-hydroxybutyrate filaments.
32. The suture of claim 21, wherein two of the yarns have violet
colored threads and ten of the yarns have natural colored
threads.
33. The suture of claim 21, wherein the suture comprises a diameter
within the range of 0.637 mm to 0.696 mm.
34. The suture of claim 21, wherein the multifilament sheath is
configured to maintain a cylindrical configuration when the
monofilament core is removed.
35. A suture, comprising: a bioabsorbable monofilament core; a
bioabsorbable multifilament sheath disposed thereabout the
bioabsorbable monofilament core; and wherein the suture consists
essentially of poly-4-hydroxybutyrate, wherein the bioabsorbable
monofilament core and the bioabsorbable multifilament sheath
comprise the same material, wherein the multifilament sheath is
configured to maintain a cylindrical configuration when the
monofilament core is removed, wherein the bioabsorbable
monofilament core is about a size 0, wherein the bioabsorbable
multifilament sheath comprises twelve yarns.
36. The suture of claim 35, wherein the multifilament sheath has
from about 54 to about 71 picks per inch.
37. The suture of claim 35, wherein the suture has an ultimate
tensile strength between 139.9 Newtons and 195.7 Newtons.
38. The suture of claim 35, wherein the suture has an elongation to
break between 34.8% and 50.9%.
39. A suture, comprising: a multifilament sheath including a
plurality of yarns, the plurality of yarns comprising
poly-4-hydroxybutyrate; and a monofilament core comprising
poly-4-hydroxybutyrate, wherein the multifilament sheath is
disposed thereabout the monofilament core, wherein the suture
comprises a diameter within the range of 0.637 mm to 0.696 mm,
wherein the monofilament core is about a size 0, wherein the
multifilament sheath comprises twelve yarns.
40. The suture of claim 35, wherein the suture has an ultimate
tensile strength between 139.9 Newtons and 195.7 Newtons.
Description
TECHNICAL FIELD
[0001] The present application is a continuation of U.S.
application Ser. No. 15/039167, filed May 25, 2016, which is a
national phase of PCT Application No. PCT/US2014/067760, filed Nov.
26, 2014 titled "HIGH-STRENGTH BIOABSORBABLE SUTURE," which claims
priority benefit under 35 U.S.C. .sctn. 119(e) to U.S. Provisional
Patent Application Ser. No. 61/918083, filed Dec. 19, 2013, both of
which are incorporated by reference in their entirety herein. Any
and all applications for which a foreign or domestic priority claim
is identified in the Application Data Sheet as filed with the
present application are hereby incorporated by reference under 37
CFR 1.57.
TECHNICAL FIELD
[0002] The present invention relates to sutures used in medical
procedures. In particular, the present invention relates to
high-strength bioabsorbable sutures used in orthopedic
procedures.
BACKGROUND
[0003] "High strength" sutures are typically used in orthopedic
procedures due to the relatively high loading requirements in such
applications. Currently, high strength sutures are formed using
non-absorbable materials, such as ultra-high molecular weight
polyethylene (UHMWPE) and the like, or a combination of
non-absorbable yarns and bioabsorbable yarns which may be woven or
braided together. As such, high strength sutures are typically
considered either permanent sutures (if formed by non-absorbable
materials) or partially permanent (formed from a combination of
non-absorbable and absorbable materials). Improvements in the field
are desired.
SUMMARY
[0004] A suture is provided including a multifilament sheath having
a plurality of yarns, the plurality of yarns comprising
poly-4-hydroxybutyrate; and a monofilament core comprising
poly-4-hydroxybutyrate, wherein the multifilament sheath is
disposed thereabout the monofilament core.
[0005] Sutures may have an ultimate tensile strength of from about
140 Newtons to about 190 Newtons, and an elongation to break of
about 30 percent to about 50 percent.
[0006] Sutures may also be provided having a bioabsorbable
monofilament core and a bioabsorbable multifilament sheath disposed
thereabout the bioabsorbable monofilament core wherein the suture
consists essentially of poly-4-hydroxybutyrate.
[0007] Methods for manufacturing sutures in accordance with the
present invention are also disclosed.
[0008] While multiple embodiments are disclosed, still other
embodiments of the present invention will become apparent to those
skilled in the art from the following detailed description, which
shows and describes illustrative embodiments of the invention.
Accordingly, the drawings and detailed description are to be
regarded as illustrative in nature and not restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIG. 1 illustrates a partial side view of a suture according
to an embodiment of the present invention;
[0010] FIG. 2 illustrates a schematic cross-sectional view of the
suture of FIG. 1;
[0011] FIG. 3 illustrates a side view of a suture apparatus
according to an embodiment of the present invention;
[0012] FIG. 4 illustrates a side view of a suture according to an
embodiment of the present invention;
[0013] FIG. 5 illustrates a partial side view of another embodiment
of a suture according to the present invention;
[0014] FIG. 6 illustrates a partial side view of the suture of FIG.
5;
[0015] FIG. 7 illustrates a partial perspective view of a
suture/anchor apparatus according to an embodiment of the present
invention;
[0016] FIG. 8 illustrates a side view of the anchor of the
suture/anchor apparatus of FIG. 7;
[0017] FIG. 9 illustrates a side view of another anchor of a
suture/anchor apparatus according to an embodiment of the present
invention;
[0018] FIG. 10 illustrates a side view of another anchor of a
suture/anchor apparatus according to an embodiment of the present
invention;
[0019] FIG. 11 illustrates a partial perspective view of a
suture/anchor apparatus according to an alternate embodiment of the
present invention;
[0020] FIG. 12 illustrates a side view of the anchor of the
suture/anchor apparatus of FIG. 11;
[0021] FIG. 13 illustrates a side view of another anchor of a
suture/anchor apparatus according to an embodiment of the present
invention;
[0022] FIG. 14 illustrates a side view of an alternate anchor of a
suture/anchor apparatus according to an embodiment of the present
invention;
[0023] FIG. 15 illustrates a side view of a suture/anchor apparatus
insertion tool for use with the present invention;
[0024] FIG. 16 illustrates a top view of a kit including the
suture/anchor apparatus insertion tool of FIG. 15; and,
[0025] FIG. 17 illustrates a flowchart of an exemplary method of
manufacturing a suture according to an embodiment of the present
invention.
[0026] While the invention is amenable to various modifications and
alternative forms, specific embodiments have been shown by way of
example in the drawings and are described in detail below. The
intention, however, is not to limit the invention to the particular
embodiments described. On the contrary, the invention is intended
to cover all modifications, equivalents, and alternatives falling
within the scope of the invention as defined by the appended
claims.
DETAILED DESCRIPTION
[0027] FIGS. 1 and 2 illustrate a suture 110 according to an
embodiment of the present invention. The suture 110 generally
includes a body 116 which extends between a first end 118 and a
second end 120 of the suture 110. In particular, the body 116
comprises a core 112 surrounded by a multifilament sheath 122. The
multifilament sheath 122 further includes a plurality of individual
threads (not labeled) which may be woven, braided or otherwise
entangled to form yarns 124, 140. In some embodiments, the suture
110 may include a needle (not illustrated) disposed on at least one
of the first end 118 or the second end 120 of the suture.
[0028] Referring back to FIGS. 1 and 2, the suture 110 includes a
multifilament sheath 122 surrounding the core 112. In particular,
the multifilament sheath 122 includes from about eight yarns to
about twelve yarns. In particular, a multifilament sheath 122
including 7, 8, 9, 10, 11, 12 and 13 yarns are contemplated. In
embodiments, the sheath 122 may include about twelve yarns. In
other embodiments, the sheath 122 includes about eight yarns. In
particular, the yarns 125, 140 having a denier of 100, 110, 120,
130, and 140 and any denier in between these ranges are
contemplated. Further, thread counts of 30, 35, 40, 45, 50, 55, 60,
65, 70, 75, and 80 are contemplated. In one particular embodiment,
each yarn 124, 140 is about 120 denier and includes about 60
threads.
[0029] Numerous braid patterns can be used in forming the
multifilament sheath including "one yarn under two yarns over,"
"one yarn over two yarns under," "two yarns over two yarns under,"
"one yarn under one yarn over." Specifically, the yarns 124, 140
may be braided with one another in a specified pattern, such as,
for example, in a repeating "over two, under two" pattern, to form
the multifilament sheath 122. Other patterns are also envisioned
and within the purview of those skilled in the art. Alternatively,
the yarns 124, 140 may be comingled, knitted, woven, or otherwise
entwined to form the multifilament sheath.
[0030] Further, sutures of the present disclosure may have from
about 54 to about 71 picks per inch. In particular, sutures may
have 54.3, 55.8, 56, 64.5, 64.7, 69.7, and 70.5 picks per inch.
Further, depending on multifilament sheath construct, the picks per
inch may vary. In specific embodiments, sutures of the present
disclosure may have about 70.5 picks per inch.
[0031] In some embodiments, some of the yarns 124, 140 or threads
may be provided with different colors to provide a visible pattern
on the suture 110. For example, two of the yarns 124, 140 may have
violet colored threads and ten of the yarns 124, 140 may have
natural colored threads.
[0032] The sheath 122 defines an inner or internal passageway 126
(see FIG. 2) of the sheath 122 that houses the core 112. The inner
passageway 126 has a diameter D.sub.1 that is sized to receive the
core 112. Stated otherwise, D.sub.1 is the inner diameter of the
multifilament sheath 122. In embodiments, D.sub.1 is equal to or
greater than the diameter of the monofilament core. In some
embodiments, at least one of the yarns 124, 140 contact the core
112. The outermost portion of the sheath 122 also defines an outer
diameter D.sub.2 of the suture 110.
[0033] The core 112 and sheath 122 are provided with a
bioabsorbable polymeric material that facilitates high suture
strength. Sutures described herein are formed from
poly-4-hydroxybutyrate (P4HB). Poly-4-hydroxybutyrate is a
polyester having the chemical structure illustrated below.
##STR00001##
[0034] In particular, the monofilament core 112 is comprised of
P4HB. Additionally, threads and yarns of the multifilament sheath
122 are comprised of P4HB. Stated otherwise, sutures 110 of the
present disclosure include a monofilament core 112 formed of P4HB
and each thread, and in turn, all of the yarns are formed entirely
of P4HB.
[0035] In alternate embodiments, sutures of the present disclosure
may be provided without a core. In other words, the sutures may be
provided with a multifilament sheath as described herein, having an
inner passageway which is hollow and absent of a monofilament core.
It should be noted that when the core is removed, the multifilament
sheath maintains a cylindrical configuration in some embodiments,
rather than a flat or otherwise collapsed configuration. Sutures of
smaller sizes, for example, sizes 2-0 and 0 (see USP guidelines)
may be provided as a multifilament sheath, absent of a monofilament
core.
[0036] Methods for manufacturing P4HB are within the purview of
those skilled in the art and can be found, for example in `Medical
applications of poly-4-hydroxybutyrate: a strong absorbable
biomaterial` (Biochemical Engineering Journal 16 (2003) 97-105),
the contents of which are incorporated by reference herein. In
particular, the core 112 and the threads may be obtained, for
example, from Tepha Inc. of Cambridge, Mass., USA.
[0037] Suture 110 may be formed using any technique within the
purview of those skilled in the art, such as, for example,
extrusion, molding and/or gel spinning. Threads of the sheath may
be drawn, oriented, crinkled, twisted, commingled or air entangled
to form yarns as part of the suture forming process. In one
embodiment, the suture is produced by braiding the multifilament
sheath around the monofilament core. The braiding may be done by
any method within the purview of those skilled in the art.
Alternatively, the multifilament sheath may be formed and
subsequently the monofilament core inserted therein.
[0038] Once the suture is constructed, it can be sterilized by any
means within the purview of those skilled in the art.
[0039] In some embodiments, the suture 110 may include therapeutic
agents in the form of, by example, a coating. Therapeutic agents
include, but are not limited to, drugs, amino acids, peptides,
polypeptides, proteins, polysaccharides, muteins, immunoglobulins,
antibodies, cytokines (e.g., lymphokines, monokines, chemokines),
blood clotting factors, hemopoietic factors, interleukins (1
through 18), interferons (.beta.-IFN, .alpha.-IFN and .gamma.-IFN),
erythropoietin, nucleases, tumor necrosis factor, colony
stimulating factors (e.g., GCSF, GM-CSF, MCSF), insulin, anti-tumor
agents and tumor suppressors, blood proteins, fibrin, thrombin,
fibrinogen, synthetic thrombin, synthetic fibrin, synthetic
fibrinogen, gonadotropins (e.g., FSH, LH, CG, etc.), hormones and
hormone analogs (e.g., growth hormone, luteinizing hormone
releasing factor), vaccines (e.g., tumoral, bacterial and viral
antigens); somatostatin; antigens; blood coagulation factors;
growth factors (e.g., nerve growth factor, insulin-like growth
factor); bone morphogenic proteins, TGF-B, protein inhibitors,
protein antagonists, and protein agonists; nucleic acids, such as
antisense molecules, DNA, RNA, RNAi; oligonucleotides;
polynucleotides; cells, viruses, and ribozymes.
[0040] In some embodiments, the therapeutic agent includes at least
one of the following drugs, including combinations and alternative
forms of the drugs such as alternative salt forms, free acid form,
free base forms, pro-drugs and hydrates: analgesics/antipyretics
(e.g., aspirin, acetaminophen, ibuprofen, naproxen sodium,
buprenorphine, propoxyphene hydrochloride, propoxyphene napsylate,
meperidine hydrochloride, hydromorphone hydrochloride, morphine,
oxycodone, codeine, dihydrocodeine bitartrate, pentazocine,
hydrocodone bitartrate, levorphanol, diflunisal, trolamine
salicylate, nalbuphine hydrochloride, mefenamic acid, butorphanol,
choline salicylate, butalbital, phenyltoloxamine citrate,
diphenhydramine citrate, methotrimeprazine, cinnamedrine
hydrochloride, and meprobamate); antiasthmatics (e.g., ketotifen
and traxanox); antibiotics (e.g., neomycin, streptomycin,
chloramphenicol, cephalosporin, ampicillin, penicillin,
tetracycline, and ciprofloxacin); antidepressants (e.g., nefopam,
oxypertine, doxepin, amoxapine, trazodone, amitriptyline,
maprotiline, phenelzine, desipramine, nortriptyline,
tranylcypromine, fluoxetine, doxepin, imipramine, imipramine
pamoate, isocarboxazid, trimipramine, and protriptyline);
antidiabetics (e.g., biguanides and sulfonylurea derivatives);
antifungal agents (e.g., griseofulvin, ketoconazole, itraconizole,
amphotericin B, nystatin, and candicidin); antihypertensive agents
(e.g., propanolol, propafenone, oxyprenolol, nifedipine, reserpine,
trimethaphan, phenoxybenzamine, pargyline hydrochloride,
deserpidine, diazoxide, guanethidine monosulfate, minoxidil,
rescinnamine, sodium nitroprusside, rauwolfia serpentina,
alseroxylon, and phentolamine); anti-inflammatories (e.g.,
(non-steroidal) indomethacin, ketoprofen, flurbiprofen, naproxen,
ibuprofen, ramifenazone, piroxicam, (steroidal) cortisone,
dexamethasone, fluazacort, celecoxib, rofecoxib, hydrocortisone,
prednisolone, and prednisone); antineoplastics (e.g.,
cyclophosphamide, actinomycin, bleomycin, dactinomycin,
daunorubicin, doxorubicin, epirubicin, mitomycin, methotrexate,
fluorouracil, gemcitabine, carboplatin, carmustine (BCNU),
methyl-CCNU, cisplatin, etoposide, camptothecin and derivatives
thereof, phenesterine, paclitaxel and derivatives thereof,
docetaxel and derivatives thereof, vinblastine, vincristine,
goserelin, leuprolide, tamoxifen, interferon alfa, retinoic acid
(ATRA), nitrogen mustard alkylating agents, and piposulfan);
antianxiety agents (e.g., lorazepam, buspirone, prazepam,
chlordiazepoxide, oxazepam, clorazepate dipotassium, diazepam,
hydroxyzine pamoate, hydroxyzine hydrochloride, alprazolam,
droperidol, halazepam, chlormezanone, and dantrolene);
immunosuppressive agents (e.g., cyclosporine, azathioprine,
mizoribine, and FK506 (tacrolimus)); antimigraine agents (e.g.,
ergotamine, propanolol, isometheptene mucate, and
dichloralphenazone); sedatives/hypnotics (e.g., barbiturates such
as pentobarbital, and secobarbital; and benzodiazapines such as
flurazepam hydrochloride, triazolam, and midazolam); antianginal
agents (e.g., beta-adrenergic blockers; calcium channel blockers
such as nifedipine, and diltiazem; and nitrates such as
nitroglycerin, isosorbide dinitrate, pentearythritol tetranitrate,
and erythrityl tetranitrate); antipsychotic agents (e.g.,
haloperidol, loxapine succinate, loxapine hydrochloride,
thioridazine, thioridazine hydrochloride, thiothixene,
fluphenazine, fluphenazine decanoate, fluphenazine enanthate,
trifluoperazine, chlorpromazine, perphenazine, lithium citrate, and
prochlorperazine); antimanic agents (e.g., lithium carbonate);
antiarrhythmics (e.g., bretylium tosylate, esmolol, verapamil,
amiodarone, encamide, digoxin, digitoxin, mexiletine, disopyramide
phosphate, procainamide, quinidine sulfate, quinidine gluconate,
quinidine polygalacturonate, flecamide acetate, tocamide, and
lidocaine); antiarthritic agents (e.g., phenylbutazone, sulindac,
penicillanine, salsalate, piroxicam, azathioprine, indomethacin,
meclofenamate, gold sodium thiomalate, ketoprofen, auranofin,
aurothioglucose, and tolmetin sodium); antigout agents (e.g.,
colchicine, and allopurinol); anticoagulants (e.g., heparin,
heparin sodium, and warfarin sodium); thrombolytic agents (e.g.,
urokinase, streptokinase, and alteplase); antifibrinolytic agents
(e.g., aminocaproic acid); hemorheologic agents (e.g.,
pentoxifylline); antiplatelet agents (e.g., aspirin);
anticonvulsants (e.g., valproic acid, divalproex sodium, phenyloin,
phenyloin sodium, clonazepam, primidone, phenobarbitol,
carbamazepine, amobarbital sodium, methsuximide, metharbital,
mephobarbital, mephenyloin, phensuximide, paramethadione, ethotoin,
phenacemide, secobarbitol sodium, clorazepate dipotassium, and
trimethadione); antiparkinson agents (e.g., ethosuximide);
antihistamines/antipruritics (e.g., hydroxyzine, diphenhydramine,
chlorpheniramine, brompheniramine maleate, cyproheptadine
hydrochloride, terfenadine, clemastine fumarate, triprolidine,
carbinoxamine, diphenylpyraline, phenindamine, azatadine,
tripelennamine, dexchlorpheniramine maleate, methdilazine, and);
agents useful for calcium regulation (e.g., calcitonin, and
parathyroid hormone); antibacterial agents (e.g., amikacin sulfate,
aztreonam, chloramphenicol, chloramphenicol palirtate,
ciprofloxacin, clindamycin, clindamycin palmitate, clindamycin
phosphate, metronidazole, metronidazole hydrochloride, gentamicin
sulfate, lincomycin hydrochloride, tobramycin sulfate, vancomycin
hydrochloride, polymyxin B sulfate, colistimethate sodium, and
colistin sulfate); antiviral agents (e.g., interferon alpha, beta
or gamma, zidovudine, amantadine hydrochloride, ribavirin, and
acyclovir); antimicrobials (e.g., cephalosporins such as cefazolin
sodium, cephradine, cefaclor, cephapirin sodium, ceftizoxime
sodium, cefoperazone sodium, cefotetan disodium, cefuroxime axetil,
cefotaxime sodium, cefadroxil monohydrate, cephalexin, cephalothin
sodium, cephalexin hydrochloride monohydrate, cefamandole nafate,
cefoxitin sodium, cefonicid sodium, ceforanide, ceftriaxone sodium,
ceftazidime, cefadroxil, cephradine, and cefuroxime sodium;
penicillins such as ampicillin, amoxicillin, penicillin G
benzathine, cyclacillin, ampicillin sodium, penicillin G potassium,
penicillin V potassium, piperacillin sodium, oxacillin sodium,
bacampicillin hydrochloride, cloxacillin sodium, ticarcillin
disodium, azlocillin sodium, carbenicillin indanyl sodium,
penicillin G procaine, methicillin sodium, and nafcillin sodium;
erythromycins such as erythromycin ethylsuccinate, erythromycin,
erythromycin estolate, erythromycin lactobionate, erythromycin
stearate, and erythromycin ethylsuccinate; and tetracyclines such
as tetracycline hydrochloride, doxycycline hyclate, and minocycline
hydrochloride, azithromycin, clarithromycin); anti-infectives
(e.g., GM-CSF); bronchodilators (e.g., sympathomimetics such as
epinephrine hydrochloride, metaproterenol sulfate, terbutaline
sulfate, isoetharine, isoetharine mesylate, isoetharine
hydrochloride, albuterol sulfate, albuterol, bitolterolmesylate,
isoproterenol hydrochloride, terbutaline sulfate, epinephrine
bitartrate, metaproterenol sulfate, epinephrine, and epinephrine
bitartrate; anticholinergic agents such as ipratropium bromide;
xanthines such as aminophylline, dyphylline, metaproterenol
sulfate, and aminophylline; mast cell stabilizers such as cromolyn
sodium; inhalant corticosteroids such as beclomethasone
dipropionate (BDP), and beclomethasone dipropionate monohydrate;
salbutamol; ipratropium bromide; budesonide; ketotifen; salmeterol;
xinafoate; terbutaline sulfate; triamcinolone; theophylline;
nedocromil sodium; metaproterenol sulfate; albuterol; flunisolide;
fluticasone proprionate; steroidal compounds and hormones (e.g.,
androgens such as danazol, testosterone cypionate, fluoxymesterone,
ethyltestosterone, testosterone enathate, methyltestosterone,
fluoxymesterone, and testosterone cypionate; estrogens such as
estradiol, estropipate, and conjugated estrogens; progestins such
as methoxyprogesterone acetate, and norethindrone acetate;
corticosteroids such as triamcinolone, betamethasone, betamethasone
sodium phosphate, dexamethasone, dexamethasone sodium phosphate,
dexamethasone acetate, prednisone, methylprednisolone acetate
suspension, triamcinolone acetonide, methylprednisolone,
prednisolone sodium phosphate, methylprednisolone sodium succinate,
hydrocortisone sodium succinate, triamcinolone hexacetonide,
hydrocortisone, hydrocortisone cypionate, prednisolone,
fludrocortisone acetate, paramethasone acetate, prednisolone
tebutate, prednisolone acetate, prednisolone sodium phosphate, and
hydrocortisone sodium succinate; and thyroid hormones such as
levothyroxine sodium); hypoglycemic agents (e.g., human insulin,
purified beef insulin, purified pork insulin, glyburide,
chlorpropamide, glipizide, tolbutamide, and tolazamide);
hypolipidemic agents (e.g., clofibrate, dextrothyroxine sodium,
probucol, pravastitin, atorvastatin, lovastatin, and niacin);
proteins (e.g., DNase, alginase, superoxide dismutase, and lipase);
nucleic acids (e.g., sense or anti-sense nucleic acids encoding any
therapeutically useful protein, including any of the proteins
described herein); agents useful for erythropoiesis stimulation
(e.g., erythropoietin); antiulcer/antireflux agents (e.g.,
famotidine, cimetidine, and ranitidine hydrochloride);
antinauseants/antiemetics (e.g., meclizine hydrochloride, nabilone,
prochlorperazine, dimenhydrinate, promethazine hydrochloride,
thiethylperazine, and scopolamine); as well as other drugs useful
in the compositions and methods described herein include mitotane,
halonitrosoureas, anthrocyclines, ellipticine, ceftriaxone,
ketoconazole, ceftazidime, oxaprozin, albuterol, valacyclovir,
urofollitropin, famciclovir, flutamide, enalapril, mefformin,
itraconazole, buspirone, gabapentin, fosinopril, tramadol,
acarbose, lorazepan, follitropin, omeprazole, fluoxetine,
lisinopril, tramsdol, levofloxacin, zafirlukast, interferon, growth
hormone, interleukin, erythropoietin, granulocyte stimulating
factor, nizatidine, bupropion, perindopril, erbumine, adenosine,
alendronate, alprostadil, benazepril, betaxolol, bleomycin sulfate,
dexfenfluramine, diltiazem, fentanyl, flecainid, gemcitabine,
glatiramer acetate, granisetron, lamivudine, mangafodipir
trisodium, mesalamine, metoprolol fumarate, metronidazole,
miglitol, moexipril, monteleukast, octreotide acetate, olopatadine,
paricalcitol, somatropin, sumatriptan succinate, tacrine,
nabumetone, trovafloxacin, dolasetron, zidovudine, finasteride,
tobramycin, isradipine, tolcapone, enoxaparin, fluconazole,
lansoprazole, terbinafine, pamidronate, didanosine, diclofenac,
cisapride, venlafaxine, troglitazone, fluvastatin, losartan,
imiglucerase, donepezil, olanzapine, valsartan, fexofenadine,
calcitonin, and ipratropium bromide. In some embodiments, the drug
may be water soluble. In other embodiments, the drug may not be
water soluble. Alternatively, the suture 110 may be coated with
other absorbable or non-bioabsorbable materials, such as polymers,
which may alter suture degradation. Polymers for coatings may be
comprised of polycaprolactone, poly lactic acid, poly glycolic
acid, polyethylene oxide, polydioxanone, or other biodegradable
materials. Alternatively, non-absorbable polymers may be applied as
coatings for sutures described herein. Coatings may be used to
alter other mechanical properties of the sutures such as handling
characteristics (e.g., knot run down, knot security). Suitable
non-absorbable and bioabsorbable polymer coatings are within the
purview of those skilled in the art.
[0041] Referring back to FIGS. 1 and 2, and as previously
mentioned, the suture 110 includes a core 112 and a multifilament
sheath 122. The core 112 may be from about a size 0 to about a size
5-0, per USP (United States Pharmacopia) guidelines. In some
embodiments, the core 112 is about a size 0 while in other
embodiments, the core 112 is about a size 5-0. Core sizes of 2-0,
3-0, 4-0, and also any fractional size between sizes 0 and 5-0 are
also contemplated. Additionally, the outer diameter D.sub.2 may be
sized to provide the suture 110 with an overall USP size of from
about size 2 to about size 2-0. Overall sized of size 1, 0, 1-0,
and also any fractional size between sizes 2 and 2-0 are also
contemplated. In some embodiments, the outer diameter D.sub.2 may
be sized to provide the suture 110 with an overall size of about
size 2. In other embodiments, the outer diameter D.sub.2 may be
sized to provide the suture 110 with an overall size of about size
2-0. In some embodiments, the outer diameter D.sub.2 may be sized
to provide the suture 110 with an overall USP size of from about
size 2 to about size 2-0. In some embodiments, the outer diameter
D.sub.2 may be sized to provide the suture 110 with an overall size
of about size 2. In other embodiments, the outer diameter D.sub.2
may be sized to provide the suture 110 with an overall size of
about size 2-0.
[0042] Sutures 110 of the present disclosure have an ultimate
tensile strength of from about 140 Newtons to about 190 Newtons. In
particular, sutures 110 having an ultimate tensile strength of at
least 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185,
190, 195, and 200 Newtons are contemplated. In specific
embodiments, the suture has an ultimate tensile strength of about
180 Newtons. It should be noted that the ultimate tensile strength
values described herein are for straight pull testing of the
sutures, unless otherwise indicated. Straight pull testing as
referenced herein means that the suture had been tested, in this
case, tension tested, in a unknotted, straight configuration.
[0043] Further, sutures 110 are provided with an elongation to
break of about 30 percent to about 50 percent. In particular,
sutures 110 having an elongation to break of at least 25, 30, 35,
40, 45, 50, 55, 60, 65, and 70 percent are contemplated. In
specific embodiments, the suture has an elongation to break of at
least about 34 percent. It should be noted that the elongation to
break values described herein are for straight tension testing of
the sutures, unless otherwise indicated.
[0044] In some embodiments, the suture 110 may have a strength
resorption (relative to the ultimate tensile strength) of about
64.9 percent at two weeks after implantation, about 67.1 percent at
four weeks after implantation, about 67.0 percent at eight weeks
after implantation, about 44.9 percent at 12 weeks after
implantation, about 18.8 percent at 26 weeks after implantation,
and about 0.6 percent at 52 weeks after implantation. For example,
strength resorption at 2 weeks is defined as the strength of the
suture after 2 weeks implantation in vivo as a percentage of the
strength of the suture at the start of or prior to implantation in
vivo.
[0045] It should be noted that for different surgical procedures,
alternate strength and resorption profiles may be preferred.
Accordingly it is envisioned that for certain procedures the
sutures comprising P4HB may be modified with other materials, such
as, for example, coatings.
[0046] The suture 110 may be coupled to tissue of a patient, or
subject, in medical procedures including orthopedic procedures,
such as repairing rotator cuff tears. It should be noted that
various size sutures are envisioned for other surgical procedures.
The sutures described herein may be configured or arranged for use
in various orthopedic applications or used together with other
components commonly used in different applications. For example,
the sutures described herein may be configured for use as
scaffolds, meshes, wound closure devices, and the like. As another
example, the sutures described herein may be used together with a
suture passer, such as, for example, the ArthroTunneler.TM. device
available from Tornier, Inc. (Bloomington, Minn.).
[0047] FIG. 3 illustrates a suture apparatus 200 according to an
embodiment of the present invention. The suture apparatus 200
includes a suture 210 that may be, for example, any of the sutures
described herein. The first end 218 and/or the second end 220 of
the suture 210 connect to a needle 230. As such, the suture 210
forms a loop 232 connected to the needle 230. In some embodiments,
the needle 230 has an arcuate shape. In one example, the needle 230
may be a half-circle taper point needle. Other needles and needle
shapes are also contemplated such as, for example, straight and
sickle.
[0048] FIG. 4 illustrates a suture 310 according to an embodiment
of the present invention. The suture 310 includes monofilament core
that is surrounded by a multifilament sheath. However, the suture
310 also includes an enlarged portion 334 that is thicker or larger
in diameter than other portions, such as portion 322 of the suture
310. The enlarged portion 334 includes the sheath and the core. In
the embodiment illustrated, the enlarged portion 334 is larger in
diameter than either end portion 340, 338. In specific embodiments,
the enlarged portion 334 is disposed on an inner portion of the
suture (rather than at one of the ends 340, 338), as illustrated in
FIGS. 4-6. FIG. 4 is also disclosed in US 2012/0059468 (FIG. 1),
assigned to Tornier, Inc (Bloomington, Minn.) the contents and
description of FIG. 1 are incorporated by reference herein.
[0049] FIGS. 5-6 illustrate a similar embodiment to FIG. 4. The
suture 350 includes a monofilament core 352 surrounded by a
multifilament sheath 362. The suture 350 also includes an enlarged
portion 374 that has a larger diameter than other portions such as,
for example, portion 360, of the suture 350. The enlarged portion
includes both the sheath 362 and the core 352. Further, the sheath
362 surrounds one or more additional filaments 376 (see FIG. 6) at
the enlarged portion 374. The additional filaments 376 may be, for
example, monofilaments or multifilament yarns. The additional
filaments 376 may include one or more of various materials, for
example, a polymer, such as P4HB. In one particular embodiment, the
all of the filaments 376 comprise P4HB. In certain embodiments, the
enlarged portion 374 is disposed between opposite ends 378 and 380
of the suture 350.
[0050] FIGS. 7 and 8 illustrate a suture/anchor apparatus 400
according to an embodiment of the present invention. The apparatus
400 includes one or more sutures that may be, for example, any of
the sutures described herein in combination with a suture anchor
442. In some embodiments and as shown in FIG. 7, the apparatus 400
may include two sutures 410A and 410B, although other numbers of
sutures may be used. The apparatus 400 also includes the suture
anchor 442 coupled to the sutures 410A and 410B. The anchor 442 may
be, for example, an Insite.RTM. FT Titanium anchor, disclosed in US
2012/0053626 assigned to Tornier, Inc (Bloomington, Minn.), the
contents of which are incorporated by reference herein. In some
embodiments, the anchor 442 is titanium. The anchor 442 includes a
self-drilling starter tip 444 and screw threads 446 for engaging
bone of a subject. In some embodiments, the anchor 442 includes an
inner chamber (not shown) and one or more eyelets 448 for coupling
to the sutures 410A and 410B. Suture anchors as described herein
are primarily for orthopedic procedures, although other procedures
are envisioned and within the scope of this application.
[0051] FIGS. 9 and 10 illustrate other anchors 542 and 642,
respectively, of suture/anchor apparatus for use with sutures of
the present invention. The anchors 542 and 642 are generally
similar to the anchor 442, although each of the anchors 442, 542,
and 642, has different dimensions (for example, diameters of 4.5
mm, 5.5 mm, and 6.5 mm, respectively) and/or numbers of features
(for example, a different number of eyelets for coupling to
sutures).
[0052] FIGS. 11 and 12 illustrate a suture/anchor apparatus 700
according to another embodiment of the present invention. The
apparatus 700 includes one or more sutures that may be, for
example, any of the sutures described herein. In some embodiments
and as shown in FIG. 11, the apparatus 700 may include two sutures
710A and 710B, although other numbers of sutures may alternatively
be used. The apparatus 700 also includes an anchor 742 coupled to
the sutures 710A and 710B. The anchor 742 may be, for example, an
Insite.RTM. FT PEEK-OPTIMA.RTM. anchor, disclosed in US
2012/0053626, assigned to Tornier, Inc (Bloomington, Minn.), the
contents of which are incorporated by reference herein. In some
embodiments, the anchor 742 includes PEEK-OPTIMA.RTM. material
available from Invibio Limited. In some embodiments, the anchor 742
includes a "bullet-shaped" tip 744 to facilitate ease of insertion
into a pre-formed bone hole. In some embodiments, the anchor 742
includes screw threads 746 for engaging bone of a subject. In some
embodiments, the anchor 742 includes an inner chamber (not shown)
and one or more eyelets 748 for coupling to the sutures 710A and
710B.
[0053] FIGS. 13 and 14 illustrate other anchors 842 and 942,
respectively, of suture/anchor apparatus for use with sutures the
present invention. The anchors 842 and 942 are generally similar to
the anchor 742, although each of the anchors 742, 842, and 942, has
different dimensions (for example, diameters of 4.5 mm, 5.5 mm, and
6.5 mm, respectively) and/or numbers of features (for example, a
different number of eyelets for coupling to sutures).
[0054] The sutures described herein may be used in conjunction with
various other types of anchors or "stops". For example, the sutures
described herein may be used in conjunction with the Endobutton.TM.
available from Smith & Nephew, Inc. (Andover, Mass.), the
EZLoc.TM. femoral fixation device available from Biomet, Inc.
(Warsaw, Ind.), the ToggleLoc.TM. femoral fixation device available
from Biomet, Inc. (Warsaw, Ind.), and the like.
[0055] FIG. 15 illustrates an insertion tool 1050 that detachably
supports a suture/anchor apparatus 1000. The suture/anchor
apparatus 1000 may be, for example, any of the suture/anchor
apparatus described herein. In particular, the insertion tool 1050
may be used to interface with and install a suture anchor in the
bone of a patient. More specifically, the distal end of the
insertion tool 1050 can be inserted into a proximal end of the
suture anchor in order to transmit thereto a rotary movement and
torque. A more detailed description of the insertion tool 1050 may
be found in US 20012/0053626 (FIG. 18 and description thereof),
assigned to Tornier, In (Bloomington, Minn.), the contents of which
are incorporated by reference herein.
[0056] FIG. 16 illustrates a kit 1152 that includes various tools
for implanting a suture/anchor apparatus into a subject. The kit
1152 may include, for example, one or more punches 1154 for forming
a hole in bone of a subject. The punches 1154 may each have
different diameters (for example, 4.5 mm, 5.5 mm, and 6.5 mm) for
forming holes of different sizes. The kit 1152 may also include,
for example, one or more suture/anchor apparatus insertion tools
1150, such as the insertion tool 1050 described above. The
insertion tools 1150 may each detachably carry anchors of different
types and/or different sizes.
[0057] FIG. 17 illustrates a flowchart of an exemplary method of
manufacturing a suture according to an embodiment of the present
invention. The suture may be, for example, the suture 110 or any of
the other exemplary sutures described herein. The method begins at
block 1800 by providing a monofilament core that includes P4HB and
a plurality of yarns that each include a plurality of threads, and
the threads each include P4HB. At block 1802, the yarns are
manipulated to form a sheath about the monofilament core. In some
embodiments, the yarns are intertwined (for example, braided) about
the monofilament core to form the sheath about the monofilament
core.
[0058] Various modifications and additions can be made to the
exemplary embodiments discussed without departing from the scope of
the present invention. For example, while the embodiments described
above refer to particular features, the scope of this invention
also includes embodiments having different combinations of features
and embodiments that do not include all of the described features.
Accordingly, the scope of the present invention is intended to
embrace all such alternatives, modifications, and variations as
fall within the scope of the claims, together with all equivalents
thereof.
[0059] It should be noted that in the below examples, and as
previously stated, the term "straight" testing as used herein means
the sutures have been tested in an unknotted or straight
configuration. The term "knot" or "knotted" testing as used herein
means that the sutures have been tested with the suture having
knots tied therein.
EXAMPLE 1
[0060] In one exemplary embodiment of the present invention, a
suture included a size 0 P4HB monofilament core. The core was
surrounded by a braided multifilament sheath that includes twelve
multifilament yarns. The yarns each included threads, and each
thread included P4HB. Each yarn was 120 denier and included 60
threads. The braided multifilament sheath had 69.7 picks per inch.
Overall, the suture was a size 2 suture and had a diameter of about
0.68 mm.
[0061] Test data indicated that such a suture had an ultimate
tensile strength (straight pull) of about 211.8 Newtons and an
elongation to break (straight pull) of about 48.1 percent.
[0062] Additional test data, based on testing nine lots of such
sutures (each lot including either 10 or 29 sutures for a total of
147 data points), indicated that such a suture had an ultimate
tensile strength (straight pull) of 181.0 .+-.9.1 Newtons
(individual data points ranged from 195.7 to 139.9 Newtons) and an
elongation to break (straight pull) of 45.3 .+-.2.7 percent
(individual data points ranged from 50.9 to 34.8 percent) and, in a
knotted configuration (e.g., the suture is tied with knots), an
ultimate tensile strength of 99.1 .+-.6.8 Newtons (individual data
points ranged from 113.8 to 79.0 Newtons) and an elongation to
break of 32.0 .+-.1.5 percent (individual data points ranged from
35.8 to 27.2 percent). See Tables 1 and 2 below.
TABLE-US-00001 TABLE 1 Test data for nine lots of "Example 1"
sutures. USP Straight Diam- Ultimate Straight Knot Knot eter
Tensile Elon- Tensile Elon- (mm) Su- Strength gation Strength
gation (Avg Lot ture (N) (%) (N) (%) of 6) Notes 1 1 170.5 42.15
110.13 34.46 0.674 2 178.04 45.22 110.25 33.21 0.69 3 175.22 44.68
103.53 32.67 0.687 4 173.64 44.1 105.87 32.5 0.696 5 180.44 46.19
104.19 32.83 0.674 6 172.73 44.13 103.73 32.91 0.693 7 177.56 46.17
106.73 33.46 0.684 8 175.24 45.49 107.73 33.12 0.683 9 176.63 44.87
106.33 33.03 0.672 10 171.88 43.18 106.84 33.54 0.673 11 178.21
47.44 109.42 32.94 0.672 12 185 50.03 103.73 33.38 0.692 13 174.38
44.54 113.84 33.84 0.682 14 178.24 45.76 107.6 33.53 0.679 15
176.47 44.53 105.48 33.36 0.675 16 174.52 44.43 107.54 33.38 0.682
17 165.75 40.65 107.76 33.47 0.679 18 156.34 38.18 102.78 31.74
0.681 19 179.67 46.26 108.28 32.99 0.673 20 181.96 47.01 104.59
33.39 0.679 21 181.45 45.43 107.52 32.27 0.675 22 177.65 44.7
104.63 33.01 0.676 23 177.9 45.56 103.68 32.65 0.679 24 179.43
47.17 109.55 33.67 0.686 Broken Filament 25 177.9 44.79 101.93 31.7
0.682 Broken Filament 26 179.75 46.21 110.67 33.24 0.679 Broken
Filament 27 173.32 43.52 102.9 32.88 0.673 Broken Filament 28
176.29 44.89 104.85 32.89 0.678 Broken Filament 29 173.75 43.26
104.53 32.88 0.676 Broken Filament 2 1 180.27 45.26 87.35 30.46
0.68 2 176.53 44.57 110.63 33.93 0.682 3 181.97 46.44 109.39 33.19
0.68 4 179.06 45.76 105.93 33.38 0.677 5 182.08 45.86 102.25 32.3
0.676 6 180.34 46.74 99.47 31.06 0.679 7 177.96 45.09 106.31 33.22
0.686 8 179.64 45.94 102.21 32.72 0.68 9 179.71 45.08 104.88 32.22
0.677 10 182.49 46.73 100.53 32.38 0.669 Broken Filament 3 1 180.43
45.99 105.25 32.11 0.685 2 175.07 44.06 106.68 33.16 0.675 3 177.97
45.11 103.93 35.25 0.68 4 181.04 45.29 107.38 33.05 0.683 5 181.33
46.32 110.58 34.38 0.686 6 178.37 44.78 104.92 33.62 0.681 7 179.72
44.45 102.1 33.17 0.683 8 174.48 43.3 103.53 31.99 0.679 9 179.02
45.68 104.29 32.64 0.674 Broken Filament 10 175.95 44.35 110.65
33.49 0.68 Broken Filament 4 1 181.98 47.48 88.8 31.02 0.674 2
182.98 47.38 96.44 31.87 0.683 3 183.8 50.35 97.66 33.62 0.676 4
187.49 48.7 89.17 31.39 0.679 5 195.67 50 99.09 33.1 0.681 6 139.92
35.98 95.18 32.62 0.673 7 192.22 50.6 96.85 33.45 0.682 8 186.33
48.44 97.69 33.62 0.681 9 191.03 49.65 104.09 34.68 0.683 10 188.76
48.51 99.53 33.04 0.669 11 190.04 49.35 95.53 30.69 0.682 12 193.88
49.42 100.28 33.2 0.683 13 189.33 49.02 98.67 33.01 0.686 14 186.37
47.82 100.03 32.73 0.678 15 181.87 47.05 97.37 32.9 0.68 16 145.01
38.28 92.18 32.56 0.685 17 185.65 48.16 95.71 32.43 0.67 18 181.89
47.94 92.63 31.36 0.683 19 178.26 44.52 95.33 32.44 0.674 Broken
Filament 20 160.06 42.82 95.77 35.01 0.664 Broken Filament 21
189.26 48.57 94.79 32.65 0.673 Broken Filament 22 191.64 50.9 96.23
33.07 0.683 Broken Filament 23 188.5 48.94 91.9 33.64 0.68 Broken
Filament 24 191.89 49.7 98.54 34.12 0.677 Broken Filament 25 187.98
48.68 106.23 35.82 0.684 Broken Filament 26 182.76 47.7 96.57 33.9
0.672 Broken Filament 27 187.35 46.97 94.03 33.01 0.673 Broken
Filament 28 190.16 40.2 90.54 32.15 0.681 Core pop 29 183.3 48.79
94.42 32.23 0.678 Core pop 5 1 187.85 46.76 99.84 33.08 0.674 2
158.61 39.55 90.26 30.64 0.67 3 181.44 46.48 88.92 30.18 0.672 4
191.92 49.16 92.19 30.36 0.675 5 195.16 49.88 98.62 31.22 0.67 6
189.14 46.9 93.22 30.95 0.66 Broken Filament 7 193.52 48.42 96.67
31.37 0.654 Broken Filament 8 190.62 46.95 97.08 30.98 0.654 Broken
Filament 9 191.12 48.64 92.9 30.49 0.65 Broken Filament 10 187.68
46.27 94.79 30.09 0.652 Broken Filament 6 1 194.42 46.98 98.73
32.18 0.651 2 189.06 45.42 87.03 29.98 0.657 3 191.04 44.84 80.21
27.19 0.653 4 179.99 42.52 92.91 30.57 0.657 5 179.32 42.97 99.16
31.24 0.659 6 143.32 37.26 93.35 31.1 0.657 7 190.45 46.85 95.41
31.81 0.649 8 190.04 44.85 96.12 31.72 0.665 Broken Filament 9
182.64 45.6 99.65 33.05 0.654 Broken Filament 10 187.85 46.89
101.83 31.52 0.65 Broken Filament 7 1 185.87 47.11 93.27 30.4 0.654
2 182.98 44.35 95.01 31.02 0.653 3 183.32 44.1 101.62 31.39 0.65 4
142.23 34.82 97.96 30.67 0.665 5 179.15 42.46 111.03 33.36 0.65 6
188.83 46.48 90.43 29.96 0.647 7 176.26 44.35 88.35 30.27 0.652 8
184.92 44.25 94.37 32.48 0.651 9 185.33 45.15 104 32.31 0.651 10
180.44 44.65 106.11 32.9 0.648 11 177.85 43.18 97.52 31.87 0.644 12
182.67 43.73 98.89 31.8 0.65 13 182.27 43 95.21 30.47 0.65 14
188.12 46.66 95.61 30.24 0.642 15 183.77 45.17 102.84 32.75 0.645
16 181.84 42.71 97.08 32.05 0.642 17 178.44 41.68 97.15 31.33 0.655
18 188.53 44.25 96.23 30.55 0.645 19 187.1 47.22 94.76 31.14 0.648
20 182.7 45.38 96.74 31.49 0.651 21 182.12 42.4 86.37 28.87 0.658
22 181.43 42.8 98.38 31.42 0.658 23 181.73 43.6 98.36 31.7 0.644 24
183.28 44.04 104.13 31.98 0.651 25 179.23 45.43 102.95 32.45 0.659
26 181.01 43.06 100.76 32.36 0.655 27 180.21 44.19 93.92 31.24
0.668 Broken Filament 28 179.85 43.51 100.98 31.89 0.661 Broken
Filament 29 184.67 47 90.89 30.48 0.651 Broken Filament 8 1 184.76
43.93 93.76 31.26 0.644 2 184.61 45.05 99.49 30.67 0.658 3 183.06
46.11 88.13 29.05 0.65 4 182.57 45.16 90.65 29.55 0.641 5 183.22
45.43 99.1 30.83 0.642 6 184.25 45.2 87.58 28.28 0.643 7 185.75
46.22 78.99 27.44 0.647 8 180.58 43.72 82.54 28.33 0.646 Broken
Filament 9 181.89 44.23 91.62 30.15 0.648 Broken Filament 10 184.56
45.82 100.91 31.41 0.643 Broken Filament 9 1 176.92 41.26 96.92
30.94 0.648 2 182.4 43.16 96.31 29.8 0.648 3 185.15 45.33 104.2
31.21 0.643 4 187.4 44.33 94.66 31.24 0.651 5 182.36 42.29 94.01
30.05 0.647 6 187 44.97 81.66 27.64 0.637 7 184.63 44.5 94.5 30.32
0.653 8 178.93 42.76 100.92 30.42 0.645 9 172.1 40.38 101.8 30.61
0.647 Broken Filament 10 178.97 43.83 100.15 30.9 0.645 Broken
Filament
TABLE-US-00002 TABLE 2 Test data statistics for nine lots of
"Example 1" sutures. Ultimate Straight Knot Tensile Straight
Tensile Knot Strength Elongation Strength Elongation Lot (N) (%)
(N) (%) 1 Average 175.86 44.85 106.43 33.07 Standard Deviation 5.36
2.16 2.84 0.57 2 Average 180.01 45.75 102.90 32.49 Standard
Deviation 1.99 0.74 6.55 1.07 3 Average 178.34 44.93 105.93 33.29
Standard Deviation 2.46 0.93 2.89 0.99 4 Average 183.29 47.31 96.25
32.94 Standard Deviation 13.05 3.62 3.91 1.14 5 Average 186.71
46.90 94.45 30.94 Standard Deviation 10.57 2.87 3.58 0.87 6 Average
182.81 44.42 94.44 31.04 Standard Deviation 14.75 2.95 6.56 1.59 7
Average 181.25 44.03 97.62 31.41 Standard Deviation 8.15 2.32 5.38
1.01 8 Average 183.53 45.09 91.28 29.70 Standard Deviation 1.56
0.88 7.30 1.38 9 Average 181.59 43.28 96.51 30.31 Standard
Deviation 4.85 1.62 6.27 1.05 Maximum 195.7 50.9 113.8 35.8 Maximum
139.9 34.8 78.99 27.2 Average of all data points 181.0 45.3 99.1
32.0 Std. Dev. Of all data 9.1 2.7 6.8 1.5 points
[0063] The above data were obtained using the following procedures.
Diameter measurements were performed using a diameter fixture and a
thickness gage. A 2.2 kg mass was used to tension each suture. Six
measurements were taken on each suture, and the data in Table 1 for
each suture is the average of the six measurements.
[0064] Tensile tests were performed using an ADMET Tester, a load
cell, and grips. The gage length was set at 219 mm using a gap
gage. The grips were displaced at a rate of 30 mm per minute to a
load of 1.3345 Newtons (logging every 0.0033 minutes), then at a
rate of 0.1 mm per minute for a duration of 0.1 minutes (logging
every 0.0033 minutes), and then at a rate of 300 mm per minute to a
load of 44482.2148 Newtons or until failure (recording every 0.0004
minutes). Failure was determined by a drop in the load to 50
percent of the peak load.
[0065] Additionally, sutures displayed reduced memory (compared to
other sutures) when removed from packaging and improved handling
and knot security (again, compared to other sutures).
EXAMPLE 2
[0066] In another embodiment of the present invention, the suture
included a size 5-0 P4HB monofilament core. The core is surrounded
by a multifilament sheath that included eight multifilament yarns.
Each yarn included P4HB threads. Each yarn is 120 denier and
included 60 threads. Overall, the suture is a size 2-0 suture and
had a diameter of about 0.423 mm.
[0067] Test data indicated that such a suture had an ultimate
tensile strength (straight pull) of about 61.5 Newtons and an
elongation to break (straight pull) of about 28.37 percent and, in
a knotted configuration, had an ultimate tensile strength of about
44.0 Newtons and an elongation to break of about 71.5 percent.
EXAMPLE 3
[0068] In an alternate embodiment of the present invention, a
suture included a size 0 P4HB monofilament core. The core is
surrounded by a braided multifilament sheath that included twelve
multifilament yarns. The yarns each included threads, and each
thread included P4HB. The multifilament sheath had 64.7 picks per
inch. Overall, the suture was a size 2 suture and had a diameter of
about 0.67 mm.
[0069] Test data indicated that such a suture had an ultimate
tensile strength (straight pull) of about 207.4 Newtons and an
elongation to break (straight pull) of about 46.6 percent.
EXAMPLE 4
[0070] In another embodiment of the present invention, a suture
included a size 0 monofilament core. The core included P4HB. The
core is surrounded by a braided multifilament sheath that included
twelve multifilament yarns. The yarns each included threads, and
each thread included P4HB. The multifilament sheath had 56 picks
per inch. Overall, the suture was a size 2 suture and had a
diameter of about 0.67 mm.
[0071] Test data indicate that such a suture had an ultimate
tensile strength (straight pull) of about 173.7 Newtons and an
elongation to break (straight pull) of about 38.9 percent.
EXAMPLE 5
[0072] In yet another embodiment of the present invention, a suture
included a size 0 P4HB monofilament core. The core is surrounded by
a braided multifilament sheath that included twelve multifilament
yarns. The yarns each included threads, and each thread included
P4HB. The multifilament sheath had 70.5 picks per inch. Overall,
the suture was a size 2 suture and had a diameter of about 0.68
mm.
[0073] Test data indicate that such a suture had an ultimate
tensile strength (straight pull) of about 210.0 Newtons and an
elongation to break (straight pull) of about 49.0 percent.
EXAMPLE 6
[0074] In another embodiment of the present invention, a suture
included a size 1 P4HB monofilament core. The core is surrounded by
a braided multifilament sheath that included eight multifilament
yarns. The yarns each included threads, and each thread included
P4HB. The multifilament sheath had 54.3 picks per inch. Overall,
the suture was a size 2 suture and had a diameter of about 0.67
mm.
[0075] Test data indicated that such a suture had an ultimate
tensile strength (straight pull) of about 254.0 Newtons and an
elongation to break (straight pull) of about 33.7 percent.
EXAMPLE 7
[0076] In an alternate embodiment of the present invention, a
suture included a size 4-0 P4HB monofilament core. The core is
surrounded by a braided multifilament sheath that included eight
multifilament yarns. The yarns each included threads, and each
thread included P4HB. The multifilament sheath had 64.5 picks per
inch. Overall, the suture was a size 2-0 suture and had a diameter
of about 0.46 mm.
[0077] Test data indicate that such a suture, in a straight
configuration, had an ultimate tensile strength of about 71.4
Newtons and an elongation to break of about 44.0 percent.
EXAMPLE 8
[0078] In another embodiment of the present invention, a suture
included a size 0 P4HB monofilament core. The core is surrounded by
a braided multifilament sheath that included sixteen multifilament
yarns. The yarns each included threads, and each thread included
P4HB. Overall, the suture is a size 3 suture and had a diameter of
about 0.705 mm.
[0079] Test data indicated that such a suture in a straight
configuration had an ultimate tensile strength of about 231.0
Newtons and an elongation to break of about 59.50 percent and, in a
knotted configuration, had an ultimate tensile strength of about
91.1 Newtons and an elongation to break of about 39.4 percent.
EXAMPLE 9
[0080] In another embodiment of the present invention, a suture
included a size 0 P4HB monofilament core. The core is surrounded by
a braided multifilament sheath that included twelve multifilament
yarns. The yarns each included threads, and each thread included
P4HB. Overall, the suture was a size 3-4 suture and had a diameter
of about 0.815 mm.
[0081] Test data indicate that such a suture, in a straight
configuration, had an ultimate tensile strength of about 259.7
Newtons and an elongation to break of about 58.38 percent and, in a
knotted configuration, had an ultimate tensile strength of about
120.5 Newtons and an elongation to break of about 46.4 percent.
EXAMPLE 10
[0082] In one exemplary embodiment of the present invention, a
suture included a size 0 monofilament core. The core included P4HB.
The core is surrounded by a braided multifilament sheath that
included sixteen multifilament yarns. The yarns each included
threads, and each thread included P4HB. Overall, the suture was a
size 2 suture and had a diameter of about 0.68 mm.
[0083] Test data indicate that such a suture, in a knotted
configuration, had an ultimate tensile strength of about 87.8
Newtons.
[0084] For comparison, other sutures were also tested to determine
their ultimate tensile strength, elongation to break, knot ultimate
tensile strength, knot elongation to break, and diameter. These
sutures include FiberWire.RTM. available from Arthrex Inc. of
Naples, Fla., USA, Orthocord.RTM. available from DePuy Mitek, Inc.
of Raynham, Mass., USA, and Ethibond Excel.TM. available from
Ethicon, Inc. of Somerville, N.J., USA. All of the sutures were
size 2 sutures, and all of the sutures were tested using the same
procedure described above in Example 1 (except for the lot sizes
used; see Table 3 below).
[0085] The test data indicate that Arthrex FiberWire.RTM. sutures
have an ultimate tensile strength(straight pull) of about 279
Newtons (an average of 278.85 Newtons with a standard deviation of
15.81 Newtons), an elongation to break(straight pull) of about 10
percent (an average of 9.64 percent with a standard deviation of
0.85 percent), a knot ultimate tensile strength of about 133
Newtons (an average of 133.21 Newtons with a standard deviation of
7.08 Newtons), and a knot elongation to break of about 6 percent
(an average of 5.84 percent with a standard deviation of 0.67
percent).
[0086] The test data indicate that the Depuy Mitek Orthocord.RTM.
have an ultimate tensile strength(straight pull) of about 219
Newtons (an average of 218.74 Newtons with a standard deviation of
21.56 Newtons), an elongation to break(straight pull) of about 15
percent (an average of 15.06 percent with a standard deviation of
0.85 percent), a knot ultimate tensile strength of about 147
Newtons (an average of 146.82 Newtons with a standard deviation of
8.13 Newtons), and a knot elongation to break of about 14 percent
(an average of 14.07 percent with a standard deviation of 1.76
percent).
[0087] The test data indicate that Ethicon Ethibond Excel.TM.
sutures have an ultimate tensile strength(straight pull) of about
141 Newtons (an average of 141.45 Newtons with a standard deviation
of 3.67 Newtons), an elongation to break(straight pull) of about 20
percent (an average of 20.19 percent with a standard deviation of
0.80 percent), a knot ultimate tensile strength of about 68 Newtons
(an average of 67.98 Newtons with a standard deviation of 2.36
Newtons), and a knot elongation to break of about 14 percent (an
average of 13.82 percent with a standard deviation of 0.38
percent).
TABLE-US-00003 TABLE 3 Test data for other sutures. Straight USP
Ultimate Straight Knot Knot Diameter Tensile Elon- Tensile Elon-
Su- (mm) Strength gation Strength gation ture (Avg of 6) (N) (%)
(N) (%) Arthrex 1 0.603 208.39* 5.49* 120.15 6.49 FiberWire .RTM. 2
0.556 287.76 9.43 130.69 7.09 3 0.537 222.50* 5.73* 128.91 5.74 4
0.536 257.11 9.22 133.31 5.49 5 0.553 273.39 10.87 134.51 4.77 6
0.541 257.64 8 150.57 5.19 7 294.61 11.06 133.62 5.85 8 294.74 9.62
135.27 6.1 9 299.85 10.23 130.82 4.82 10 283.04 9.34 125.71 5.8 11
256.80 9.14 138.21 6.58 12 283.57 9.44 136.69 6.11 Avg. 0.554
278.85 9.64 133.21 5.84 Std. 0.023 15.81 0.85 7.08 0.67 Dev. DePuy
1 0.552 219.52 14.5 142.79 14.82 Orthocord .RTM. 2 0.56 217.47
14.99 136.78 14.41 3 0.572 238.60 15.49 144.70 15.65 4 0.571 214.58
14.15 145.68 15.22 5 0.563 243.23 14.94 147.06 16.95 6 0.564 224.06
14.44 141.81 16.29 7 251.99 16 145.59 12.95 8 208.22 16.54 153.29
12.71 9 161.69 13.46 168.01 14.25 10 216.72 16.18 154.71 12.96 11
210.80 14.76 143.50 11.15 12 217.96 15.22 137.94 11.51 Avg. 0.564
218.74 15.06 146.82 14.07 Std. 0.007 21.56 0.85 8.13 1.76 Dev.
Ethicon 1 0.551 140.30 19.51 66.06 13.54 Ethibond 2 0.54 142.97
20.51 70.59 14.35 Excel .TM. 3 0.549 145.55 21.07 70.59 14.1 4
0.535 144.79 20.76 66.37 13.73 5 0.544 135.45 19 68.06 13.89 6
0.537 143.77 20.88 70.46 13.95 7 137.09 19.21 67.21 13.62 8 140.21
19.92 68.41 14.08 9 134.83 18.91 71.39 14.29 10 145.46 20.92 66.95
13.73 11 143.86 21.11 62.90 12.87 12 143.14 20.47 66.81 13.71 Avg.
0.543 141.45 20.19 67.98 13.82 Std. 0.006 3.67 0.80 2.36 0.38
Dev.
[0088] The two denoted sutures (*) did not completely break when
failure was detected. Beginning with FiberWire.RTM. suture 4, the
break detection parameter was modified from a drop in load to 50
percent of the peak load to a drop in load to 25 percent of the
peak load, which permitted the suture to break before a failure is
detected. This parameter remained for FiberWire.RTM. samples 4
through 12, as FiberWire.RTM. was the last product tested. The
results from these sutures were not included in the average or
standard deviation calculations.
* * * * *