U.S. patent application number 12/577057 was filed with the patent office on 2010-04-29 for surgical implantable stabilizer sling for basal joint arthroplasty.
Invention is credited to Jeanne L. DelSignore.
Application Number | 20100106254 12/577057 |
Document ID | / |
Family ID | 42118233 |
Filed Date | 2010-04-29 |
United States Patent
Application |
20100106254 |
Kind Code |
A1 |
DelSignore; Jeanne L. |
April 29, 2010 |
SURGICAL IMPLANTABLE STABILIZER SLING FOR BASAL JOINT
ARTHROPLASTY
Abstract
The concepts disclosed herein offer a new simple and reliable
reconstructive option for the treatment of first carpal-metacarpal
joint (basal joint) arthritis and consists of an intra-articular
basal joint stabilizer sling combined with a surgical method of
implantation.
Inventors: |
DelSignore; Jeanne L.;
(Rochester, NY) |
Correspondence
Address: |
Jeanne L. DelSignore, M.D.
127 Heatherstone Lane
Rochester
NY
14618
US
|
Family ID: |
42118233 |
Appl. No.: |
12/577057 |
Filed: |
October 9, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61197060 |
Oct 23, 2008 |
|
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Current U.S.
Class: |
623/21.15 |
Current CPC
Class: |
A61F 2/0811 20130101;
A61B 17/826 20130101; A61F 2002/4253 20130101; A61B 17/06066
20130101; A61F 2/4241 20130101; A61B 17/0401 20130101; A61B
2017/0464 20130101; A61B 17/06166 20130101; A61B 2017/0427
20130101; A61F 2/08 20130101; A61B 17/82 20130101 |
Class at
Publication: |
623/21.15 |
International
Class: |
A61F 2/42 20060101
A61F002/42 |
Claims
1. An implantable sling for use in basal joint arthroplasty having
a central section and at least one suture woven into said center
section, the improvement comprising: at least one suture anchor
embedded in at least one edge of said center section.
2. The sling according to claim 1, wherein said suture is attached
to at least one suture anchor.
3. The sling according to claim 1, wherein said suture is attached
to at least one surgical needle.
4. The sling according to claim 1, wherein said suture is a long
lasting absorbable suture.
5. The sling according to claim 1, wherein the center section has a
quadrilateral, elliptical, or regular polygonal shape.
6. The sling according to claim 1, wherein the center section is
made from a terminally sterile material.
7. The sling according to claim 1, wherein the center section is
made from a biologic material.
8. The sling according to claim 1, wherein the center section is
made from a porous material.
9. The sling according to claim 1, wherein the center section is
made from a non-porous material.
10. The sling according to claim 1, wherein the center section is
made from combination of materials Including a long lasting
absorbable weave.
11. An implantable sling for use in basal joint arthroplasty having
a central section and at least one suture woven into said center
section, the improvement comprising: at least one surgical needle
attached to at least one said suture.
12. The sling according to claim 11, wherein said suture is a long
lasting absorbable suture.
13. The sling according to claim 11, wherein the center section has
a quadrilateral, elliptical, or regular polygonal shape.
14. The sling according to claim 11, wherein the center section is
made from a terminally sterile material.
15. The sling according to claim 11, wherein the center section is
made from a biologic material.
16. The sling according to claim 11, wherein the center section is
made from a porous material.
17. The sling according to claim 11, wherein the center section is
made from a non-porous material.
18. The sling according to claim 11, wherein the center section is
made from combination of materials Including a long lasting
absorbable weave.
Description
[0001] This application claims priority from U.S. Provisional
Application 61/197,060, filed on Oct. 23, 2008, which is
incorporated by reference in its entirety.
FIELD OF THE INVENTION
[0002] This application relates to an implantable stabilizer sling
for the surgical repair and reconstruction of joints, preferably of
the hands, in particular the basal joint.
BACKGROUND OF THE INVENTION
[0003] Degenerative osteoarthritis of the first carpal-metacarpal
joint (basal joint) of the thumb is a common, disabling condition,
especially in middle-aged women. Investigations show that about 25%
of all women and 8% of men in their fifties complain of pain at the
base of the thumb, secondary to osteoarthritis. This condition
causes joint instability and subluxation, due to incompetence of an
important stabilizing structure, the volar oblique ligament,
resulting in dorsal subluxation, adduction contracture, and
subsequent compensatory metacarpal-phalangeal joint hyperextension
deformity. As arthritis progresses, patients suffer from
load-related pain, affecting pinching and gripping activities, and
experience weakness, severe dysfunction, reduced mobility, and loss
of functionality. Several methods of basal joint reconstruction
have been proposed, most of which involve some form of soft tissue
reconstruction which have historically involved harvesting tendons
which are subsequently transferred and re-directed via drill holes
in the thumb metacarpal to restore proper balance, alignment, and
prevent cantilever displacement forces at the base of the thumb.
These methods involve harvesting and thereby sacrificing an entire
or a portion of a functioning tendon, which is utilized to create a
suspension and stabilization of the basal joint. Many of the past
described surgical methods require temporary pin fixation of the
joint, subsequent pin removal and have been associated with pin
tract complications, such as infection, nerve damage, neuroma
formation, and these methods which utilize more extensive and often
multiple incisions cause increased surgical morbidity. One method
simply involves removing the arthritic articulation by excising the
trapezium and temporarily pinning the joint in distraction. This
procedure can provide pain relief, but is associated with
persistent collapse deformity, proximal migration, and weakness.
The key principles of successful basal joint arthroplasty involve
trapezial excision, which is required for pain relief, and some
form of ligament reconstruction, which restores the function of the
important volar stabilizing ligament, thereby re-creating the
proper balance, alignment, longitudinal length, and function of the
thumb. With ligament reconstruction, not only is pain relief
attained but strength, alignment and stability are achieved.
[0004] Several methods of artificial joint replacement have been
utilized including those made of silicone, metal/plastic with
cemented or non-cemented implants, and more recently, synthetic
fabrics for interposition. Each of these methods have had
significant failure rates and complications related to implant
failure, fracture of the bone interfaces, particulate synovitis,
dislocation and loss of stability over time. Revision rates have
been high with the prosthetic implants, most of which have not
addressed the concept of ligamentous reconstruction and re-creation
of the important function of the volar oblique ligament, which
appears to be essential for restoring proper balance and function
to the reconstructed basal joint. Additional problems with the
recently developed synthetic fabric inserted into the basal joint
include irritation over the synthetic fabric, which is secured to
the dorsal base of the thumb metacarpal, potential fixation
problems, as well as the fact that the synthetic fabric design only
addresses the distal articular surface of the basal joint, leaving
the proximal joint (scaphoid-trapezial joint) interface intact.
This particular form of synthetic implant is limited in use for
patients with very early arthritis, involving only the distal
carpal-metacarpal joint and is not appropriate for the larger
cohort of arthritic patients who suffer from arthritis in a more
extensive, pan-trapezial (surrounding the trapezium on all
articular surfaces) fashion.
[0005] The various techniques employed in basal joint arthroplasty
have recently been the subject of discussion in several medical
journals. "Basal Joint Arthritis of the Thumb" has been reviewed by
Michael S. Shuler, Shai Luria, and Thomas E. Trumble in the Journal
of the American Academy of Orthopaedic Surgeons 2008; 16: 418-423,
which is hereby incorporated by reference. "CMC Arthroplasty of the
Thumb: A Review" has been reviewed by Kristofer S. Matullo, Asif
Hyas, and Joseph J. Thoder in Hand (2007) 2: 232-239, which is
hereby incorporated by reference. "Basal Joint Arthroplasty:
Indications and Treatment" has been reviewed by Steven Z. Glickel
and Landon T. Home in Current Opinion in Orthopaedics 2001, 12:
290-294, which is hereby incorporated by reference.
[0006] One of the methods frequently utilized, the Ligament
Reconstruction, Tendon Interposition technique, (LRTI) involves
sacrificing the flexor carpi radialis tendon, either in whole or in
part. This technique requires one or two additional forearm
incisions to harvest a wrist flexor tendon, formation of a drill
hole within the metacarpal base to re-direct the tendon
reconstruction, rolling up the remaining tendon which is placed
into the arthroplasty space, pinning the joint for 4-6 weeks, and
immobilization in a post-operative cast for 4-6 weeks, after which
thumb/wrist orthotics are utilized and hand therapy is instituted
for 2-3 months. Typical return to normal activities can be expected
in about 6 months to a year. Long term results have been excellent
with regard to pain relief, but the healing process is lengthy,
incisions are extensive and multiple, subsidence with loss of
arthroplasty space has been reported, pin tract complications do
occur, aid the technique is technically demanding, lengthy and
requires sacrificing a normal, functioning wrist flexor tendon.
[0007] One method for treatment of basal joint arthritis is a
simple excision of the trapezium and pinning the joint in slight
distraction with the pin removed at 4-6 weeks post-operative. This
technique does not address ligament reconstruction to restore
function of the incompetent volar oblique ligament, and includes
the disadvantages and risks of pin fixation. Collapse of resection
arthroplasty space (subsidence), persistent dorsal subluxation,
persistent adduction contracture, and compensatory
metacarpal-phalangeal joint hyperextension deformity is common, but
pain relief is reported to be satisfactory. This technique may not
be appropriate for younger, higher demand patients.
[0008] Another method for soft tissue reconstruction that has been
disclosed in the American Society for Surgery of the Hand
Correspondence Newsletter, 2004-52, DelSignore, August, 2004, which
is hereby incorporated by reference, involves a modification of the
Weilby technique, by utilizing an ulnarly based slip of the
abductor pollicis longus tendon, and avoids the need for drill
holes to redirect the tendon, avoids the need for pin fixation, and
requires only 4 weeks of cast immobilization, with typical return
to heavy manual activities for the majority of patients at 3 months
(12 weeks) post operative. This technique utilizes only one
distally based slip of the abductor pollicis longus tendon which
does not sacrifice it's function, but does require an incision that
extends proximal to the wrist flexion crease and can be associated
with some residual wrist stiffness, as wrist immobilization is
recommended for four weeks post-operatively which can result in a
longer period of recovery of wrist and hand motion. Patients may
experience some temporary and rarely permanent irritation of the
dorsal sensory branch of the radial nerve, as the incision does
cross the wrist flexion crease in a proximal and radial direction,
requiring very careful identification and retraction of branches of
the nerve.
[0009] A surgical method developed by the author of this patent
application is disclosed in Suture Suspension Arthroplasty
Technique for Basal Joint Arthritis Reconstruction, DelSignore and
Accardi, to be published in Techniques in Hand and Upper Extremity,
December, 2009, which is hereby incorporated by reference. This
novel technique avoids tendon harvesting altogether and provides
the distinct advantage of utilizing a single small incision
(Wagner), which does not cross the wrist flexion crease. It
involves a suture suspension (stabilizer) arthroplasty technique,
whereby a deep, intra-articular 0 braided polyblended
non-absorbable suture is utilized to form a suture suspension sling
by anchoring the suture to fixed points of attachments to the
flexor carpi radialis insertion and deep ulnar capsule at the base
of the index metacarpal, crossing the arthroplasty space and
anchoring the radial attachment to the fixed point of insertion of
the abductor pollicis longus and dorsal capsule at the dorsal base
of the thumb metacarpal. This suture stabilization construct is
twice woven back and forth within the arthroplasty space, tightened
and firmly sutured over the insertion point of the abductor
pollicis longus and dorsal capsule, as longitudinal distraction
force and downward (ulnarly-directed) pressure is applied to the
metacarpal base. Wrist immobilization is required for only 12-14
days postoperatively, followed by short opponens splinting and
active motion, followed by subsequent range of motion and
strengthening protocol, with resumption of full use by 3 months
postoperatively for the majority of patients. This construct has
been shown to effectively stabilize the metacarpal base by
tethering it to the index metacarpal via firm anchorage of a heavy
non-absorbable suture sling that supports the reconstruction and
has been shown to have excellent short-term and long-term, up to
3.5 years, results in the majority of patients, achieving the goals
of excellent pain relief, and accurately rebalances the thumb
metacarpal with minimal proximal migration (subsidence), excellent
restoration of the first webspace angle, and excellent functional
recovery with regard to strength and return to activities of daily
living. This technique eliminates the specific complications and
increased morbidity of the tendon harvesting and transfer
procedures and those procedures that require temporary pin fixation
or drill holes for tendon passage. This technique does require
excessive surgical skill, as it is technically demanding as it
requires the skill of back-handed suture passing within a small
arthroplasty space. It also requires excision of the entire
trapezium to create the suture sling construct and relies on good
quality soft tissue for anchorage of the sling.
[0010] U.S. Pat. No. 3,496,940 discloses a combined suture and
sling for closing an open wound or surgical incision, wherein an
elongated strip of flexible hypo-reactive material is formed with a
series of integral flexible filaments extending from each
longitudinal side edge thereof. The filaments are sewn through the
flesh on opposite sides of the wound opening and opposed pairs of
filaments are drawn together across the opening and secured to each
other to close the wound tightly, with the elongated strip
underlying the wound opening and acting as a supporting sling on
the under surface of the wound.
[0011] U.S. Pat. No. 3,545,008 discloses a tendon prosthesis for
use in tendon surgery particularly where there is complete or
extensive loss of the tendon, structurally including an elongated
member made from a flexible, chemically inert material having at
least one flap at each end adapted to overlap the tendon and means
for firmly anchoring the prosthesis to the tendon providing a
strong, functional anastamotic union.
[0012] U.S. Pat. No. 3,805,300 discloses a tendon prosthesis for
repair or replacement of a damaged or diseased natural tendon which
comprises an elongated member made of biocompatible material having
a central portion and two end sections at least one of which has a
plurality of longitudinally arranged fenestrations for interweaving
with a resected tendon to provide a strong, functional anastomosis.
In one embodiment, the second end section of the prosthesis is
formed of a pair of flexible cord-like members adapted to anchor
the prosthesis to bone structure. In a second embodiment, both end
sections include fenestrations allowing each end section to be
secured to interwoven segments of a resected tendon.
[0013] U.S. Pat. No. 4,187,558 discloses a surgically implantable
skeletal ligament having secured thereto at least one deformable
collar having a velour-like outer surface adapted to invite tissue
ingrowth. In use, the collar portion of the ligament is positioned
within a surgically prepared passageway in a bone to protect the
ligament from bone abrasion and to assist in ligament attachment by
accepting tissue ingrowth into the velour-like surface.
[0014] U.S. Pat. No. 4,713,075 discloses a prosthetic device for
repairing or replacing connective tissue such as ligaments and
tendons in the human or animal body is described. The device
comprises a cord of artificial connective tissue formed from a
composite, partly absorbable thread. The thread comprises a
combination of permanent material and absorbable material
susceptible to being dissolved into surrounding living tissue. The
dissolving of the absorbable material leaves space for the living
tissue to grow into and adhere to the structure formed by the
permanent material.
[0015] U.S. Pat. No. 4,775,380 discloses a prosthetic ligament for
implantation between at least two bones and which takes the form of
a tubular body made of woven flexible material through which tissue
ingrowth can take place after implantation. A cord is attached to
one end of the ligament to thread and to pull the ligament through
channels formed in the bones, and a protective detachable sheath is
attached to the ligament in order to facilitate the implantation of
the ligament as it is pulled through the channels, the sheath
immediately thereafter being detached. A bone plug introducer is
used to insert a bone plug into one end of the ligament within the
bone tunnel, which thereby secures the ligament end in
position.
[0016] U.S. Pat. No. 6,010,447 discloses a sling device for implant
in a human body as a bladder support includes a rectangular,
flexible strip of cloth with stiffening members extending across
each of the two shorter sides. The stiffening members at each end
include a pair of spaced, parallel beams, integrally connected at
their ends. Marginal end portions of the flexible strip are passed
through the space between the beam around one of the beams, and
folded back upon and affixed to the opposing surface of the
flexible strip. A flexible suture is attached to a loop at the
midpoint of the other beam.
[0017] U.S. Pat. No. 6,042,534 relates to prefabricated urethral
suspension slings, methods of making the slings, methods of
attaching suture to the slings, kits comprising the slings, and
methods of using the slings to treat urinary incontinence. The
slings comprise a biocompatible material having an elongate shape
adapted for urethral suspension. The material has a central portion
extending longitudinally between a first end portion and a second
end portion. Each end portion of the sling contains at least one
suture receiving site. The suture receiving sites are formed prior
to surgery and may be reinforced through a variety of means.
Sutures may be attached to the suture receiving sites during the
manufacturing process or by the physician prior to or during
surgery. Additionally, the end portions of the sling containing the
suture receiving sites may be thicker than the central portion of
the sling.
[0018] U.S. Pat. No. 6,110,101 discloses a sling for supporting the
urethra and neck of the bladder to prevent urinary incontinence is
disclosed. The sling is designed to provide sufficient support to
inhibit the unintended flow of urine, yet stretch in a controlled
fashion so that the bladder can be voided at approximate times.
[0019] U.S. Pat. No. 6,517,578 describes a graft suspension device
for suspending a ligament in a bone hole. The suspension device
comprises a first loop and second loop suspended from an anchor and
has a cradle at the opposite end of the loop to the anchor.
Ligament grafts are looped over the cradle and loose ends may be
pulled by finger loops whereby the surgeon can adjust the distance
of the cradle from the anchor thereby tensioning the grafts as
desired.
[0020] U.S. Pat. No. 6,872,227 discloses a strip-like implant that
has a tape with a first end and with a second end. In the area of
at least one of the two ends, a disk-like application aid aligned
with the plane of the tape is arranged. The disk-like application
aid can also be constructed in the shape of two jaws of a surgical
gripping instrument which is set up to grip an implant tape.
[0021] U.S. Pat. No. 7,083,568 discloses an implantable article and
method of use are disclosed to treat urological disorders. The
biocompatible device includes a sling assembly configured to be
minimally invasive and provide sufficient support to the target
site. In addition, the configuration of the sling assembly also
allows the position of the sling to be permanently changed during
and/or after implantation.
[0022] U.S. Publication No. 2002/0019670 discloses an implantable
tissue augmentation device having a multiplicity of biocompatible
strands, each of said strands having at least one end wherein the
multiplicity of strands are integrally joined at the at least one
end of each of the multiplicity of strands. Optionally, the
augmentation device has an attachment feature allowing easy
attachment to a suture, a needle or other surgical instrument. The
strands can have various cross sectional configurations such as
rectangles or polygons.
[0023] U.S. Publication No. 2002/0123750 relates to orthopedic
implants made from a mesh material. The mesh material can be
treated in order to promote bone growth, to provide antibiotics, or
to provide other beneficial treatment. Specific applications for
the implants include, for example, a prosthetic ligament, a tension
band, an interbody device, or a fixation device that extends across
one or more joints or fractures.
[0024] U.S. Publication No. 2006/0149261 discloses a spacer member
that is intended to be placed between the ends of the bones which
are to be connected, one end of the spacer member being designed to
form a joint surface against one of the bone ends. A
joint-stabilizing connection is arranged to connect the bones. The
spacer member is made of at least one tissue-compatible
material.
[0025] U.S. Publication No. 2006/0241617 discloses a bone plate and
method of forming a bone plate having a plurality of suture loops
pre-attached to the bone plate. The suture loops may be flexible
and formed of a strong suture material. The suture loops may have
various shapes, forms and configurations and may be provided on the
bone plate in any number, depending on the characteristics of the
fractured bone or bone segments, or of the plate design.
Preferably, the suture loops are attached to a surface of the bone
plate. The suture loops may receive a strand of suture for fixation
of soft tissue to the bone plate.
[0026] U.S. Publication No. 2009/0018655 discloses a biocompatible
implants that combine a scaffold material for supporting long term
repair of a soft tissue with an elongated member such as a suture
for aiding in placement of the scaffold during a surgical procedure
as well as for immediate mechanical reinforcement of a repair site.
The components of an implant are combined such that a longitudinal
load placed upon a composite structure can be borne primarily by
the elongated member and the scaffold material is isolated from the
longitudinal load. Thus, the scaffold material of a composite can
be protected from damage due to applied loads and stresses during
and following a surgical procedure.
[0027] PCT Publication No. WO 2006/034719 discloses a stent which
is composed of an external rigid skeleton shaped like an incurving
rectangle made of the organically inert substance (Polypropylene).
The area in the center or the inside area of the skeleton is filled
with a macroporous polypropylene mesh (pores>78 um). Fixed to
each of the four corners of the stent is a surgical thread (3) made
of Polydioxanone (PDS) number Zero (1-0) with a swaged on curved
needle. The stent is of two different sizes to accommodate
variations in vaginal capacity. The large measures: 9 cm in length,
5 cm in width and 5 mm in thickness. The small measures: 7 cm in
length, 3.5 cm in width and 3.5 mm in thickness.
[0028] PCT Publication No. WO 2007/002071 discloses surgical
procedures, kits and implants for alleviating human incontinence,
and particularly providing improved methods and apparatus to secure
a urethral sling to pubic bone to support the urethra and alleviate
incontinence are disclosed. Bone anchors are driven into pubic
bones with elongated bone anchor sutures configured to be passed
through openings of a urethral sling. Suture retainers are applied
to the sutures to apply retentive force to the urethral sling to
maintain the fixation of the urethral sling proximate to the pubic
bone.
[0029] Existing surgical devices and methodology, as described
above, exhibit several unique drawbacks and disadvantages. In the
case of artificial joint replacement surgery, several complications
may be encountered; including fracture, bosening, subluxation or
dislocation, particulate synovitis and other reported complications
that may result in eventual failure of the implant. Additionally,
surgical implants designed for other parts of the human body have
been difficult to adapt to basal joint arthroplasty, due to the
complex nature of the anatomy of the basal joint, the arthritic
deformity of subluxation and adduction contracture that occurs with
progression of basal joint arthritis, and the cantilever forces
applied across the metacarpal base. More complex soft tissue
reconstructive methods for basal joint arthroplasty can be
associated with the potential for greater short and occasionally
long-term impairment of the hand, requiring prolonged
rehabilitation. Many of these methods involve more extensive (and
at times multiple) surgical incisions, sacrificing normal tendons
that are utilized to stabilize the basal joint after trapeziectomy
and must be re-directed via bone drill holes to support the thumb
metacarpal base. The abductor pollicis longus suspensionplasty
technique as disclosed in the American Society for Surgery of the
Hand Correspondence Newsletter, DelSignore, 2004-52, August, 2004
eliminates the need to re-direct a tendon through a drill hole, but
does sacrifice a slip of the abductor pollicis longus tendon and
utilizes an incision which crosses proximal to the wrist flexion
crease, requiring immobilization for 4 weeks and thus can be
associated with increased morbidity of wrist stiffness and longer
recovery, as seen with the other soft tissue tendon-sacrificing
techniques. In order to successfully reconstruct an advanced stage
arthritic basal joint, all arthritic surfaces must be addressed.
The important volar oblique ligament function must be restored, the
base of the thumb metacarpal must be approximated close to the base
of the index metacarpal, thereby regaining and improving first
webspace abduction angle, and the joint arthroplasty space should
be preserved to prevent proximal migration and subsequent weakness
and collapse deformity. With the utilization of the basal joint
stabilizer sling, these goals can be accomplished, with less
morbidity, smaller incision, shorter operative time, less demanding
surgical technique, and faster short term recovery with earlier
resumption of activities of daily living.
SUMMARY OF THE INVENTION
[0030] Accordingly, one object of the techniques and apparatus
discussed herein is to create an intra-articular basal joint
stabilizer sling to serve as a reconstructive implant to treat
basal joint arthritis. This basal joint stabilizer sling, made of
either synthetic material (mesh, tape, bioabsorbable,
biocompatible, or woven fabric), or biologic material (xenograft,
autograft, allograft, or human tissue from regenerative tissue
matrix), interwoven with strong non-absorbable suture, is firmly
anchored via suture anchor to a fixed point of insertion into the
radial base of the index metacarpal near the flexor carpi radialis
insertion ulnarly, and the volar-radial articular base of the thumb
metacarpal radially, via two small holes, created with a small
drill into the volar-radial articular surface of the thumb
metacarpal through which the suture can be passed on swaged-on
curved, slightly curved or straight needles, creating a direct
bone-to-bone attachment for the stabilizer sling. Alternatively,
the stabilizer sling could be attached radially to the base of the
thumb metacarpal with a second suture anchor, or the sling could be
secured with soft tissue-to-soft tissue attachments by attaching
the sling to the flexor carpi radialis at its insertion onto the
base of the index metacarpal and deep ulnar capsule ulnarly and the
abductor pollicis longus and dorsal capsule radially. A third
alternative would be to attach the sling via suture anchor into the
base of the index metacarpal ulnarly and to the soft tissue of the
basal joint capsule radially, along a direct line of pull from the
base of the index metacarpal.
[0031] This technique and implant design provides a simpler, less
invasive method for basal joint reconstruction with less donor site
morbidity, earlier institution of motion post-operatively, faster
healing time and resumption of normal activities, and none of the
complications which are uniquely associated with other techniques
such as improper drill hole placement or fracture associated with
the creation of bone tunnels necessary for passing tendon grafts,
malalignment of metal or synthetic implant device into bone,
implant breakage, pin tract complications, including infection,
hypersensitivity or chronic pain from neuroma formation, as well as
the potential loss of function including stiffness of the wrist and
hand, which may result from more extensive surgery and lengthy
immobilization required in procedures which involve sacrificing and
utilizing tendons for stabilizing the reconstruction. The technique
of this concept appropriately addresses the larger patient
population who suffer from advanced, pan-trapezial, basal joint
arthritis by removing the entire trapezium and stabilizes the thumb
by tethering it to the base of the index metacarpal, maintaining
first web space abduction alignment and preserves the resection
arthroplasty space by minimizing proximal migration. This method
could also be appropriate for patients with earlier stage
trapezio-metacarpal arthritis, as the stabilizer sling insertion
method and anchorage with a suture anchor into the radial base of
the index metacarpal and passage of the suture through two small
holes created in the volar-radial articular base of the thumb
metacarpal via curved, slightly curved or straight swaged-on
needles, or with a second anchor into the base of the thumb
metacarpal articular surface, can be accomplished through a small
incision, suitable even if the surgeon chooses a hemi-trapeziectomy
(partial distal resection) procedure.
[0032] One aspect of this disclosure is directed to the fact that
utilization of an intra-articular basal joint stabilizer sling,
interwoven with strong non-absorbable or long-lasting absorbable
suture, firmly anchored to fixed points of bony insertion at radial
base of the index metacarpal ulnarly, and the volar-radial
articular base of the thumb metacarpal radially avoids the need for
sacrificing a functioning tendon, in part or in whole.
[0033] Another aspect of this disclosure is the distinct advantage
of performing basal joint reconstruction which firmly tethers the
base of the thumb metacarpal in close approximation to the base of
the index metacarpal, thereby balancing the thumb in an abducted
and distally tethered position, thereby restoring the function of
the incompetent volar oblique ligament, maintaining joint
arthroplasty space and preventing proximal migration.
[0034] Yet another aspect of this disclosure provides the ability
to perform basal pint arthroplasty through a smaller incision which
does not cross the wrist flexion crease, without the need for
sacrificing and re-directing tendons through bone tunnels. This
method avoids the need for stabilization with pins and thus avoids
the well-known complications and morbidities associated with pin
fixation.
[0035] Still another aspect of this disclosure provides the fact
that, since no tendons are harvested and the incision remains
distal to the wrist flexion crease, early active range of motion
can commence at 12-14 days post-operatively, which will be
associated with an earlier return of wrist motion, less stiffness,
and more rapid recovery in the early healing phases of
rehabilitation.
[0036] Yet another aspect of this disclosure provides the fact that
the implantation of a basal joint stabilizer sling can be more
easily performed by hand surgeons, with greater reliability of
outcomes, due to the simplicity of the design, firm bony anchorage
into fixed points of insertion, ease of performance and anticipated
uniform results, as the technique is not as technically demanding
as many of the previously described soft tissue techniques. This
technique, when applied with the preferred embodiment design, does
not require the precise formation of bone tunnels for tendon
passage or need for tendon sacrifice and transfer. There is far
less risk of technical failure when compared to artificial
metallic, synthetic, or silicone joint implants due to improper
bone cuts and potential malalignment of components, since
artificial joint replacement procedures do require a steep learning
curve, are more costly, and have several pitfalls associated with
improper implantation technique when inserting metallic or
artificial prostheses into osteoporotic bone that can lead to
implant failure, loosening, malalignment, fracture, and
subluxation. Even with meticulous technique, artificial joint
implants have had a high failure rate.
[0037] Further objects, features, and advantages of the techniques
and apparatus disclosed herein will be apparent to those skilled in
the art from detailed consideration of the preferred embodiments
that follow.
BRIEF DESCRIPTION OF THE DRAWINGS
[0038] For all figures, the perspective view is from the dorsal
side (back) of the right hand such that the thumb is to the left,
referred to as the radial side or edge, and the index finger and
other fingers are to the right, referred to as the ulnar side or
edge. The basal joint stabilizer sling and alternative embodiments
disclosed herein exhibit rotational symmetry and hence can be
implanted in either the right or left hand.
[0039] FIG. 1A is a schematic representation of the basal joint
stabilizer sling, showing a rectangular central section 102. This
preferred sling embodiment is configured such that a single suture
with two sutures ends, 101 having attached swaged-on curved,
slightly curved or straight needles 100 enters the radial edge 105,
traverses the sling body 102 with a plurality of interlaced
cross-stitches 103, passing through the central portion of the
sling, enters a hole near the bottom of a suture anchor 106
embedded into the ulnar edge 104, re-traverses the sling body 102
with a plurality of interlaced cross-stitches 103, and emerges from
the radial edge 105.
[0040] FIG. 1B is two views of the details of the suture anchor.
The side view shows the suture anchor body 109 having a plurality
of detents 108 to hold the suture anchor in place once inserted in
a hole in bone. The base of the suture anchor body 109 has a
pre-manufactured circular hole 107, oriented parallel to the
drawing, to accept a suture. The side view rotated axially
90.degree. shows the pre-manufactured circular hole 107 in the base
of the suture anchor body 109 such that the circular hole's
orientation is perpendicular to the drawing.
[0041] FIG. 2A is a plan diagram of a preferred embodiment of the
basal joint stabilizer sling showing a center section 102 where the
sutures 101 on the radial edge 105 and sutures 201 on the ulnar
edge 104 are attached to the center section 102 by a plurality of
interlaced cross-stitches 103. The sutures 101 and 201 are not
swaged onto suture anchors or needles in this embodiment. This
preferred sling embodiment is configured such that there are two
sutures ends 101 emerging from the radial edge 105 and two sutures
ends 201 emerging from the ulnar edge 104.
[0042] FIG. 2B is a side view of a modified basal joint stabilizer
sling. The plurality of interlaced cross-stitches 103 and attached
sutures 101 and 201 are indicated.
[0043] FIG. 3 is a diagram of the bones of the hand where the
enlarged section shows that the trapezium 301 has been removed,
leaving the arthroplasty space 305, and the basal joint stabilizer
sling center section 102 has been anchored in place on the ulnar
edge 104 using a suture anchor 106 which is embedded into the ulnar
edge of the sling and inserted into the radial base of the index
metacarpal 307. The suture anchor 106 is able to resist pull-out
forces. On the radial edge, the exiting sutures are utilized to
attach the radial edge 105 of the sling to the volar-radial
articular base of the thumb metacarpal 306 through two small holes,
made with a small drill. The two sutures 101 are tied off with
multiple square knots 303. The flexor carpi radialis 302 and
abductor pollicis longus 304 tendons are identified in the
figure.
[0044] FIG. 4A is a diagram of an alternative embodiment of the
basal joint stabilizer sling where both bony attachments are
performed with suture anchors on the radial and ulnar sides. This
embodiment has a central portion 102 which is rectangular and
incorporates a suture 101 which is attached by a simple stitch 401
to the central portion 102 of the sling. On the ulnar side 104, the
suture 101 passes through a hole in the base of the suture anchor
106. On the radial side 105, the suture exits the side in two
places and is threaded through a hole in the base of a second
suture anchor 400.
[0045] FIG. 4B is a diagram of the implanted stabilizer sling
having a central; portion 102. On the ulnar edge 104, a suture
anchor 106, which is embedded into the ulnar edge of the sling, is
inserted into the radial base of the index metacarpal 307. The
second anchor 400 is inserted into the volar-radial articular
surface of thumb metacarpal base 306 and is progressively tensioned
and secured with a knotless suture technique or with manual tension
applied and securing the suture 101 with multiple square knots 303.
The flexor carpi radialis 302 and abductor pollicis longus 304
tendons plus the arthroplasty space 305 are identified in the
figure.
[0046] FIG. 5A is a diagram of an alternative embodiment of the
basal joint stabilizer sling. Each suture end 101 or 201 is swaged
onto a tapered surgical needle 100 for subsequent attachment to
tendon insertion and capsule anchoring points. This alternative
embodiment is configured such that there are two sutures 101 with
attached tapered surgical needles 100 emerging from the radial edge
105 and two sutures 201 with attached tapered surgical needles 100
emerging from the ulnar edge 104. A plurality of interlaced
cross-stitches 103 is used to attach the sutures to the central
portion 102 of the stabilizer sling.
[0047] FIG. 5B is a diagram of the implanted stabilizer sling. The
sutures 201 arising from the ulnar edge are firmly attached by
passing each needle through the flexor carpi radialis 302 at its
insertion near the index metacarpal 307, firmly anchoring the ulnar
border 104 of the sling with multiple square knots 303 tied deeply
within the arthroplasty space 305. The sutures emerging from the
radial edge 105 are passed from the arthroplasty space 305, out
through the abductor pollicis longus 304 and dorsal capsule as they
insert onto the radial base of the thumb metacarpal 306. The sling
is tightly tensioned and secured with multiple square knots 303,
tethering the base of the thumb 306 towards the base of the index
metacarpal 307 with a soft tissue-to-soft tissue construct
attachment for the stabilizer sling.
[0048] FIG. 6A is a diagram of an alternative embodiment of the
stabilizer sling. The sling configuration is similar to the
configuration of FIG. 1 except the central portion 102 of the sling
is oval and the suture 101 is woven through the central portion 102
of the sling closer to the periphery of the sling. The ulnar side
104 of the sling has a suture anchor 106 embedded into the ulnar
edge of the sling and the two ends of the suture 101 emerging from
the radial side 105 have swaged-on curved, slightly curved or
straight needles 100 attached.
[0049] FIG. 6B is a diagram of the implantation of the sling of
FIG. 6A. The basal joint stabilizer sling center section 102 has
been anchored in place on the ulnar edge 104 using a suture anchor
106, which is embedded into the ulnar edge of the sling, and
inserted into the radial base of the index metacarpal 307. On the
radial edge, the exiting sutures are utilized to attach the radial
edge 105 of the sling to soft tissue, including joint capsule, (not
shown) in a direct line of pull from the base of the index
metacarpal. The two sutures 101 are tied off with multiple square
knots 303. The flexor carpi radialis 302 and abductor pollicis
longus 304 tendons are identified in the figure.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0050] The techniques and apparatus disclosed herein enables
surgeons to treat basal joint arthritis with a reconstructive
method that allows for simplicity, ease of performance, more
predictable outcome among surgeons of varied backgrounds, training
and ability, shorter operative time, lower surgical site morbidity,
smaller incision, no need for harvesting and sacrificing of
functioning tendons, no pin fixation, faster recovery, and earlier
return to activities of daily living.
[0051] This technique and implant design will provide a simpler,
less invasive method for basal joint reconstruction with less donor
site morbidity, earlier institution of motion post-operatively,
faster healing time and resumption of normal activities, and none
of the complications that are uniquely associated with other
techniques.
[0052] The benefits of these concepts are enhanced by meeting the
goals of basal joint reconstruction which include removal of the
entire arthritic interface, particularly important for those
patients with the more common form of advanced, pan-trapezial
arthritis, along with reconstruction of the function of the
important volar oblique ligament, maintenance of the first web
space abduction angle by approximating the base of the thumb
metacarpal towards the base of the index metacarpal, maintenance of
joint arthroplasty space by distally tethering the base of thumb
metacarpal towards the base of the index metacarpal, and correction
of the arthritic subluxation deformity.
[0053] In describing the techniques and apparatus disclosed herein,
the following term(s) have been used in the description.
[0054] The term "terminally sterilized" refers herein to a device
that has been rendered sterile by demonstrating a sterility
assurance level (SAL) of at least 10.sup.-6 with B.
stearothermophilus spores, an organism that has been shown to be
highly resistant to any sterilization process. Terminally
sterilized also refers to a sterilization procedure which passes
the requirements of the Association of Official Analytical Chemists
(AOAC) Sporicidal Test and has the ability to sterilize medical
devices containing diffusion-restricted areas, including mated
surfaces and lumens.
[0055] The term "sutures" refers to surgical suture materials made
from non-absorbable synthetic substances such as polyester
multifilament, braided polymer blends, wire, or nylon monofilament.
Sutures are sized by the United States Pharmacopoeia scale from
largest 5=0.70 mm in diameter to the smallest, 10-0=0.020 mm in
diameter and may consist of a single 0 sized non-absorbable suture,
or a double 2-0 size non-absorbable suture or some other
combination of threads.
[0056] The term "absorbable sutures" refers to surgical suture
materials made from substances that gradually dissolve in a matter
of weeks and are eventually removed by the body.
[0057] The term "long lasting absorbable sutures" refers to
surgical suture materials made from substances that dissolve in 18
to 24 months and are eventually removed by the body.
[0058] The term "strong material" or "strong suture" includes
non-absorbable and long lasting absorbable surgical suture capable
of performing tendon repairs having a tensile strength in the range
of substantially 15 newtons to 70 newtons depending upon the suture
method employed. The concept of a "strong suture" is explored in
depth by Shaieb and Singer in the Journal of Hand Surgery (British
and European Volume, 1997) 22b: 6: 764-767, which is hereby
incorporated by reference.
[0059] The term "Wagner incision" refers b a midaxial incision
along the volar-radial aspect of the thumb metacarpal base, which
extends proximally along the radial border of the thenar eminence,
between the glabrous and non-glabrous skin, and extends ulnarly,
just distal to the wrist flexion crease.
[0060] The term "xenograft" refers to the transplantation of living
cells, tissues, or organs from one species to another such as from
pigs to humans.
[0061] The term "autograft" refers to tissue transplanted from one
part of the body to another in the same individual. An autograft is
also called an autotransplant.
[0062] The term "allograft" refers to tissue transplanted from a
human cadaver that is utilized for implantation in a living
human.
[0063] The term "subluxation" refers to an incomplete or partial
dislocation of a joint.
[0064] The term "drill hole" refers to holes drilled into bone for
the purpose of inserting and holding suture anchors. These drill
holes are on the order of 2.0-2.4 mm (0.079-0.094 inch) in diameter
and are made to place non self-tapping suture anchors. Self-tapping
suture anchors can be inserted into bone without the need for
making drill holes.
[0065] The term "small drill hole" refers to holes in bone, created
with a small drill bit for the purpose of threading, with a
swaged-on curved, slightly curved or straight needle,
non-absorbable or long-lasting absorbable sutures emerging from the
radial edge of the sling through the small drill holes to firmly
anchor the radial edge of the sling to the base of the thumb
metacarpal. These sutures are tightly tensioned and secured with
multiple square knots over the dorsum of the thumb metacarpal over
a bone bridge. These drill holes are made with a wire or a small
drill bit on the order of 1.14-1.37 mm (0.045-0.054 inch) in
diameter.
[0066] The term "suture anchor" refers to the class of generic
non-metallic and metallic devices placed into bone to enable the
attachment of soft tissue to bone. Various configurations of suture
anchors are discussed by Philippe Saffar, Peter C. Amadio, and Guy
Foucher in Current Practice in Hand Surgery, Informa Healthcare,
1997, which is hereby incorporated by reference.
[0067] The term "apparatus" refers to any of the several variations
of the basal joint stabilizer sling, sutures, swaged-on curved,
slightly curved or straight needles, suture anchors and
combinations there of.
[0068] The term "embedded" refers to attachment of a suture anchor
to the central portion of the stabilizer sling along an edge where
the base of the suture anchor abuts or slightly projects into the
central portion such that the suture that runs through the hole in
the base of the suture anchor maintains approximately continuous
contact with the central portion except for the small segment which
lies within the central hole of the suture anchor.
[0069] For a general understanding of the techniques and apparatus
disclosed herein, reference is made to the drawings. In the
drawings, like reference numerals have been used to designate
identical elements.
[0070] FIG. 1 is a diagram of the schematic representation of the
preferred embodiment of the basal joint stabilizer sling, showing a
rectangular central section 102 where a strong, central core
non-absorbable single braided suture 101 enters the radial edge
105, is woven through the sling 102, with a plurality of interlaced
cross-stitches 103. This suture passes through the hole in a suture
anchor 106 embedded into the ulnar edge of the central portion 102
of the sling. The suture 101 then weaves through the central
portion of the sling 102 with a plurality of interlaced
cross-stitches 103 and exits through the radial edge 105. The
radial edge suture ends 101 are attached to swaged-on curved,
slightly curved or straight needles 100 which are utilized to
attach the radial edge of the sling to the volar-radial articular
base of the thumb metacarpal through two small holes.
[0071] The preferred basal joint stabilizer sling embodiment is
configured such that there are two sutures ends 101 with attached
swaged-on curved, slightly curved or straight needles emerging from
the radial edge 105 and a suture anchor 106 embedded into the ulnar
edge 104 of the central portion of the sling 102. The suture
associated with the central portion of the suture within the
stabilizer sling is interwoven throughout sling 102 with
interlocking stitches 103. This central portion 102 is composed of
terminally sterilized material made of either synthetic material
(mesh, tape, bioabsorbable or biocompatible material or woven
fabric), or biologic material. Appropriate biodegradable synthetic
material includes polyurethane ureas, polylactides, polydiaxones,
poly-.beta.-hydrobutylates, and other suitable flexible, but
non-elastic polymers. Appropriate non-biodegradable synthetic
materials include poly(ethylene terephthalate),
polytetrafluoroethylene, silicone, perfluoroalkoxy polymer,
fluorinated ethylene propylene polymer, and other suitable
flexible, but non-elastic polymers. Appropriate biologic materials
include xenograft, allograft, autograft, and/or human tissue from
regenerative tissue matrix. Alternatively, the central portion of
the sling could be composed of long-lasting absorbable sutures made
from substances that dissolve in 18 to 24 months and are eventually
removed by the body. This sling and the sutures arising from the
sling could be made of the same material as an all-in-one construct
with the ends of this sling comprised of sutures, two of which
extend out through the radial edge 105 of the sling, to be attached
to curved, slightly curved or straight needles in one embodiment,
or an second anchor 400 in another method. The suture braided
within the sling itself could traverse the ulnar edge 104 of the
sling where the suture will pass through the anchor 106 which is
embedded into the ulnar edge 104 of the sling. This all-in-one
construct of sling material and matching suture will act as a
single structure and the sutures which extend beyond the edge of
the sling will serve as a substitute for the sutures described in
the described embodiments. The flexibility of the synthetic and
biologic materials allow the center section 102 of the basal joint
stabilizer sling to be deformable and to conform to the base of the
thumb metacarpal 306. The synthetic materials are made with
surfaces that are either porous or non-porous depending upon the
specific application. Porous surfaces potentially allow the
ingrowth of new biological tissue firmly holding the implant in
place. In FIG. 3, the enlarged section shows that the trapezium 301
has been removed leaving the arthroplasty space 305 and the basal
joint stabilizer sling center section 102 has been secured in place
on the ulnar side by the suture anchor 106 being inserted into the
radial base of the index metacarpal 307. On the radial edge, the
exiting sutures 101 are utilized to attach the radial edge 105 of
the sling to the volar-radial articular base of the thumb
metacarpal 306 through two small drill holes. FIG. 3 shows the
closely approximated relationship of the base of the thumb
metacarpal 306 towards the base of the index metacarpal 307. Note
that the first web space abduction angle has been restored by
tethering the base of the thumb metacarpal 306 to the base of the
index metacarpal 307. Note also the distal tethering of the thumb,
minimizing proximal migration and preserving the joint arthroplasty
space 305.
[0072] The preferred surgical procedure for basal joint
arthroplasty using the preferred embodiment of the basal joint
stabilizer sling is as follows:
[0073] A Wagner incision is utilized, at the junction of the
glabrous and non-glabrous skin, curving ulnarly at the proximal
edge of the basal joint remaining distal to the wrist flexion
crease. The thenar muscles are stripped off the volar aspect of the
basal joint capsule and reflected ulnarly, exposing the capsule in
entirety. A longitudinal incision is made in the basal joint
capsule, with medial and lateral flaps being sub-periosteally
elevated and preserved for later repair. The flexor carpi radialis
302 and abductor pollicis longus 304 tendons are identified and
their insertion sites are carefully preserved as the entire
trapezium 301 is removed. Following trapeziectomy, longitudinal
distraction force is applied to the thumb, pulling it as far
distally as possible, exposing the flexor carpi radialis 302
insertion onto the base of the index metacarpal 307. The basal
joint stabilizer sling, with the attached suture anchor embedded
into and emerging from the ulnar edge 104 is then placed into the
joint arthroplasty space 305, and the suture anchor 106, which is
attached to a suture loop 101 coincident with and embedded into the
ulnar edge 104 of the stabilizer sling, is then firmly inserted
into the exposed radial base of the index metacarpal 307, just
radial to the flexor carpi radialis insertion, rigidly affixing the
ulnar edge 104 of the sling to the index metacarpal base 307. The
stabilizer sling is brought across the arthroplasty space 305 with
the sutures ends 101 emerging from the radial edge 105 of the basal
joint stabilizer sling center section 102 being swaged onto curved,
slightly curved or straight tapered surgical needles 100. Two small
holes are made in the volar-radial base of the thumb metacarpal
articular surface with a small drill, to allow passage of swaged-on
curved, slightly curved or straight needles 100 attached to the
sutures 101 arising from the radial edge of the sling through these
holes. With continual firm longitudinal traction being applied to
the thumb, the basal joint stabilizer sling is drawn tightly across
the arthroplasty space 305, and the two remaining free ends of the
suture 101 emerging from the radial edge 105, are passed by
directing the tapered needles 100 from within the arthroplasty
space 305, out through the small holes in the base of the thumb
metacarpal 306. Tension is applied to the sutures, as downward
(ulnarly directed) pressure is placed on the dorsal base of the
thumb metacarpal 306, approximating and tethering it towards the
base of the index metacarpal 307, while continually maintaining a
distal longitudinal distraction force. The radial edge 105 sutures
101 which are passed through the thumb metacarpal small drill holes
are secured with multiple square knots 303 over a bony bridge,
drawing the basal joint stabilizer sling tightly across the
arthroplasty space 305. If desired, additional reinforcement can be
achieved by placing a heavy non-absorbable #0 suture as a suture
suspension arthroplasty, as disclosed in Suture Suspension
Arthroplasty Technique for Basal Joint Arthritis Reconstruction,
DelSignore and Accardi, to be published in Techniques in Hand and
Upper Extremity, December, 2009. This additional suturing method
can provide additional support, creating a suture suspension bridge
just proximal to the stabilizer sling and serves to augment the
first web space abduction angle. The basal joint capsule is
repaired with 3-0 polyester multifilament (non-absorbable) suture.
The thenar muscles are reattached to the base of thumb metacarpal
306 with 4-0 absorbable suture, completely covering the suture
multiple square knots 303 from the basal joint stabilizer sling,
and 5-0 nylon sutures are placed in the skin. Post operatively,
immobilization in a bulky post-op bandage with a thumb spica
plaster splint is worn for 12-14 days, after which bandage and 5-0
nylon sutures are removed and a short opponens orthoplast splint is
applied, worn continually for 2 weeks, off only for bathing and
gentle active range of motion exercises. Progressive use and
strengthening exercises are introduced by 6 weeks post-operative
with the splint being discontinued at 8 weeks post-operative. The
majority of patients will be released to resume full, unrestricted
activities by 12 weeks post-operatively, with some continuing to
show improvement with regard to motion and strength for up to 6-12
months post-operatively.
[0074] The stabilizer sling with its bone-to-bone attachment will
function similar to a "hammock" bridging the arthroplasty space 305
forming a suspension construct to cradle and stabilize the thumb
metacarpal 306 with the base of the thumb firmly approximated
towards the base of the index metacarpal 307 and tethered distally,
supporting the arthroplasty space 305, providing a strong basal
joint stabilizer sling, thereby restoring the function of the volar
oblique ligament. This construct maintains the first web space
abduction angle positioning of the thumb metacarpal 306, maintains
the arthroplasty space 305, prevents proximal migration, and
approximates and effectively tethers the base of the thumb to the
base of the index metacarpal 307.
[0075] Another surgical attachment option for the basal joint
stabilizer sling involves the implantation of another alternative
embodiment of the basal joint stabilizer sling as shown in FIG. 4A
where a suture anchor 106 embedded in the ulnar edge 104 of the
basal joint stabilizer sling center section 102 is inserted into
the base of the index metacarpal 307, and where suture ends 101
emerging from the radial edge 105 of the basal joint stabilizer
sling center section 102 are attached to the volar radial base of
the thumb metacarpal 306 articular base with a second suture anchor
400. This technique utilizes a Wagner incision, stopping distal to
the wrist flexion crease. The thenar muscles are reflected off the
underlying basal joint capsule and a longitudinal incision in the
capsule is made. The trapezium 301 is removed in entirety and
longitudinal distraction force is applied to the thumb. The flexor
carpi radialis 302 is traced distally to it's insertion onto the
base of the index metacarpal 307. The stabilizer sling is placed
into the arthroplasty space 305. The suture anchor 106 embedded in
the ulnar edge 104 of the stabilizer sling, is then firmly inserted
into the radial base of the index metacarpal 307, rigidly affixing
the ulnar edge of the sling to the index metacarpal base. The ulnar
edge 104 of the stabilizer sling is thus closely approximated to
the index metacarpal 307 base. The second suture anchor 400,
through which the suture ends 101 emerging from the radial edge 105
have been previously attached from the manufacturer, is inserted
into the volar-radial base of the thumb metacarpal 306 articular
surface. Tension is applied to the two suture ends emerging from
the radial edge 105 of the sling which pass through the second
suture anchor 400, as downward (ulnarly directed) pressure is
placed on the dorsal base of the thumb metacarpal 306,
approximating it towards the base of the index metacarpal 307,
while continually maintaining a distal longitudinal distraction
force. With continual firm longitudinal traction being applied to
the thumb, the basal joint stabilizer sling is tensioned across the
arthroplasty space 305, and the two remaining free ends of the
suture 101 emerging from the suture anchor at the radial edge 105
of the stabilizer sling, are tightly secured, fastened and cut off,
tethering the base of the thumb metacarpal towards the base of the
index metacarpal. If desired, additional reinforcement can be
achieved by placing a heavy non-absorbable #0 suture as a suture
suspension arthroplasty, as disclosed in article Suture Suspension
Arthroplasty Technique for Basal Joint Arthritis Reconstruction,
DelSignore and Accardi, to be published in Techniques in Hand and
Upper Extremity Surgery, December, 2009. This additional suturing
method can provide additional support, creating a suture suspension
bridge just proximal to the stabilizer sling and serves to augment
the first web space abduction angle. The basal joint capsule is
repaired with 3-0 polyester multifilament (non-absorbable) suture.
The thenar muscles are reattached to the base of thumb metacarpal
306 with 4-0 absorbable suture, and 5-0 nylon non-absorbable
sutures are placed in the skin. Postoperative treatment and follow
up is the same as described in the case of the preferred operative
embodiment. This procedure also maintains the first web space
abduction angle positioning of the thumb metacarpal 306, maintains
the arthroplasty space 305, prevents proximal migration, and
approximates and effectively tethers the base of the thumb
metacarpal 306 to the base of the index metacarpal 307. This form
of bone-to bone attachment draws the basal joint stabilizer sling
tightly across the arthroplasty space 305, similar to a "hammock"
bridging the arthroplasty space 305 and forms a suspension
construct to cradle and stabilize the thumb metacarpal 306 with the
base of the thumb firmly approximated towards the base of the index
metacarpal 307 and tethered distally, supporting the arthroplasty
space 305, providing a strong basal joint stabilizer sling, thereby
restoring the function of the volar oblique ligament.
[0076] Alternatively, another surgical attachment option for the
basal joint stabilizer sling involves the implantation of another
alternative embodiment of the basal joint stabilizer sling as shown
in FIG. 5A whereas the sling is attached with swaged-on curved
needles with soft tissue-to-soft tissue attachments with no bony
fixation. The alternative embodiment is configured such that there
are two sutures 101 with attached tapered surgical needles 100
emerging from the radial edge 105 and two sutures 201 with attached
tapered surgical needles 100 emerging from the ulnar edge 104. As
shown in FIG. 5B, this technique utilizes a Wagner incision,
stopping distal to the wrist flexion crease. The thenar muscles are
reflected off the underlying basal joint capsule and a longitudinal
incision in the capsule is made. The trapezium 301 is removed in
entirety and bngitudinal distraction force is applied to the thumb.
The flexor carpi radialis 302 is traced distally to its insertion
onto the base of the index metacarpal 307. Following trapeziectomy,
longitudinal distraction force is applied to the thumb, pulling it
as far distally as possible, exposing the flexor carpi radialis 302
insertion onto the base of the index metacarpal 307. The basal
joint stabilizer sling is then placed into the joint arthroplasty
space 305, and both needles, swaged onto the sutures 201, emerging
from the ulnar edge 104 of the basal joint stabilizer sling, are
passed, in opposite directions, through the fixed insertion point
of the flexor carpi radialis 302, with additional anchorage by
grasping some of the deep ulnar basal joint capsule and flexor
carpi radialis 302 subsheath. The ulnar edge 104 sutures 201 are
tightly tensioned and secured deep within the arthroplasty space
with multiple square knots 303, tightly drawing the ulnar edge of
the stabilizer sling flush against the flexor carpi radialis 302
insertion near the base of the index metacarpal 307. With continual
firm longitudinal traction being applied to the thumb, the basal
joint stabilizer sling is brought across the arthroplasty space
305, and the two remaining free ends of tie suture 101 emerging
from the radial edge 105, are passed by directing the tapered
needles 100 from within the arthroplasty space 305, out dorsally,
through the fixed insertion point of the abductor pollicis longus
304 tendon and the dorsal basal joint capsule, as they insert onto
the dorsal base of the thumb metacarpal 306. Tension is applied to
the sutures, as downward (ulnarly directed) pressure is placed on
the dorsal base of the thumb metacarpal 306, approximating it
towards the base of the index metacarpal 307, while continually
maintaining a distal longitudinal distraction force. The sutures
101 are passed twice through the abductor pollicis longus 304
insertion point and are tightly tensioned and secured with multiple
square knots 303, drawing the basal joint stabilizer sling tightly
across the arthroplasty space 305, similar to a "hammock" bridging
the arthroplasty space 305 and forming a suspension construct to
cradle and stabilize the thumb metacarpal 306 with the base of the
thumb firmly approximated towards the base of the index metacarpal
307 and tethered distally, supporting the arthroplasty space 305,
providing a soft tissue attachment for the basal joint stabilizer
sling, thereby restoring the function of the volar oblique
ligament. This procedure maintains the first web space abduction
angle positioning of the thumb metacarpal 306, maintains the
arthroplasty space 305, prevents proximal migration, and
approximates and effectively tethers the base of the thumb
metacarpal 306 to the base of the index metacarpal 307. The sling
is tightly tensioned and secured with multiple square knots 303,
tethering the base of the thumb towards the base of the index
metacarpal with a soft tissue-to-soft tissue construct attachment
for the stabilizer sling. If desired, additional reinforcement can
be achieved by placing a heavy non-absorbable #0 suture as a suture
suspension arthroplasty, as disclosed in Suture Suspension
Arthroplasty Technique for Basal Joint Arthritis Reconstruction,
DelSignore and Accardi, to be published in Techniques in Hand and
Upper Extremity Surgery, December, 2009. This additional suturing
method can provide additional support, creating a suture suspension
bridge just proximal to the stabilizer sling and serves to augment
the first veb space abduction angle. The basal joint capsule is
repaired with 3-0 polyester multifilament (non-absorbable) suture.
The thenar muscles are reattached to the base of thumb metacarpal
306 with 4-0 absorbable suture, completely covering the suture
multiple square knots 303 from the basal joint stabilizer sling,
and 5-0 nylon non-absorbable sutures are placed in the skin.
Postoperative treatment and follow up is the same as described in
the case of the preferred operative embodiment.
[0077] With this alternative embodiment, the stabilizer sling is
attached via soft tissue anchorage points only, with sutures
arising from the ulnar edge 104 which are firmly attached by
passing each needle through the flexor carpi radialis 302 at its
insertion near the index metacarpal 307 and firmly anchoring the
ulnar border 104 of the sling with multiple square knots 303 tied
deeply within the arthroplasty space 305. The sutures 101 emerging
from the radial edge 105 are passed from the arthroplasty space 305
out through the abductor pollicis longus 304 and dorsal capsule as
they insert onto the radial base of the thumb metacarpal 306.
[0078] Alternatively, another surgical attachment option for the
basal joint stabilizer sling involves the implantation of yet
another alternative embodiment of the basal joint stabilizer sling
as shown in FIG. 6A whereas the stabilizer sling is attached on the
ulnar side with a suture anchor and on the radial side using suture
secured into soft tissue with no bony fixation. The technique of
implantation of the stabilizer sling on the ulnar side is the same
as the technique used for the implantation of the preferred
embodiment stabilizer sling on the ulnar side as shown in FIG. 1
and FIG. 3. The implantation of this embodiment on the radial side;
however, differs from the implantation seen in FIG. 5A and FIG. 5B
in that the soft tissue attachment is into the basal joint capsule
and soft tissues (not shown) in a direct line of pull from the base
of the index metacarpal insertion point.
[0079] The preferred basal joint stabilizer sling embodiment in
FIG. 1A and the alternative basal joint stabilizer sling embodiment
in FIG. 4A, as described, both of which utilize bone-to-bone
fixation techniques provide the benefits of ease of performance
through a small incision, ability to treat early disease for which
partial trapeziectomy is warranted, as well as late stage disease
for which entire trapeziectomy is required, and the safety,
stability as well as greater reliability of bone-to-bone
attachment. Although there are some minor increased morbidities and
risks associated with placing suture anchors including increased
cost, potential anchor pull-out failure in patients with
osteoporotic bone and improper anchor placement, the advantages of
a simpler, lower morbidity and easily reproducible procedure
outweigh the potential disadvantages. If bone fixation is felt to
be inadequate, additional soft tissue reinforcement could be
considered to provide additional support to the repair. Fixation to
soft tissue alone, as described as the second alternative
embodiment, can be more difficult as it requires suturing and tying
knots deep within the basal joint arthroplasty space and requires
entire trapeziectomy, which is not warranted in patients with early
stage arthritis, limited to the trapeziometcarpal joint alone.
There is also some potential concern that older patients undergoing
basal joint reconstruction may not have good quality soft tissue,
on which the soft tissue-to-soft tissue alternative fixation must
rely. If patients have poor quality soft tissue attachments (or
absence of the flexor carpi radials due to pre-operative
attritional rupture), the suspension construct is more likely to
fail and allow thumb metacarpal subsidence and loss of correction
with time. In these cases, bone-to-bone attachment methods would be
preferable.
[0080] It will be apparent to those skilled in the art that various
modifications and variations can be made to the methods, processes
and apparatus disclosed herein. Thus, it is intended that these
concepts cover such modifications and variations, provided they
come within the scope of the appended claims and their
equivalents.
[0081] The disclosure of all publications cited above is expressly
incorporated herein by reference in their entireties to the same
extent as if each were incorporated by reference individually.
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