U.S. patent application number 15/684881 was filed with the patent office on 2018-01-04 for prosthetic devices.
The applicant listed for this patent is Ortho-Space Ltd.. Invention is credited to Shaul Shohat.
Application Number | 20180000603 15/684881 |
Document ID | / |
Family ID | 48141492 |
Filed Date | 2018-01-04 |
United States Patent
Application |
20180000603 |
Kind Code |
A1 |
Shohat; Shaul |
January 4, 2018 |
PROSTHETIC DEVICES
Abstract
Expandable prosthetic devices used for treating a variety of
conditions, including rotator cuff injuries, broken and/or
depressed bone fractures, infection and/or inflammation in the
body. In one embodiment, a prosthesis includes an implant having a
pressure regulating valve. The implant is capable of being
positioned between a first tissue and an opposing second tissue in
a void space and of deforming under pressure in response to
articulation of a joint. The pressure regulating valve is
configured to open based on a predetermined pressure in the
implant.
Inventors: |
Shohat; Shaul; (Kfar
HaOranim, IL) |
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Applicant: |
Name |
City |
State |
Country |
Type |
Ortho-Space Ltd. |
Caesarea |
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IL |
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|
Family ID: |
48141492 |
Appl. No.: |
15/684881 |
Filed: |
August 23, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15076109 |
Mar 21, 2016 |
9770337 |
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15684881 |
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14352614 |
Apr 17, 2014 |
9289307 |
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PCT/IB2012/002088 |
Oct 18, 2012 |
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15076109 |
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61548232 |
Oct 18, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2002/30579
20130101; A61F 2002/087 20130101; A61F 2002/30581 20130101; A61F
2/40 20130101; A61F 2250/0003 20130101; A61F 2002/30754 20130101;
A61F 2210/0004 20130101; A61F 2/02 20130101; A61B 17/562 20130101;
A61F 2002/485 20130101; A61F 2/4081 20130101 |
International
Class: |
A61F 2/40 20060101
A61F002/40; A61B 17/56 20060101 A61B017/56 |
Claims
1-31. (canceled)
32. A prosthesis comprising: an inflatable chamber defining an
opening through which fluid can flow into the inflatable chamber to
fill the inflatable chamber and defining a single cavity comprising
an outer surface having one or more external features configured to
facilitate engagement between the outer surface of the single
cavity and one or both of a first tissue and a second tissue
opposite the first tissue; a rigid ring defining a lumen coupled to
the opening of the inflatable chamber; and a plug configured to
seat in the lumen of the rigid ring to seal the opening of the
inflatable chamber, wherein the rigid ring is slidably disposed
about a tube interfacing with the inflatable chamber in a manner to
prevent fluid from passing through an interface between the rigid
ring and the tube, wherein the prosthesis is configured to be
positioned in a void space of a joint between the first tissue and
the second tissue, and wherein the inflatable chamber deforms under
pressure in response to articulation of the joint.
33. The prosthesis of claim 32, wherein a maximum volume of the
inflatable chamber is in a range between 0.5 cc and 60 cc.
34. The prosthesis of claim 33, wherein the inflatable chamber is
filled to over 70% of the maximum volume of the inflatable chamber
with a filler.
35. The prosthesis of claim 33, wherein the inflatable chamber is
filled to less than 50% of the maximum volume of the inflatable
chamber with a filler.
36. The prosthesis of claim 33, wherein the inflatable chamber is
filled to 50% to 70% of the maximum volume of the inflatable
chamber with a filler.
37. The prosthesis of claim 33, wherein, when the inflatable
chamber is filled to the maximum volume of the inflatable chamber,
the prosthesis is configured to deflate upon application of
pressure to an exterior of the inflatable chamber.
38. The prosthesis of claim 32, wherein the one or more external
features comprise one or more of an anchoring device, a contour of
the outer surface, a shape of the outer surface as influenced by
one or both of the first and second tissues, and a friction
coefficient of the outer surface.
39. The prosthesis of claim 32, wherein a maximum volume of the
inflatable chamber is in a range between 5 cc and 100 cc.
40. The prosthesis of claim 39, wherein the inflatable chamber is
filled to 50% to 70% of the maximum volume of the inflatable
chamber with a filler.
41. The prosthesis of claim 39, wherein the inflatable chamber is
filled to over 70% of the maximum volume of the inflatable chamber
with a filler.
42. The prosthesis of claim 39, wherein the inflatable chamber is
filled to less than 50% of the maximum volume of the inflatable
chamber with a filler.
43. The prosthesis of claim 39, wherein, when the inflatable
chamber is filled to the maximum volume of the inflatable chamber,
the prosthesis is configured to deflate upon application of
pressure to an exterior of the inflatable chamber.
44. The prosthesis of claim 32, wherein the inflatable chamber is
attached to the rigid ring in a manner such that fluid is prevented
from leaking from the inflatable chamber through an interface
between the rigid ring and the inflatable chamber.
45. The prosthesis of claim 44, wherein the inflatable chamber is
attached to an exterior surface of the rigid ring.
46. The prosthesis of claim 32, wherein the inflatable chamber is a
fluid filled bladder.
47. The prosthesis of claim 46, wherein the fluid filled bladder is
filled with saline.
48. The prosthesis of claim 46, wherein the fluid filled bladder is
filled with a material that is different from saline.
49. The prosthesis of claim 48, wherein the material comprises a
liquid or a gel.
50. The prosthesis of claim 46, wherein the fluid filled bladder is
filled with a biological material.
51. The prosthesis of claim 50, wherein the biological material
comprises hyaluronic acid.
52. The prosthesis of claim 32, wherein at least one of the
inflatable chamber and the plug is formed of a biodegradable
material.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 15/076,109, filed on Mar. 21, 2016, which is a divisional of
U.S. application Ser. No. 14/352,614, filed on Apr. 17, 2014 (now
U.S. Pat. No. 9,289,307), which is a national phase filing under 35
U.S.C. 371 of International Application No. PCT/IB2012/002088,
filed on Oct. 18, 2012, which claims the benefit of U.S.
Provisional Application No. 61/548,232. The entirety of the
disclosures of the prior applications are herein incorporated by
reference.
FIELD OF INVENTION
[0002] The present inventions relate generally to the field of
medical devices and the treatment of human medical conditions using
the medical devices. More specifically, the present inventions
include expandable prosthetic devices used for treating a variety
of conditions, including rotator cuff injuries, broken and/or
depressed bone fractures, infection and/or inflammation in the
body.
BACKGROUND
[0003] Through repeated strenuous motion, sensitive soft tissues
often suffer wear and tear injuries from repeatedly rubbing against
one another and/or hard tissues, such as bone. Tears of rotator
cuff tendons and articular capsule disintegration are examples of
this type of injury. In addition, these tissues can be adversely
affected by inflammation, infection, disease and/or genetic
predispositions which lead to degeneration of these tissues.
[0004] Severe or complete tears and deterioration of articulations
(i.e., bodily joints) related tissues (such as tendons, ligaments,
capsules, cartilage and bony parts), and other bodily elements
(such as bursae, synovium and other membranes) may cause severe
pain, hindered movement up to complete disability, joint parts
dislocation, and other possible phenomena.
[0005] Some joints related deteriorations can be amended by filling
voids and spaces between tissues with volumetric fillers especially
in scenarios where there is a need to create or revive unhindered
relative motion between such tissues. Such volumetric fillers
should possess specific combined characteristics such as 3D
geometry, external surface texture and overall consistency in order
to avoid inefficacy on the one hand and stiff sensation on the
other. Since that patients differ much on such voids geometries,
mechanical and physical properties of voids' boundaries, and
overall shoulder consistency, weight and strength, it is therefore
needed that the volumetric fillers will be patient-specific in the
sense that it will be deployed, shaped and fine-tuned in vivo.
SUMMARY
[0006] In some embodiments, the present invention includes a method
of implanting a prosthesis in a body that includes at least the
following steps: providing a prosthesis that includes at least an
implant capable of deformation under pressure; inserting the
implant in a void space in a joint; inflating the implant by adding
a first amount of filler to the implant where the first amount of
filler is X; articulating the joint; releasing a second amount of
filler from the implant where the second amount of filler released
from the implant is Y; and sealing the implant where X is greater
than Y. In some embodiments, inflating the implant by adding a
first amount of filler causes the implant to fully expand, fully
unroll, and/or expand a void to a predetermined shape and/or
size.
[0007] In some embodiments, the articulating the joint step and the
releasing a second amount of filler from the implant where the
second amount of filler released from the implant is Y step occur
concomitantly. In some embodiments, the releasing a second amount
of filler from the implant where the second amount of filler
released from the implant is Y step is caused by the articulating
the joint step.
[0008] In some embodiments, the method includes the implant having
a first face and an opposing second face, where the method further
includes articulating the joint to result in a predetermined
distance between the first face of the implant and the opposing
second face of the implant, where the predetermined distance
between the first face of the implant and the opposing second face
of the implant is greater than 0 millimeters.
[0009] In some embodiments, the ratio of X:Y is less than or equal
to 4:1. In some embodiments, the ratio of X:Y is less than or equal
to 2:1. In some embodiments, the ratio of X:Y is less than or equal
to 1.3:1.
[0010] In some embodiments, the implant is a bladder. In some
embodiments, the implant is formed of a biodegradable material. In
some embodiments, the implant is formed of a biodegradable material
that may include polycaprolactone, polyglycolide,
polyhydroxybutyrate, plastarch material, polyetheretherketone,
zein, polylactic acid, polydioxanone, poly(lactic-co-glycotic
acid), poly(lactice acid-co-epsilon caprolactone), collagen, and/or
methyl cellulose.
[0011] In some embodiments, the joint is a mammalian joint. In some
embodiments, the joint is a shoulder joint.
[0012] In some embodiments, the filler includes at least a
biocompatible fluid. In some embodiments, the filler includes at
least a biocompatible fluid that is saline.
[0013] In some embodiments, the method includes a step of inflating
the implant sufficiently to contact at least one surface of a
tissue in the joint.
[0014] In some embodiments the method includes articulating the
joint that includes at least a forward flexion, an abduction, an
external rotation, an internal rotation and/or a cross-body
adduction.
[0015] In some embodiments, the present invention includes a method
of implanting a prosthesis in a body that includes at least the
following steps: providing a prosthesis that includes at least an
implant capable of deformation under pressure; inserting the
implant in a void space in a joint; inflating the implant by adding
a first amount of a filler to the implant, where the first amount
of the filler is X; articulating the joint; releasing a second
amount of the filler from the implant through a pressure regulating
valve based on a predetermined pressure in the implant, where the
second amount of the filler released from the implant is Y; and
sealing the implant, where X is greater than Y. In some
embodiments, the joint is a shoulder joint.
[0016] In some embodiments, the implant includes the pressure
regulating valve. In some embodiments, the pressure regulating
valve is external from the implant.
[0017] In some embodiments, the predetermined pressure in the
implant is at least 8 pounds per square inch. In some embodiments,
the predetermined pressure in the implant is at least 12 pounds per
square inch. In some embodiments, the predetermined pressure in the
implant is at least 20 pounds per square inch.
[0018] In some embodiments, the method further includes releasing
filler from the implant into the void space in the joint.
[0019] In some embodiments, the articulating the joint step and the
releasing a second amount of filler from the implant through a
pressure regulating valve based on a predetermined pressure in the
implant, where the second amount of filler released from the
implant is Y step occur concomitantly. In some embodiments, the
releasing a second amount of filler from the implant through a
pressure regulating valve based on a predetermined pressure in the
implant, where the second amount of filler released from the
implant is Y step is caused by the articulating the joint step.
[0020] In some embodiments, the ratio of X:Y is less than or equal
to 2:1.
[0021] In some embodiments, the present invention is a prosthesis
having an implant having a pressure regulating valve, where the
implant is capable of being positioned between a first tissue and
an opposing second tissue in a joint, where the implant is capable
of deforming under pressure in response to articulation of the
joint, and where the pressure regulating valve is configured to
open based on a predetermined pressure in the implant.
[0022] In some embodiments, the implant is a fluid filled bladder.
In some embodiments, the pressure regulating valve is configured to
open based on a predetermined pressure of 8 pounds per square inch.
In some embodiments, the fluid filled bladder is filled with
saline. In some embodiments, the implant and/or the pressure
regulating valve are formed of a biodegradable material.
[0023] In some embodiments, the filler includes, at least a
biocompatible fluid. In some embodiments, the filler includes at
least a biocompatible fluid that is saline. In some embodiments,
the pressure regulating valve is formed of a biodegradable
material.
[0024] In an aspect of some embodiments, there is provided a
prosthesis use in a mammalian joint. In some embodiments, the
prosthesis includes an implant configured for spacing the tissue
associated with articulation away from adjacent tissue. In some
embodiments, the implant is capable of being deforming to
accommodate for pressure applied thereupon by the tissue associated
with articulation and/or the adjacent tissue. In some embodiments,
the implant is subject to viscoelastic deforming or resembling
viscoelastic-like behavior. Optionally, the implant is formed from
a biodegradable material.
[0025] In some embodiments, the pressure applied to the implant
results from movement of tissue associated with articulation and/or
the adjacent tissue. Optionally, the implant is sized and
configured for a rotator cuff tissue.
[0026] In some embodiments, the implant is a fluid filled bladder,
optionally partially filled, optionally filled with saline. In some
embodiments, the deforming does not result in a substantial
increase in stress on a wall of the bladder. In some embodiments,
the bladder is formed from a non-compliant or a semi-compliant
material. In some embodiments, an internal fluid pressure of the
fluid filled bladder does not rise above 8 psi during the
deforming.
[0027] In some embodiments, the fluid filled bladder includes a
valve for regulating a fluid pressure within the bladder. The value
may be configured for releasing fluid out of the fluid filled
bladder above a predetermined internal fluid pressure, optionally 8
psi. Optionally, the valve is biodegradable. In some embodiments, a
system is provided comprising the implant and an inflation
apparatus detachably coupled to the bladder.
[0028] In an aspect of some embodiments, there is provided a
prosthesis for use in the articulation of a mammalian joint
comprising an implant configured for providing floatation-like
support to the tissue associated with articulation thereby
minimizing interface pressure and friction on tissue associated
with articulation.
[0029] Also provided, in accordance with some embodiments of the
invention, is a method of implanting a prosthesis configured for
use in the articulation of a mammalian joint. In some embodiments,
the method includes implanting the prosthesis in contact with the
tissue associated with articulation, and articulating the joint,
thereby enabling the prosthesis to deform and accommodate for
pressure applied thereupon by the tissue associated with
articulation and/or adjacent tissue.
[0030] In some embodiments, the tissue associated with articulation
is a rotator cuff tendon, a humerus, an acromion or a coracoid
process.
[0031] In some embodiments, the method further includes measuring a
natural void between a limb bone and an adjacent trunk bone
surrounding the joint and selecting the prosthesis according to a
size and/or shape of the void. Optionally, the limb bone is a
humerus and the trunk bone is an acromion or a glenoid.
[0032] In some embodiments, the prosthesis is a fluid expandable
bladder and the method includes expanding the prosthesis to a first
size and/or a shape prior to articulation the joint. Optionally,
joint articulation results in deformation of the prosthesis to a
second size and/or a shape. The second size and/or the shape may
result from release of fluid from the bladder. Optionally, the
bladder is sealed at the second size and/or the shape.
[0033] In some embodiments, articulating the joint is through a
full range of motion, optionally a passive range of motion,
optionally any of a forward flexion, an abduction, an external
rotation, an internal rotation and a cross-body adduction.
[0034] In some embodiments, the method further includes debriding
tissues in the natural void, Optionally, the method further
includes fixating the prosthesis in position. In some embodiments,
the bladder includes at least one smooth surface and the second
size and/or the shape impose a predetermined friction
characteristic between the at least one smooth surface and the
tissue associated with articulation. Optionally, the friction
characteristic is at least one of a static dry friction force, a
kinetic friction force, a friction coefficient and a normal force
applied to the tissue type in continuous contact with the smooth
surface. Optionally, the friction characteristic allows a chosen
transient between a static friction force and a kinetic friction
force, thereby allowing movement of the prosthesis in a stable
equilibrium positioning.
[0035] In an aspect of some embodiments, the prosthesis includes a
tissue positioning device, comprising: a biocompatible member
having a size and shape suitable for placement within a space
adjacent to a tissue to be positioned, the tissue forming a portion
of an articulatable joint; such that, when placed within the space,
the member acts to maintain the tissue in a desired position.
Optionally, the member is a spacer which has a defined shape when
acting to maintain the tissue in the desired position. Optionally,
the member arranged such that its size and shape are suitable for
placement within a given space and for positioning a particular
tissue. In some embodiments, the member comprises: a bladder having
an associated deflated state and which is capable of receiving and
being at least partially expanded by a filler material; and a valve
by which a filler material can be delivered into the bladder; such
that the bladder is capable of insertion into the space when in the
deflated state and acts to maintain the tissue in the desired
position when at least partially expanded by the delivery of filler
material via the valve. Optionally, the tissue is hard or soft
tissue. Optionally, the space is between the acromium, deltoid
muscle, and humerus, such that, while placed within the space, the
member acts to maintain the head of the humerus within the cup of
the glenoid.
[0036] An aspect of some embodiments of the invention relates to
prostheses adapted to reduce injuries between soft tissues of the
body and other tissues. In an embodiment of the invention, soft
tissues are for example, tendons and/or ligaments. In an embodiment
of the invention, other tissues are, for example, bones. In an
embodiment of the invention, the prosthesis is expandable.
Optionally, the prosthesis is elastic. In some embodiments of the
invention, the prosthesis is rigid. In an embodiment of the
invention, the prosthesis is shaped and/or sized to simulate a
bursa naturally occurring in the body. Optionally, the bursa
simulated is the one expected to be present at the implantation
site of the prosthesis in a healthy patient.
[0037] Optionally, the expandable prosthesis is sponge-like.
Optionally, the expandable prosthesis is inflatable. In some
exemplary embodiments of the invention, the expandable prosthesis
is adapted to be inserted between the tendons of the rotator cuff
and the acromion and/or coracoid process. Expandable prosthesis is
biocompatible and/or biodegradable, in an exemplary embodiment of
the invention. Optionally, the expandable prosthesis is adapted to
elute pharmaceutical agents once implanted in a patient's body. In
an embodiment of the invention, inflatable expandable prosthesis is
inflated with filler, for example a gas, liquid, and/or gel.
Optionally, the filler is biocompatible and/or biodegradable,
and/or contains the pharmaceutical agents. In some embodiments,
elution of pharmaceutical agents is according to a schedule timed
with the biodegradable properties of the expandable prosthesis. In
some embodiments of the invention, the prosthesis is only partially
filled.
[0038] In some embodiments of the invention, the prosthesis is
provided with anchoring devices adapted to maintain the prosthesis
in a steady relationship with the anatomical features around the
implantation site. Optionally, the prosthesis is contoured along
its exterior to accommodate anatomical features around the
implantation site.
[0039] An aspect of some embodiments of the invention relates to a
method for implanting an expandable prosthesis adapted to reduce
and/or eliminate injury between soft tissues of the body and other
tissues, for example to the rotator cuff. In an embodiment of the
invention, the expandable prosthesis is either sponge-like or
inflatable and is expanded in a space between the tendons of the
rotator cuff and the acromion and/or coracoid process. In some
embodiments of the invention, a prosthesis implantation and/or
inflation device is used to implant and/or inflate the expandable
prosthesis.
[0040] An aspect of some embodiments of the invention relates to an
expandable prosthesis for treating inflammation and/or infection.
Optionally, the expandable prosthesis is a sponge-like structure,
sponge-like being defined as including at least one of the
following properties: porous, absorbent and/or compressible.
Optionally, the expandable prosthesis is inflatable. Expandable
prosthesis is biocompatible and/or biodegradable, in an exemplary
embodiment of the invention. Optionally, the expandable prosthesis
is adapted to elute pharmaceutical agents once implanted in a
patient's body. Expandable sponge-like device optionally contains
within its cavities at least one biocompatible and/or biodegradable
gelling material that expands when it comes into contact with at
least one bodily fluid, for example by absorbing water.
[0041] In an embodiment of the invention, inflatable expandable
prosthesis is inflated with filler, for example a gas, liquid,
and/or gel. Optionally, the filler is biocompatible and/or
biodegradable and/or contains the pharmaceutical agents. In some
embodiments, elution of pharmaceutical agents is according to a
schedule timed with the biodegradable properties of the expandable
prosthesis.
[0042] In an embodiment of the invention, at least one section of
the prosthesis is inflated with filler, for example a gas, liquid,
cement and/or gel. Optionally, the filler is biocompatible and/or
biodegradable. In some embodiments of the invention, the expandable
prosthesis is adapted to have at least one section removed prior to
closing the patient. In an embodiment of the invention, at least
one section is adapted to withstand the expected pressures. In an
embodiment of the invention, the expandable prosthesis is inflated
and/or implanted using a plurality of prosthesis inflation and/or
implantation devices.
[0043] An aspect of some embodiments of the invention relates to a
prosthesis implantation and/or inflation device. In an embodiment
of the invention, the prosthesis implantation and/or inflation
device includes a syringe designed to inject filler into an
expandable prosthesis, for example through a tube which operatively
connects syringe to the expandable prosthesis. In some embodiments
of the invention, the syringe is comprised of at least a plunger
and a canister. Optionally, the plunger is advanced through the
canister by the device in order to inject filler into the
prosthesis. Optionally, the canister is advanced against the
plunger, which remains relatively fixed due to counterforce from a
backstop, in order to inject filler into the prosthesis.
[0044] In some exemplary embodiments of the invention, the
prosthesis implantation and/or inflation device includes a safety.
Optionally, the safety comprises at least a spring and a ball,
wherein the ball acts as a counterpart to a groove in the backstop.
Excessive force on the backstop by continued advancement of the
canister towards the plunger triggers the safety, popping the ball
out of the groove and freeing the backstop to move. In an
embodiment of the invention, the placement of the backstop is
according to a predetermined level of desired inflation of the
prosthesis.
[0045] There is thus provided in accordance with an embodiment of
the invention, a prosthesis comprising: a member designed to
simulate at least one of a size or a shape of a naturally occurring
bursa.
[0046] In an embodiment of the invention, the member is expandable.
Optionally, the member is designed to be at least partially
inflated. Optionally, the member is inflated sufficiently to reduce
rubbing of the soft tissues against other tissues while permitting
at least some movement of the soft tissues relative to the other
tissues. Optionally, at least some movement of the soft tissues
relative to the other tissues is full movement. In an embodiment of
the invention, the member is sponge-like. Optionally, the
sponge-like member is provided with a fluid absorbent material
which when fluids are absorbed induces expansion of the sponge-like
expandable member.
[0047] In an embodiment of the invention, the prosthesis is
constructed of at least one of a biocompatible or biodegradable
material. Optionally, the at least one of a biocompatible or
biodegradable material is poly(lactice acid-co-epsilon
caprolactone), PCL, PGA, PHB, plastarch material, PEEK, zein, PLA,
PDO, PLGA, collagen or methyl cellulose.
[0048] In an embodiment of the invention, the prosthesis is
constructed of at least one non-biodegradable material. Optionally,
the at least one non-biodegradable material is polyethylene,
polyurethane, silicon, or poly-paraphenylene terephthalamide.
[0049] In an embodiment of the invention, the prosthesis further
comprises a rigid ring having a lumen therein attached to the
member, wherein the lumen provides fluid communication to an inner
space of the member.
[0050] In an embodiment of the invention, the prosthesis further
comprises a plug designed to lodge in the lumen thereby sealing the
inner space of the member. Optionally, the plug is constructed of
at least one of a biocompatible or biodegradable material.
[0051] In an embodiment of the invention, the member is
elastic.
[0052] In an embodiment of the invention, the prosthesis further
comprises at least one anchoring device for stabilizing the
prosthesis upon implantation. Optionally, the at least one
anchoring device is constructed of at least one of a biocompatible
or biodegradable material.
[0053] In an embodiment of the invention, the member is contoured
to act as a counterpart to natural anatomical features of an
implantation site.
[0054] In an embodiment of the invention, the member is designed to
elute at least one pharmaceutical agent.
[0055] In an embodiment of the invention, the size of the
prosthesis is approximately 2 cm to 15 cm in length, optionally 10
cm or less, along a long axis, approximately 2 cm to 10 cm in
length, optionally 7 cm or less, along a short axis and
approximately 0.5 mm to 20 mm in height, when expanded.
[0056] In an embodiment of the invention, the member is rigid.
Optionally, the member is contoured to act as a counterpart to
natural anatomical features of an implantation site while
permitting at least some movement of the soft tissues relative to
other tissues.
[0057] In an embodiment of the invention, the member is designed
for use in a rotator cuff. In an embodiment of the invention, the
member is designed for use in at least one of a flexor or an
extensor. In an embodiment of the invention, the member is designed
for use between a quadriceps and a femur. In an embodiment of the
invention, the member is designed for use between a skin and a
plantar fascia and a calcaneus of the body. In an embodiment of the
invention, injury is at least one of inflammation or infection.
[0058] There is further provided in accordance with an exemplary
embodiment of the invention, a method for implanting a prosthesis
between soft tissues and other tissues of a body, comprising:
placing the prosthesis into an implantation site between the soft
tissues and the other tissues; and, simulating with the prosthesis
a bursa naturally occurring at the implantation site. In an
embodiment of the invention, the method further comprises eluting
at least one pharmaceutical agent from the prosthesis at the
implantation site. Optionally, placing and simulating occurs
without significantly reducing movement of the soft tissues
relative to the other tissues. Optionally, the soft tissues are
tendons of a rotator cuff and the other tissues are at least one of
a humerus, an acromion or a coracoid process.
[0059] There is further provided in accordance with an exemplary
embodiment of the invention, a system for sealing an inflatable
prosthesis, comprising: a prosthesis inflation device; a tube
operatively connected to the prosthesis near one end and the
prosthesis inflation device on the other end; a plug attached to
the tube at the prosthesis end of the tube; and, a rigid ring
attached to the prosthesis and slidably attached around the tube
between the prosthesis inflation device and the plug; wherein
pulling the tube towards the prosthesis inflation device causes
plug to lodge in the rigid ring, sealing the prosthesis with the
plug. Optionally, the plug is attached to the tube by gripping
protrusions.
[0060] There is further provided in accordance with an exemplary
embodiment of the invention, a method of sealing an inflatable
prosthesis, comprising: pulling a tube out of the prosthesis and
through a rigid ring; and, lodging a plug located on the end of the
tube in the rigid ring.
DESCRIPTION OF DRAWINGS
[0061] Non-limiting embodiments of the invention will be described
with reference to the following description of exemplary
embodiments, in conjunction with the figures. The figures are
generally not shown to scale and any measurements are only meant to
be exemplary and not necessarily limiting. In the figures,
identical structures, elements or parts which appear in more than
one figure are preferably labeled with a same or similar number in
all the figures in which they appear, in which:
[0062] FIG. 1 is an illustration of a sponge-like expandable
prosthesis in accordance with an exemplary embodiment of the
invention;
[0063] FIG. 2 is a cutaway view of a portion of a prosthesis
implantation and/or inflation device and an inflatable expandable
prosthesis, in accordance with an exemplary embodiment of the
invention;
[0064] FIG. 3 is an anatomical view of a human shoulder with an
expandable prosthesis in vivo, in accordance with an exemplary
embodiment of the invention;
[0065] FIGS. 4A-C are cutaway side views showing the progression
removably attaching a prosthesis implantation and/or inflation
device and an expandable prosthesis, in accordance with an
exemplary embodiment of the invention;
[0066] FIG. 5 is a cutaway side view of a portion of a prosthesis
implantation and/or inflation device including a counter-pressure
sheath and an expandable prosthesis, in accordance with an
exemplary embodiment of the invention;
[0067] FIG. 6 is a cutaway side view of an alternative sealing
mechanism, in accordance with an exemplary embodiment of the
invention;
[0068] FIGS. 7A-B are flowcharts demonstrating methods of
implanting an expandable prosthesis, in accordance with some
exemplary embodiments of the invention;
[0069] FIG. 7C is a diagram demonstrating pressure-change graphs of
a pressure regulated expandable prosthesis versus an over-inflated
and an under-inflated expandable prostheses, in accordance with
some exemplary embodiments of the invention;
[0070] FIG. 8 is a cutaway side view of an expandable prosthesis
packed prior to use, in accordance with an exemplary embodiment of
the invention;
[0071] FIG. 9 is a perspective view of a device in accordance with
an exemplary embodiment of the invention;
[0072] FIG. 10 is an isometric view of a prosthesis implantation
and/or inflation device and an inflatable expandable prosthesis, in
accordance with an exemplary embodiment of the invention;
[0073] FIG. 11 is a cutaway view of an expandable prosthesis
deployed in a glenohumeral joint, in accordance with an exemplary
embodiment of the invention;
[0074] FIGS. 12A-C are schematic cut views of a prosthesis and a
portion of an implantation and/or inflation device comprising a
pressure regulating valve, in accordance with an exemplary
embodiment of the invention; and
[0075] FIGS. 13A-E are schematic cutaway views and an isometric
view illustrating deployment stages of a prosthesis between two
adjacent joint related tissues, in accordance with an exemplary
embodiment of the invention.
DETAILED DESCRIPTION
[0076] Among those benefits and improvements that have been
disclosed, other objects and advantages of this invention will
become apparent from the following description taken in conjunction
with the accompanying figures. Detailed embodiments of the present
invention are disclosed herein; however, it is to be understood
that the disclosed embodiments are merely illustrative of the
invention that may be embodied in various forms. In addition, each
of the examples given in connection with the various embodiments of
the invention which are intended to be illustrative, and not
restrictive.
[0077] Throughout the specification and claims, the following terms
take the meanings explicitly associated herein, unless the context
clearly dictates otherwise. The phrases "In some embodiments" and
"in some embodiments" as used herein do not necessarily refer to
the same embodiment(s), though it may. Furthermore, the phrases "in
another embodiment" and "in some other embodiments" as used herein
do not necessarily refer to a different embodiment, although it
may. Thus, as described below, various embodiments of the invention
may be readily combined, without departing from the scope or spirit
of the invention.
[0078] In addition, as used herein, the term "or" is an inclusive
"or" operator, and is equivalent to the term "and/or," unless the
context clearly dictates otherwise. The term "based on" is not
exclusive and allows for being based on additional factors not
described, unless the context clearly dictates otherwise. In
addition, throughout the specification, the meaning of "a," "an,"
and "the" include plural references. The meaning of "in" includes
"in" and "on."
[0079] As described above, repeated strenuous motion often causes
sensitive soft tissues associated with a mammalian joint to suffer
wear and tear injuries from repeatedly rubbing against one another
and/or hard tissues, such as bone. Tears of tendons and/or
ligaments and articular capsule disintegration are examples of this
type of injury. In addition, these tissues can be adversely
affected by inflammation, infection, disease and/or genetic
predispositions which lead to degeneration of these tissues.
[0080] Injuries to soft tissues such as tendons can cause pain and
impaired function of the area served by the tendon. Typically, a
bursa can be found near areas where "friction" injuries due to the
rubbing are prone to occur. A bursa is a natural fluid collection
that permits movements between tendons and/or ligaments and bone
parts and prevents injury to these tendons by acting as a cushion
and/or movement facilitator between them.
[0081] In some embodiments of the invention, prostheses described
herein are shaped and/or sized to simulate the natural bursa found
in the intended area of implantation. For example, in some of the
rotator cuff embodiments described below, the described exemplary
prostheses are shaped and/or sized to simulate the subacromial
bursa. Optionally, in some embodiments, the prostheses are sized to
supplement a natural bursa which is misshapen and/or undersized,
bringing the combination of the natural bursa and the prosthesis
into line with the shape and/or size of a healthy bursa.
[0082] In some embodiments of the invention, prostheses described
herein possess characteristics. In some embodiments, the prostheses
described herein are designed and configured to gently resist an
immersion of a bony prominence and to slowly regain at least
partially an expanded size once normal stresses diminishes.
[0083] In some embodiments of the invention, prostheses described
herein include an inflatable chamber (e.g., a bladder) having at
least one malleable wall, optionally elastic or semi-elastic,
optionally made from a non-compliant or a semi-compliant material,
provided in contact with a bony prominence under dynamic and
continuously changing pressures and immersion capacities. In some
embodiments, the wall is subjected to deform by at least partially
imprinting immersions, optionally its deforming does not result in
a substantial increase in stress therein. In some embodiments, the
malleable wall is supported with a fluid, either Newtonian or
non-Newtonian, which fills the chamber to a less than a maximal
inflation volume and therefore allowed to freely flow and
redistribute under continuously changing chamber form and/or
volume. In some embodiments, the chamber is filled to a certain
chosen degree in order that the chamber will avoid bottoming under
maximally known compressive forces, in the sense that any opposing
surfaces thereof will not engage. In some embodiments, a chosen
filling volume is patient-specific, optionally determined according
to a maximally allowed elevated in-chamber pressure at a maximally
known compressive force. In some embodiments, the chamber includes
at least two opposing walls in continuous contact with two opposing
body prominences of a mammalian joint/articulation. In some
embodiments, the walls are nonstretchable in transverse plane of
the prosthesis under normal sear forces created in the articulation
but is pliable other planes. In some embodiments, the at least one
wall or at least two walls are peripherally and/or laterally
supported with a stiffer portion of the chamber, acting as a frame
support.
[0084] In some embodiments of the invention, the described
exemplary prostheses are implanted in a collapsed form thereby
allowing minimally invasive related techniques and instrumentation.
In some embodiments, such implantation may include a delivery to
site via a small incision and/or created passage having a maximally
preferred size (e.g., diameter) equal or less than 5 mm, optionally
equal or less than 3 mm.
[0085] In some embodiments, the described exemplary prostheses are
expanded in site to a first form and/or size, thereby irreversibly
uncollapsible.
[0086] In some embodiments, the described exemplary prostheses are
expanded and/or contracted from the first form and/or size to a
second form and/or size, thereby achieving a chosen dimension,
characteristic and/or functionality derived from the prostheses
form and/or size.
[0087] In some embodiments, the described exemplary prostheses are
regulated such to contract down to a patient-specific and/or a
minimal value and/or to build a maximally allowed inner pressure,
thereby to provide a chosen prosthesis consistency (e.g., a maximal
malleability) but still maintain a minimally allowed distance
and/or avoiding any physical contact between adjacent tissues
(e.g., adjacent joint bones) under any non-breaking compressive
stresses applied to the implanted prosthesis. In some embodiments,
the pressure regulated expandable prostheses of the present
invention are singularly programmed or calibrated to a patient, in
vivo, to thereby set a maximally allowed generated pressure to a
maximal prosthesis contraction under a certain movement scenario of
a hosting environment (e.g., the host shoulder).
[0088] In some embodiments, the present invention relates to joints
including, but not limited to shoulder joints and bodily areas
adjacent joints and/or interlinked with joints' function, such as
the rotator cuff. The rotator cuff is an anatomical term given to
the group of muscles and their tendons that act to stabilize the
shoulder and to permit rotation and abduction of the arm. Along
with the teres major and the deltoid, the four muscles of the
rotator cuff make up the six muscles of the human body which
connect to the humerus and scapula. Injury to the tendons and/or
these muscles can cause pain and impaired function of the shoulder.
The subacromial bursa is a natural fluid collection that permits
movement of these rotator cuff tendons beneath the acromion and
coracoid process, both of which are part of scapula bone. In some
rotator cuff injuries, the subacromial bursa becomes inflamed and
suffers from a reduced ability to prevent injury to the tendons
through friction.
[0089] Referring to FIG. 1, an expandable prosthesis I00 is shown
as an exemplary embodiment of the invention. In an exemplary
embodiment of the invention, expandable prosthesis 100 is
introduced between the above mentioned acromion and coracoid
processes and the rotator cuff tendons and designed to permit
relatively unhindered (relative to the movement afforded to the
shoulder without treatment) or free shoulder movement, shown and
described in more detail with respect to FIG. 3. In some
embodiments of the invention, expandable prosthesis 100 comprises
an expandable member which is a sponge-like structure. In some
embodiments, the sponge-like expandable prosthesis 100 is adapted
to elute pharmacological substances such as anti-inflammatory
and/or antibiotic and/or pro-angiogenesis substances, in some
exemplary embodiments of the invention.
[0090] In an exemplary embodiment of the invention, the expandable
prosthesis 100 is biodegradable and/or biocompatible. In some
embodiments, the sponge-like structure is manufactured from at
least one biodegradable and/or biocompatible synthetic material
such as, but not limited to, polycaprolactone ("PCL"),
polyglycolide ("PGA"), polyhydroxybutyrate ("PHB"), plastarch
material, polyetheretherketone ("PEEK"), zein, polylactic acid
("PLA"), polydioxanone ("PDO"), poly(lactic-co-glycolic acid)
("PLGA"), poly(lactice acid-co-epsilon caprolactone) or any
combination and/or family members thereof. In some exemplary
embodiments of the invention, the sponge-like structure is
manufactured from at least one "naturally-derived" biodegradable
and/or biocompatible materials such as collagen and/or methyl
cellulose. In an exemplary embodiment of the invention, sponge-like
expandable prosthesis 100 is imparted expandable properties, at
least in part, by placing within its cavities at least one
biocompatible and/or biodegradable material which expands after
coming into contact with fluids. Optionally, in some embodiments,
the fluids are bodily fluids. Optionally, in some embodiments, the
at least one biocompatible and/or biodegradable material is a
gel.
[0091] In some embodiments, the implant can be used to prevent pain
and/or friction for a predetermined duration during which there is
at least partial self-healing of adjacent tissues. In some
embodiments, the implant can be used until it is punctured and/or
degraded.
[0092] In some exemplary embodiments of the invention, sponge-like
expandable prosthesis 100 is non-biodegradable. Non-biodegradable
expandable prostheses are manufactured of biocompatible materials
such as polyethylene, Kevlar.RTM. (poly-paraphenylene
terephthalamide), polyurethane or silicon, or any combination
thereof, in some embodiments of the invention. In some exemplary
embodiments of the invention, the expandable prosthesis is
manufactured from biologically derived, biocompatible and/or
biodegradable materials such as collagen. In an exemplary
embodiment of the invention, prosthesis 100, when expanded, has
approximately the same dimensions as other prostheses when
expanded, described below.
[0093] Referring to FIG. 2, a cutaway view of a portion of a
prosthesis implantation and/or inflation device 200 and a
prosthesis 202 with an expandable member which is inflatable is
shown, in accordance with an exemplary embodiment of the invention.
In an exemplary embodiment of the invention, inflatable expandable
prosthesis 202 is introduced between the acromion and coracoid
processes and the rotator cuff tendons designed to permit
relatively unhindered or free shoulder movement, shown and
described in more detail with respect to FIG. 3. Optionally, in
some embodiments, alternatively and/or additionally, an expandable
prosthesis comprises an inflatable structure and a sponge-like
structure in combination.
[0094] In an exemplary embodiment of the invention, inflatable
expandable prosthesis 202 is rectangular shaped when deflated and
resembles a cuboid parallelepiped when inflated. In an exemplary
embodiment of the invention, inflatable expandable prosthesis 202
is circular or oval in shape when deflated and when inflated
resembles a cylindrical disc or ovoid. In some embodiments, many
shapes could be adapted to be implanted between the acromion and
coracoid processes and the rotator cuff tendons designed to permit
relatively unhindered or free shoulder movement for a patient, in
an exemplary embodiment of the invention. In some embodiments of
the invention, prosthesis 202 is adapted to be inserted deflated
into a patient's body through a cannula. Optionally, in some
embodiments, the cannula is a 5 mm-7 mm cannula. In an embodiment
of the invention, a long axis 207 (x-axis) of inflatable expandable
prosthesis 202 is approximately 2 cm to 10 cm in length when
inflated, in some embodiments of the invention, a short axis 208
(y-axis) of inflatable expandable prosthesis 202 is approximately 2
cm to 10 cm in length when inflated. In some exemplary embodiments
of the invention, inflatable expandable prosthesis 202 is 0.5 mm to
20 mm in height (z-axis). Optionally, in some embodiments,
inflatable expandable prosthesis 202 is 1 mm to 10 mm in height. In
some embodiments, the deflated and/or inflated size of prosthesis
202 may be adapted to fit for a patient's particular needs or to
simulate the size and/or shape of the natural bursa, in an
embodiment of the invention, and therefore, prosthesis 202 does not
necessarily conform to the size ranges given above.
[0095] In some embodiments, inflatable expandable prosthesis 202 is
manufactured by dip molding, in an exemplary embodiment of the
invention. In some embodiments of the invention, inflatable
expandable prosthesis 202 is a seamless balloon-like structure made
from biocompatible and/or biodegradable synthetic materials such
as, but not limited to; PCL, PGA, PHB, plastarch material, PEEK,
zein, PLA, PDO, PLGA, poly(lactice acid-co-epsilon caprolactone) or
any combination and/or family members thereof.
[0096] Additionally, optionally and/or alternatively, in some
embodiments, inflatable expandable prosthesis 202 is manufactured
from natural, biocompatible and/or biodegradable materials such as
collagen and/or methyl cellulose. In some exemplary embodiments of
the invention, the inflatable prosthesis 202 is manufactured from
at least one non-biodegradable material such polyethylene,
polyurethane, silicon, and/or Kevlar.RTM.. In an embodiment of the
invention, prosthesis 202 is comprised of a material which is
approximately 100-200 microns in thickness, although, as with the
other dimensions, the thickness dimension of the material is
adapted depending on the intended use and/or the needs of the
patient. In some exemplary embodiments of the invention, inflatable
expandable prosthesis 202 is adapted to elute pharmaceuticals such
as anti-inflammatory drugs and/or antibiotics and/or
pro-angiogenesis factors to promote healing.
[0097] Inflatable expandable prosthesis 202 is releasably attached
to prosthesis implantation and/or inflation device 200, in an
exemplary embodiment of the invention. Prosthesis implantation
and/or inflation device 200 is adapted to inflate and/or deflate
prosthesis 202, allow prosthesis 202 to be positioned in vivo,
and/or separate from prosthesis 202 after implantation, leaving
prosthesis 202 at the implantation site, in an embodiment of the
invention. In some exemplary embodiments of the invention,
prosthesis implantation and/or inflation device 200 includes a tube
or catheter type structure 204 which interfaces with prosthesis 202
in the proximity of a sealing mechanism 206 which is located at the
end of tube 204 nearest prosthesis 202.
[0098] In an embodiment of the invention, sealing mechanism 206
includes a plug 402, shown in FIG. 4B inter alia, attached to the
end of tube 204 nearest prosthesis 202. In an embodiment of the
invention, plug 402 is constructed of the same material or
materials as any of the prostheses described herein. In some
embodiments, tube 204 is adapted to allow passage therethrough of a
filler to inflate prosthesis 202, for example by placing at least
one orifice 404 in tube 204. In some embodiments of the invention,
the filler is air. Additionally, alternatively and/or optionally,
in some embodiments, the filler is a biodegradable and/or
biocompatible material and/or fluid. In some embodiments, the
biodegradable material and/or fluid is saline. In some embodiments
of the invention, the filler is a gel and/or liquid. In an
embodiment of the invention, tube 204 is provided with gripping
protrusions 406 in order to increase the contact surface between
tube 204 and plug 402 and therefore the force that may be applied
to plug 402 when sealing prosthesis 202. In some embodiments of the
invention, plug 402 is ovoid shaped, and/or has a shape such that
plug's 402 loose end 408 is larger than the attached end 410 so
that, as described in more detail below with respect to FIGS. 4A-C,
5 and 7, plug 402 seals inflatable expandable prosthesis 202 during
implantation.
[0099] FIGS. 4A-C are cutaway side views showing the progression of
removably attaching prosthesis implantation and/or inflation device
200 and prosthesis 202, in accordance with an exemplary embodiment
of the invention. Referring to FIG. 4A, in some embodiments, a
rigid ring 412 is cast on and/or connected to tube 204 of
prosthesis implantation and/or inflation device 200, in an
embodiment of the invention. In an embodiment of the invention,
rigid ring 412 fits snugly onto tube 204 such that air and/or other
fluid injected into prosthesis 202 does not escape via the
intersection of rigid ring 412 and tube 204, however tube 204 is
slidable in relation to rigid ring 412. This slidability is used,
for example, when prosthesis implantation and/or inflation device
200 is separated from prosthesis 202 in accordance with an
exemplary embodiment of the invention. In an exemplary embodiment
of the invention, plug 402 is cast on tube 204 such that gripping
protrusions 406 grasp at least a portion of attached end 410 of
plug 402, shown in FIG. 4B. Optionally, mold injection and/or dip
molding, and/or any other method known in the art, may be used for
manufacturing plug. At least tube 204 and/or plug 402 and/or rigid
ring 412 are made of biodegradable and/or biocompatible materials,
in an embodiment of the invention.
[0100] In some embodiments, rigid ring 412 is cast on or connected
to tube 204 before plug 402 is cast tube 204 because in an
exemplary embodiment of the invention, plug 402 has a larger
diameter than the inner diameter of rigid ring 412 thereby
preventing plug 402 from passing through rigid ring 412. In an
embodiment of the invention, inflatable expandable prosthesis 202
is placed around plug 402 and tube 204 such that tube 204 and plug
402 extend into a cavity proscribed by prosthesis 202. Prosthesis
202 is attached to an exterior surface of rigid ring 412 such that
air and/or other fluid injected into prosthesis 202 does not escape
via the intersection of prosthesis 202 and rigid ring 412, in an
embodiment of the invention. Optionally, a thermal and/or chemical
method is used to attach prosthesis 202 to rigid ring 412.
[0101] FIG. 5 shows an assembly 500 including a portion 502 of
inflation device 200 and a portion 504 of expandable prosthesis 202
further comprising a counterforce ring 506, in accordance with an
exemplary embodiment of the invention. In an embodiment of the
invention, counterforce ring 506 is adapted to apply counterforce
to rigid ring 412 during separation of prosthesis inflation device
200 from prosthesis 202, as described in more detail below with
respect to FIG. 7. In some embodiments of the invention,
counterforce ring 506 is constructed of a biocompatible material,
for example stainless steel and/or plastic, that is approximately
at least as hard as rigid ring 412.
[0102] In some embodiments of the invention, at least one pressure
regulating valve 600, shown in FIG. 6, is used in addition to or
alternatively to plug 402 and rigid ring 412 for sealing prosthesis
202 after at least partially inflating prosthesis 202 with
prosthesis implantation and/or inflation device 200. In some
embodiments, pressure regulating valve 600 release of filler based
on a predetermined and/or pre-set pressure in the prosthesis 202.
In some embodiments, pressure regulating valve 600 allows
unhindered inflation but allows deflation based on a predetermined
pressure inside prosthesis 202. In some embodiments, the maximal
inflation volume is between 5 to 100 cubic centimeters (cc),
optionally 10 to 60 cc, optionally 15 to 45 cc, or higher, or
lower, or intermediate. In some embodiments, the final (partially
inflated) volume is between 0.5 to 60 cc, optionally 5 to 40 cc,
optionally 9 to 30 co, or higher, or lower or intermediate. In some
embodiments, inflating the implant by adding a first amount of
filler causes the implant to fully expand, fully unroll, and/or
expand a void to a predetermined shape and/or size.
[0103] In some embodiments, pressure regulating valve 600 is
deployed for effective operability at a certain/chosen interval
during implantation, deploying and/or setting up of prosthesis 202
at the hosting environment. In some embodiments, pressure
regulating valve 600 is set to operate after inflating prosthesis
202 to a maximal or otherwise chosen value. In some embodiments,
pressure regulating valve 600 allows filler to be released out
until pressure in prosthesis 202 goes down to a chosen value, e.g.,
a maximally allowed pressure. In some embodiments, the pressure
regulating valve 600 allows filler to be released into a void space
in the joint. This is achievable, for example, if pressure
regulating valve 600 is set to burst over a threshold value which
may be same or slightly greater or smaller than the maximally
allowed pressure. Certain external forces may be applied, either
passively by a physician and/or actively by the patient, for
example forces exerted by maneuvering the hosting environment
(e.g., the joint or an adjoined arm), to thereby expel out from
prosthesis 202. After utilizing pressure regulating valve 600, in
some embodiments, it may then be neutralized or discarded and/or
prosthesis 202 may be sealed.
[0104] In some embodiments, the pressure regulating valve 600 is
attached to the prosthesis. In some embodiments, the pressure
regulating valve is external from the implant. In some embodiments,
the pressure regulating valve 600 is biodegradable and/or
biocompatible. In some embodiments, the valve 600 is manufactured
from at least one biodegradable and/or biocompatible synthetic
material such as, but not limited to, polycaprolactone ("PCL"),
polyglycolide ("PGA"), polyhydroxybutyrate ("PHB"), plastarch
material, polyetheretherketone ("PEEK"), zein, polylactic acid
("PLA"), polydioxanone ("PDO`), poly(lactic-co-glycolic acid)
("PLGA"), poly(lactice acid-co-epsilon caprolactone) or any
combination and/or family members thereof. In some exemplary
embodiments of the invention, the valve is manufactured from at
least one "naturally-derived" biodegradable and/or biocompatible
materials such as collagen and/or methyl cellulose.
[0105] In some exemplary embodiments of the invention, valve 600 is
non-biodegradable. Non-biodegradable valves 600 are manufactured of
biocompatible materials such as polyethylene, Kevlar.RTM.
(poly-paraphenylene terephthalamide), polyurethane or silicon, or
any combination thereof, in some embodiments of the invention. In
some exemplary embodiments of the invention, the valve 600 is
manufactured from biologically derived, biocompatible and/or
biodegradable materials such as collagen.
[0106] FIG. 3 shows an anatomical view of a human shoulder 300 with
an expandable prosthesis 100, 202 in vivo, in accordance with an
exemplary embodiment of the invention. Prosthesis 100, 202 is
inserted between the acromion 302 and the coracoid process 304, in
an embodiment of the invention. In some embodiments of the
invention, prosthesis 100, 202 and any other prosthesis described
herein, is inserted proximal to the bursa 306. Optionally, if there
is no bursa 306 of any remarkable size, the prosthesis is inserted
in lieu of bursa 306. In an embodiment of the invention, an
implanted prosthesis, such as those described herein, is adapted to
cover the humerus head during shoulder 300 motion, while remaining
relatively fixed in relation to the acromion 302 and/or the
coracoid process 304.
[0107] In some embodiments of the invention, an anchoring
expandable prosthesis is adapted to prevent and/or reduce injury to
the rotator cuff and/or to permit relatively unhindered or free
shoulder movement, for example if the rotator cuff soft tissues are
partially or completely torn and/or deteriorated. In some
embodiments, the anchoring expandable prosthesis comprises an
expandable member and at least one anchoring device which is
adapted to be attached to a part of the patient, for example the
humerus head/tendons, acromion and/or coracoid process, thereby
anchoring the prosthesis in place. In an embodiment of the
invention, the anchoring expandable prosthesis comprises at least
one anchoring device attached to an expandable portion adapted to
operate similarly to prostheses 100, 202. The at least one
anchoring device is manufactured of biocompatible and/or
biodegradable or non-biodegradable metals and/or alloys and/or
composites, for example titanium, stainless steel or magnesium
alloys. In an embodiment of the invention, the expandable portion
is manufactured of biocompatible and/or biodegradable or
non-biodegradable materials such as high density polyethylene or
those described with respect to prostheses 100, 202. In an
embodiment of the invention, the at least one anchoring device is
attached to the expandable member using filaments and/or wires.
[0108] In some embodiments of the invention, prostheses described
herein are adapted for anchoring, for example by contouring the
outer surface such that surrounding tissues can be placed within
the contours, thereby "anchoring" the device. In some embodiments
of the invention, the contours are adapted to act as counterparts
to anatomical features at the implantation site, whereby the
features settle into the contours upon implantation, but still
permit relatively unhindered movement of the treated area.
[0109] Alternatively, in some embodiments, the prostheses 100, 202
do not include anchoring and kept in place and/or be allowed to
partial and/or limited relative movement with a tissue in contact
due to shape correlation in the void maintained by peripheries of
adjacent tissues. In some embodiments, prostheses 100, 202 are
adapted for moving in a limited range of motion, optionally
reflecting changes in surrounding boundaries due to joint movement.
Such movements may alternatively or additionally derive from
shifting between static to kinetic dry friction forces created
between a surface of a prosthesis in contact with a moving tissue.
In some embodiments, the prosthesis is selectively changed to
impose a chosen maximal friction characteristic (e.g., a maximally
allowed static friction force between a surface and a specific
tissue type in contact), for example a friction coefficient and/or
a normal force applied to the tissue in contact.
[0110] In some embodiments, prostheses 100, 202 are shaped,
internally pressurized and/or inflated/deflated to a degree which
maintains or facilitates, optionally in an allowed range of motion,
a stable equilibrium in which the prosthesis will restore a nominal
position when the joint returns to a non- of a less-stressed
position and/or when the void substantially returns to a nominal
shape and/or size, such as a shape and/or size during prosthesis
implantation. Alternatively or additionally, prostheses 100, 202
are shaped, internally pressurized and/or inflated/deflated to a
maximal predetermined or patient-specific size (e.g., a height);
optionally while substantially not changing other dimensions (e.g.,
width and/or thickness), thereby avoiding potential dislocations
due to tissue (e.g., bony tissues) movements in the void. For
example, an acromion portion may enter and/or decrease the height
of the void (in this example: the subacromial space or portion
thereof) during a shoulder movement (e.g., flexion and/or
extension/external rotation) so if the prosthesis is inflated to a
height greater than the void's decreased height, it may be forced
by the acromion portion to dislocate; optionally out of the allowed
range of motion and/or to an unstable equilibrium in an embodiment
of the invention.
[0111] As mentioned above, prostheses 100, 202, and/or any of the
other prostheses described herein, may be designed for use in
places where there is sliding of soft tissues or other tissues,
such as tendons against other tissues, such as bones as: a) between
the quadriceps and femur after operations on the knee, b) near the
finger flexor and/or extensor to prevent adhesions, for treatment
of ailments such as carpal tunnel syndrome and/or, c) between the
skin and plantar fascia and calcaneus in case of calcaneal spur, in
some exemplary embodiments of the invention. As described above,
the prosthesis used for treatment of particular ailments is sized
and/or shaped to simulate the natural bursa found at the location
being treated, in an exemplary embodiment of the invention, in some
embodiments, same or different sliding characteristics facilitated
by the prostheses of the present invention allow relative motion
between hard tissue types, such as cartilages and/or bones, for
example when tendons and ligaments are completely torn.
[0112] In an embodiment of the invention, an expandable prosthesis
which is at least slightly elastic, but not inflatable, is designed
to permit relatively unhindered or free shoulder movement. In some
embodiments of the invention, the elastic prosthesis is
manufactured from polyethylene and/or silicon and/or in combination
with metals, such as titanium. Optionally, the elastic prosthesis
is contoured to serve as a counterpart to the surfaces with which
it will come into contact. For example in the case of a rotator
cult; the elastic prosthesis may be contoured to fit at least the
acromion.
[0113] In an embodiment of the invention, a prosthesis is provided
which is substantially rigid. The rigid prosthesis is constructed
of a biocompatible material, for example stainless steel and/or a
hard plastic: in some embodiments of the invention. Optionally, in
some embodiments, the rigid prosthesis is also biodegradable. In
some embodiments of the invention, the rigid prosthesis is adapted
to act as a counterpart to at least one anatomical feature at the
implantation site, whereby the feature mates with the rigid
prosthesis upon implantation, but still permits relatively
unhindered movement of the treated area. As an example, the rigid
prosthesis is adapted to mate with both the humerus head and the
acromion upon implantation, in an embodiment of the invention.
[0114] Referring to FIG. 7A, a method 700 of implanting an
expandable prosthesis 100, 202, or any other prosthesis described
herein is described, in some exemplary embodiments of the
invention. In an embodiment of the invention, implantation method
700 is adapted for implantation of prostheses 100, 202, or any
other prosthesis described herein, into the shoulder of a patient
to prevent and/or reduce injury to the rotator cuff and/or to
permit relatively unhindered or free shoulder movement. In an
embodiment of the invention, prostheses 100, 202, or any other
prosthesis described herein, are introduced percutaneously or by
making (702) a small incision, optionally performed by posterior,
lateral or anterior approaches using, for example, palpation,
arthroscopy, ultrasound ("US"), computed tomography ("CT"),
magnetic resonance imaging ("MRI"), fluoroscopy, transmission scan
("TX"), or any combination thereof. In an embodiment of the
invention, a needle is inserted (704) into the void space between
the rotator cuff tendons and the acromion 302 and coracoid process
304. A guide wire is introduced (706) via the needle into the void
space between the rotator cuff tendons and the acromion 302 and
coracoid process 304, in an exemplary embodiment of the invention.
In some embodiments of the invention, a dilator is placed (708)
over the guide wire and extended into the space. Subsequently, a
trocar of the dilator is removed (710), leaving a dilator sheath in
place in some embodiments.
[0115] In an embodiment of the invention, inflatable expandable
prosthesis 202 is placed (712) into the void space using the
dilator sheath and/or the prosthesis inflation device 200 for
guidance and/or movement impetus. Once prosthesis 202 is
approximately in the proper position, in some embodiments, the
dilator sheath and an external sheath 802 of prosthesis inflation
device 200, shown and described in more detail with respect to FIG.
8, are withdrawn (714) to allow for inflation (716) of prosthesis
202. Inflation (716) using prosthesis inflation device 200 is
described in more detail below. Inflation (716) of prosthesis 202
is achieved, in some embodiments of the invention, during
arthroscopy. In some embodiments of the invention, for example if
prosthesis 202 is implanted during open surgery or arthroscopy,
proper deployment of prosthesis 202 is ascertained by visual
inspection of prosthesis 202. In an embodiment using arthroscopy,
prosthesis may be introduced through an arthroscopy port. In some
embodiments of the invention, inflation (716) is achieved using
palpation and US guidance to ascertain proper deployment of
prosthesis 202. In some embodiments of the invention, inflation
(716) is achieved using fluoroscopy to ascertain proper deployment
of prosthesis 202. Proper deployment of prostheses, in some
embodiments of the invention, means no interposition of tendons
and/or other soft tissue between the implanted prosthesis and
acromion 302 or coracoid process 304 and/or that during movement of
the humerus, the prosthesis remains below acromion 302.
[0116] Inflation (716) of prosthesis 202 is performed using
prosthesis inflation device 200, in an embodiment of the invention.
Referring to FIG. 8, an expandable prosthesis 202 is shown packed
for implantation and prior to deployment, in accordance with an
exemplary embodiment of the invention. Components of the assembly
800 are enclosed in an external sheath 802 which surrounds at least
prosthesis 202, in an exemplary embodiment of the invention.
External sheath 802 is adapted to maintain prosthesis 202 in a
collapsed condition during placing (712) in order to ease insertion
of prosthesis 202 into the implantation space or site through the
dilator sheath, in an embodiment of the invention. As described
above, once prosthesis 202 is in the implantation space, external
sheath 802 is removed, enabling prosthesis 202 to be inflated
without hindrance apart from the body parts against which
prosthesis 202 is pressing in an embodiment of the invention.
[0117] In an embodiment of the invention, inflation (716) of
prosthesis 202 is performed by adding a sufficient filler such as
physiologic fluid such as saline, Hartman or Ringer solutions
and/or any other biocompatible and/or biodegradable fluid. In some
embodiments of the invention, inflation (716) is performed using a
biocompatible and/or biodegradable gel. In an embodiment of the
invention, inflation (716) of prosthesis 202 is performed using a
gas, for example air and/or carbon dioxide. In some embodiments of
the invention, the inflating gel and/or fluid contains
pharmaceutical agents, for example anti-inflammatory drugs and/or
antibiotics and/or pro-angiogenesis factors to promote healing,
which are eluted into the patient's body. In some embodiments of
the invention, prosthesis 202 is inflated to the maximum volume
possible without reducing the shoulder's range of movement. In an
embodiment of the invention, prosthesis 202 is filled to less than
its maximum volume in order to permit shifting of the contents of
prosthesis 202 during movement. Optionally, in some embodiments,
the prosthesis 202 is filled to 50%-70% of its maximal inflation
volume (for example, an expandable member with a 14 cc volume is
filled with 9 cc of filler). It should be noted that other
prosthesis embodiments described herein are deployed in a similar
fashion, in some embodiments of the invention.
[0118] Sealing (718) of prosthesis 202, once inflated to the
desired level, is performed by pulling tube 204 towards rigid ring
412 as they slide in relation to one another plug 402 becomes
lodged in a lumen 804 of rigid ring 412 and continued pulling
brings rigid ring 412 into contact with counterforce ring 506, in
an embodiment of the invention. In an embodiment of the invention,
tube 204 passes through lumen 804 with lumen 804 providing fluid
communication between prosthesis implantation and/or inflation
device 200 and an inner space defined by the dimensions of
prosthesis 202. In an embodiment of the invention, an attending
medical professional performing the implantation procedure holds
counterforce ring 506 substantially steady while pulling on tube
204 away from the patient. Optionally, in an embodiment, prosthesis
inflation device 200 is adapted to perform the steadying of
counterforce ring 506 and/or retraction of tube 204 automatically.
In some embodiments of the invention, a mechanism is provided to
prosthesis inflation device 200 which translates rotational
movement to a retracting force on tube 204. Optionally, rotation
movement is applied manually.
[0119] Continued pulling ("retraction" away from patient) of tube
204 causes a portion of plug 402 to break off, the portion of plug
402 lodging itself in lumen 804 of rigid ring 412 thereby sealing
(718) prosthesis 202. In some embodiments of the invention, the
portion of plug 402 becomes partially deformed as it lodges in
lumen 804. Prosthesis inflation device 200 (referred to as
"implantation device" in the figure), now being separated from
prosthesis 202 as a result of sealing (718) is withdrawn (720) from
the patient and patient is closed, in an exemplary embodiment of
the invention. It should be understood that in some embodiments of
the invention, a sponge-like expandable prosthesis device is used
and therefore, inflation (716) and inflation related actions may
not be carried out, for example prosthesis 100 expands rather than
inflates.
[0120] In an exemplary embodiment of the invention, the implanted
prosthesis is secured, using methods known in the art, to soft
tissue and/or bone to prevent the prosthesis from being easily
displaced by shoulder movement. In some embodiments of the
invention, sutures, clips and/or anchors are used to secure the
prosthesis in place. Optionally, an anchoring expandable prosthesis
is used. In an embodiment of the invention, simulating a naturally
occurring bursa using a prosthesis is an action taken with respect
to method 700. Optionally, simulating is related to inflation (716)
in that the prosthesis is inflated to resemble the appropriate size
and/or shape and/or characteristics (malleability, compressibility,
etc.) of the naturally occurring bursa. In an embodiment of the
invention, placing the prosthesis at the implantation site and
simulating a naturally occurring bursa does not significantly
reduce movement of the soft tissues being protected in relation to
the other tissues at the implantation site.
[0121] In an exemplary embodiment of the invention, prosthesis 100
is implanted by placing prosthesis 100 into a cannula, such as
those described elsewhere herein, and advancing it to the
implantation site using a plunger.
[0122] In an exemplary embodiment of the invention, prosthesis 100
or the elastic prosthesis, described above, is implanted by
inserting the device directly through a small incision, without a
cannula, near the implantation site.
[0123] FIG. 7B shows a method for implanting prostheses 100, 202,
or any other prosthesis described herein according to another
embodiment. In an embodiment, an incision is made (731) as known in
the art and/or similar to step 702 above. Optionally, in some
embodiments, a passage from incision and/or an implantation space
are created (732). Passage and/or implantation space may be created
(732) manually/digitally and/or by using a dedicated instrument,
such as a dilator in some embodiments. Alternatively, a passage
and/or an implantation space are anatomically and/or readily
present in some embodiments. Alternatively or additionally, a
passage to an anatomical space (e.g., a subacromial space) is
created (732) by pushing therethrough the prosthesis and/or any
implantation/delivery apparatus in some embodiments. Once the
implantation site is located and/or prepared, as discussed above, a
sized prosthesis, such as any of prostheses 100, 202, or any other
prosthesis described herein, is introduced and placed (733) into
the implantation space in a collapsed and/or rolled form through
the incision in some embodiments. In some embodiments, prostheses
100, 202, or any other prosthesis described herein is introduced
(712) covered, at least partially, with a protective sheath or a
cannula, which is then withdrawn and removed (734). An outer
diameter of the protective sheath may be 10 mm or less, optionally
6 mm or less in some embodiments. In some embodiments, the
prosthesis and/or protective sheath and/or introducer is inserted
with or followed by a camera or any other imaging device.
[0124] The prosthesis is then inflated (735), for example by adding
a sufficient amount of filler such as saline thereto, for example
as described above as with respect to step 716. In some
embodiments, the prosthesis is filled with a sufficient amount of
filler X to or over a predetermined or a chosen degree, optionally
to over 70% of its maximal inflation volume, optionally 90-100% of
its maximal inflation volume. In some embodiments, the prosthesis
is then deflated by releasing an amount of filler Y from the
implant to a lesser degree, optionally to a final chosen
characteristic (e.g., a volume and/or consistency), optionally to
less than 70% of its maximum volume, optionally 50-70%, optionally
to less than 50% its maximal inflation volume.
[0125] In some embodiments, the ratio of X:Y is less than or equal
to 10:1. In some embodiments, the ratio of X:Y is less than or
equal to 7:1. In some embodiments; the ratio of X:Y is less than or
equal to 4:1. In some embodiments, the ratio of X:Y is less than or
equal to 2:1. In some embodiments, the ratio of X:Y is less than or
equal to 1.5:1. In some embodiments, the ratio of X:Y is less than
or equal to 1.3:1. In some embodiments, the ratio of X:Y is less
than or equal to 1.2:1. In some embodiments, the ratio of X:Y is
less than or equal to 1.1:1.
[0126] In some embodiments, deflation occurs by using inflation
device 200 (or any other fluid passing means) in a reverse mode.
Alternatively or additionally, in some embodiments, pressure
regulator means are deployed (736), such as pressure regulating
valve 600, allowing filler expulsion or release when the prosthesis
is pressurized to over a predetermined pressure such as by
articulation of a joint. In some embodiments, the pressure
regulating valve 600 is preset to burst at or over a threshold
pressure of 1 psi, optionally at or over about 5 psi, optionally at
or over 8 psi, optionally at or over 12 psi, optionally at or over
20 psi.
[0127] In some embodiments, actual deflation occurs by applying
(737) external forces to the fully expanded prosthesis via its
surrounding environment (e.g., tissues surrounding and/or
supporting the implantation space and/or engage with the
prosthesis). In some embodiments, external forces are applied by
articulating the shoulder joint or moving the shoulder in a chosen
range of motion (ROM) scenario, in a manner that contracts the
prosthesis and increases its internal pressure. Such ROM may
include a set of maneuvers, some of which may instantly build
pressures peaks which are over the predetermined pressure, thereby
allowing filler release through pressure regulating valve 600 until
the prosthesis inner pressure decreases to under the threshold
pressure. The ROMs may be passive in the sense that no intentional
or unintentional patient related force and/or muscle tone is
actively present but only maneuvers performs by the physician when
the patient is anesthetized. In some embodiments, such deflation
scheme may be used as the prosthesis is patient-specific
calibrated. After prosthesis adjustment, pressure regulating valve
600 is neutralized, deactivated or removed and the prosthesis is
sealed (738) in some embodiments. Inflation device 200 is then
withdrawn and the incision is closed (739) as known in the art
and/or as with respect to step 720 above in some embodiments.
[0128] It should be noted that the methods shown and described with
respect to FIGS. 7A-B are by way of example only, and that similar
methods could be used for implantation of any bursa simulating
prosthesis designed for use between soft tissues and other tissues
of the body.
[0129] FIG. 7C shows a diagram 740 which is purely schematic and
illustrative, demonstrating a pressure-change graph 742 of a
prosthesis, such as prostheses 100, 202, or any other regulating
valve 600, and that is readily implanted using method 730. Graph
742 is presented versus equivalent graphs of identical prostheses
being inflated to a chosen degree with no prosthesis and graph 746
of an under-inflated prosthesis. The horizontal axis is set
according to the variable ROM maneuvers which may be present as a
sequence of prosthesis pressurizations in time, and is referred to
as "ROM." The vertical axis presents the variable pressure P that
is built in the prostheses in view of the variable ROM. As shown,
all graphs include several pressure peaks which present sudden
increases of inner pressure due to maximal decrease in volume of
the sealed prostheses. Certain movements, e.g., max flexion or
extension, may cause highest pressure peaks, although this may be
mostly dependent on other patient-specific factors such as the
prosthesis surrounding environment (e.g., its consistency, geometry
and/or size) and/or its engagement with the prosthesis periphery
(e.g., slight over-sizing or under-sizing at nominal positioning,
etc.). Graph 742 includes max peaks which stop at (or otherwise be
only less than) a maximally allowed pressure P.sub.max which was
set during ROM scenario at step 737 in prosthesis implantation
method 730 using valve 600 preset with a threshold pressure
substantially same or similar to P.sub.max. Graph 744 shows the
pressurization curve of the over-inflated prosthesis under ROM
having two peaks which are over the maximally allowed pressure
P.sub.max. At such pressure peaks, the prosthesis is prone to be
compressed and/or contracted to such a degree where its two
confronting walls may be too close and even in-contact, an
undesired possibility which may cause pain, illness and/or
prosthesis failure and malfunction. Moreover, the average inner
pressure, including a minimal pressure substantially over
P.sub.min, suggests that the prosthesis is substantially stiffer
than desired and therefore may be prone to migrate on certain joint
movements. Therefore application of pressure regulating means may
ease and/or facilitate boundaries for any expected generated
pressure, prosthesis compression and/or possible migration. Graph
746 shows the pressurization curve of the under-inflated prosthesis
under ROM: although having no peak which crosses or even come close
to maximally allowed pressure P.sub.max, it is prone to instances
in which inner pressure will be less than a minimal value
P.sub.min, especially when no external forces are applied thereto.
This way, the prosthesis may not function properly as a spacer,
sliding surface and/or a cushion and may even be prone to unstable
equilibrium by which certain movements will cause it to permanently
shift out of place. This emphasizes an advantage of first inflating
the prosthesis to a certain degree higher than a chosen threshold
value, and even providing pressure regulating means.
[0130] FIG. 9 is a perspective view of a device 1200 in accordance
with an exemplary embodiment of the invention. In an embodiment of
the invention, device 1200 is a sponge-like device 1200 is adapted
to be placed at a site in the body for treating inflammation and/or
infection, in an embodiment of the invention.
[0131] In an exemplary embodiment of the invention, a sponge-like
device 1200 is manufactured of biocompatible and/or biodegradable
synthetic materials such as, but not limited to, PLA, PLGA, PCL,
PDO, poly(lactice acid-co-epsilon caprolactone) or any combination
thereof. Alternatively and/or additionally and/or optionally, in
some embodiments, the sponge-like device 1200 may be manufactured
from biologically derived biodegradable materials such as collagen.
Expandable sponge-like device 1200 optionally contains within its
cavities at least one biocompatible and/or biodegradable gelling
material, such as methyl cellulose, agarose, poly(ethylene-glycol)
("PEG") gel and/or PLA gel, that expands when it comes into contact
with at least one bodily fluid, for example by absorbing water. In
an embodiment of the invention, such absorption is partly
responsible for an expansion of sponge-like device 1200 into its
intended deployed position.
[0132] As described above, in some exemplary embodiments of the
invention, device 1200 comprises an inflatable structure. In an
embodiment of the invention, inflatable device 1200 is constructed
of at least one biocompatible and/or biodegradable material, such
as those described herein. In some embodiments of the invention,
inflatable device 1200 is spherical or cylindrical, having a
diameter of 0.5 cm to 5 cm for a sphere or in the long direction
(x-axis) and 0.5 cm to 4 cm in the short direction (y-axis) and a
height (z-axis) of 0.5 mm to 20 mm. In some embodiments of the
invention, device 1200 is adapted to be inserted deflated into a
patient's body through a cannula. Optionally, the cannula is a 5
mm-7 mm cannula. Optionally, device 1200 dimensions are adapted for
a particular intended use.
[0133] In some exemplary embodiments, device 1200 is inflated
and/or implanted as described herein with respect to prostheses 100
and 202. Device 1200 optionally contains pharmaceutical agents, for
example anti-inflammatory drugs and/or antibiotics and/or
pro-angiogenesis factors to promote healing, which are eluted into
the body. In some embodiments of the invention, device 1200 is
adapted to elute pharmaceutical agents according to a predefined
schedule. Adaptation of device 1200 includes construction of device
1200 using materials or combinations of materials which degrade at
a predetermined rate, thereby releasing pharmaceutical agents
contained therein at a predetermined rate. In an exemplary
embodiment of the invention, more than one device 1200 is used for
treating inflammation and/or infection. Optionally, each device is
adapted to elute pharmaceutical agents in view of an overall plan
incorporating a plurality of devices.
[0134] In another exemplary embodiment of the invention, an
expandable device, such as those described herein, is adapted to be
used near an articulation to reinforce the articular capsule. In an
embodiment of the invention, the expandable device is introduced in
anterior fashion to the shoulder articulation between the articular
capsule and the deltoid and pectoralis muscle, in order to prevent
recurrent dislocation of the shoulder. In another embodiment, the
expandable device is introduced in front of the hip joint capsule
to prevent anterior dislocation of the hip, especially in cases of
congenital dysplasia of hip. In an exemplary embodiment of the
invention, the expandable device consists of in inflatable member
made of biocompatible and/or biodegradable material. In some
embodiments of the invention, the expandable device has a diameter
of 1 cm to 10 cm in the long direction (x-axis) and 1 cm to 9 cm in
the short direction (y-axis) with a height (z-axis) of 0.5 mm to 25
mm. Optionally, the device has a height of 3 mm to 15 mm.
[0135] Reference is now made to FIG. 10 which shows an isometric
view of a prosthesis implantation and/or inflation device 2000
readily connected to an inflatable expandable prosthesis 2100, in
accordance with an exemplary embodiment of the invention.
[0136] Prosthesis 2100 which is shown fully expanded may be any of
the previously described prostheses or may include at least one
characteristic thereof, in some embodiments, prosthesis 2100 is an
inflatable implant adapted to reach, at a maximal or over a
predetermined partial inflation volume, a disc like shape as shown
in FIG. 10. As shown, the disc shape generally includes two at
least partially parallel and substantially flat, oval surfaces,
which are distant one to the other by a relatively small width, and
a peripheral, optionally rounded wall connecting the surfaces while
allowing a single port for inflation-deflation. In some
embodiments, prosthesis 2100 is manufactured as a single piece,
optionally seamless. In some embodiments, prosthesis 2100 consists
essentially of a biodegradable material, optionally of a
homogenously created wall. In some embodiments, at least one of the
flat oval surfaces are smooth enough to allow or even facilitate a
continuous unhindered sliding thereon of a tissue in contact, such
as a ligament, a tendon, a cartilage or a bone.
[0137] In some embodiments, prosthesis 2100 is mounted on a needle
2200 using detachable connection means. Prosthesis 2100 is provided
completely deflated and rolled or otherwise collapsed to a small
volume for a minimally invasive delivery, while covered, protected
and maintained in collapsed form by a sheath 2300. Once in place
and before inflation, sheath 2300 is withdrawn thereby allowing
prosthesis 2100 to unroll and expand. In some embodiments, during
inflation, prosthesis 2100 first unrolls, and only during or after
complete unrolling, it begins to expand in width until reaching a
fully or predetermine inflated shape or size, for example as shown
in FIG. 10.
[0138] In some embodiments, prosthesis implantation and/or
inflation device 2000 further includes a handheld operator 2400
comprising of housing 2410 ergonomically designed for manual
manipulation of needle 2200 and the connected prosthesis 2100 in
patient's body.
[0139] Operator 2400 includes a knob 2440 that is clock-wise
rotatable from a first closed position until a fully opened
position, while rotating a tubular stopper 2460 connected thereto
over a proximal portion of needle 2200. In some embodiments, needle
2200 includes locking means (not shown) to prosthesis 2100 that are
selectively released when stopper 2460 revolves to a partial or
full opened position of knob 2440. Alternatively or additionally,
clock-wise rotation of knob 2440 promotes axial movement of needle
2200 within tubular stopper 2460 away from prosthesis 2100 until
detachment. Optionally, a proximal axial movement further promotes
sealing of prosthesis port by forcefully pulling a seal therein. In
some embodiments, rotation of knob 2440 is selectively allowed or
prevented using safety 2430.
[0140] An operator port 2450 located optionally at a proximal end
of housing 2410 is connectable to an external inflation medium
reservoir and/or pressurizing device, such as a pump or a syringe
(not shown). Inflation medium is preferably a fluid (e.g., saline)
which is transferable from the external reservoir through a lumen
in housing 2410, needle 2200 and into prosthesis 2100.
[0141] Needle 2200 and/or stopper 2460 can be made of any
biocompatible rigid or semi-rigid material, such as but not limited
to metals (e.g., stainless steel). Housing 2410 and other parts
affixed thereto can be made of plastic or other polymers such as
Polycarbonate, Any of the disclosed parts and elements may be
disposable or non-disposable and meant for single or multiple
use.
[0142] In some embodiments, operator 2400 includes connecting means
2420 to auxiliary devices or instruments, such as a pressure meter,
a temperature meter and/or a flow rate meter.
[0143] In an exemplary embodiment of the invention, an expandable
prosthesis is introduced in a glenohumeral joint capsule between
the humerus and glenoid cartilage surfaces, and/or in a subacromial
space between a humerus portion and an acromion portion, to prevent
injury thereof, or other joint related illness, and/or to permit
relatively unhindered or free shoulder movement. Optionally,
alternatively and/or additionally, an expandable prosthesis
comprises an inflatable structure and a sponge-like structure in
combination.
[0144] FIG. 11 is a cutaway view of inflatable expandable
prosthesis 3000 deployed in a glenohumeral joint capsule, in
accordance with an exemplary embodiment of the invention. In some
embodiments, a first surface of prosthesis 3000 is at least
occasionally and/or partially in contact with an external surface
of a cartilage portion of the humerus head/ball. Alternatively or
additionally, a second surface of prosthesis 3000 is at least
occasionally and/or partially in contact with an external surface
of a glenoid cartilage portion and or with the labrum, in some
embodiments, at least one surface of prosthesis 3000 is smooth and
allows gliding and/or frictionless motion of a cartilage portion in
contact. Alternatively or additionally, at least one surface is
coarse and/or comprising a frictional element (e.g., a mesh)
thereby avoiding relative motion with respect to a cartilage
portion in contact.
[0145] In some embodiments, prosthesis 3000 is configured to change
its overall consistency to a specific chosen degree. "Consistency"
will be considered herein as any property or combination of
properties that directly relate to the prosthesis ability to hold
and retain its original shape. Consistency may be the element
density, softness, firmness, viscosity or any combination thereof.
Prosthesis 3000 consistency may be altered by the degree of
relative inflation (vol. of actual inflation medium divided by vol.
in maximal inflation) and/or by the properties (e.g., viscosity) of
the inflation medium. In some embodiments, prosthesis 3000 is
deployed in a consistency that is similar, identical or equivalent
to that of a synovial membrane or synovium, optionally the ones of
the glenohumeral joint. It should be noted that a viscosity of
normal synovial fluid is about 1 to 2 inch string (using a string
test model: the max stretchable length of a measured fluid drop).
Alternatively, the physician may choose another consistency
according to need, which may or may not resemble a consistency of a
cartilage or a bone.
[0146] In some embodiments, prosthesis 3000 is fully inflated so it
may be applied to firmly occupy a space, be uncompressible under
unyielding forces and/or separate away the two adjacent joint
surfaces, in some embodiments, prosthesis 3000 is not fully
inflated at end of procedure so it is compressible under inward
pressures. In some embodiments, an inflation device and/or
prosthesis 3000 are configured and equipped to allow selective
inflation/deflation and/or adjustments to a chosen volume and/or
relative inflation. In some embodiments, prosthesis 3000 is filled
with a filler such as a Newtonian fluid (e.g., water or saline).
Alternatively or additionally, the filler includes a non-Newtonian
fluid (e.g., hyaluronic acid) having a determined and/or variable
viscosity. Alternatively or additionally, the inflation medium
includes a lubricating material, either fluidic or non-fluidic,
optionally a non-polar fluid such as lipid or oil. In some
embodiments, only a minute quantity of material is introduced into
prosthesis 3000 inner volume, optionally inefficient as to promote
expansion, but still improves frictionless motion capabilities of
prosthesis 3000 inner surfaces one with respect to the other. In
some embodiments, prosthesis 3000 wall is sized and configured to
have a chosen consistency when inflated partially and/or fully,
optionally by combining specific wall thickness and wall
material.
[0147] Reference is now made to FIGS. 12A-C which show schematic
cut views of prostheses 4000A, 4000B and 4000C, and portions of
implantation and/or inflation devices 4300A, 4300B and 4300C,
respectively, further comprising pressure regulating valves 4200A,
4200B and 4200C, respectively, at different locations, in
accordance with an exemplary embodiment of the invention. The
pressure regulating valves are in some embodiments preset or
designed to burst or open at a predetermined pressure that is built
inside the prostheses. In FIG. 12A, valve 4200A is affixed to a
distal end of inflation device 4300A and is releasably attachable
to a port of prosthesis 4100A or adjacent releasably attachable
connection means on the inflation device. In FIG. 12B, valve 4200B
is affixed to a proximal portion of prosthesis 4100B and is
releasably attachable to a distal end of inflation device 4300B or
adjacent a releasably attachable connection means of the
prosthesis. In some embodiments, valve 4200B is made of same
materials as prosthesis 4100B and/or is biodegradable. In FIG. 12C,
valve 4200C is affixed along the length or at a proximal end of
inflation device 4300C and is relatively remote from prosthesis
4100C.
[0148] FIGS. 13A-E are schematic cutaway views and an isometric
view illustrating deployment stages of prosthesis 4000A between two
adjacent joint related tissues, in accordance with an exemplary
embodiment of the invention. In some embodiments, the two joint
related tissues surround a subacromial space and may include for
example ligaments or tendons of a rotator cuff, and/or a humerus,
an acromion or a coracoid process. In other embodiments, the two
adjacent joint related tissues are bone or cartilage tissues of a
synovial joint, for example a humerus tissue and a glenoid tissue
in a glenohumeral joint capsule. The following steps will be
devoted for subacromial space prosthesis implantation for
demonstrative purpose.
[0149] In some embodiments, the implant includes a first face and
an opposing second face. In some embodiments, the articulation of
the joint results in a predetermined distance between the first
face and the opposing second face of the implant. In some
embodiments, the predetermined distance between the first face and
the opposing second face of the implant is the first face and the
opposing second face of the implant is greater than 0.1 mm, greater
than 0.5 mm or greater than 1 mm. In some embodiments, the
predetermined distance between the first face and the opposing
second face of the implant is sufficient so that the first face and
the opposing second face do not touch each other and/or allow
unhindered movement there between.
[0150] In some embodiments, the predetermined distance between the
first face and the opposing second face is a predetermined minimal
distance. In some embodiments, the predetermined minimal distance
is selected in vivo and/or based on parameters specific to each
patient. In some embodiments, the parameters specific to each
patient include a maximum pressure reached during ROM. In some
embodiments, the maximum pressure reached during ROM is equal to or
greater than 1 psi, optionally equal to or greater than 5 psi,
optionally equal to or greater than 8 psi, optionally equal to or
greater than 12 psi, and/or optionally equal to or greater than 20
psi.
[0151] In some embodiments, prior to implantation some patient
preparations are performed, for example providing of anxiety
reducing medication and/or prophylactic broad spectrum antibiotics.
Patient may then be positioned as needed in shoulder surgeries, and
surgical procedure begins by firstly accessing the subacromial
space using relevant surgical instrumentation (not shown).
[0152] Following the routine operational steps measurements of the
patient's specific subacromial space are taken, as schematically
illustrated in FIG. 13A, for example with a measurement probe such
as those which are routinely used in orthopedic surgeries. In some
embodiments, the measurements are taken through a true lateral port
and optionally include the distance between the lateral Acromion
periphery to the superior Glenoid rim.
[0153] In some embodiments, a kit comprising a plurality of
inflatable prostheses that are differentiated sizes is provided,
allowing the surgeon improve fitting to different spaces sized. In
some embodiments, the surgeon uses certain correlative keys between
subacromial space measurements and provided prostheses sizes, for
example: for an acromion-glenoid distance smaller than 5.5 cm, the
surgeon is requested to use a "small" sized balloon (for example,
having a length of approximately 5 cm or less), for a distance
between 5.5 and 6.5 cm, the surgeon is requested to use a "medium"
sized prosthesis (for example, a length of approximately 6 cm) and
for distance over 6.5 cm the surgeon is requested to a "large"
sized prosthesis (for example, a length of approximately 7 cm).
[0154] In some embodiments, before or after measurements, the
anatomical area of the subacromial space is debrided to a level
that enables or improves device implantation. Alternatively or
additionally, subacromial space is forcefully increased, for
example by pulling away the joint members at a certain direction
(as schematically designated by a two sided arrow in FIG. 13B).
Alternatively, no change is made to subacromial space size prior to
implantation of prosthesis 4000A.
[0155] In some embodiments, prior to implantation, prosthesis 4000A
is moderately heated and for example is immersed in warm
(optionally about 40 degrees Celsius), sterile water thereby
becoming more compliant to deployment at bodily temperatures.
[0156] As shown in FIG. 13B, the surgeon then picks a chosen sized
prosthesis, in this example prosthesis 4000A, which is provided
connected to a delivery and/or inflation device (shown is only a
portion thereof). Prosthesis 4000A is inserted through an access
port or directly--in ease of mini-open and open procedures. In some
embodiments, prosthesis 4000A is delivered through a minimally
invasive created passage, for example having a cross section
diameter of approximately 3 mm or less, therefore is provided fully
deflated and collapsed to a small enough size. FIG. 13C shows a
partial isometric view of prosthesis 4000A with an exemplary
non-binding collapsed form, suggesting a double inward rolling of
two opposing prosthesis ends, optionally rolled in opposite
directions. In some embodiments, the collapsed prosthesis is
delivered enclosed in a dedicated sheath (not shown) which is
withdrawn and removed from site when prosthesis 4000A is properly
positioned in the subacromial space.
[0157] Next, a syringe prefilled with a sterile saline solution is
coupled to the inflation device (not shown) in some embodiments of
the invention. In some embodiments, a specific amount of saline is
filled and/or is delivered, for example as indicated on the chosen
sized prosthesis, optionally by a marking or a label. In some
embodiments, prior to syringe filling or prior to delivery, the
saline is warmed to approximately 40.degree. C.
[0158] As shown in FIG. 13D, prosthesis 4000A is then inflated to
minimal size needed for a full unrolling, optionally to a maximal
size and/or a maximally allowed size. Optionally, prosthesis 4000A
is inflated until substantially or completely filling the
subacromial space, either at rest position (for example when in
normal rest size) or at extended position (for example when joint
members are forcefully pulled apart). In some embodiments, the
prosthesis 4000A is inflated sufficiently to contact at least one
surface of the tissue inside the joint or subacromial space.
Alternatively, prosthesis 4000A is inflated to an oversized
expanded shape which presses or even forcefully increases the
subacromial space.
[0159] In some embodiments, and as shown in FIG. 13E, prosthesis
4000A is deflated to a smaller size until a requested parameter is
met, such as prosthesis internal volume, internal pressure, overall
consistency, cushioning degree or another. In some embodiments,
deflation is selectively performed. In some embodiment, deflation
is performed by actively withdrawing the inflation medium from
prosthesis 4000A interior. Alternatively or additionally, deflation
occurs passively or actively due to compression forces applied by
the two opposing tissues, for example when joint parts falls back
into normal position or when deliberate joint movements are done.
In some embodiments, deflation is achieved by performing passive
(partial or full) range of motion (ROM) of the shoulder. Such ROMs
may include at least one of a forward flexion, an abduction, an
external rotation, an internal rotation and/or a cross-body
adduction. The ROMs may include series of motions in clockwise
and/or counterclockwise directions and may include but not be
limited to any of the motions specified above in some embodiments.
In some embodiments, deflation occurs actively by withdrawing
solution from the prosthesis up to 60-70% the maximal volume (when
optionally, a final/optimal volume is confirmed by performing
smooth ROM maneuvers).
[0160] In some embodiments, prosthesis 4000A is deflated to a
chosen internal pressure, optionally predetermined, which may be
between 1 and 100 psi, optionally between 1 and 20 psi, optionally
between 5 and 10 psi, optionally about 8 psi, or higher, or lower,
or any intermediate value. Such deflation may be actively
performed, for example by using the syringe in a reverse mode.
Alternatively, a pressure regulating valve, which may or may not be
unidirectional and settable to deflation, can be preset to burst
over a chosen internal pressure. Such a pressure regulating valve
may be set either by the prosthesis manufacturer and/or be
selectively set by an operator before or during the medical
intervention to a predetermined or to a patient-specific value. In
some embodiments, the pressure regulating valve may be set to burst
at a pressure or at any chosen margin thereof which is equal or
associated with a maximal internal pressure which develops in the
prosthesis when the treated shoulder is articulated or performs a
chosen ROM.
[0161] When reaching a chosen volume and/or pressure, the surgeon
then operates the prosthesis and/or delivery device to seal the
inflation port of prosthesis 4000A and detach it from the inflation
device. Alternatively or additionally deflation is done after
prosthesis detachment, for example by performing a full ROM
maneuver.
[0162] The present invention has been described using detailed
descriptions of embodiments thereof that are provided by way of
example and are not intended to limit the scope of the invention.
The described embodiments comprise different features, not all of
which are required in all embodiments of the invention. Some
embodiments of the present invention utilize only some of the
features or possible combinations of the features. Variations of
embodiments of the present invention that are described and
embodiments of the present invention comprising different
combinations of features noted in the described embodiments will
occur to persons of the art. When used in the following claims, the
terms "comprises," "includes," "have" and their conjugates mean
"including but not limited to." The scope of the invention is
limited only by the following claims.
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