U.S. patent application number 12/621872 was filed with the patent office on 2010-06-03 for devices, systems and methods for tissue repair.
This patent application is currently assigned to CAYENNE MEDICAL, INC.. Invention is credited to Heber Crockett, Sidney Fleischman, Kevin L. Ohashi, James G. Whayne, John Wright.
Application Number | 20100137887 12/621872 |
Document ID | / |
Family ID | 37084691 |
Filed Date | 2010-06-03 |
United States Patent
Application |
20100137887 |
Kind Code |
A1 |
Crockett; Heber ; et
al. |
June 3, 2010 |
DEVICES, SYSTEMS AND METHODS FOR TISSUE REPAIR
Abstract
Devices, systems and methods are disclosed for repairing soft
tissue. The surgical system allows for the creation of tissue
repair by grasping, aligning and sewing or fixing tissue. For
example, this system may be used for clipping together excessive
capsular tissue and reducing the overall capsular volume. The
deployment device includes a central grasping mechanism and an
outer clip delivery system. The clip embodiments may be single or
multi-component (penetration and locking base components) that
penetrate tissue layers and deploy or lock to clip the tissue
together. An example of the system is used to reduce the joint
capsule tissue laxity and reduces the potential for subluxation or
dislocation of the joint by either restricting inferior laxity
(anterior or posterior) and resolving or eliminating pathologic
anterior or posterior translation.
Inventors: |
Crockett; Heber; (Kearney,
NE) ; Wright; John; (Kearney, NE) ; Whayne;
James G.; (Chapel Hill, NC) ; Ohashi; Kevin L.;
(Jamaica Plain, MA) ; Fleischman; Sidney; (Durham,
NC) |
Correspondence
Address: |
STOUT, UXA, BUYAN & MULLINS LLP
4 VENTURE, SUITE 300
IRVINE
CA
92618
US
|
Assignee: |
CAYENNE MEDICAL, INC.
Scottsdale
AZ
|
Family ID: |
37084691 |
Appl. No.: |
12/621872 |
Filed: |
November 19, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11045209 |
Jan 31, 2005 |
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12621872 |
|
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60570627 |
May 13, 2004 |
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60584585 |
Jul 1, 2004 |
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Current U.S.
Class: |
606/144 ;
607/116 |
Current CPC
Class: |
A61B 2017/0618 20130101;
A61B 2017/00867 20130101; A61B 17/0643 20130101; A61B 2017/00827
20130101; A61B 2017/00349 20130101; A61B 17/0469 20130101; A61B
2017/0464 20130101; A61B 2017/0458 20130101; A61B 2017/2901
20130101; A61F 2/0811 20130101; A61B 2017/306 20130101; A61B 17/083
20130101; A61B 17/29 20130101; A61B 17/00234 20130101; A61B
2017/00004 20130101; A61B 17/1285 20130101; A61B 2017/0419
20130101; A61B 2017/0647 20130101; A61B 2017/0454 20130101; A61B
17/0682 20130101; A61B 2017/00243 20130101 |
Class at
Publication: |
606/144 ;
607/116 |
International
Class: |
A61B 17/04 20060101
A61B017/04; A61N 1/00 20060101 A61N001/00 |
Claims
1-21. (canceled)
22. A system for transdermal repair of soft tissue, the system
comprising: a first element for securing and moving a portion of
soft tissue that is to be repaired, the first element having an
undeployed retracted state and a deployed extended state; a second
element for repairing the portion of soft tissue that is secured by
the first element, the second element having jaws that clamp down
on the portion of soft tissue in order to retain the portion of
soft tissue for the transdermal repair; and a third element for
actuating the first element and the second element in turn for
performing the transdermal repair; wherein the first element is
disposed within the jaws of the second element when it is in its
undeployed retracted state, and is disposed outside of the jaws of
the second element when it is in its deployed extended state.
23. The system as recited in claim 22, wherein the first element,
in its deployed state, captures the portion of soft tissue and then
is retracted to its undeployed state to bring the portion of soft
tissue to a location within the jaws of the second element.
24. The system as recited in claim 22, wherein the portion of soft
tissue comprises an interior concave surface of a capsular body,
and the transdermal repair comprises plication.
25. The system as recited in claim 22, and further comprising a
neuro-stimulator for stimulating nerves near the portion of soft
tissue, so that a user is signaled of the presence of a nearby
nerve.
26. The system as recited in claim 25, wherein said
neuro-stimulator comprises a probe element which comprises a
portion of said first element.
27. The system as recited in claim 22, wherein at least one of the
first and second elements includes abrading tools for abrading the
portion of soft tissue in order to irritate the tissue and aid in
natural tissue repair.
28. The system as recited in claim 22, wherein the second element
utilizes a suture to repair the portion of soft tissue.
29. The system as recited in claim 28, wherein the suture remains
attached to the second element after the soft tissue is repaired
and the jaws of the second element are opened.
30. The system as recited in claim 28, wherein the suture is
automatically released from the second element after the tissue is
repaired and the jaws of the second element are opened.
31. The system as recited in claim 22, wherein the second element
employs a tissue locking mechanism to repair the portion of soft
tissue.
32. The system as recited in claim 31, wherein the tissue locking
mechanism comprises: an anchor element having a shaft with two
penetrating ends for penetrating the soft tissue, wherein each
penetrating end has a movable anchor stop which permits the end to
penetrate tissue initially, and then turns to lock the anchor stop
on the side of the portion of soft tissue that is opposite to the
side of the shaft.
33. The system as recited in claim 31, wherein the tissue locking
mechanism further comprises: a first anchor element having a shaft
with a penetrating end to penetrate soft tissue, and a receiving
end to accommodate the penetrating end, wherein the first anchor
element at least partially contains a metallic interior to assist
in the maintenance of its shape, and wherein the penetrating end
and the receiving end communicate to plicate the soft tissue held
within.
34. The system as recited in claim 31, wherein the tissue locking
mechanism further comprises: a penetrating element having a point
and a perpendicular stop; and an accommodating element having a
point receiving slot and a perpendicular stop, wherein the
penetrating point and the accommodating point plicate tissue
between each of the perpendicular stops by mating the point on the
penetrating element with the point receiving slot on the
accommodating element.
35. The system as recited in claim 31, wherein the tissue locking
mechanism further comprises: a substantially planar surface having
an opening therein and a plurality of teeth positioned inwardly
toward the opening, wherein a portion of the captured soft tissue
is pulled within the opening and plicated therein by the plurality
of teeth when the tissue is released.
36. A system for plicating a capsular structure, the system
comprising: a pinching element for pinching and capturing a portion
of an interior surface of a capsular structure to be plicated, the
pinching element having a deployed extended state and an undeployed
retracted state; a plicating element for plicating the portion of
the interior surface of the capsular structure that has been
captured by the pinching element; and a deployment element for
actuating the pinching element and the plicating element in turn to
plicate the portion of the interior surface of the capsular
structure which is captured; wherein the pinching element is
disposed within an interior portion of the plicating element when
it is in its undeployed retracted state, and is disposed outside of
and a substantial distance from the interior portion of the
plicating element when it is in its deployed extended state.
37. The system as recited in claim 36, and further comprising a
plicating actuator to lock the plicating element on the portion of
the captured portion of the interior surface of the capsular
structure.
38. The system as recited in claim 36, wherein the interior surface
of the capsular structure has a concave geometry.
39. The system as recited in claim 36, wherein the plicating
element includes a suture.
40. The system as recited in claim 36, wherein the plicating
element includes a locking mechanism comprising a single body.
41. The system as recited in claim 36, and further comprising a
neuro-stimulator for stimulating nerves near the portion of the
interior surface of the capsular structure to be captured, so that
a user is signaled of the presence of a nearby nerve.
42. The system as recited in claim 36, and further comprising
abrading elements for abrading the portion of the interior surface
of the capsular structure and thus irritate the interior surface to
aid in natural tissue repair.
Description
[0001] This U.S. Utility patent application claims priority to U.S.
Provisional Patent Application Ser. No. 60/570,627, filed May 13,
2004, and to U.S. Provisional Patent Application Ser. No.
60/584,585, filed Jul. 1, 2004, the contents of each of which are
hereby incorporated by reference in their entirety into this
disclosure.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates generally to devices, systems
and methods for tissue repair. More particularly, the present
invention relates to devices, systems and methods for treating
unidirectional and multidirectional instability of tissue
structures.
[0004] 2. Background of the Invention
[0005] Tissue instability or compromise is a common occurrence in
all persons, whether induced by age, repeated use, disease,
accident or natural and abnormal formation. Such instability may
include, for example, intentional or accidental tears, cuts,
stretching, loosening, deterioration of structure, loss of
firmness, and the like. Furthermore, such tissue may relate to
orthopedics, as in the skeletal system and its associated muscles,
joints and ligaments and the like, or non-orthopedic systems, such
as smooth muscles, gastrointestinal, cardiac, pulmonary, neural,
dermal, ocular and the like.
[0006] No matter what type of instability is present or whether the
tissue to be repaired is classified as orthopedic or
non-orthopedic, similar issues and objectives are encountered by
the surgeon, namely, creating a stable and reliable structure and
doing so in as easy and reliable manner as possible. For example, a
neurosurgeon aims to create a stable and reliable adhesion of two
neural tissue structures, while at the same time creating minimal
damage. The neurosurgeon desires a technique that is minimally
invasive, highly reproducible and reliable, and highly effective in
connecting the tissue to itself or other similar or dissimilar
tissue. It would be even more beneficial to somehow have the tissue
become induced to adhere to itself or the other tissue.
[0007] In another similar example, in orthopedics soft tissue
surgery, the surgeon desires to repair the damaged or diseased
tissue in such a manner such that the tissue binds with itself or
other tissue in a firm but minimally damaging manner. In muscle or
ligament repair, for example, it is necessary to suture the tissue
together to promote strength and unity in the structure while at
the same time, allow for natural movement to occur.
[0008] More broadly, traditional soft tissue repair is a common
procedure that typically involves some form of conventional
suturing or stapling. For example, certain joints, such as hips,
knees, shoulders and elbows contain tissues that are common sources
of problems, whether natural or induced, that require extensive
physical therapy or surgery to correct. There are similarities
between such examples of tissues that present a uniform set of
issues for the health care worker such that a treatment of one type
of tissue will be in many ways similar to the treatment of another
type of tissue, even though the shape, properties and architecture
of each tissue is uniquely different. Of such tissues or tissue
structures, a common source of medical problems occurs in the
joints. Although the below example will be described with respect
to the shoulder joint as an example, similar problems are inherent
in other soft tissue areas and one having ordinary skill in the art
would be cognizant of such problems and how to apply the principles
of the present invention to address the problems in such other
tissues or tissue systems.
[0009] Joint instability is a complex clinical problem associated
with a variety of treatment options that include the use of
arthroscopic and open surgical methods. For example, for the
shoulder joint, open surgical methods for producing a capsular
shift to increase the capsular ligament tension and improving the
joint stability have been demonstrated. However, adequate
arthroscopic methods that approximate the clinical outcome achieved
by open surgical methods for reducing excessive joint laxity have
been slow to develop or have begun to show less than optimal long
term clinical outcomes (e.g., thermal methods).
[0010] The shoulder joint, in particular, has inherent instability
because of its large range and motion combined with the relatively
shallow joint bony socket (glenoid). Anatomically, the rotator cuff
acts as the primary dynamic joint stabilizer, while the inferior
glenohumeral ligament acts as the primary static shoulder joint
stabilizer. Damage to or laxity of one of these stabilizing
structures can result in the presentation of clinically relevant
shoulder instability.
[0011] The onset of shoulder instability is generally associated
with a traumatic injury, an atraumatic motion injury, or chronic
overuse of the shoulder. Most typically, the instability of the
shoulder stems from disruption and/or looseness (excessive capsule
laxity) of the shoulder capsule. The resulting subluxation or
dislocation of the joint can be painful and debilitating for the
individual. The overall approach of shoulder stabilization surgery
is to first repair the disrupted/torn capsule and second to tighten
the loose capsule ligaments. Of note there are instances where the
capsule is intact (e.g., no tear) and only tightening of the
capsule ligaments is required to restore joint stability. The
ultimate goals of shoulder stabilization include restoring
appropriate capsule tension, limiting of humeral head translation,
and excessively decreasing range of motion.
[0012] Up to 98% of all shoulder joint dislocations occur in the
anterior direction, 95% of which are first time dislocations. Over
70% of these individuals will have recurrent instability
(subluxation or dislocation) within two years after the first
event, potentially requiring surgical intervention.
[0013] Certain conventional devices serve to assist with repair of
the shoulder capsule when it is disrupted, such as in the case of
Bankart Lesions. It is noted that Bankart Lesions are identified by
the characteristic stripping/tearing of the anterior inferior
labrum from the glenoid. Treatment of these lesions is typically
accomplished through a standard open incision or with existing
arthroscopic technology.
[0014] Clinically described excessive joint laxity in the joint
capsule can range from 1.0 to more than 20.0 mm in ligament
elongation, resulting in recurrent glenohumeral subluxation or
dislocation. A loose shoulder capsule may be tightened readily when
a standard open incision is used, but tightening the shoulder
capsule arthroscopically poses significant challenges with existing
instruments. For example, the acute angles at which the surgical
devices are able to approximate the soft tissue and identify
regions where suturing would be desirable are limiting.
Furthermore, the ability to pass a suture and tie snug surgical
knots that compress the tissue in the desired plane with a
reasonable suture time is difficult if not cumbersome. Finally, the
ability to dictate the level of tissue tied is limited to the
tissue needle bite size and remains difficult for the surgeon to
reproducibly specify the level of tissue compression desired.
[0015] A recently introduced technology, thermal capsulorrhaphy,
initially held significant promise as a means of facilitating and
expediting arthroscopic shoulder capsule tightening. The premise of
this technique is to manipulate the characteristics of the
approximately 90% Type I collagen structure of ligaments by thermal
exposure. It has been demonstrated that at temperatures above 65
degrees Celsius, collagen begins to denature (e.g., unwinding of
the helical structure), resulting in tissue shrinkage. Collagen
shrinkage of up to 50% has been demonstrated using thermal energy.
However, this technology has yielded equivocal results and
progressive skepticism from shoulder surgeons. Specifically,
concerns related to long term clinical outcomes for shoulder
instability with altered capsular structure have been noted. There
is a strong current sentiment among shoulder surgeons that
tightening the shoulder capsule by plication with sutures will
prove to be more efficacious and more reproducible than the use of
thermal mechanisms to reduce the ligament laxity in the
capsule.
[0016] Additional concerns of thermal capsulorrhaphy application
include potential injury to the axillary nerve, bleeding, pain, and
excessive swelling of the capsule. More importantly, the technical
methods used during thermal capsulorrhaphy do not allow the surgeon
to control the level of plication that is desired or anticipated.
Specifically, thermal methods are technique-specific and have a
required learning curve associated with obtaining specified
clinical plication outcomes. Moreover, once treated, the level or
resulting tissue alteration achieved is irreversible. The paucity
of data demonstrating the long-term mechanical characteristics and
viability of these treated ligaments limits the confident and
continued use of this technique.
[0017] Conventional methods for arthroscopic plication of the
shoulder capsule with sutures typically involve freehand techniques
that are technically challenging and often time-consuming. An
additional shortcoming common to both thermal capsular shrinkage
and existing suturing techniques is that neither method can
effectively control the amount of capsular tightening in a
calibrated fashion. "Over-tightening" of the anterior capsule can
lead to problems such as excessive loss of external rotation,
limiting shoulder joint function.
[0018] Thus, a need exists in the art for an alternative to the
conventional methods of tissue repair. There is a need in the art
for novel systems and methods for arthroscopic soft tissue repair
and/or plication that is adaptable to any soft tissue or soft
tissue system and can overcome the shortcomings of conventional
methods and improve the clinical outcome as well as be generally
adopted by surgeons.
SUMMARY OF THE INVENTION
[0019] The present invention provides an alternative and
enhancement to conventional methods of tissue repair. More
specifically, the present invention presents devices, systems and
methods for arthroscopically treating unidirectional and
multidirectional instability of tissue in general, and through
suturing and/or plication by non-limiting example. An essential and
powerful aspect of this invention is its wide applicability to a
non-limiting extent of tissues and tissue systems of any shape or
size, such as, for example the plication of loose tissue from the
interior surface of a spheroidal capsule. One having ordinary skill
in the art is cognizant of the applicability of the present
invention to as diverse fields as reduction in gastric reflux to
lung volume reduction to atrial valve repair and shoulder joint
plication. The present invention is not limited to the examples set
forth in this disclosure but is extended to all other procedures
that would benefit from the devices, systems and methods as
described herein. Thus, the scope of the present invention extends
beyond the non-limiting examples set forth herein and encompasses
that which would be or should be within the purview of one having
ordinary skill in the art of tissue repair.
[0020] In one described embodiment, the invention relates to suture
structures and related deployment devices to repair, plicate and/or
reduce the capsular laxity at the glenohumeral joint, improving
joint stability. However, the techniques disclosed in the examples
below are adaptable and usable for all tissues and tissue systems
where repair is beneficial to improve the health and function of
the tissue or tissue system. Such techniques and uses, particularly
relating to embodiments of the present invention, are particularly
useful in applications requiring transdermal access to a particular
internal tissue by penetrating one or more layers of tissue.
However, such transdermal access is not limiting and the present
invention may be applicable in non-transdermal applications as
well, such as in fundoplication. Further, "repair" of such tissue,
as defined herein and throughout this disclosure, is a slowing down
or reversal of the instability such that the tissue is somehow
manipulated to deal with or overcome the instability, usually
involving some form of surgery. Common, but not limiting, examples
include suturing, plicating, stapling, restructuring, adhering,
tightening, attaching, firming or the like.
[0021] In one exemplary embodiment, the present invention is a
system for transdermal repair of soft tissue. The system comprises
a first element to pinch a portion of soft tissue that is to be
repaired; a second element to repair the portion of soft tissue
that is pinched by the first element, such portion of soft tissue
being accessed transdermally; and a third element to deploy the
first element and the second element in turn to repair the portion
of soft tissue that is being pinched.
[0022] In another exemplary embodiment, the present invention is a
system for plicating a capsular structure. The system comprises a
pinching element to pinch a portion of an interior surface of a
capsular structure to be plicated; a plicating element to plicate
the portion of the interior surface of the capsular structure that
is pinched by the pinching element; and a deployment element to
deploy the pinching element and the plicating element in turn to
plicate the portion of the interior surface of the capsular
structure that is being pinched.
[0023] In yet another exemplary embodiment, the present invention
is a method for arthroscopic plication of an interior concave
surface of a capsular structure. The method comprises pinching a
portion of the interior concave surface of the capsular structure;
and securing the portion of the interior surface that is
pinched.
[0024] In yet another exemplary embodiment, the present invention
is a method for arthroscopic repair of soft tissue within a hollow
structure. The method comprises pinching a portion of soft tissue
on the interior surface of the hollow organ; and fixing the portion
of soft tissue that is pinched.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] FIG. 1 shows a graphical cross-sectional illustration of
conventional arthroscopic instrument position relative to anatomic
structures.
[0026] FIGS. 2A and 2B show an exemplary arthroscopic plication
deployment device according to the present invention in a capsular
region with clips positioned in the areas of plication.
[0027] FIGS. 3A to 3D show an exemplary grasper mechanism according
to the present invention during advancement and grasping of a
tissue pleat.
[0028] FIGS. 4A and 4F show an exemplary embodiment of the
deployment device according to the present invention.
[0029] FIGS. 5A to 5E show a distal end of an exemplary deployment
device according to the present invention demonstrating a method of
tissue plication.
[0030] FIGS. 6A to 6L show a distal end of an exemplary deployment
device according to the present invention demonstrating a method of
tissue plication.
[0031] FIGS. 7A to 7J show a distal end of an exemplary deployment
device according to the present invention demonstrating a method of
tissue plication.
[0032] FIG. 8A to 8I show a distal end of an exemplary deployment
device according to the present invention demonstrating a method of
tissue plication.
[0033] FIGS. 9A to 9G show a distal end of an exemplary deployment
device according to the present invention demonstrating a method of
tissue plication.
[0034] FIGS. 10A to 10D show an embodiment of the distal tip and
shaft of the plication deployment device according to the present
invention.
[0035] FIGS. 11A to 11H show an exemplary embodiment of the distal
tip and shaft of the plication deployment device according to the
present invention with an exemplary embodiment of a clip device at
a distal tip of the jaws.
[0036] FIG. 12A to 12E show exemplary deployment device jaws with
needle retrieval elements according to the present invention.
[0037] FIGS. 13A to 13D show a procedural deployment of a hinge
lock plication clip using a grasping mechanism according to an
exemplary embodiment of the present invention.
[0038] FIGS. 14A to 14D show a procedural deployment of a hinge
lock plication clip without a grasping mechanism according to an
exemplary embodiment of the present invention.
[0039] FIGS. 15A to 15C show a procedural use of a neurostimulator
to verify the position of the axillary nerve relative to the area
of plication according to an exemplary embodiment of the present
invention.
[0040] FIGS. 16A to 16C show a top, side and prospective views of a
deployment device containing a single armed anchoring device and a
suture retrieval mechanism according to an exemplary embodiment of
the present invention.
[0041] FIGS. 17A to 17D show an exemplary procedural use of an
exemplary device according to the device shown in FIG. 16.
[0042] FIGS. 18A to 18D show a three-pronged grasper device
mechanism according to an exemplary embodiment of the present
invention.
[0043] FIGS. 19A and 19B show a two pronged grasper device
mechanism according to an exemplary embodiment of the present
invention.
[0044] FIGS. 20A and 20B show an undeployed single armed grasper
anchor mechanism according to an exemplary embodiment of the
present invention.
[0045] FIGS. 21A and 21B show a deployed single armed grasper
anchor mechanism according to an exemplary embodiment of the
present invention.
[0046] FIGS. 22A and 22B show a deployed single armed grasper
anchor mechanism according to an exemplary embodiment of the
present invention.
[0047] FIG. 23 shows a distal tip and shaft of a plication
deployment device according to an exemplary embodiment of the
present invention.
[0048] FIGS. 24A to 24B show an embodiment of a distal tip and
shaft of a plication deployment device according to an exemplary
embodiment of the present invention.
[0049] FIGS. 25A to 25C show an embodiment of a distal tip and
shaft of a plication deployment device according to an exemplary
embodiment of the present invention: (a) from the side; (b) view
from bottom jaw looking toward top jaw; and (c) a perspective
view.
[0050] FIG. 26 shows a distal tip and shaft of a plication
deployment device according to an exemplary embodiment of the
present invention.
[0051] FIGS. 27A to 27F show an embodiment of the plication
delivery device according to an exemplary embodiment of the present
invention with a distal tip in the closed and open positions and a
bottom flange having a flexible member that may be displaced to
expose a penetrating element.
[0052] FIGS. 28A to 28D show a plication delivery device according
to an exemplary embodiment of the present invention with a distal
tip in the closed and open positions and a bottom flange having a
flexible member that may be displaced to expose a penetrating
element.
[0053] FIGS. 29A to 29F show a plication delivery device according
to an exemplary embodiment of the present invention with a distal
tip in the closed and open positions and a bottom flange having a
flexible member that may be displaced to expose a penetrating
element.
[0054] FIGS. 30A to 30F show a plication delivery device according
to an exemplary embodiment of the present invention with a distal
tip in the closed and open positions and a bottom flange having a
flexible member that may be displaced to expose a penetrating
element.
[0055] FIGS. 31A to 31D show a plication delivery device according
to an exemplary embodiment of the present invention with a distal
tip in the closed and open positions and a bottom flange having a
flexible member that may be displaced to expose a penetrating
element.
[0056] FIG. 32 shows a flexible delivery device shaft according to
an exemplary embodiment of the present invention to allow for
approaching plication surface at various angles.
[0057] FIGS. 33A and 33B show an internal capsular plication
according to an exemplary embodiment of the present invention by
grasping the tissue and sliding a plicating clip over the tissue
fold and the final plication with clip in position.
[0058] FIGS. 34A to 34D show perspective, top, and side views of a
two component plication device according to an exemplary embodiment
of the present invention that contains a single point of
penetration.
[0059] FIGS. 35A to 35C show perspective, top, and side views of a
two component plication device according to an exemplary embodiment
of the present invention that has two points of penetration,
extending the region of attachment and distributing the stresses on
the device.
[0060] FIGS. 36A to 36F show perspective, top, and side views of a
two component plication device according to an exemplary embodiment
of the present invention that has two points of penetration,
extending the region of attachment and distributing the stresses on
the device.
[0061] FIGS. 37A to 37C show perspective, top, and side views of a
two component plication device according to an exemplary embodiment
of the present invention that has two points of penetration,
extending the region of attachment and distributing the stresses on
the device.
[0062] FIGS. 38A to 38E show perspective, top, and side views of a
two component plication device according to an exemplary embodiment
of the present invention that has two points of penetration,
extending the region of attachment and distributing the stresses on
the device.
[0063] FIGS. 39A to 39C show perspective views of a two component
plication device according to an exemplary embodiment of the
present invention that includes two locking positions.
[0064] FIG. 40A to 40D show perspective and side views of a two
component hinged plication device according to an exemplary
embodiment of the present invention.
[0065] FIGS. 41A to 41F show a two component sleeve-lock device
with multiple stages according to an exemplary embodiment of the
present invention.
[0066] FIGS. 42A to 42F show a perspective, top, and side views of
a single component plication device according to an exemplary
embodiment of the present invention in the undeployed and deployed
configuration. This embodiment can also include use with a pledget
backing making it a two component plication device.
[0067] FIGS. 43A to 43C show perspective and side views of a single
component spring plication device according to an exemplary
embodiment of the present invention along with illustrations of
device implementation.
[0068] FIG. 44A to 44C show a perspective view of a single
component plication device according to an exemplary embodiment of
the present invention.
[0069] FIG. 45A to 45C show a perspective and top views of a single
component plication device according to an exemplary embodiment of
the present invention.
[0070] FIG. 46A to 46D show a perspective and side views of a
single component plication device according to an exemplary
embodiment of the present invention.
[0071] FIG. 47A to 47C show a perspective and top views of a single
component plication device according to an exemplary embodiment of
the present invention.
[0072] FIG. 48A to 48C show perspective, top, and side views of a
single component plication device according to an exemplary
embodiment of the present invention.
[0073] FIG. 49A to 49E show perspective, top, and side views of a
single component plication device according to an exemplary
embodiment of the present invention.
[0074] FIG. 50A to 50F show perspective, top, and side views of a
single component plication device according to an exemplary
embodiment of the present invention.
[0075] FIG. 51A to 51C show a perspective and top views of a single
component plication device according to an exemplary embodiment of
the present invention.
[0076] FIGS. 52A to 52C show a plication of the capsule to the
labrum using device clip devices according to an exemplary
embodiment of the present invention.
[0077] FIG. 53 shows lung volume reduction application with suture
or clip tissue fixation according to an exemplary embodiment of the
present invention.
[0078] FIG. 54 shows a laparoscopic gastric fundoplication with
laparoscopic suture or clip tissue fixation according to an
exemplary embodiment of the present invention.
[0079] FIG. 55 shows a thorascopic lung reduction procedure with
thorascopic suture or clip tissue fixation according to an
exemplary embodiment of the present invention.
[0080] FIG. 56 shows a thorascopic mitral valve repair with
thorascopic suture or clip tissue fixation according to an
exemplary embodiment of the present invention.
[0081] FIGS. 57A and 57B show an exemplary atrial appendage
isolation (or removal) procedure on the heart according to an
embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0082] The present invention relates to devices, systems, and
methods that address deficiencies in conventional methods of tissue
repair. The present invention may be applied to a number of
different medical applications, including but not limited to repair
and/or plication or attachment of soft tissue, such as lung
reduction or resection, gastric reduction, intestinal, liver
reduction or resection, kidney reduction or resection, esophageal
modification, atrial appendage isolation or removal, and anatomic
structures. These are mere examples of locations where such
devices, systems and methods may be used and in no way are limiting
of the broader scope of the present invention.
[0083] The devices, systems and methods according to the present
invention may be applied to any tissue or tissue structure in any
geometry. For example, exemplary embodiments of the present
invention may be used to plicate a capsular joint from the interior
concave surface of the capsular joint by connection to and mending
or suturing of the interior capsular tissue. This ability is one of
the advantages of the present invention and is characteristic of
its diverse range of application in terms of tissue targets as well
as target shape and/or geometry. Conventional methods of plication
are either limited to repair from an exterior convex surface of a
capsular joint or by traditional hand suturing.
[0084] For sake of demonstration, exemplary embodiments of the
present invention are shown by providing a technically facile means
of arthroscopic plication of the shoulder capsule using a tissue
clip or suturing device deployed with a single calibrated hand-held
device for the treatment of unidirectional and multidirectional
instability of the shoulder joint. The exemplary embodiments of the
invention address deficiencies in shoulder capsule ligament
plication for shoulder joint stabilization. The same or similar
techniques as shown with respect to the shoulder capsule may also
be used in virtually any other tissue or tissue structure that
could benefit from the embodiments of the present invention. In
addition, the exemplary embodiments address similar deficiencies
that are apparent in other applications involving plication of
tissues such as lung reduction or resection, gastric reduction or
bypass, intestinal modifications, liver reduction or resection,
kidney, esophageal, atrial appendage isolation or removal, cardiac
tissue plication or attachment, and other soft tissue attachment or
plication reductions.
[0085] A primary purpose of the present invention as shown in some
of the exemplary embodiments is to better enable the tightening of
the shoulder capsule ligaments either concomitantly or as a
primarily course of treatment rather than to specifically repair a
disrupted capsule. The expected clinical outcome includes reducing
or eliminating any excess anterior inferior translation of the
joint as well as resolving any pathologic anterior or posterior
translation of the joint, thereby stabilizing the shoulder.
[0086] The exemplary plication systems according to the present
invention may also be used to reduce or plicate, or attach soft
tissue structures for other applications including, but not limited
to, applying tension to remove slack in other joint ligaments
(e.g., anterior cruciate ligament, medial collateral ligament),
re-attaching partially or completely torn soft tissue structures
during applications such as meniscus repair, re-attaching partially
or completely detached soft tissue structures to bones via bone
anchors during rotator cuff repair, Bankart Lesion repair, or other
soft tissue to bone attachment procedure, plicating hernias,
clipping lung tissue during lung reduction or resection procedures
that result in reduced lung volume, gastric reduction or bypass
procedures involving plication of the stomach or intestines to
reduce the volume of the anatomy, atrial appendage isolation or
removal involving clipping the atrial appendage at the orifice to
reduce the atrial volume and isolate the interior of the atrial
appendage from the circulating blood pool, vessel ligation
procedures, tubal ligation procedures, resection of cancer tissue
(e.g., liver, breast, lung, colon, etc.), mitral valve repair
(leaflet and annular ring) and other procedures which may require
soft tissue plication or attachment.
[0087] Additionally, various exemplary embodiments of the present
invention are described that may be used to repair, plicate and
reduce capsular laxity by attaching the capsule to the glenoid
labrum or surrounding bony structures in the glenohumeral joint.
The deployment devices are capable of grasping the capsular
tissues, aligning capsular tissues into the plication region of the
device, and deploying a plication clip into the tissue to securely
attach the folded tissues. The exemplary deployment devices have
the ability to adjust the level of plication by variable pull back
of the grasping element or by variable adjustment of the clip
device. Furthermore, the exemplary deployment devices may be used
to abrade the plicated tissue section to irritate the synovium,
eliciting the biological healing and remodeling response of the
soft tissue. The dimensions of the exemplary devices may be
tailored for orthopedic access with standard arthroscopic
equipment. Additionally, the exemplary deployment devices may
reposition capsular tissue, or other tissue, and secure tensioned
capsular tissue, or other soft tissue, to the labrum, bone, or
other anatomy.
[0088] By example, the present invention relates to devices,
systems and methods that enable plication of ligaments, tendons,
and/or other soft tissue structures to reduce unidirectional and
multidirectional instability of the shoulder, or other anatomic
structure. The region of interest includes the entire 360 degrees
of the joint capsule. However, more typically the repair covers
approximately 180 degrees (from the 8 o'clock to 2 o'clock anterior
position of the capsule). In the instance of multidirectional
instability it is common for a surgeon to close the rotator
interval that will restrict the anterior and posterior inferior
joint laxity and thereby restricting or limiting translation.
[0089] In exemplary embodiments of the present invention relating
to the shoulder joint, capsular tensioning regions of interest
include, but are not limited to, the posterior--inferior and
anterior--inferior quadrants of the glenohumeral joint capsule as
well as the rotator cuff interval. Capsular plication with device
clip embodiments or suture embodiments includes, but is not limited
to, capsule-to-labrum plication and capsule-to-capsule interval
closure/reduction. An advantage of the capsule-to-labrum plication
includes augmentation of the labral shelf by increasing the size of
the labral "bumper," reducing the potential for joint subluxation
or dislocation.
[0090] To accomplish joint stability using the exemplary devices,
systems and methods described herein, standard surgical preparation
of the site and arthroscopic portals for access of the shoulder
joint are performed. The joint may be dilated with an arthroscopic
pump. The deployment device is introduced through a standard 5, 6
or 8 mm cannula placed in the anterosuperior arthroscopy portal.
The anterior and posterior sections of the capsule may be
visualized via placement of the arthroscope through the accessory
anterior inferior portal or the posterior portal. Regions of the
anterior and posterior inferior glenohumeral ligament are assessed
and identified for removal of excess capsule laxity by plication
with the primary goal of reducing the overall capsular volume. The
deployment device is moved into position over the ligament region
to be reduced/plicated. The tissue grasping mechanism is deployed
through the centerline of the deployment device jaws, creating a
tissue fold that is drawn up to and into the jaws of the deployment
device. To improve the angle of approach of the deployment device
in relation to the capsular plication region, the shaft of the
device can be designed to have different configurations, including
but not limited to straight, angled, or curved (S or C-shaped)
shaft or angled distal jaw region.
[0091] Various embodiments can be utilized for the tissue grasping
mechanism and include, but are not limited to, jaw clamp with or
without an active hinge, J-hook (made of deformable metal,
superelastic material, or plastic), penetrating tip element with a
deploying end (e.g., umbrella, balloon, or T-shaped) that resists
pullout of the device, or a corkscrew design (made of deformable
metal, superelastic material, or plastic). A common ability with
tissue grasping mechanisms is the ability to grab, hold, and move
tissue into the jaws of the deployment device. The advantage of
using a grasping mechanism to align the tissue and bring the tissue
into the deployment device jaws is the ability to adjust the level
of plication that will be employed. The force required to pull back
the tissue into the deployment device jaws is maintained by the
grasping mechanism through a spring or elastic joint/hinge. The jaw
of the deployment device may have a center channel which enables
closing of the jaw without being impeded by the grasper.
[0092] An exemplary embodiment of the deployment device includes an
electrode stimulator that can be engaged along with the grasping
mechanism or the clamping mechanism. (See, for example, FIG. 15.)
The purpose of the stimulator is to identify the potential
proximity of the axillary nerve (other nerve or muscle tissue) to
the plication region prior to deploying the tissue plication clip.
The axillary nerve is typically located within 1-2 cm of the
inferior capsule. In short, the grasping mechanism can include
coupling of a stimulator element that can be excited to a level
that would invoke activation of the axillary nerve and
corresponding muscular response (e.g., deltoid muscle contraction)
if the area of plication is located at or near the position of the
axillary nerve. Any indication of muscle stimulation will provide a
warning mechanism to the surgeon of the close proximity of the
axillary nerve structure and potentially prevent unintended damage
to the nerve.
[0093] Several strategic locations along the deployment device jaw
will have embodiments that allow for tissue penetration (e.g.,
needles, barb) and/or abrasion (e.g., rasp or roughened) of select
regions of the ligament tissue. This stimulation/abrasion of the
ligament is intended to occur simultaneous with engagement of the
deployment device jaw. The purpose of this penetration and/or
abrasion is to elicit a biological response that promotes more
rapid healing and remodeling/scarring of the plicated ligament
tissue by irritating the synovium.
[0094] Some exemplary embodiments of the suture device may include
the use of flexible and rigid elements, suture or suture materials,
and pledget backings that may allow for proper securing of the
plicated or attached soft tissue. The embodiments of the deployment
device jaw may include mechanisms to engage the suture to the jaws
(e.g., at the distal tip, along the jaw flange). One flange of the
jaws holds the penetrating element of the suture device, while the
opposite side has locking ports to grab the suture tips. Engagement
of the jaws is performed by user actuation of the proximal handle.
Upon engagement of the deployment device jaw, with the plicated
tissue grasped and aligned, the suture tips engage the tissue
between the jaws, penetrate the tissue, and engages with the
opposite locking ports. Once full engagement of the deployment jaw
has been achieved, the suture ends have been fully deployed through
the tissue fold to be plicated, the suture tips will be locked into
the jaw flange. The deployment device jaw is then opened, and
tissue released. The deployment device is then withdrawn from the
site along with the suture ends. The suture ends are retrieved by
the surgeon and standard sliding knots are tightened and locked by
pulling the free end of the suture and advancing the knot to the
plication site. The shoulder is then placed through a trial range
of motion while the tension portion of the capsule is visualized
with the arthroscope. Adequate fixation of the capsular plications
is verified.
[0095] Exemplary embodiments of the suturing device mechanism may
also include various locking port configurations which do not
require passing of rigid suture tips, but rather suture ends.
Further embodiments also includes passing of multiple sutures
during one deployment that can be distributed in different
configurations along the phalanges of the jaw (e.g., perpendicular,
parallel, overlapped, cross-over, etc.). Other embodiments may also
include pre-tied suture devices and/or pledget backings.
[0096] Surgically, the reduction in ligament laxity is continued
and repeated along and round the capsule, deploying as many suture
devices that may be required and in any 3-dimensional geometric
pattern around the capsule to reduce capsular volume and stabilize
the joint. Deployment of multiple devices can be required during
the capsular laxity treatment procedure. This is particularly true
for the treatment of multidirectional instability of the shoulder.
The number, orientation and position of deployed clip devices will
be user defined, no limitation is specified. Furthermore, the level
of capsular plication or reduction in capsular laxity will be user
defined, no limitation is specified. Furthermore, it should be
noted that various embodiments of the suture device may be deployed
in each case, particularly in cases where a combination of capsule
to capsule and capsule to labrum or capsule to glenoid plication
are indicated.
[0097] It should be appreciated that the plication devices
described, including sutures and deployment mechanisms, can be
applicable for use in other indications involving devices that are
used for plicating and attaching tissue layers where small
arthroscopic access is required. The embodiments of this invention
can be tailored to human anatomy, however, they may also be
tailored for use in other species such as horses, dogs, sheep, and
pigs as well as invertebrates.
[0098] These plication systems can be used to reduce or plicate
soft tissue structures or attach tissue layers for application
including, but not limited to, other joint ligaments (e.g.,
anterior cruciate ligament, medial collateral ligament), rotator
cuff repair, Bankart Lesions, meniscus repair, hernias, lung
resection, gastric reduction procedures, cancer tissue removal
(e.g., liver, breast, colon, lung, etc.), and other procedures
which may require soft tissue plication. One having ordinary skill
in the art would be cognizant of the procedure to use in performing
the above operations using the exemplary devices described
herein.
[0099] The exemplary embodiments of the present invention provide
additional advantages that include, but are not limited to:
providing an arthroscopic approach for the plication and reduction
in ligament laxity; reducing the visible scars associated with open
surgical procedures by small port access required by the deployment
device; reducing the complexity associated with arthroscopic knot
tying; reducing the incidence of axillary nerve damage by a
verification of device positioning; enabling a maneuverable and
rapid deployment of plication sutures, reducing the required
surgical time as well as the level of complexity associated with
the procedure; allowing for adjustable and reproducible levels of
tissue plication; adding the option of releasability and
removability of a device from the plication region; minimizing
potential damage to the articular surface by using devices and
materials that can be secured to the tissue as well as have less
abrasive properties relative to tissue; and using active
embodiments of the device which may allow for diagnostic
measurement of positioning relative to neuromuscular tissues and
active tensioning of plication regions.
[0100] Although many examples below are provided with respect to
the shoulder capsule and using a plication procedure, these are
only exemplary and are used for their sake of simplicity. Wherever
the term "plication" is used with respect to the examples, the
broader term "repair" may be substituted to refer to surgical
procedures that may not necessarily be plication. Similarly, the
shoulder capsule, as described in the examples below, may be
substituted by any other tissue or tissue structure that could also
benefit from the procedure as described below.
[0101] A conventional arthroscopic approach to the glenohumeral
joint with the humeral head removed for clarity is shown in FIG. 1.
A standard posterior portal for diagnostic arthroscopy is shown
along with two anterior portals created using an outside-inside
technique, approaching the joint through the rotator interval area
above the subscapularis tendon. An additional accessory superior
posterior inferior portal can also be created. From a combination
of these portal positions, a standard diagnostic glenohumeral
arthroscopic examination can be performed. This includes
examination of glenohumeral ligament laxity or damage at the
glenoid labrum region of the joint. Excessive ligament laxity or
excessive capsular volume is identified by the ability to move the
arthroscope from the posterior to anterior inferior glenohumeral
ligament space without much difficulty. Once capsular laxity is
identified, methods for plication or reduction in the excessive
tissue are performed in order to improve the joint stability.
Clinical results suggest that the combination of arthroscopic
plication of the glenohumeral ligaments in combination with thermal
shrinkage procedures can provide results similar to those observed
with open surgical procedures. However, as is typically the case,
open surgical techniques have an increased risks associated with
further tissue damage and infection than through arthroscopic
means.
[0102] The present invention may be used arthroscopically, shown in
FIGS. 2A to 2B as a schematic cross-sectional drawing of an
arthroscopic approach of the glenohumeral joint with the humeral
head removed for clarity. These figures demonstrate the insertion
and position of an exemplary embodiment of an arthroscopic
deployment device 232 according to the present invention in
position (A) during pre-deployment and in position (B) during
post-deployment of exemplary clip plication devices according to
the present invention. The clip plication devices shown in these
figures are a single example of the many exemplary embodiments that
may be used herein and are described in this disclosure.
Additionally, the position, orientation, and location of the clip
devices are intended only for representation, and do not limit or
dictate the positions, orientations, location, and number of
devices that should be used. One having ordinary skill in the art
would be cognizant of the position, orientation, location and
number to use for a specific purpose without undue experimentation.
Furthermore, the figures shown here and throughout this disclosure
are not intended to be drawn to scale, but rather are for
illustrative purposes.
[0103] An exemplary embodiment of the capsular grasper is shown in
FIG. 3. This embodiment is comprised of a distal tip 302 that has
articulating cantilevered arms 303 with teeth that can perforate
the shoulder capsule tissue 301 when deployed using a handle 310
(shown partially). The grasper is advanced forward to position it
in contact with the capsule tissue 301. The cantilevered arms 303
with teeth engage the capsule tissue 301 and clasp the tissue as
the articulation is closed forming a tissue pleat, such as shown in
FIG. 3D. Articulation of the grasper mechanism is controlled at the
proximal handle 310. The grasping of the tissue pleat permits the
ability to provide traction on the shoulder capsule and mobilize
the pleat into the jaws of the plication deployment device
embodiment.
[0104] In another exemplary embodiment of the invention shown in
FIG. 4, a distal tip of a plication deployment device 304 is shown
in more detail. The device is composed of a grasping embodiment
positioned at the centerline of the jaws and two articulating
phalanges 305 and 306 (forming the device jaw). The grasping
embodiment as shown, can be extended beyond the mouth of the device
jaw, grasp tissue, and bring the tissue back into the jaws. The
upper and lower phalanges 305 and 306 of the device are
articulating elements that are controlled at the device handle 310
by the user. In an exemplary embodiment, one phalange 308 embodies
two hollow spikes 308 that upon closure of the jaw will perforate a
retracted capsular pleat 331. The phalange on the opposite side 306
embodies two circular orifices 309 that are in-line with the spikes
308 and act to capture the spikes of the other phalange when the
jaw is closed, as shown in FIG. 4B. To facilitate the jaws ability
to completely close, the phalanges 305 and 306 have channels that
can be through thickness, allowing the grasper to sit within the
jaws, but not impede actuation or closure of the jaws. In other
embodiments, one of the phalanges may be fixed, thereby having only
one articulating phalange of the jaw. In other embodiments, the
spiked phalange can have only one hollow spike or more, for
example, up to 6 hollow spikes.
[0105] It should be appreciated that in the embodiment shown in
FIG. 4, the shaft of the capsular grasper 302 is contained in the
shaft of the plication deployment device 304. In other embodiments,
the shaft of the capsular grasper 302 may also be contained
adjacent or off center to the jaws of the plication deployment
device. In the embodiment where the capsular grasper is at the
centerline of the device, this relationship permits the grasper to
piston axially within the passer so that retraction of the deployed
grasper delivers the capsular pleat into the jaws of the deployment
device. Furthermore, in another embodiment, the extent of pistoning
or displacement of the capsular grasper within the shaft of the
deployment device can be calibrated. This calibration permits
quantification of the length (size) of the capsular pleat and,
hence, the amount of tightening of the shoulder capsule (e.g., more
retraction of the grasper creates a larger pleat which, in turn
affects the tightness of the capsule). The handle 310 may have
various triggers 311 and 312 to allow the movement of the shafts of
the grasper 302, the suture passer 304 and the suture retriever 313
relative to one another.
[0106] Another exemplary embodiment for passing suture to secure
the pleat of the capsule is shown in FIG. 5. In this figure, a
suture retrieval arm 313 is contained within one of the phalanges
306 in the plication deployment device. An embodiment of the suture
retrieval arm has a distal tip that allows for catching of the
suture in one preferential direction. The suture retrieval arm 313
may be advanced in a piston motion axially within the shaft of the
plication deployment arm 313. An embodiment of the suture
(including a pre-tied sliding knot) is pre-loaded into the
plication deployment device in the form of a reloadable cartridge
315. The pre-tied sling knot can be loaded into the proximal spike
of the phalange 314, and the positioning of the knot ensures that
the suture retrieval arm passes through the loop of the knot when
the arm is deployed. After the free end of the suture is hooked,
the suture arm is retracted. The integrated instrument is removed,
leaving a horizontal mattress suture 314 at the base of the
capsular pleat. The sliding knot is tightened by pulling the free
end of the suture, as shown in FIG. 5E. Various embodiments can use
either resorbable or non-resorbable suture types as well as varying
suture sizes. In addition, instead of sliding knots, anchors (not
shown) that pass over the suture ends and prevent retraction of the
suture can be advanced over the suture ends until the knot is
secured.
[0107] An alternate embodiment includes the phalange spikes having
a pre-loaded U-shaped short suture segment whose ends are attached
to elastic barbs. The opposite phalange is pre-loaded with a short
suture segment with rigid rings attached at both ends. The orifices
of the non-spiked phalange dictate the position of the two suture
rings. When the jaws of the plication deployment device are closed,
the two barbs deploy into their two respective rings. This creates
a closed ring of suture (in a horizontal mattress pattern) through
the base of the capsular pleat.
[0108] FIG. 6 depicts a series of exemplary steps that may be used
to repair or plication tissue 601 using a repair deployment device
610 according to the present invention. After advancing the repair
deployment device 610 to the region of interest, the grasper
mechanism 611 is deployed. The grasper is advanced beyond the jaws
of the device, as shown in FIG. 3, and the cantilevered arms of the
grasper engages the tissue 602, as shown in FIG. 6. The grasper 611
is then retracted, forming a tissue pleat 602 as it is drawn into
the jaws of the repair deployment device 610.
[0109] In the exemplary embodiment shown, the jaws of the device
610 open as the grasper is retracted 611. In other embodiments, the
jaws may be manipulated independently to the grasper mechanisms
from the proximal handle of the device. The retracted grasper draws
the tissue pleat 602 into position within the jaws of the device.
As mentioned in the embodiment described in FIG. 4, the amount of
plication or tightening of the capsule is a function of the amount
of pleat that is drawn into the jaws, which is controlled by the
position of the grasper. Once the tissue pleat is in position, the
jaws of the repair deployment device are engaged.
[0110] In the embodiment shown, there may be one, two or more
hollow penetrating spikes positioned in a horizontal or vertical
position at the distal tip of the device, such as shown in FIG. 3
and FIG. 7. Upon engaging of the jaws, these spikes will penetrate
the tissue pleat. Similar to the mechanism described in FIG. 5, a
preloaded suture 612 with a pre-tied sliding knot, extending
through the suture grasper 620 and anchored to a suture grasper
630, can be loaded into the spikes. A suture retrieval arm is
advanced along the jaw of the deployment device and as previously
described can engage the suture. After the free end of the suture
is hooked, the suture arm is retracted. The integrated instrument
is removed, leaving a horizontal mattress suture 631 at the base of
the capsular pleat. The sliding knot is tightened and locked by
pulling the free end of the suture and advancing the knot. Various
embodiments can use either resorbable or non-resorbable suture
types as well as varying suture sizes.
[0111] FIG. 7 depicts another exemplary embodiment 710 of the
suture clip with a grasper 711 engaging tissue 701 with a suture
712 anchored supplied through a suture grasper 730. Shown in this
example is a suture element with both ends having spikes or needles
that allow for loading into the repair deployment device distal tip
and deployment through the capsule tissue upon engagement of the
jaws, as described in the previous embodiments. In this embodiment,
the dual spiked suture clip is passed through the tissue pleat 702
from phalange to phalange. The ends are retrieved and standard
sliding knots are tightened and locked by pulling the free end 733
of the suture and advancing the knot.
[0112] FIG. 8 shows another exemplary embodiment of a suture clip
and repair deployment device 810 wherein the suture 812 or clip
material is loaded into a non-spiked phalange 811. In this
embodiment, the spiked ends of the opposite phalange will engage
the suture or clip material when full jaw engagement is performed.
As a result, the spikes will penetrate the tissue pleat 802 then
engage the suture 812 or clip material. Opening of the jaw will
result in the suture or clip material to be withdrawn with the
spiked phalange, pulling the material through the tissue pleat. The
device would then be withdrawn. The suture slack 818 and ends are
retrieved and standard sliding knots are tightened and locked by
pulling the free end of the suture and advancing the knot.
[0113] The exemplary embodiment shown in FIG. 9 shows another
suture clip according to the present invention. Similar to the
previously described systems of FIGS. 3 to 8, the embodiment here
utilizes the same grasping mechanisms to generate the tissue pleat
902 and pull the pleat within the jaws of the repair deployment
device 910. The difference in this embodiment is the use of a
suture clip 940 or a U-shaped clip that can be loaded into the
distal end of the spiked jaws. In this case, the spikes can be a
characteristic of the jaws or a characteristic of the distal tips
of the suture clip or U-shaped clip devices. In either case, the
purpose of the spiked ends is to penetrate the tissue pleat. On the
opposite jaw, a locking base is loaded to mate with the suture clip
or U-shaped clip. Once the grasper mechanism has been deployed and
the tissue pleat is in position within the jaws of the repair
deployment device, the jaws can be engaged. Engagement of the jaws
results in the suture clip or U-shaped clip to penetrate the tissue
pleat and lock into the base on the opposite phalange. The locking
of the clip into the base then does not require knot tying, but
rather a firm repair of the tissue pleat is generated. The pleat is
then released from the grasper and plication deployment device
withdrawn.
[0114] In the exemplary embodiment shown in FIGS. 10A to 10D and
FIGS. 11A to 11H, a repair deployment device 1000 is shown without
and with a clip device 1030 at the distal tip of the device jaw,
respectively. The proximal end of the deployment device 1000 is not
shown for sake of simplicity. Note that the proximal handle of the
device will allow for actuation of the distal tip jaws as well as
manipulation of the grasper mechanism. This actuation can be
independently controlled or interconnected so a single handle
actuates both mechanisms, similar to the handle shown in FIG.
4F.
[0115] The overall dimensions of the deployment shaft for device
1000 include the ability to be delivered through a 5 to 8 mm
arthroscopic cannula. In addition, embodiments of the proximal end
of the device can include a rotational translating mechanism
associated with the shaft, allowing for adjustment in the
rotational alignment of the shaft and hence the jaws with respect
to the actuating handle. This rotational adjustment can be located
at or adjacent to the pivot point of the jaws to the shaft, or
along the shaft.
[0116] Alternatively, the shaft can be fabricated from a shape
memory alloy configured to exhibit martensitic properties at the
operational temperatures (e.g., 37 degrees Celsius). Therefore, the
shaft can be bent into the desired curve, along with the inner
cabling components. After the procedure, the device may be heated
above the austenitic transformation temperature such that the
instrument returns to its memory straight position. A primary
purpose of changing the jaw actuation axis versus the handle axis
is to allow the user to change the angle or position of the jaws
relative to the ligament tissue without requiring the user to
perform macroscopic manipulate the actuating handle, which is
confined by the cannula and access point into the working cavity.
In addition, a ratcheting rotating mechanism for positioning of the
device shaft over up to 360 degrees enables locking the device
shaft at a specified rotational position to the handle so the
operator can access more capsular locations than would be available
with a rigid straight shaft. The instrument shaft can alternatively
be fabricated with a curve or bend, the instrument can be
fabricated from a malleable alloy that doesn't exhibit shape memory
properties provided the permanent bends do not affect the fatigue
lifecycle of the instrument or render it aesthetically
inadequate.
[0117] In practice, various clip device embodiments (see clip
design embodiments) could be implemented at the distal tip of the
device jaws. The centerline grasper embodiment has variations (see
grasper embodiments). In the grasper embodiment shown, the
deflection of the grasper is inherent in the design. The grasper
may be constructed of material(s) that allow for elastic
deformation of the arm elements (e.g., super-elastic materials such
as Nitinol, stainless steel, 17-7, stainless steel 304, stainless
steel 316, or other biocompatible stainless steel, other alloy,
aluminum, superelastic polymers, sintered metals, machined metals,
carbon fiber, gas impregnated nylon, polycarbonate, ABS, other
polymers, or insert molded composite materials).
[0118] The end of the grasper may be pre-shaped into the open
position, opening to an angle from 0 to 90 degrees. The distal tip
length of the grasper (which is deformed to a predetermined opening
angle) may range, from, for example, from 1 to 50 mm in length. The
grasper may be positioned in a central lumen of the deployment
device. As shown in the figures, the upper and lower jaws of the
deployment device may have tapered channels or guiding channels in
which the undeployed grasper arms can sit during the initial
advancement of the deployment device through the arthroscopic
cannula. Furthermore, the shape of these channels aid in the
guiding of the deployed grasper back into the jaws. Note the
spacing between jaws allows room for both the clip device at the
distal tip as well as the thickness of tissue drawing into the jaws
with the grasper. The capsular tissue thickness varies between 1
and 7 mm.
[0119] Upon deployment (e.g., forward push out) of the centerline
grasper, the specified angular deformation of the grasper tip will
open up the arms 1010 because they are no longer constrained by the
centerline channel. Pull back of the centerline grasper will result
in closing of the clamps and pull back of a specified segment 1101
of tissue 1100 into the jaws of the deployment device. The level of
plication will depend on the distance at which the grasper arms are
drawn into the deployment device. The range of plication distance
for capsular plication application is typically between 1 and 25
mm, more specifically between 2 and 10 mm. More or less tissue
plication can be chosen by adjustment in the position of the
grasper arms. The length of tissue plicated (e.g., plication
distance), depending on the application and extent of the capsular
laxity, will typically range between 1 and 50 mm; more specifically
between 5 and 20 mm. It should be noted that for this and other
non-capsular plication applications, the plication distance can be
greater than 25 mm, depending on the application and soft tissue
characteristics. The amount of tissue plication can be chosen by
adjusting the position of the grasper arms relative to the
plication clamp jaws. Force gauges can be connected to the grasper
to measure the tension placed on the capsule during plication.
[0120] Alternatively, springs (static or adjustable) can be
connected to the grasper to direct a specified amount of tension
applied to the capsule by the grasper thereby producing a specific
amount of tissue plication. In addition, axial distance of grasper
movement relative to the plication clamp can be regulated to
control the amount of plication as determined by distance as
opposed to tension as described above.
[0121] The actuation of the jaws 1010 and grasper deployment 1020
can be linked or can be independent in motion. The benefit of
individual independent motion is augmentation in clamping that the
jaws can provide with this embodiment of grasping. In other
embodiments, the benefit of independent motion may not demonstrate
this distinct advantage. The mechanism of actuation of the
deployment device jaws includes both forward and backward linkage
actuation by simple linear motion from the actuating handle. The
arrangement of the hinge linkage allow for considerable force
generation at the distal tip of the deployment device. Moreover,
the simplicity in design provides a relatively problem free hinge
mechanism that can be cleaned easily. The shaft of the deployment
device is made to have characteristics that allow for easy
insertion though the arthroscopic cannula and no clinically
relevant abrasion to the surrounding soft tissues.
[0122] Once the tissue has been drawn into space between the jaws
of the deployment device and the grasper position is locked, the
jaws of the deployment device can be fully actuated, engaging the
tissue fold between the ends of the plication clip, as shown in
FIG. 11F. The exemplary clip device 1300 shown in this embodiment
is a two-piece device with the penetrating component held in the
upper jaw and the base or locking component held in the lower jaw.
The individual components are held into position at the distal tip
of the jaw either using a snap-fit or mechanical locking mechanism
that can be released by simple actuation at the proximal handle.
The penetrating component has two arms that are tapered to allow
for easy penetration through the soft tissue to be plicated. By
fully engaging the deployment device jaws, the two-piece clip
device will lock into position, plicating the tissue together. The
clip device is then released from the deployment device and
deployment device withdrawn from the site. The deployment device
can be reloaded with an additional clip device and subsequent
plication performed using the methods described above.
[0123] The exemplary clip shown in FIG. 11 shows the plication clip
oriented perpendicular to the axis of the plication clamp such that
the penetration sites of the clip are parallel to the capsule
plane. It should be noted that the plication clip can alternatively
be oriented along the plication clamp axis such that the
penetration sites are perpendicular to the capsular plane and are
oriented vertical along the plicated tissue fold. Further, the
plication clamp jaws can be curved (or rotatable as described
above) and the plication clip oriented along this curved axis such
that the penetration sites are located parallel to the capsule
plane. The plication clip embodiment in FIG. 11 is shown with two
clip penetration sites through the folded tissue. It should be
noted that as few as a single penetration site and up to as many as
6 or more penetration sites can be incorporated into a single
plication clip. Similarly, in FIG. 23 an alternative embodiment is
shown with a different grasping mechanism 2330, but with plication
clips 2311 oriented perpendicular to the axis of the plication
clamp. FIG. 24 shows a variation in the distal tip embodiment with
the plication clip embedded in the jaws of the device. Dimensions
of the device shown in FIG. 24 will accommodate the dimensions
required for clinical device delivery and tissue fold
plication.
[0124] FIGS. 11A to 11H show an exemplary plication clip supported
at the distal tip of the deployment jaws. It should be noted that
various one-piece and two-piece clip device embodiments can be used
to plicate the soft tissue and are described in the subsequent
Figure descriptions. Moreover, although FIGS. 10 and 11 depict the
centerline grasper having two arms, various embodiments may have
additional arms or even as few as one arm. The various embodiments
for grasping tissue and pulling the tissues into the deployment
device jaws are described in subsequent Figure descriptions. It is
important to note that in some instances the centerline grasping
mechanism is not the ideal orientation and off-center grasping
methods are preferred. In such instances, most of the described
grasping embodiments can be adapted to off-center grasping
positions. For example, in the instance where one of the jaws of
the deployment device is stationary, an off-center grasping
mechanism, with respect to the jaws may be required.
[0125] The deployment device shown in FIGS. 10 and 11 shows an
embodiment with two articulating jaws, in some embodiments only one
articulating jaw may be desirable. In the single articulating jaw
instances, either the upper or low jaw will be fixed, while the
opposing jaw will have the ability to pivot into the open and
closed position (See, for example, FIGS. 16 and 17).
[0126] The exemplary deployment device embodiment shown in FIG. 12
shows the distal jaws of the device and in some aspects is similar
to that described with respect to FIG. 8. However in this
embodiment the suture tips 1212 (which are the penetrating
spikes/needles) can be passed between jaws of the device by a
locking mechanism located on the opposite jaw. The embodiment in
FIG. 12 shows a single suture strand 1220 with two suture tips 1221
and 1222 oriented at the ends of the strands. It should be noted
that from 1 to 6 or more suture tips may be utilized and located at
any combination of suture ends or segments located along the length
of a complete suture strand. For example, three suture tips can be
incorporated with two located at the ends of the suture and one at
the mid-point between the ends of the suture.
[0127] The suture tip transfer mechanism incorporated in the
plication clamp jaws can comprise a simple lock-fit/snap fit (as
shown in FIG. 12), or can incorporate magnetic components that
facilitate passing the suture tips from one clamp jaw to the other.
For example, the receiving end of the jaws can be magnetized to
attract the suture tip (either complementary magnetized or
fabricated from an appropriate metal or alloy) of the opposing side
after the jaws have been engaged. Additional embodiments can
include receiving ends with bi-leaflet, tri-leaflet, or other
multi-leaflet configurations that allow for a frictional lock of
the suture tips to hold or capture the suture on the clamping jaw
after passing through the tissue fold. These receiving slots can be
positioned along the jaw in various orientations and numbers. The
slots can span the width of the jaw or have multiple slots in
series and parallel along the jaw. Moreover, the edges of the
leaflet coaption points can have stress-relieving edges to allow
for expansion of the orifice to catch the sutures. In the snap fit,
frictional lock or magnetized scenarios, the suture ends would be
withdrawn from the site along with the suture tips. The suture ends
are retrieved and standard sliding knots are tightened and locked
by pulling the free end of the suture and advancing the knot.
Alternatively, anchors can be passed over the suture ends to
eliminate the need for manually creating and passing knots. In the
case of multiple suture tips, the discrete suture ends associated
with each tip can be tied together or individually tied to create
the desired attachment of the plication.
[0128] In the embodiment shown in FIG. 12 the phalanges of the jaws
are intended to aid in the agitation of the synovium. Variations of
these embodiments include roughed surfaces (e.g., rasp) and spikes
1211 with variable sizes for penetration. These embodiments may be
static or can also be actuated both in the open or closed position
of the jaws. In one instance, as tissue is withdrawing into the
jaws using the grasping mechanism, the tissue would rub along the
roughened embodiments or be pulled passed the roughened embodiments
to irritate the synovium. In an instance where the roughened
surface is actuated, after engagement with the jaws of the device,
the phalange roughened area can move relative to the surrounding
jaw, resulting in a localized irritation of the synovium.
[0129] More specifically, as shown in FIG. 12, various embodiments
of the deployment device jaws can include mechanism for roughening,
abrading, or penetrating the plicated tissue fold to elicit a
biological healing response, as described previously. These
embodiments can include mechanical methods such as sharpen needle
points, blunt points, rasping elements, or elements which can
produce the desired abrasion, roughening, or penetration to elicit
the desired biological healing response. These embodiments can also
include non-mechanical mechanisms such as thermal, chemical, x-ray,
electrical, ultrasonic, ultraviolet light, or microwave signal
mechanisms to cause the localized tissue damage to the synovium
that would also elicit the biological healing response that is
desired.
[0130] In the exemplary embodiment shown in FIGS. 13 and 14, the
procedural application of a hinged clip device is shown with and
without the use of a grasper 1311. The distal end of the deployment
device 1300 is shown in FIG. 13 where in (A) a portion 1331 of the
ligament tissue 1330 is captured by the grasper mechanism, in (B)
pulled into the jaws of the deployment device, in (C) penetrated by
the clip device and plicated, and in (D) the deployment device
removed. This embodiment is shown to exemplify the stepwise
procedure in deploying one of the clip devices 1320. For
simplicity, the element for abrading, roughening, penetrating, or
exciting the biological healing response of the synovium are not
shown, but may be similar to that shown in FIG. 12.
[0131] In some embodiments, a surgeon may agitate the synovium with
a general rasping arthroscopic instrument in the region of interest
prior to positioning of the deployment device and deployment of the
plication clip. Furthermore, unlike the embodiment shown in FIGS.
10 and 11, the placement of the clip device is positioned along the
jaws of the deployment device, not specifically at the distal tip.
The advantage of the placement of this device in this position
along the jaw of the deployment device can be appreciated in FIG.
14 where the embodiment shown does not utilize a grasper to draw
the tissue into the jaws of the deployment device. In various
embodiments of the clip device, hinged or pivoted actuation of the
clip may allow for plication of the ligament or soft tissue without
the need of the grasper to bring the tissue into position.
[0132] In FIGS. 13 and 14 the clip device is snapped into its
locked configuration, clip released, and deployment device removed.
In FIG. 13 the level of plication would be dictated by position
(e.g., pull back) of the grasping mechanism. With this hinged
embodiment, the limitation to the plication length will be limited
to the size of the clip design. Specifically, as shown in FIG. 13D,
the clip device will surround the area of plication. Noting that in
the embodiment shown, the centerline grasper and the jaws of the
deployment device may be off-set from each other. Specifically,
certain embodiments, if within the jaws of the deployment device,
may require the grasper to be stacked either adjacent of the jaws
or on one side of the jaws (non-center).
[0133] As shown in FIGS. 13 and 14, there may be instances where
the general capsular volume or excessive laxity will allow for
plication of the tissue fold without the need for a grasper to
bring the tissues into position. In such instances a simplified
plication deployment device may prove to be advantageous. However,
it is anticipated that the advantage gained with respect to
adjustment in the length of plication, alignment and drawing of the
tissue into the deployment device jaws may dictate the need for a
grasping mechanism. As indicated previously, the length of
plication of this hinged embodiment will be limited to the size of
the clip device. However, other embodiments (as described elsewhere
in this disclosure) will not have these sizing limitations. The
primary emphasis of FIG. 14 is to demonstrate that the clip designs
themselves can act as jaws that can grasp tissue without the need
of a dedicated grasping mechanism.
[0134] The embodiment shown in FIG. 15 shows the use of
neuro-stimulation as a verification tool indicating the proximity
of neurovascular structures, in particular the axillary nerve 1540.
Similar neuro-stimulation application can be applied to some of the
exemplary embodiments, for example the devices shown in FIGS.
23-33. Hence, the delivery and suture plication devices shown in
FIGS. 23-33 can contain a centralized or non-centralized grasping
element that can carry the neuro-stimulating signal to allow for
verification of the proximity of neurovascular structures, in
particular the axillary nerve. As discussed earlier, the position
of the axillary nerve relative to the inferior capsule is within
approximately 1 cm. The close proximity of this nerve raises
concerns when applying any plication method to the capsule. An
exemplary embodiment of the deployment device includes the
incorporation of a neuro-stimulation probe to excite the region of
plication prior to engagement of the plication clip. The probe
element can comprise either the grasping mechanism and/or the
deployment device jaw. An external energy source capable of
delivering pacing stimuli having an amplitude from 0.1 mA to 50 mA
is connected to the probe element 1550 and stimulator/detector 1560
(e.g., the grasper, plication clamp jaws, or independent electrode
probe) to transmit the electrical stimulation to the capsular
tissue in direct proximity to the grasper and/or plication
clamp.
[0135] Activation of the axillary nerve 1540 (or other nerve or
muscle tissue) would be caused if the grasper or plication clamp
jaw is too close to the axillary nerve (or other nerve or muscle
tissue). Activated response would be observed by twitching of
muscles associated with the neurovascular structure. For example,
activation of the axillary nerve will result in a muscle response
from the deltoid muscles. The intended neuro-stimulation is
intended to provide minimal excitation for positional
identification only, not for diagnostic or treatment purposes.
[0136] Stimulation of the axillary nerve (or other nerve or muscle
tissue) provides a clear warning that the grasper and/or plication
clamp jaws are at risk of damaging the axillary nerve and indicates
the physician should move the plication device to another location,
thereby avoiding unwanted nerve (or muscle) damage.
[0137] Commercially available stimulators can be utilized to
delivery the 0.1 mA to 50 mA pacing pulse. The waveform can be
monophasic, biphasic, or other pattern known to evoke stimulation
of nerve or muscle tissue. The pulse duration can vary between 1
msec to 500 msec. The amplitude determines the proximity of the
probe element to the stimulated nerve or muscle. For example, a
plication device that stimulates the axillary nerve by delivering a
biphasic pacing pulse having a duration of 10 msec and an amplitude
of 1 mA is closer to the axillary nerve than a plication device
that requires 10 mA to stimulate the axillary nerve with the
waveform and duration being the same. As such, the proximity of the
axillary nerve can be determined by the amplitude of the pacing
pulse thereby ensuring that plication does not damage the axillary
nerve (or other nerve or muscle), and/or mapping the location of
the axillary nerve to plan the location of tissue placations.
[0138] Although the exemplary embodiment of the invention as shown
in FIG. 15 is described with respect to the shoulder capsule and
the axillary nerve, one having ordinary skill in the art would be
cognizant that the same technique may be applied to other tissues
or tissue systems having other nerves passing therethrough.
[0139] The exemplary embodiments shown in FIGS. 16 and 17
illustrate a device that has a grasper mechanism 1631, a suture
retrieving mechanism 1641, and a jaw mechanism 1610. This device
configuration has a hinged distal jaw 1610 with one jaw 1620 in a
fixed configuration. Similar to previously described grasper
mechanisms, this single armed grasper is shown in a deformed
configuration, but can also be oriented into any angular position
(including a straight configuration) by pre-deforming the grasper
shaft. The grasper embodiment shown includes two primary
components: an exterior guiding tube 1630 and an interior
deployment anchor 1631. The anchor 1631 begins within the guiding
tube sheet in an undeployed/low profile configuration. The distal
tip of the anchor 1631 is tapered to allow for penetration through
soft tissue layers. The surface of the guiding tube 1630 is smooth
or can be lubricated or coated (e.g., hydrophilic coatings) to
allow for easy penetration and passage through tissues.
[0140] The guiding tube 1631 can be advanced beyond the jaws as
illustrated in FIG. 17A. After penetration of the anchor 1631 and
guiding tube through the tissue layers 1650, deployment/advancement
of the anchor and subsequently deployment of the anchor wings (to
prevent pull out) is performed. Once anchor 1631 is fully deployed,
the grasping mechanism is drawn back into the jaw of the device,
pulling a tissue fold 1651 into the jaws. Once the grasping
mechanism is withdrawn, the jaws are engaged. The suture retrieving
mechanism also includes two components: an outer guiding tube 1640
and an inner suture grabber 1641. During engagement of the jaws,
the outer guiding tube 1640 penetrates the folded tissue 1651. Once
fully engaged, the suture grabber 1641 is deployed.
[0141] Once the suture is engaged, the jaws are released, and
suture pulled through the tissue layers. The grasping mechanism may
be maintained in position or released depending on the surgeon's
preference. In some instances, the surgeon may elect to keep the
grasping mechanism in position to maintain the tissue pleat until
final plication is finished. Repeated passing of the suture is
performed and knots tied to secure the region of plication.
Coordinated movements of the jaws and deployment of the suture
grabber add to the simplicity of the device embodiment. Various
embodiments can be included in the jaws of this deployment device
embodiment to accommodate the use of clip devices at the distal
tip, as exemplified in FIGS. 10 and 11.
[0142] The anchor wings may be made from metals, shape memory
metals, polymers and shape memory polymers that can be deployed and
retraced into the guiding tube. The shape of the wing deployment
can vary (e.g., elliptical, spherical, triangular, corkscrew,
hook). The primary purpose of the wing shape is to provide an
anchoring point to pull the tissue into the grasper. Other
embodiments of the anchor deployment may also include inflation of
balloon anchors of various configurations and materials (e.g.,
silicone, polyurethane, PET, Nylon, etc.). An advantage of the
single armed grasping embodiment is the ability to leave the device
engaged while releasing and rotating the overall device. This
motion is allowable because of the wing shape or balloon tip
anchoring mechanism, which is does not actively grasp the tissue as
shown in FIGS. 10 and 11.
[0143] An embodiment of the deployment device has a total length
(including the actuating handle) to be about 20-100 cm with the
shaft of the device being about 12-92 cm of the length. The range
in maximal width or maximum diameter of the shaft and working end
of the device will range between 4.0 to 8.0 mm. The length of the
deployment device jaws will range from 10 to 40 mm in length.
[0144] Grasper embodiments 1800 and 1900 shown in FIGS. 18 and 19
depict variations of the grasping mechanism described for other
embodiments, such as those shown in FIGS. 3 and 4. Engaged and
unengaged illustrations are shown for two pronged and three pronged
embodiments. As indicated in the figures, the ends 1810 and 1910 of
the grasper embodiment can include tips 1820 and 1920 that are
triangular in shape or another similar tooth-like structure that
would allow for gripping or engaging of soft tissues when engaged.
These tips could also include reverse hook configurations (similar
shape to knitting needles). Additional embodiments that include
additional prongs can also be included as well as an embodiment
containing only one arm. The single armed embodiment will include a
similar distal tip that can hook and engage soft tissues, allowing
for grasping and drawing of the device into the jaws of the
deployment device.
[0145] Grasper embodiments 2000, 2100 and 2200 shown in FIGS. 20,
21 and 22 depict variations of a single armed grasping mechanism
using an anchoring system. In addition to the embodiment described
in FIGS. 16 and 17, the embodiments shown in FIGS. 20, 21, and 22
show a method for grasping tissue using a deployed anchoring
system. In FIG. 20 the undeployed grasper is held within the
guiding tube. The distal tips 2010, 2110 and 2210 of the grasper
embodiments are a tapered or sharpened point that allow for tissue
penetration. The shaft of the guiding tube as well as the grasper
device are polished or coated to allow for easy passage through
tissues. The diameter size of these devices can range from 0.5 to
3.0 mm. Once the grasper penetrates the tissue layers, the grasper
is advanced beyond the guiding tube to allow for deployment of the
anchor. The embodiments shown are hook and corkscrew
configurations; however, the shape and deployment can vary as
described for FIGS. 16 and 17. The materials used to accommodate
these distal configuration changes can include shape memory
metals/polymers or other specified metals or polymer materials. An
advantage of these embodiments is the ability to adjust the shape
to make the device more compatible with surrounding structures
(e.g., axillary nerve) as well as improve the ability to adequately
grasp the tissue and pull the tissue into the jaws of the
deployment device.
[0146] Alternative graspers include balloons incorporated at the
distal tip of a central tube that can be expanded once positioned
through or into the capsular tissue. The balloon can be oriented
proximal to a needle or can incorporate a central lumen such that a
separate needle can pass. Alternatively, a tube coupled to a vacuum
source can be used as the grasper such that as suction is applied
through the tube the tissue is pulled into engagement with the tube
and can be manipulated by the vacuum grasper. To augment the vacuum
grasper, a flexible flange can be incorporated to enlarge the
vacuum orifice and better secure the vacuum grasper to the tissue
surface. This flange can solely comprise a flexible silicone or
polyurethane membrane (or other flexible polymer) or can
incorporate strips of support material formed in an outward fashion
and covered by a flexible membrane. The strips expand the flexible
membrane outward as they are released from the confines of the
guiding tubes and compress the flexible membrane as they are
retracted into the guiding tubes. The enlarged opening increases
the surface area of tissue that is contacted by the vacuum grasper
increasing the grasping force.
[0147] The grasper embodiments shown can be connected to an
external simulator for neuro-stimulation to verify the location and
position of the plication relative to neurovascular structures
(e.g., axillary nerve), in a similar way as that shown for FIG. 15.
Once the plication has been effected, the grasper anchor is
released from engagement to the plicated tissue and is drawn back
into the guiding tube. The low profile and simplicity of deploying
these anchors to grasp tissue provides a mechanism that is
reproducible, can have a secondary function of irritating the
synovium (eliciting a biological healing response) by penetrating
the tissue layer in local proximity to the plication, and provide a
sturdy anchoring system that the surgeon can pull back the tissue
pleat into the jaws of the deployment device.
[0148] Grasper embodiment 2300 shown in FIG. 23 depicts a variation
in the grasping mechanism with an outer sleeve in which an inner
element with a pre-shaped distal tip 2330 is located. The purpose
of the pre-shaped distal tip is that it can be drawn by shaft 2320
into the outer sleeve to close the jaws 2310 of the grasper. This
mechanism provides the ability to advance and withdraw the grasper
independent of the closing of the jaws.
[0149] In FIG. 23 an alternative embodiment is shown with a
grasping mechanism with plication clips 2311 oriented perpendicular
to the axis of the plication clamp. FIG. 24 shows a variation in
the distal tip embodiment with the plication clip 2411 embedded in
the jaws of the device. Dimensions of the device shown in FIG. 43
will accommodate the dimensions required for clinical device
delivery and tissue fold plication.
[0150] FIGS. 25A to 25C and FIG. 26 show exemplary embodiments 2500
and 2600 of a distal tip of a suture delivery device intended for
the same purposes and functions as described for the embodiments in
FIGS. 4-9. The grasping embodiment shown in FIG. 26 can be
substituted with any of the grasping embodiments presented within
this disclosure. The penetrating suture elements can be one or
greater in number. In FIGS. 25 and 26, two suture penetrating
elements are shown as 2511 and 2611 within jaws 2510 and 2610. In
these embodiments the suture is held on one side of the jaw and the
penetrating elements on the opposite jaw. The suture side holds the
suture in a manner that allows for engagement of the penetrating
elements to catch the suture and during engagement and pull the
suture back through the tissue fold when released. The suture can
be freely advanced through the tissue fold during withdrawal of the
device. It should be noted that 1 to, for example, 6 suture tips
oriented at the ends of the strands and located at any combination
of suture ends or segments located along the length of the complete
suture strand. For example, three suture tips can be incorporated
with two located at the ends of the suture and one at the mid-point
between the ends of the suture. The suture side of the jaw can be
removable and replaceable for use as a cartridge for additional
sutures.
[0151] In various embodiments, different suture lengths can be
incorporated to allow for delivery of one or more suture
plications. The penetrating suture tips can have a variety of
embodiments that allow for catching of the suture. As shown in FIG.
26, the penetrating element 2611 can have a hook edge along the
axis that allow for capture of the suture as it passes through the
suture holding side of the jaw. The shape and geometry of the hook
edge is inverted as to minimize the potential for catching on
tissue during the withdrawal of the penetrating elements while
enabling capture of the suture for withdrawal. Additional
embodiments of these suture tips can include variations that have
flexible latches that cover the hook edge and allow for capture of
the suture as well as securing of the suture while providing a
smooth transition along the penetrating element axis (reducing the
potential for catching of the tissue during withdrawal). Other
embodiments can include deeper and more curved J-hooked edges that
have smooth edges and allow for capture of the suture while
reducing the possibility of tissue catching during withdrawal. Once
the suture end is captured and retrieved, standard sliding knots
are tightened and locked by pulling the free end of the suture and
advancing the knot. Alternatively, anchors can be passed over the
suture ends to eliminate the need for manually creating and passing
knots.
[0152] Similar to previously described embodiments, the jaws of the
device can also incorporate roughed surfaces (e.g., rasp) and
spikes with variable sizes for penetration. These embodiments may
be static or can also be actuated both in the open or closed
position of the jaws. In one instance, as tissue is withdrawing
into the jaws using the grasping mechanism, the tissue would rub
along the roughened embodiments or be pulled passed the roughened
embodiments to irritate the synovium. In another instance, after
engagement of the jaws, the device will penetrate the tissue,
resulting in localized irritation of the synovium along distinct
roughened or spiked locations along the flange of the jaw.
[0153] In addition, similar to that described for the embodiment
shown in FIG. 15, neuro-stimulation can be added to these device
tips either through the grasping mechanism or through the
penetrating elements. The primary purpose would be for verification
of the proximity of neurovascular structures, in particular the
axillary nerve.
[0154] FIGS. 27-31 show various alternative embodiments of the
distal tip of a suture plication delivery device. As shown, single
or multiple sutures can be passed at the device tip in various
orientations. Not shown, but included in these embodiments is a
central or non-central grasping mechanism. Any of the grasping
mechanisms described for the devices in this document can be
utilized in this embodiment. Similarly, as described for the
embodiment shown in FIG. 15, neuro-stimulation can be added to
these device tips either through the grasping mechanism or through
the penetrating elements. A primary purpose would be for
verification of the proximity of neurovascular structures, in
particular the axillary nerve.
[0155] A purpose of presenting FIGS. 27-31 is to demonstrate
various non-limiting distal tip embodiments for suture passing
where one side of the jaw holds the suture and the opposite side
has the penetrating and suture capture element. Similar to that
described in FIGS. 25 and 26, the suture side holds the suture in a
manner that allows for engagement of the penetrating elements to
catch the suture and during engagement and pull the suture back
through the tissue fold when released. The suture can be freely
advanced through the tissue fold during withdrawal of the device.
It should be noted that 1 to, for example, 6 suture tips may be
oriented at the ends of the strands and located at any combination
of suture ends or segments located along the length of the complete
suture strand. For example, three suture tips can be incorporated
with two located at the ends of the suture and one at the mid-point
between the ends of the suture.
[0156] The suture side of the jaw can be removable and replaceable
for use as a cartridge for additional sutures. In various
embodiments, different suture lengths can be incorporated to allow
for delivery of one or more suture plications. The penetrating
suture tips can have a variety of embodiments that allow for
catching of the suture. As shown in FIG. 27-31, the penetrating
element can have a hook edge along the axis that allow for capture
of the suture as it passes through the suture holding side of the
jaw. The shape and geometry of the hook edge is inverted as to
minimize the potential for catching on tissue during the withdrawal
of the penetrating elements while enabling capture of the suture
for withdrawal. Additional embodiments of these suture tips can
include variations that have flexible latches that cover the hook
edge and allow for capture of the suture as well as securing of the
suture while providing a smooth transition along the penetrating
element axis (reducing the potential for catching of the tissue
during withdrawal). Other embodiments can include deeper and more
curved J-hooked edges that have smooth edges and allow for capture
of the suture while reducing the possibility of tissue catching
during withdrawal. Once the suture end is captured and retrieved,
standard sliding knots are tightened and locked by pulling the free
end of the suture and advancing the knot. Alternatively, anchors
can be passed over the suture ends to eliminate the need for
manually creating and passing knots.
[0157] An additional element shown with the exemplary embodiments
in FIGS. 27-31 is a flexible cantilever, flexible bow, or guard on
the penetrating element flange that allows the opposing flange to
rest without engagement of the suture and the penetrating element.
In this resting position, the device can be introduced through a
standard 5, 6, or 8 mm cannula without engagement.
[0158] Various embodiments show that different shapes and
configuration with variable numbers of penetrating elements and
position of penetrating elements can be chosen and not limited to
those shown in FIGS. 27-31. A common element of these embodiments
is the ability to engage the suture and penetrating element by
further engaging the jaws. The additional engagement, achieved by
closing the jaws by applying additional pressure, will result in
deformation, bending, or shifting of the cantilever, flexible bow,
or guard to expose the penetrating element. The exposure of the
penetrating element allows for penetration of through the tissue
fold and engagement of the element with the suture. The subsequent
opening of the jaw results in pulling of the suture back through
the tissue fold and return of the cantilever, flexible bow, or
guard to its original position.
[0159] Similar to previously described embodiments, the jaws of the
device can also incorporate roughed surfaces (e.g., rasp) and
spikes with variable sizes for penetration. These embodiments may
be static or can also be actuated both in the open or closed
position of the jaws. For example, as tissue is withdrawing into
the jaws using the grasping mechanism, the tissue would rub along
the roughened embodiments or be pulled passed the roughened
embodiments to irritate the synovium. In another example, after
engagement of the jaws, the device will penetrate the tissue,
resulting in localized irritation of the synovium along distinct
roughened or spiked locations along the flange of the jaw.
[0160] In addition, similar to that described for the embodiment
shown in FIG. 15, neuro-stimulation can be added to these device
tips either through the grasping mechanism or through the
penetrating elements. A primary purpose would be for verification
of the proximity of neurovascular structures, in particular the
axillary nerve.
[0161] The exemplary embodiment in FIG. 32 shows a repair device
3200 having a flexible shaft to allow for insertion, movement and
manipulation through contoured body geometry to access the
necessary target tissue. An internal slide mechanism 3230 allows
for manual or automated manipulation of the jaws 3210 to allow the
gripper 3220 to pierce the penetrating point 3221 into the target
tissue. An abraded surface and/or neuro-stimulator may also be
added to this exemplary embodiment to enhance the tissue repair
process and nerve avoidance, respectively.
[0162] FIG. 33 illustrates another exemplary embodiment of the
delivery device in which the plicating suture or clip is delivered
over the outside of the device shaft. In this embodiment, the
tissue 3330 is grabbed to form the tissue fold 3331. Then the
plication suture or clip is advanced down the shaft of the device.
Once in position, the tissue is released. The suture element can be
a pre-tied embodiment or an elastic band embodiment. The plication
clip can be of the forms shown in FIGS. 43 and 44.
[0163] Various plication devices were disclosed by example within
the exemplary embodiments described above. Such plication devices
may have a number of different shapes and sizes, which are all
within the scope of the present disclosure. Various specific shapes
and sizes will be discussed herein but the present invention is not
limited to such exemplary embodiments.
[0164] The exemplary embodiment shown in FIG. 34 depicts a
plication clip device that includes a penetrating base 3410 and a
locking base 3420. The overall device shown is circular in
cross-section as an example. However this cross section could also
be square, rectangular, triangular, or any other geometric
cross-section. The penetrating base 3410 of the clip device has a
distal tip that is sharpened or tapered to allow for easy passage
through tissue 3440. Just below the distal tip are multiple
protruding tapered, outwardly extending locking elements that mate
with corresponding holes 3421 on the locking base 3420. The number
of locking elements can range from 1 to, for example, 6. When
engaged together, the plication clip locks into position, securing
the tissue pleat 3441. This embodiment or variation can be
delivered through plication clamps described above.
[0165] The embodiment shown in FIG. 35 depicts a two-component
plication clip system having a dual arm penetrating tubular
U-shaped component 3510 and a locking base 3520. Both ends of the
penetrating component are tapered to allow for easy penetration
through soft tissue. In addition, locking tabs are positioned at
the distal tips and extend outward for mating and securing of the
U-shaped component to the locking base. The locking base 3520 has
two sets of through-holes 3521 for the U-shaped component to engage
and lock to the base. The bottom set of through-holes are smaller
in diameter to allow for seating of the distal tips of the U-shaped
component, but does not allow the device to slip through. The width
of the device can range from 2 to 30 mm; and more specifically from
2 to 10 mm. The height of the device can range from 2 to 20 mm; and
more specifically 2 to 6 mm. The thickness of the device clip
members can range from 0.25 mm to 3 mm.
[0166] The embodiment shown in FIG. 36 depicts a three-component
plication clip system: a dual arm penetrating tubular U-shaped
component 3610, an outer covering for the U-shaped component 3611,
and a locking base 3620. Both ends of the penetrating component are
tapered to allow for easy penetration through soft tissue. The
locking tabs are positioned at the distal tips for mating and
securing of the U-shaped component to the locking base. These
locking tabs are tapered to allow for easy sliding into the holes
3621 of the locking base. The locking base has two sets of
through-holes 3621 for the U-shaped component to engage and lock
with the base. The holes in the locking base have tapered and
shaped holes, such as the star shaped holes used in the figure,
that allow for easy engagement of the lock mechanism. The bottom of
the locking base includes through-holes for the U-shaped distal
tips to seat, but does not allow the device to slip through the
locking base.
[0167] The outer covering can be fabricated form a resorbable
material or a polymer such as polypropylene or other suture
materials to cover the central support that can be fabricated from
a metal or alloy, or a polymer with sufficient structural
properties to engage the locking base and prevent release of the
two components once engaged. The width of the device can range from
2 to 30 mm; more specifically from 2 to 10 mm. The height of the
device can range from 2 to 20 mm; more specifically 2 to 6 mm. The
thickness of the device components can range from 0.25 to 3 mm.
[0168] The embodiments 3710 and 3810 shown in FIGS. 37 and 38
depict two-component plication clip systems having a dual arm
3720/3721 and 3820/3821 penetrating tubular U-shaped component and
a dual arm tubular locking base. Various embodiments of these
devices can include circular, rectangular, square, or other
geometric cross-sections. Both ends of the penetrating component
are tapered/sharpened to allow for easy penetration through soft
tissue. Alternatively, one end can be blunt while the other end
sharpened. The locking tabs, extending outwardly, are positioned
near the distal tips for mating and securing of the U-shaped
components to the locking bases. In each embodiment, the
penetrating component slides into the locking base arms and tabs
securely lock the devices together when engaged together.
[0169] The embodiment in FIG. 37 incorporates a rigid tab 3730 that
extends outwardly with a locking component that incorporates a slot
3740 from the distal tip to the locking opening. This allows radial
expansion of the base around the locking tab 3730 until the locking
tab is situated in the opening where the base returns to its
original shape locking the tab within the opening. The embodiment
in FIG. 37 can be fabricated completely from polymers (e.g.,
polypropylene, other suture material, or other biocompatible
polymer) since the tab of the base does not need to deflect and
spring back to its preformed shape but can be rigid since the
larger diameter lock expands during engagement of the two
components.
[0170] The embodiment in FIG. 38 incorporates an outwardly
extending tab 3830 to the clip base that engages an opening 3840 in
the clip lock. As such the tab 3830 must deflect during insertion
of the base into the lock and return to its original orientation
once positioned within the opening of the lock to secure the base
to the lock. As such, the tab must incorporate enough spring such
that the thin member can deflect and return once the confining
forces are removed, commiserate with placing the tabs into the
opening of the clip lock. In this embodiment the base can comprise
a metal tube cut and formed into the illustrated shape or short
metal inserts that are insert molded inside a polymer to reduce the
surface area and volume of metal incorporated in the device thereby
reducing the radiopacity. Alternatively, the base can comprise a
polymer with sufficient thickness and rigidity to define a hinge
over which the tab can flex and define enough of a spring constant
to engage the opening of the clip lock once positioned into
engagement.
[0171] The embodiments in FIGS. 37 and 38 penetrate both the base
and lock into the plicated tissue thereby reducing the height of
each component (base and lock) from the crossbar to the distal tip.
As such, the profile of the clip on the deployment device is
reduced and the locking point is positioned within the plicated
tissue. The width of the device can range from 2 to 30 mm; more
specifically 2 to 10 mm. The height of the device can range from 2
to 20 mm; more specifically 2 to 7 mm. The thickness of the device
components can range from 0.25 to 3 mm.
[0172] FIG. 39 depicts an alternative embodiment that can be
incorporated in any of the U-shaped components which have a
multiple stage locking mechanism. The purpose of the multiple stage
locking mechanism is to provide a method to increase the tightness
of the plication. Although this embodiment shows only two stages or
components 3910 and 3920 of locking, the number of locking stages
or components can be increased until full engagement or overlap of
the cross bars is achieved.
[0173] Similarly, the embodiment shown in FIG. 41 shows a
two-component plication clip system with penetrating elements 4111
on each component 4110. Opposing sides of the components have
tapered penetrating components 4111 to allow for easy penetration
though soft tissue. In addition, locking tabs 4112 are positioned
at the distal tips of the penetrating elements for mating and
securing of the U-shaped components to engage the opposing base.
Two positions of locking are demonstrated in the illustrations;
however in other embodiments the number of positions can be
increased. Moreover, the distance between each locking point is
adjustable from 0.001 mm to 1.0 cm. A purpose of the multiple stage
locking mechanism is to provide a method to increase the tightness
of the plication. The width of the device can range from 2 to 6 mm.
The height of the device can range from 2 to 5 mm. The thickness of
the device can range from 1 to 3 mm.
[0174] The exemplary embodiment shown in FIG. 40 presents a
U-shaped plication clip device with a hinge attachment 4030 that
the device pivots around. The hinge is shown as a pivoting
mechanism. Alternatively a flexible hinge inherent to an
integrated, unitary device can be utilized. One end 4010 of the
clip device has a distal tip that is tapered to allow for tissue
penetration while the proximal end 4020 is bevel shaped to accept
the distal tip. As shown, the distal tip 4010 of the device has a
locking region 4040 that inserts and engages the proximal end.
Other embodiments of this clip can include variations on the hinge
mechanism, variations in cross-sectional geometry (e.g., circular,
rectangular, square and other geometric shapes), and variations in
height, width, and length of the device.
[0175] Another embodiment is shown in FIG. 42 as a U-shaped repair
clip device that can be used with and without a pledget element
4220, shown in FIG. 42C. In the deformed delivery position 4210,
FIG. 42A, the clip device can be delivered through the tissue using
an introducer deployment mechanism (e.g., dual tapered needles) or
tapering of the clip feet. In the undeformed position 4211, FIG.
42B, the clip device engages the tissue by deploying feet anchors
4213, as shown in FIG. 42F. Another embodiment of this includes the
use of a backing or pledget component 4220 that is used as the
locking base of the clip device. The clip device would be deployed
as above, however, the locking base would be used to insure
adequate locking of the tissue. The locking base would be supported
by one jaw of the plication clamp while the deformed clip is
advanced through the tissue and through openings in the locking
base with the second jaw of the plication clamp. Once positioned,
the clip is released locking the clip into the base through the
plicated tissue.
[0176] Additional embodiments of this device would include
variations in the cross-sectional profile of the device (e.g.,
circular). This embodiment can be deployed as shown in FIG. 42F, or
through the base of the plication in a horizontal manner, similar
to that depicted in FIG. 36 for the U-shaped plication clip. The
deployment shown in FIG. 42F is a reverse plication where the fold
is opposite to that of the access surface. The repair clip
embodiment shown in FIG. 42A to 42F enables either the reverse
plication or original plication shown in FIG. 36. When executing a
reverse plication, the capsule is not pulled into the jaws via a
grasper. The locking ends of the clip are positioned at two points,
separated by the clamp jaws, that are compressed together such that
once positioned the released clip causes the plicated capsular
tissue to fold in the opposite direction to the crossbar.
[0177] An alternative reverse plication clip embodiment 4310 is
shown in FIG. 43 where the centralized crossbar 4312 is made of a
coiled shaped configuration that can act as a spring or the
centralized crossbar could also be made of an elastic material.
Deployment of the device would be similar to that described for
FIG. 42, including the use with pledget. The embodiment in FIG. 43
enables expansion of the spring during position of the two locking
legs 4311 such that when release the tissue is folded away from the
coiled shaped crossbar. Additional embodiments of this device can
include suture or polymer elements with distal tip collapsible
polymer umbrella shaped elements. Upon deployment the collapsed
polymer can be pushed through an introducer needle to the opposite
side of the tissue layer to be plicated, introducer needle removed
and polymer umbrella shape allowed to naturally expand. Both sides
of this embodiment would be deployed simultaneously. Attachment of
the suture or polymer connection elements to the polymer umbrella
shape would be at the central position of the umbrella. The
umbrella element would be flexible, but stiff enough and large
enough that it will not pull back through the tissue easily. The
suture or polymer connection will have a degree of elasticity to
allow for temporary stress relief. Visually this may appear as a
contact lens with a center tether. The advantage of such an
embodiment include the ability to plicate soft tissues with
materials and shapes that will be atraumatic to the tissues if
failure occurs, as well as have elastic properties that allow for
temporary stress relief. Further embodiments would include the use
of shape memory metals or shape memory polymer to deploy umbrella
or various anchor shapes to plicate the tissue, achieving the same
effect as described in the previous examples.
[0178] The exemplary embodiments shown in FIGS. 44 and 45 are
single component plication clip devices 4410 and 4510. Both of
these embodiments are circular rings with internal tooth elements
4411 and 4511 that are flat or can be layered in rows (as in FIG.
45) or concave inward. The primary purpose of the tooth elements
4411 and 4511 is to engage the tissue and prevent slipping of the
tissue. Plication with these clips is performed as follows. A
portion 4441 of tissue 4440 is grasped using the deployment device,
the tissue is wrung in either a clockwise or counterclockwise
direction for several rotations. As the tissue begins to bunch up,
the circular plication element 4410 is advanced over the tissue
4441 down to the base of the plication region. The tissue 4441 is
then released and allowed to expand. The expansion of this tissue
locks the clip into place, thereby holding the tissue in a plicated
state. The outer diameter of these rings can range from 2 to 20 mm
and the inner diameter from 1 to 18 mm.
[0179] The embodiment depicted in FIG. 46 is a single component
clip device 4610. This embodiment is a rectangular device that can
be flat or curved in either the in-plane and out-of-plane
directions, making tissue conformity better. A purpose of the tooth
elements 4611 is to engage the tissue and prevent slipping of the
tissue. Plication with these clips is performed as follows. A
portion 4641 of tissue 4640 is engaged with the grasping mechanism
of the deployment device 4610. Tissue 4641 is then drawn into the
plication clip 4610 as the plication clip (deflected to expand the
clip opening) is advanced over the tissue pleat to the base of the
plication. The tissue and/or the plication clip are then released.
The expansion of this tissue locks the clip into place, thereby
holding the tissue in a plicated state. Moreover, the direction of
the teeth can be oriented to allow for the tissue to easily pass
through the device during plication. However, once deployed, the
teeth 4611 will engage the tissue 4641 when tension in applied to
pull the tissue out. As a result, the clip will maintain a lock on
the tissue ensuring that the clip will be able to maintain the
plication of the tissue. The outer dimensional ranges of the
rectangular element are: length (2 to 40 mm) and width (1 to 10
mm). The inner dimensional ranges of the rectangular element are:
length (1 to 38 mm) and width (0.5 to 9 mm).
[0180] Variations of this embodiment are illustrated in FIGS. 47 to
51. FIG. 47 illustrates an oval shaped plication clip 4710 with a
center region that can be used to pass the clip into position, pass
the grasper element through the clip and draw the tissue pleat into
the clip. This clip can be deformed to have curvature in the
in-plane and out-of-plane directions to allow for conformity with
the tissue pleat. The teeth 4711 in this embodiment and others
described can have various shapes and patterns that allow for
tissue engagement or added friction to the tissue. Moreover, the
teeth 4711 can also consist of various other embodiments that allow
for frictional as well as active engagement of the tissue pleat,
for example bristles, flaps, or spikes. The size, width, pitch,
depth of the teeth can be adjusted to optimize the holding strength
and degree of engagement with the tissues.
[0181] FIG. 48 shows an embodiment with variable teeth sizes and
shapes 4811 and 4812. The general shape of the plication clip
embodiment has curved edges to reduce the local stress on the
tissue pleat caused by the clip. Moreover, the direction of the
clip teeth are positioned to allow for engaging of the teeth into
the tissue pleat if the pleat is tensioned (e.g., pulled) from the
bottom, thus preventing release of the tissue pleat. The side rails
of the embodiment are intended to allow for better conformity
between the clip and the tissue pleat.
[0182] FIG. 49 shows a variation of the embodiment shown in FIG. 48
where the rails are positioned in the axis parallel to the tissue
plane. The embodiments shown in FIGS. 50 and 51 are additional
variations in embodiments for methods to engage the tissue with the
locking clips. Benefits of all of these clip designs includes
irritation of the synovium which will elicit a favorable biologic
healing response. The design of the clip teeth can be optimized to
take full advantage of this characteristic. Furthermore, each of
these above designs can be manufactured from various material
combinations or single materials (e.g., metals, polymers, shape
memory alloys, etc.).
[0183] The embodiment shown in FIG. 52 is an example of using the
plication clip devices for the treatment of capsule to labrum
plication. Shown are top, side, and profile views of the plicated
capsule to labrum tissues. The embodiments shown in the figure
include the use of U-shaped plication clips 5240 in two
orientations. Various other plication clip design described above
can be used to achieve similar plication as shown. Primary factors
that are considered for embodiments for this plication include the
potential for abrasion or interaction with the articular surfaces
as well as potential for loosening of the device. The position of
the device relative to the glenoid articulating surface will be
sufficiently lateral as not to interact. Furthermore, the
embodiment of the plication clip will be of small enough as not to
protrude into the glenoid articulating space. Additionally, the
material used for the plication clip in this application will have
ideal characteristics relative to stiffness and strength.
[0184] In operation, the plication clamp is used to grasp the
capsule and pull a fold of capsular tissue into the clamp jaws. The
clamp jaws are then used to position the plication clip with one
jaw passing through the capsular fold and the other jaw passing
through the labrum and then the capsular fold. It should be noted
that the capsule to labrum plication can be executed as a separate
operation after placating the capsule (e.g., attached the already
plicated capsule distal end to the labrum), a simultaneous step of
placating the capsule directly to the labrum (as shown in FIG. 52),
or a simultaneous reverse plication where a region of the capsule
is pulled into direct contact with the labrum pushing the fold away
from the jaws of the clamp.
[0185] Various appropriate materials may be used to construct the
elements or various parts of the elements that comprise the
exemplary embodiments shown and described in this disclosure. For
example, the locking base and arms of clips, spikes, needle,
grasper, or deployment device components that require the ability
to have elastic properties relative to being able to be deformed
and deployed (returned to intended shape) using arthroscopic
devices can be fabricated from various materials, including, but
not limited to shape memory alloys (e.g., nickel titanium
(Nitinol), shape memory polymers, polymers (e.g., PTFE,
polyurethane, urethane, silicone, polyimide, polypropylene,
Polylactic Acid, Polyglycolic Acid, or other thermoset or
thermoplastic, or elastomeric materials) and metals (e.g.,
titanium, CoCrMo, stainless steel, nickel titanium, etc).
[0186] In some embodiments, the device clips or sutures may be
resorbable, in other embodiments, the device components will have
limited or no resorption characteristics. The clips components
described in this disclosure can be made in part or solely of one
material. Alternatively, the structures of the clips can be
composed of metal and/or polymer components fabricated into
composite devices. For example, low surface area and thin metal or
metal alloy components that define the puncturing and/or locking
components of the cups can be insert molded with a polymer (e.g.,
polypropylene) to produce a composite device that has very little
radiopacity but exhibits excellent puncturing and locking
characteristics. Some embodiments may include parts that are
resorbable and some that are not.
[0187] Fabrication of these clip components can be performed using
techniques familiar with manufacturing methods by those skilled in
the art of metals, polymers, shape memory alloys, shape memory
polymers, or composite materials. Sample techniques include, but
are not limited to, extrusion, casting, press-forging, rolling, or
pressing methods for the fabrication of parts for the above
materials. In specific instances, the use of techniques related to
modification of polymer chemistry to adjust the shape memory
characteristics related to thermal conditions and elastic
properties of the polymer will be utilized. With respect to shape
memory metal materials, one skilled in the art will utilize the
thermal characteristics of the specified composition to fabricate
components with the geometry and features required for the device
component. Proper thermal forming and quenching is required to
process the material and is generally known to one skilled in the
art of using, processing, and fabricating components out of shape
memory materials.
[0188] In some embodiments several components may require parts
using standard machining techniques typically known to one skilled
in the art of machining. For example, use of CNC, EDM, laser
cutting, water jet cutting, polishing methods, and other machining
techniques. Several embodiments may also require bonding or welding
of components and include adhesives, laser welding, soldering, or
other means of attachment.
[0189] Clip components that include spikes or needles may be
fabricated from any stock materials typically known to one skilled
in the art of medical device manufacturing. Attachment of suture or
other clip materials to these embodiments can be performed by
tying, welding, bonding, clamping, embedding, or use of other such
means for securing the spike or needle to the suture or other clip
materials. In some embodiments, these spikes or needles can be
mechanically polished or electropolished to produce smooth
surfaces.
[0190] Various embodiments of the clip components described can be
coated with or encapsulated with a covering of a polymer material
that can allow for the use of anti-proliferative, antibiotic,
angiogenic, growth factors, anti-cancer, or other pharmacological
substances that may provide a benefit related to inhibiting or
promoting biological proliferation. These substances would be
loaded into the encapsulating coatings and be allowed to elute into
the surrounding matrix, tissues, or space that it sits. The time
course of delivery can be tailored to the intended application by
varying the polymer or the characteristics of the coating. Such
coatings with pharmacological substances can act as
anti-proliferative treatments or can aid in the healing response of
the tissue being treated. Furthermore, these coatings can act to
reduce the local coagulation or hyperplastic response near the
chip.
[0191] Various examples of surgical procedures using the devices,
systems and methods of the present invention will be described in
the non-limiting examples provided below. In each example
described, one or more of the various embodiments shown in FIGS.
2-52 may be used.
Example A
Arthroscopic Repair of Bankart Lesion with Arthroscopic Suture
Plication of Associated Anterior Capsular Laxity
[0192] Following examination under anesthesia and standard surgical
prepping and draping, standard anterior and posterior glenohumeral
arthroscopy portal are established. The patient may be positioned
either in the lateral decubitus position or in a beach chair
position. Following completion of diagnostic arthroscopy, attention
is first focused on repair of the Bankart lesion. After the Bankart
repair has been performed, residual anterior capsular laxity is
assessed. The surgeon subsequently places the humerus in the
desired position (in terms of external rotation and abduction; this
will vary according to patient demand and individual surgeon
preference). With the shoulder placed in the desired position,
capsular redundancy is addressed via performing a suture plication.
The capsular plication deployment device is introduced through a
standard anterosuperior portal. Capsular grasper is deployed to
create a capsular pleat delivering the capsular pleat into the jaws
of the clip passing device. The clip device is subsequently
deployed. Typically, two to four separate clip implant devices will
be placed in a sequential posteroinferior to anterosuperior
direction along the capsule. Additional clips may be placed to
ensure that capsular redundancy has been adequately rectified. The
amount of capsule delivery into the jaws of the clip passing device
(and hence, the amount of capsular tightening) will vary according
to surgeon preference and the amount of capsular laxity and patient
demand. Of note, the Bankart repair must be conducted first in
order to adequately assess the amount of residual amount of
capsular laxity and determine the ideal required amount of capsular
tightening. One of the advantages of exemplary devices according to
the present invention is their ability to tighten the capsule a
variable amount based upon individual situations. Following
completion of placement of the desired plications, the arthroscopic
probe is introduced and each of the plications is individually
probed to confirm that the clip devices have been deployed in a
stable fashion. The shoulder is place through a trial range of
motion while the tensioned portion of the capsule is visualized to,
once again, confirm that adequate fixation of each of the capsular
plications has been achieved.
Example B
Capsular Laxity without an Associated Bankart Lesion (e.g.,
Anterior Unidirectional Atraumatic Instability)
[0193] Following examination under anesthesia, standard anterior
and posterior glenohumeral arthroscopic portals are established. A
thorough diagnostic glenohumeral arthroscopy is performed with
specific attention to determining the extent and distribution of
capsular laxity. With the shoulder positioned in the desired amount
of abduction and external rotation, the anterior capsule is
tensioned via placement of anterior capsular plications in a
posteroinferior to anterosuperior sequence via the anterosuperior
portal. The sequence of placement of successive plication devices
in a posteroinferior to anterosuperior direction is determined by
virtue of the fact that if the anterosuperior capsule is tensioned
first then placement of the capsular plication deployment device
more inferiorly and posteriorly will be more difficult. However,
tensioning the axillary pouch (posteroinferior section) first does
not limit access further anteriorly and superiorly on the inferior
glenohumeral ligament. Following completion of placement of the
desired plications, the arthroscopic probe is introduced and each
of the plications is individually probed to confirm that the
exemplary clip devices have been deployed in a stable fashion. The
shoulder is placed through a trial range of motion while the
tensioned portion of the capsule is visualized to, once again,
confirm that adequate fixation that each of the capsular plications
has been achieved.
Example C
Multidirectional Instability (MDI)
[0194] Following examination under anesthesia, standard
anterosuperior and posterior glenohumeral arthroscopic portals are
established and a through diagnostic arthroscopy is performed. The
redundant posterior capsule and posteroinferior capsule is
tightened first. This is accomplished via visualization through an
accessory anterior portal. The capsular plication deployment device
is introduced through the standard anterosuperior portal. The
posterior capsule is visualized via placement of the arthroscope
through the accessory anterior portal. Posterior capsular
redundancy is reduced via placement of successive capsular
plications posteriorly (in an inferior to superior sequence). The
arthroscope is subsequently reintroduced through the standard
posterior glenohumeral viewing portal and the standard
anterosuperior portal is utilized to perform the capsular
plications. The inferior and anterior glenohumeral capsule is
tensioned via placement of sequentially clip devices according to
exemplary embodiments of the present invention in an inferior to
superior direction. Following completion of placement of the
desired plications, the arthroscopic probe is introduced and each
of the plications is individually probed to confirm that the clip
devices have been deployed in a stable fashion. The shoulder is
place through a trial range o motion while the tensioned portion of
the capsule is visualized to, once again, confirm that adequate
fixation that each of the capsular plications has been
achieved.
Example D
Lung Volume Reduction Surgery (LVRS)
[0195] Preoperative imaging (e.g., radiographs, computed
tomography) is performed to identify the segments of the lung
requiring volume reduction. Following anesthesia induction, the
patient is position in the lateral decubitus position to allow
placement of thorascope as well as another access port for the
plication delivery device positioning. The lung is collapsed using
standard techniques. Using the plication delivery device grasping
mechanism, the region of lung tissue to be reduced can be retracted
into the device. Care is taken in the placement of the access port
for the plication device to insure that when the device is engaged
with the lung tissue that the tissue is not deformed or stressed to
a point where excessive trauma occurs. The identified lung tissue
section to be reduced is grasped by the device jaws. Axial rotation
of the device jaw will result in wringing of the lung tissue, FIG.
53. The wringing of the lung tissue will draw tissue surrounding
the point of grasping to be circumferentially pulled into the
center. Once sufficient lung tissue is determined to be reduced,
the plication clip is advanced into position down the shaft of the
delivery device. Advancement of the plication clip is continued
until it is positioned at the base of the wrung region, such as
shown in FIG. 53. Typical advancement of the plication clip will
range from 0.5 to 25.4 centimeters from the tip to the base of the
wrung lung tissue. The plication is examined to insure proper
alignment and deployment. The result of this plication will result
in a reduced volume capacity of the lung, minimizing the effects of
the diseased section of the lung. Once the plication clip is fully
deployed, the grasper is released and plication device withdrawn.
Additional regions of plication can also be addressed at the same
time. The use of these plication clips should not result in the
generation of air leaks of any significance. Furthermore, upon
reinflation of the lung, evaluation of whether or not sufficient
lung volume reduction is achieved can be evaluated. If necessary,
standard chest tubes can be positioned anteriorly and posteriorly
to the apex of the lung and suction initiated to remove excess
fluid from the pleural cavity. Multiple plication clips are
expected to be used to adequately reduce the lung volume.
[0196] Variations in the plication clip delivery may not require
wringing of the tissue but rather only grasping of the tissue and
then advancement of the clip over the tissue, as shown in the lung
reduction procedure shown in FIG. 55. In these types of
embodiments, the same range of advancement can be achieved (0.5 to
25.4 centimeters). Similarly, multiple devices can be deployed
until adequate lung volume reduction can be achieved.
Example E
Laparoscopic Gastric Fundoplication with Laparoscopic Suture or
Clip Tissue Fixation
[0197] Following anesthesia induction, the patient is positioned,
prepped and draped in the standard fashion for an upper abdominal
laparoscopic procedure. Using standard laparoscopic technique, a
trocar is introduced through the abdominal wall and a laparoscope
is advanced into the abdomen to provide visualization. Additional
trocars (3-4) are inserted to accommodate required instrumentation.
Under direct laparoscopic visualization, the surgeon elevates the
liver to expose the junction between the stomach and the esophagus.
Using sharp and blunt dissection, the hiatal hernia is reduced by
freeing the esophagus and the stomach of surrounding soft tissue
connections around the diaphragmatic hiatus and pulling the stomach
and about 5 or 6 cm of the esophagus down into the abdomen. A space
is created behind the esophagus and the fundus of the stomach,
exposing the diaphragmatic hiatus. The size of the hiatus (defined
by the arches of the left and right crural fiber bands) is reduced
by approximating the muscles of the left and right crura behind the
esophagus. The laparoscopic tissue fixation device is inserted
through a trocar and advanced to the hiatus. Using a laparoscopic
forcep through another trocar, the crural fibers are pulled so they
are adjacent. The tissue grasper is deployed from the fixation
device, and the adjacent fiber bands grasped together and pulled
between the jaws of the fixation device. The fixation device is
activated, securing the crural fibers with a suture, clip or other
point fixation device. The process is repeated, until the opening
of the hiatus is adequately reduced, usually requiring two or three
adjacent fixations, as shown in FIG. 54.
[0198] Using sharp dissection, the fundus of the stomach is freed
of its connections, such as the short gastric vessels to the spleen
and small ligaments connecting it to the left diaphragm. This
mobilization creates a window behind the esophagus. The redundant
portion of the stomach fundus on the left side is then pulled
behind the esophagus to the right side and then around the front of
the esophagus, forming a wrap, as shown in FIG. 54. Depending on
the type of procedure, the wrap may be secured partially or
completely around the esophagus. For a partial wrap, laparoscopic
forceps are used to position the ends of the wrap next to the
anterior wall of the esophagus, and prepared for the fixation
device. The approximated tissues are grasped together using the
tissue grasper, and the tissues pulled into the jaws of the device.
The fixation device is activated, securing the crural fibers with a
suture, clip or other point fixation device. The process is
repeated until the edge of the wrap is secured, usually requiring
2-4 fixations. The fixation is repeated in a similar fashion for
the other edge of the wrap. For a complete wrap, laparoscopic
forceps are used to position the ends of the wrap next to each
other in front of the anterior wall of the esophagus. The wrap is
prepared for fixation by grasping both left and right edges of the
wrap with a pleat of anterior esophageal wall sandwiched in
between. The approximated tissues are grasped together using the
tissue grasper, and the tissues pulled into the jaws of the device.
The fixation device is activated, securing the wrap and esophageal
tissues with a suture, clip or other point fixation device. The
process is repeated until the edge of the wrap is secured, usually
requiring 2-4 fixations.
Example F
Laparoscopic Hernia Repair with Laparoscopic Suture or Clip Tissue
Fixation
[0199] Following anesthesia induction, the patient is positioned,
prepped and draped in the standard fashion for an abdominal
laparoscopic procedure. Using standard laparoscopic technique, a
trocar is introduced through the abdominal wall and a laparoscope
is advanced into the abdomen to provide visualization. Additional
trocars (2-3) are inserted to accommodate required instrumentation.
Under direct laparoscopic visualization, the hernia contents are
reduced by taking down the adhesions to the abdominal wall and
within the hernia sack itself. Once the abdominal wall is free, a
tightly rolled prosthetic patch or mesh is inserted through one of
the ports into the abdomen, where it is unrolled and positioned
under the defect. The patch may be placed on the peritoneum or the
peritoneum may be opened and the patch placed between the
peritoneum and abdominal fascia. Several sutures may be used to
anchor the patch in place to the abdominal fascia. The laparoscopic
tissue fixation device is inserted through a trocar and advanced to
the patch. Using a laparoscopic forcep through another trocar, the
edge of the patch and peritoneum or fascia are pulled so they are
adjacent. The tissue grasper is deployed from the fixation device,
and the edge of the patch and peritoneum or fascia are grasped
together and pulled between the jaws of the fixation device. The
fixation device is activated, securing the patch to the peritoneum
or fascia with a suture, clip or other point fixation device. The
process is repeated, until the edges of the entire patch are
secured to the peritoneum or fascia at 1 cm intervals to prevent
internal hernia. The patch size is usually 8 to 10 cm larger than
the defect, in effect reconstructing the abdominal wall. If the
peritoneum was opened, this is now closed over the patch.
Example G
Thoracoscopic Mitral Valve Repair with Thoracoscopic Suture or Clip
Tissue Fixation
[0200] Following anesthesia induction, the patient is positioned,
prepped and draped in the standard fashion for a right chest
thoracoscopic procedure. Using standard thoracoscopic technique, a
trocar is introduced through the thoracic wall and a thoracoscope
is advanced into the right pleural space to provide visualization.
Additional trocars (2-4) are inserted to accommodate required
instrumentation. CO.sub.2 insufflation may be used to displace the
left lung and enhance visualization. A small intercostal incision
may be used as a working portal in addition to the trocar
ports.
[0201] Mitral valve reconstruction may be performed alone or as a
part of another thoracoscopic cardiac procedure. Under direct
thoracoscopic visualization, the pericardium is opened anterior to
and parallel to the right phrenic nerve using scissors. The patient
is systemically anticoagulated and cardiopulmonary bypass is
instituted by cannulation by femoral approach or by direct
cannulation through the thoracic incisions. The heart is arrested
and vented.
[0202] Using sharp dissection, the left atrium is entered by
incision either anterior to the right pulmonary veins or through
exposure through the atrial septum. The mitral valve is exposed
with retractors and inspected. Leaflet resection and repair may be
performed as indicated by the underlying pathology. For example,
isolated posterior leaflet cusp prolapse may be treated by a
triangular or quadrangular resection. After resection of the flail
cusp using scissors, the annulus diameter is reduced adjacent to
the defect by plicating the annulus. Using a thoracoscopic forcep,
the annular tissue is grasped and elevated. The tissue grasper is
deployed from the fixation device, and the elevated annular tissue
is grasped and pulled between the jaws of the fixation device. The
fixation device is activated, plicating the annulus together with a
suture, clip or other point fixation device. One or more adjacent
plication points may be required to create sufficient annular
reduction. Using a forcep, the cut edges of the valve leaflet are
approximated. The tissue grasper is deployed from the fixation
device, and the adjacent edges of the valve is grasped and pulled
between the jaws of the fixation device. The fixation device is
activated, securing the edges of the leaflet together with a
suture, clip or other point fixation device. Two or more adjacent
fixation points may be required to create a continuous line of
fixation, FIG. 56.
[0203] The valve repair is then reinforced with a partial or
complete circumferential annuloplasty ring. A forcep is used to
bring the ring to the annulus adjacent to one of the commissures,
and the combination is gripped by the tissue grasper in the
fixation device and pulled between the jaws of the fixation device.
The fixation device is activated, securing the ring to the annulus
with a suture, clip or other point fixation device. This is
repeated at the other commissure. Using forceps to adjust the
relative spacing, additional adjacent fixation points are serially
fashioned to create a continuous line of attachment between the
ring and the annulus. The valve is then tested to assure
competency. The atriotomy edges are approximated, then grasped and
secured using the fixation device. This is repeated at adjacent
points along the edges until the incision satisfactorily closed.
The heart is de-aired, reperfused, normal rhythm restored, and
cardiopulmonary bypass terminated.
Example H
Thoracoscopic Left Atrial Appendage Ligation with Thoracoscopic
Suture or Clip Tissue Fixation
[0204] Following anesthesia induction, the patient is positioned,
prepped and draped in the standard fashion for a left chest
thoracoscopic procedure. Using standard thoracoscopic technique, a
trocar is introduced through the thoracic wall and a thoracoscope
is advanced into the left pleural space to provide visualization.
Additional trocars (2-4) are inserted to accommodate required
instrumentation. CO.sub.2 insufflation may be used to displace the
left lung and enhance visualization. Left atrial appendage ligation
may be performed alone or as a part of another thoracoscopic
procedure. Under direct thoracoscopic visualization, the
pericardium is opened anterior to and parallel to the left phrenic
nerve using scissors, FIGS. 57A and 57B. The appendage of the left
atrium is identified, and mobilized using sharp and/or blunt
dissection. Using a thoracoscopic forcep introduced through a
trocar, the tip of the appendage is gently manipulated so that the
base of the appendage can be visually inspected to determine the
location for the ligation line. The tissue grasper is deployed from
the fixation device, and the edge of the atrial appendage is
grasped and pulled between the jaws of the fixation device. The
fixation device is activated, securing walls of the appendage
together with a suture, clip or other point fixation device. One or
more adjacent fixation points may be required to create a
continuous line of ligation. The fixation device jaws are opened,
the tissue released, the device repositioned and the process
repeated until the walls of the appendage are completely secured
from edge-to-edge along the planned line of ligation. The appendage
ligation line is inspected for hemostasis, and a soft drain may be
brought through an opening in the chest wall and directed into the
pericardial space.
[0205] Using a thoracoscopic forcep, the edges of the opening in
the pericardium are brought into approximation. The tissue grasper
is deployed from the fixation device, and the pericardial edges are
grasped and pulled between the jaws of the fixation device. The
fixation device is activated, securing the pericardial edges
together with a suture, clip or other point fixation device. One or
more adjacent fixation points may be required to adequately
re-approximate the pericardium. A drain may be brought through an
opening in the chest wall and directed into a dependent area of the
thoracic space for postoperative pleural drainage.
[0206] The foregoing disclosure of the preferred embodiments of the
present invention has been presented for purposes of illustration
and description. It is not intended to be exhaustive or to limit
the invention to the precise forms disclosed. Many variations and
modifications of the embodiments described herein will be apparent
to one of ordinary skill in the art in light of the above
disclosure. In particular, the many examples shown above that
relate to the shoulder capsule and plication are not limited to
such, and may be applied to any tissue or tissue structure as well
as any type of repair performed thereon. The scope of the invention
is to be defined only by the claims appended hereto, and by their
equivalents.
[0207] Further, in describing representative embodiments of the
present invention, the specification may have presented the method
and/or process of the present invention as a particular sequence of
steps. However, to the extent that the method or process does not
rely on the particular order of steps set forth herein, the method
or process should not be limited to the particular sequence of
steps described. As one of ordinary skill in the art would
appreciate, other sequences of steps may be possible. Therefore,
the particular order of the steps set forth in the specification
should not be construed as limitations on the claims. In addition,
the claims directed to the method and/or process of the present
invention should not be limited to the performance of their steps
in the order written, and one skilled in the art can readily
appreciate that the sequences may be varied and still remain within
the spirit and scope of the present invention.
* * * * *