U.S. patent application number 14/980198 was filed with the patent office on 2020-01-09 for tissue spreading vascular clips with locking mechanism and non-slip clamping surfaces.
The applicant listed for this patent is Covidien LP. Invention is credited to David M. Albala, Bhailal H. Patel, Manoj B. Patel.
Application Number | 20200008810 14/980198 |
Document ID | / |
Family ID | 54932213 |
Filed Date | 2020-01-09 |
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United States Patent
Application |
20200008810 |
Kind Code |
A1 |
Patel; Manoj B. ; et
al. |
January 9, 2020 |
Tissue spreading vascular clips with locking mechanism and non-slip
clamping surfaces
Abstract
A surgical clip includes a pair of opposed arms joined at one
end by an integrally formed flexible hinge. A male head element
near the free end of one arm is configured to spread tissue when
the male head element is urged towards a head mating element near
the end of the opposite arm. The clamping side of an arm may
include a protruding feature, such as a wedge shape elongated
ridge, while the clamping side of the opposite arm includes a
corresponding trough or aperture that receives the protruding
feature. Clamping surfaces may include non-slip protrusions, such
as ribs, ridges, cones or pins. An applicator holding feature, such
as a boss, near the hinge prevents the clip from yawing and
becoming askew during application. Rectangular alignment features
are provided on the distal ends of the arms to maintain clip
alignment during application.
Inventors: |
Patel; Manoj B.; (Lumberton,
NJ) ; Patel; Bhailal H.; (Kendall Park, NJ) ;
Albala; David M.; (Manlius, NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Covidien LP |
Mansfield |
MA |
US |
|
|
Family ID: |
54932213 |
Appl. No.: |
14/980198 |
Filed: |
December 28, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14053684 |
Oct 15, 2013 |
9220507 |
|
|
14980198 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/1285 20130101;
A61B 17/064 20130101; A61B 2017/0645 20130101; A61B 17/1227
20130101; A61B 2017/00858 20130101; A61B 17/083 20130101; A61B
17/122 20130101 |
International
Class: |
A61B 17/122 20060101
A61B017/122; A61B 17/08 20060101 A61B017/08; A61B 17/128 20060101
A61B017/128; A61B 17/064 20060101 A61B017/064 |
Claims
1. A surgical clip comprising a hinge; a pair of opposed arms
comprising a first arm with a proximal end and a distal end, the
first arm having a clamping side comprising a
longitudinally-oriented triangle-shaped step-like wedge clamping
feature, and a rectangular alignment guide on the distal end, and a
second arm with a proximal end and a distal end, the second arm
having a clamping side comprising a longitudinally-oriented
V-shaped trough with a plurality of step-down clamping features
that conform to the shape of the wedge, and a rectangular alignment
guide on the distal end, such that the proximal end of each arm is
attached to the hinge; a head lock comprising a tissue penetrating
male head element near the free end one arm, and a head mating
element near the free end of the opposite arm, such that the head
mating element is configured to engage a portion of the male head
element, the head mating element comprising a pair of spaced apart
tapered pillars, the pair of pillars configured to keep tissue
in-place, under tension, while the male head element enters tissue
as the head mating element engages the male head element; and.
2.-3. (canceled)
4. The surgical clip of claim 1 wherein the longitudinally-oriented
V-shaped trough comprises a bottom window.
5. (canceled)
6. The surgical clip of claim 1 wherein the male head element
further comprises a tissue spreading head.
7.-20. (canceled)
Description
RELATED APPLICATIONS
[0001] This non-provisional US patent application is a continuation
application of U.S. patent application Ser. No. 14/053,684 filed by
applicants on Oct. 15, 2013, which is related to U.S. Provisional
Application No. 61/713,597 filed on Oct. 14, 2012, and claims the
benefit of that provisional application filing date.
FIELD OF THE INVENTION
[0002] The present invention relates to surgical clips, and, more
particularly, to a biocompatible surgical clip with grooved
clamping surfaces to prevent slipping, a tissue penetrating head
lock mechanism, and a locking hinge portion to provide greater
tension and security when clamping tissue between the two arms of
the clip.
BACKGROUND
[0003] A wide number of surgical procedures employ surgical clips
(i.e., ligation clips). Such surgical procedures may require
vessels, organs or other tissues of the human body to be ligated.
Surgical clips ligate, clamp, close off or otherwise occlude the
engaged portion of the clamped vessels, organs or other tissues in
a surgical site. Such clips may also be used to secure the ends of
a suture, as in place of a conventional suture knot.
[0004] Ligation can be performed with a ligating clip (i.e., a
surgical clip) or by suturing with surgical thread. Suturing
requires complex manipulations of the needle and suture material to
form the knots required to secure the vessel. Such complex
manipulations are time-consuming and difficult to perform,
particularly in endoscopic surgical procedures, which are
characterized by limited space and visibility. By contrast,
ligating clips are relatively easy and quick to apply. So long as
the clips and applicator are designed with endoscopic procedures in
mind, they are a preferred choice.
[0005] The clips are often in the form of thin, narrow, metal or
polymeric U-shaped or V-shaped members that are placed over the
vessel, tissue or suture material and then forced into a closed
position using a clip applicator. Clips constructed of metal, may
be initially open and then permanently deformed into a closed or
clamped configuration around the desired blood vessel or other
tissue structure using an appropriate clip applicator. However,
metal clips, which are radio-opaque, interfere with x-ray imaging.
Plastic clips include a latch feature to ensure that the clip
remains closed with sufficient force to provide full and complete
hemostasis or occlusion and to ensure that the clip will not loosen
or open over time.
[0006] While ligating clips are an improvement over suturing in
many procedures, they suffer shortcomings. First the clips
typically require a surgical plane or window to be made prior to
attachment. Conventional clips are not configured to penetrate
tissue. Accurate planing and windowing manipulations are
time-consuming and difficult to perform, particularly in endoscopic
surgical procedures, which are characterized by limited space and
visibility. Furthermore, creating windows can cause extensive
bleeding, leading to decreased visibility.
[0007] Second, the clips tend to slip as they are applied. Slipping
makes accurate placement extremely difficult. Additionally, forces
applied during slipping may cause the contact surfaces of the
clamping arms to deviate from parallel. In a worst case scenario,
slipping may result in catastrophic dislodgment of the clip,
resulting in excessive bleeding and increased mortality and
morbidity.
[0008] Third, the clips are extremely difficult to remove.
Conventional clips include relatively thick hinge and arm sections
that abut and occlude a clamped vessel or tissue. The latch is not
releasable. Cutting through such a clip without damaging the
clamped vessel or tissue is extremely difficult.
[0009] U.S. Patent Publication No. 2012/0083803 is incorporated by
reference in this specification. That application describes a
penetrating lock and various clamping features, hinge
configurations, and boss configurations.
[0010] The invention is directed to overcoming one or more of the
problems and solving one or more of the needs as set forth
above.
SUMMARY OF THE INVENTION
[0011] To solve one or more of the problems set forth above, in an
exemplary implementation of the invention, a surgical clip includes
a pair of opposed arms joined at one end by an integrally formed
flexible hinge. Each arm has a free end. One arm includes a male
head element near the free end. The opposite arm includes a head
mating element near the free end. The male head element is
configured to penetrate tissue in the path of the male head element
when the male head element is urged towards the head mating
element. The male head element includes a tissue penetrating head
which may be a tissue spreading head. The head mating element
engages the male head element and resists withdrawal of the head
when the tissue spreading head of the male head element has been
urged through the head mating element. The clip may be comprised of
a biocompatible metal or plastic or a bioabsorbable plastic. The
clip may be comprised of hybrid material with various components of
metal and polymer or carbon fiber material. Each of the pair of
arms includes a clamping side.
[0012] In one embodiment, the clamping side of one arm includes a
wedge-shaped feature. The clamping side of the second arm includes
a V-shaped trough that conforms to the shape of the wedge shaped
feature. Each clamping side includes non-slip protrusions such as
non-slip protruding ribs, cones, teeth, or needles. The integrally
formed flexible hinge has a reduced thickness and protrudes
outwardly from the clamping surfaces of the arms. The hinge may be
cut to release the clip without cutting the clamped tissue or
vessel.
[0013] In an exemplary surgical clip, a pair of opposed arms are
joined at a hinged proximal end by an integrally formed flexible
hinge. Each arm has a free distal end. One arm includes a male head
element near the free distal end. The opposite arm includes a head
mating element near the free end. The male head element includes a
tissue piercing head configured to penetrate tissue in the path of
the male head element when the male head element is urged towards
the head mating element. The male head element acts as a
penetrating trocar via spreading the tissue fibers so it pierces
the tissue in an atraumatic fashion. As the male head element
punctures the tissue, it perforates and tunnels (or bores) through
the tissue to create a tissue channel/opening atraumatically. The
head mating element includes a shape that engages the male head
element and resists withdrawal of the head when the head of the
male head element has been urged through the head mating
element.
[0014] In an exemplary surgical clip, the flexible hinge is a
U-shaped segment that extends from the hinged end of each arm of
the pair of opposed arms. The hinged ends of the arms are
configured to abut each other when the surgical clip is closed. A
curved hinge guard prevents tissue from invading the flexible
hinge, while ensuring that the clamping arms maintain intimate
contact with the clamped tissue. A clamped object (e.g., tissue)
does not contact the flexible hinge when the surgical clip is
closed and the hinge may be cut to release the clamp, without
contacting the clamped object. An empty space is maintained between
the hinged ends of the arms of the pair of opposed arms and the
flexible hinge. The flexible hinge has a hinge thickness and width,
and each arm of the pair of opposed arms has an average thickness
and width. In one embodiment, the width and/or thickness of the
flexible hinge is less than the average width of each arm of the
pair of opposed arms to facilitate cutting. In one embodiment as
depicted in FIG. 8E, the clip includes a locking hinge portion that
locks the clip in the closed position when the male head element is
engaged into the head mating element.
[0015] Therefore, when the clip is closed/engaged around tissue
(blood vessels, etc.), there are two irreversible locking features
that allow the clip to maintain tension on the tissue--one at the
distal end of the clip where the male head element engages the head
mating element, and one at the proximal end with the ratchet
feature at the hinge. The ratchet feature provides improved
clamping force, and accommodates a wide range of tissue thickness
within the clamped arms without comprising the integrity of the
hinge strength.
[0016] In one embodiment, to facilitate the male head element
piercing the tissue via a spreading fashion, tissue anchor features
are provided in proximity to the head mating element. In one
example, the tissue anchor features are a pair of pillars that
serve as anchors to keep the tissue in-place, under tension, and in
a stretched orientation while the male head element enters tissue.
This mechanism allows the male head element to spread tissue apart
laterally via shearing forces in opposite direction. This tissue
spreading depicted in FIGS. 20A and 20B.
[0017] Optionally, the surgical clip may be comprised of a
bioabsorbable plastic. Other materials include biocompatible
metals, plastics and composites. Examples of suitable plastics
include acetal polyoxymethylene (POM), polyethylene terephthalate
(PET), polybutylene terephthalate (PBT), polyoxymethylene,
polyetheretherketone (PEEK), polypropylene, and polyethylene or
other thermoplastic materials having similar properties that can be
injection-molded. The clip may be comprised of polymer material in
combination with radiolucent metal alloys.
[0018] Each of the pair of arms includes a clamping side. In one
embodiment, the clamping side of one arm includes a wedge-shaped
feature, and the clamping side of the second arm includes a
V-shaped trough that conforms to the shape of the wedge shaped
feature. Each clamping side includes non-slip protrusions, such as
non-slip protruding ribs.
[0019] An alternative clip design includes one arm (either a female
arm or a male arm) having a pair of elongated arms or spars
separated by a space or gap. The gap between the spars receives an
elongated wedge-shaped ridge projecting from the clamping surface
of the opposite arm, when the arms are in a closed position. The
gap is wide enough to allow at least a portion of the ridge and
clamped tissue or vessel to fit within the gap, thus preventing
dislodgment of the clip during extreme pressure circumstances. In
another embodiment, one arm includes a central window.
[0020] An exemplary clip includes a plurality of bosses, including
a hinge boss, for gripping by an applicator and stabilizing during
use. As used herein, a boss is a projection or protuberance that
can be engaged by an applicator. The hinge boss is a grippable boss
(i.e., a protrusion suitable for gripping) at or near the hinge.
Gripping the hinge boss during use prevents undesirable angulation
(angular disorientation) of the clip during use with an applicator.
An alternative design to prevent undesired angulation of the clip
during use with the applicator is to have rectangular-shaped bosses
near the free end of each arm. Rectangular-shaped bosses maintain
the alignment of the clip within the arms of the applicator while
it is applied onto tissue, preventing the proximal end of the clip
(the hinge region) from angulating out of the jaws of the
applicator.
[0021] In one embodiment, the clip has a width of about 3.2 mm or
more, as compared to about 1.6 mm for prior art polymer ligation
clips. This extra width provides several advantages--it provides a
greater clamping surface area between the clamp arms; it permits a
relatively large, wide, and strong male head element feature to
penetrate tissue; and it permits a relatively large diameter head
mating element cross section with a larger aperture and retention
area to secure the male feature.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] The foregoing and other aspects, objects, features and
advantages of the invention will become better understood with
reference to the following description, appended claims, and
accompanying drawings, where:
[0023] FIG. 1A is a top perspective view of an exemplary surgical
clip according to principles of the invention.
[0024] FIG. 1B is a bottom perspective view of the surgical clip of
FIG. 1A.
[0025] FIG. 1C is a side view of the surgical clip of FIG. 1A.
[0026] FIG. 2 is a side view of the surgical clip of FIG. 1A in a
closed orientation.
[0027] FIG. 3 is a perspective view of the step clamp features of
the surgical clip of FIG. 1A.
[0028] FIG. 4A is a perspective view of another embodiment of a
surgical clip with continuous step clamp features.
[0029] FIG. 4B is a side view of the surgical clip of FIG. 3A in a
closed orientation.
[0030] FIG. 5 provides schematics conceptually illustrating various
exemplary surgical clip configurations according to principles of
the invention.
[0031] FIG. 6A is a detailed top perspective view of the surgical
clip of the head mating element of the surgical clip of FIG.
1A.
[0032] FIG. 6B is a detailed bottom perspective view of the head
mating element of the surgical clip of FIG. 1A.
[0033] FIG. 7A is a detailed top perspective view of the surgical
clip of the male head element of the surgical clip of FIG. 1A.
[0034] FIG. 7B is a detailed bottom perspective view of the
surgical clip of the male head element of the surgical clip of FIG.
1A.
[0035] FIG. 8A is a detailed side view of the hinge portion of the
surgical clip of FIG. 4A.
[0036] FIG. 8B is a side view of an second alternative hinge
portion of a surgical clip.
[0037] FIG. 8C is a side view of an third alternative hinge portion
of a surgical clip.
[0038] FIG. 8D is a side view of a fourth alternative hinge portion
of a surgical clip, with the hinge in an open orientation.
[0039] FIG. 8E is a side view of the fourth alternative hinge
portion of FIG. 8D, with the hinge in a closed orientation.
[0040] FIG. 8F is a side view of a hinge portion of a surgical clip
with a first example hinge lock.
[0041] FIG. 8G is a front view of the hinge lock of FIG. 8F when a
surgical clip is in an open configuration.
[0042] FIG. 8H is a front view of the hinge lock of FIG. 8F when a
surgical clip is in a closed configuration.
[0043] FIG. 9 is a front view of a male head element.
[0044] FIG. 10 is a front view of a head mating element.
[0045] FIG. 11A is a front view of a male head element and a head
mating element when a surgical clip is in a closed
configuration.
[0046] FIG. 11B is a side view of a male head element and a head
mating element when a surgical clip is in a closed
configuration.
[0047] FIG. 12 is a cross-sectional front view of a portion of an
exemplary surgical clip where the male arm has been engaged by a
female arm.
[0048] FIG. 13 is a side view cross section side view of a portion
of clip arms with alternative clamping features.
[0049] FIG. 14 is a side perspective view of the clamping features
of FIG. 13.
[0050] FIG. 15 is a side perspective view of the clamping features
of FIG. 13 with clamped tissue.
[0051] FIG. 16 is a side view cross section side view of a portion
of clip arms with a plurality of teeth clamping features.
[0052] FIG. 17 is a side perspective view of the clamping features
of FIG. 16.
[0053] FIG. 18 is a side perspective view of the clamping features
of one arm of FIG. 16.
[0054] FIG. 19 is a perspective view of the exemplary surgical clip
configured with bosses.
[0055] FIG. 20A is a side perspective view of a surgical clip in an
open orientation positioned to clamp a blood vessel.
[0056] FIG. 20B-20E are front views of the surgical clip of FIG.
20A, as the clip is closed and penetrates tissue.
[0057] FIG. 21A is a side view of a surgical clip in an open
configuration, with side hinge locks in an open configuration.
[0058] FIG. 21B is a side perspective view of a surgical clip of
FIG. 21A.
[0059] FIG. 21C is a side view of the surgical clip of FIG. 21A
with the hinge locks in an engaged configuration.
[0060] FIG. 21D is a side view of the surgical clip of FIG. 21A
positioned in a clip applicator.
[0061] FIG. 22A is a side view of a surgical clip in an open
configuration, with an a ratcheting hinge lock in an open
configuration.
[0062] FIG. 22B is a rear view of the hinge lock of FIG. 22A.
[0063] Those skilled in the art will appreciate that the figures
are not intended to be drawn to any particular scale; nor are the
figures intended to illustrate every embodiment of the invention.
The invention is not limited to the exemplary embodiments depicted
in the figures or the configuration, shapes, relative sizes,
ornamental aspects or proportions shown in the figures.
DETAILED DESCRIPTION OF EMBODIMENT--SURGICAL CLIP WITH HEAD LOCKING
CAPABILITY AND A HINGE PORTION LOCKING
[0064] In this embodiment, a ligating clip has a head locking
capability and a hinge portion locking capability.
[0065] Hinge Lock
[0066] In FIG. 8F-8H, the hinge portion 115 of a surgical clip is
constructed with a hinge lock 812 comprising a first hinge locking
element 810 and a second hinge locking element 820, thus providing
an irreversible locking mechanism at the proximal hinge end 115 of
the clip 100. As the clip arms 105, 110 are re-approximated
together to clamp tissue between the arms, a prong 815 of first
hinge locking element 810 will fit irreversibly into a slot or
groove 825 of the second hinge locking element 820. Once the prong
815 and slot 825 are united, the hinge 115 is said to be in the
locked and closed position. By having a hinge lock apparatus at the
hinge area, there will be constant pressure applied to the tissue
being clamped at the hinge region as well as the male-female
locking interface region--a parallel tension mechanism from both
ends of the clip. This hinge lock, or an alternative hinge lock can
be provided in combination with various head designs and arm
clamping surfaces, such as illustrated in the example figures.
[0067] Side Hinge Lock
[0068] FIG. 21A is a side view of a surgical clip 103 in an open
configuration, with a first side hinge lock 750 in an open
configuration with latch element 751 provided on arm 110 and catch
element 752 formed as a recess on arm 105. FIG. 21B is a side
perspective view of a surgical clip of FIG. 21A showing a latch
element 761 of second hinge lock 760 on the opposite side of arm
105 from the first side hinge lock.
[0069] FIG. 21C is a side view of the surgical clip of FIG. 21A
with the first side hinge lock in an engaged (locked)
configuration. In this example, a first lock is provided between
the male head element 800 and the head mating element 900; and a
second set of locks is provided by hinge locks 750 and 760.
[0070] FIG. 21D is a side view of the surgical clip of FIG. 21A
positioned in a clip applicator.
[0071] Ratcheting Hinge Lock
[0072] FIG. 22A is a side view of a surgical clip in an open
configuration, with an a ratcheting hinge lock 850. FIG. 22B is a
rear view of the hinge lock. In this example, the ratcheting hinge
lock 850 comprises a first hinge portion 860 integral to arm 105,
and a second hinge portion 870 integral to arm 115. A pin 852 may
be provided on either hinge portion. As arm 105 is moved toward arm
115, teeth 862 in the first hinge portion 860 rotate past teeth 872
in the second hinge portion 870. Each tooth 862 comprises a latch
element 864 which engages a corresponding catch element 874 on
teeth 872. The engagement of the latch element 864 by the catch
element 874 prevents the arms from opening. In this example, a
first lock is provided between the male head element and the head
mating element; and a second lock is provided by hinge locks
850.
[0073] Clip Arms
[0074] With reference to FIGS. 1A through 3, in one embodiment, a
clip 100 according to principles of the invention generally
includes a pair of clamping arms 105 and 110, adjoined at an
integral flexible hinged joint 115 (the "hinge") located at the
hinge end or proximal end of the clip. Each arm has a free end or
distal end 155, 160 with an opening 101 therebetween, such as an
opening having a generally u- or v-shaped space. The opening 101 is
preferably sufficiently wide to engage a vessel, organ or tissue to
be ligated. In the exemplary embodiment shown in FIGS. 1A, 1B, 1C,
the clamping arms 105, 110 are generally rigid. However, the hinged
end 115 is sufficiently flexible so that the arms, 105, 110 can be
angularly deflected bringing their free ends or distal ends 155,
160 towards each other to decrease the space between the arms 105,
110, until a locking engagement is achieved. In the exemplary clip
100 of FIGS. 1A through 1C, one or more cutouts 119, 120 formed in
the hinge 115 facilitates bending at the hinge 115. Alternatively,
other configurations with a reduced cross-sectional area at the
hinge 115 (e.g., an integrally formed living hinge) may be utilized
to facilitate such bending while maintaining structural integrity.
Because a clip 100 according to the invention is inserted into a
body cavity in a fully opened configuration, the hinge is not
required to facilitate expansion.
[0075] A first clamping arm 105 extends from the hinge 115. The
first clamping arm 105 includes an outer side 125 and a clamping
side 130.
[0076] Clamping Features
[0077] In one embodiment, first arm 105 has a convex stepdown-like
clamping side 130 and a concave or flat outer side 125. In one
example, the clamping side 130 includes a configuration resembling
"downward" steps to create a V-shaped trough portion 200 with an
opening 201 as depicted in FIG. 3. In this example, converging
downward staircase surfaces form the trough 200 in the arm of the
first clamping arm 105. As shown in FIG. 3, a plurality of
step-like intrusions such as downward steps or ribs 185 are spaced
longitudinally apart along a portion of the length of the clamping
side 130 of clamping arm 105. In this example, a tissue slippage
prevention feature is comprised of a zig-zag pattern that
interlocks into the adjacent arm. This zig-zag pattern on
cross-section resembles the steps of a pyramid; consisting of
acute, orthogonal or obtuse angles creating a step-like staircase
feature. The zig-zag pattern itself can also have acute, orthogonal
or obtuse angles or a combination there of. A boss 145 is provided
to facilitate handling and manipulation. A male head element 800
extends from the clamping surface of the first clamping arm
105.
[0078] A second clamping arm 110 includes an outer side 135 and a
clamping side 140. Second arm 110 has a concave clamping side 140
and a convex or flat outer side 135. In this example, the clamping
side 140 includes a triangle-shaped step-like wedge configuration
resembling a pyramid 210, such as the triangle-shaped pyramid wedge
conceptually illustrated in FIGS. 1A, 1B, 1C, 3 and 4. Converging
step-like staircase (i.e., angled) surfaces 215 form the an apex of
the pyramid 211. The surfaces 215 converge at an apex 211 (i.e., a
point of intersection). Concave clamping side 140 of second arm 110
and convex clamping side 130 of first arm 105 have substantially
matching radii of curvature. The trough 200 forms a female
receptacle for at least partially receiving the pyramid-like wedge
210 when the arms 105, 110 are urged together. A plurality of
protrusions such as protruding rows of benches or ribs 215 are
spaced apart along a portion of the length of the clamping side 140
of clamping arm 110. A boss 150 is provided to facilitate handling
and manipulation. A head mating element is formed in the clamping
surface 140 of the second clamping arm 110.
[0079] The embodiment in FIG. 3 includes a prominent wedge or ridge
210 (e.g., an elongated ridge having a staircase-like triangle
pyramid figured cross section) extending from the clamping surface
of one arm 110. The surface of the prominent wedge 210 is textured
with step-like protrusions 215. For example, a plurality of
striations, ribs or other protuberances 215 may be provided to
enhance frictional gripping force exerted by the clip 100. A
corresponding trough 200 or aperture is provided on the other arm
105. The trough 200 may extend from the clamping side of the arm
through the opposite side of the arm, or only partly through the
arm. The trough 200 may have a shape that generally corresponds to
the shape of the ridge 210. Thus, the ridge 210 mates with the
trough 200 when the clip 100 is closed. End portions 202 and 203 of
the clamping arm flank and define the trough 201. The tissue
contacting surfaces of these portions may also be textured, e.g.,
feature a plurality of striations, ribs, or other protuberances to
enhance frictional gripping force exerted by the clip 100. The
wedge 210 and top ridge 211 mates with the trough 200 and window
201 when the clip is closed. The surface of the trough may also be
textured. For example, a plurality of striations, ribs or other
protuberances may be provided to enhance frictional gripping force
exerted by the clip 100. The corresponding surface of one arm 105
has an open space 201 to allow bulky tissue to fill the window 201
without causing the arms 105 and 110 to bow outward when the clip
is in the closed configuration around tissue.
[0080] The arrangement and configuration of the wedge and trough
may vary within the scope of the invention. For example, the
pyramid-like wedge 210 may be formed on the first clamping arm 105
and the step-down staircase trough 200 may be formed on the other
arm 110. In this configuration, the pyramid-like wedge 210 may
enhance structural integrity and stability of the first arm 105,
which may facilitate closure.
[0081] Tissue Capture
[0082] The alternating staircase pattern within the inner aspect of
the male and female arms acts to capture tissue into the arms of
the clip as it closes rather than pushing tissue out as the clip
closes. The inner teeth or jaws of the clip act as cogs or teeth
where the teeth from one arm (such as the male arm of the clip)
fits into a corresponding slot within the other arm (such as the
female arm). Each slot is configured by the walls of two adjacent
teeth or cogs. The inner teeth or the alternative staircase pattern
of one clip arm (either the male or female arm) fits into a
corresponding slot located on the opposite clip arm (either the
female or male arm), so that the teeth from the two arms come
together as a "zipper" as the clip closes. As the clip arms are
re-approximated, the teeth anchor onto tissue to capture the tissue
within the clip arms as it closes rather than pushing the tissue
out as the clip closes.
[0083] The slot on one clip arm is a space that fits the teeth from
the opposite clip arm; it is created by two adjacent teeth walls.
The teeth from one arm (such as the male arm of the clip) fits into
a corresponding slot or space within the other arm (such as the
female arm of the clip). the teeth from one arm (such as the female
arm of the clip) fits into a corresponding slot or space within the
other arm (such as the male arm of the clip).
[0084] The two interacting surfaces of the clip is similar to a
gear or cogwheel mechanism where the teeth or tongues (created by
the alternating staircase pattern on the inner part of the clip
arms) mesh together with another toothed part in order to transmit
a force towards the hinge region of the clip, causing the tissue to
be captured into the clip rather than outwards and away from the
clip as the clip closes. There is a mechanical advantage through
this gear mechanism of the alternating staircase patterned teeth on
one side of the clip arm which corresponds to the slots on the
opposite side of the clip arm.
[0085] Hinge
[0086] Flexible hinge 115 has a continuous concave inner surface
and a continuous convex outer surface. Concave inner surface of
hinge section 115 joins concave clamping side 130 of first arm 105
and convex clamping side 140 of second arm 110. Convex outer
surface of the hinge 115 joins outer side 125 of first arm 105 and
outer side 135 of second arm 110.
[0087] Non-Slip Features
[0088] In this embodiment, the clamping arms are configured with
non-slip protrusions, such as teeth, ribs or step-like ridges. The
teeth, ribs, or step-like ridges are uniquely dimensioned and
configured to frictionally engage a vessel, organ or tissue. The
teeth, ribs or step-like ridges protrude from the clamping-side
surface of one clamping arm. The teeth, ribs or step-like ridges or
protrusions increase the clamping side pressure and surface area in
frictional contact with the engaged vessel, organ or tissue. In the
exemplary embodiment, step-like ridges or protrusions extend along
the longitudinal axis of the clamping-side surface of one arm. In
one example, the height of each layer or step-like ridge of the
pyramid may preferably be approximately 0.01 to 0.5 mm. A
substantially greater height prevents an engaged vessel, organ or
tissue from contacting the clamping side surfaces of the clamping
arms between the step-like pyramid upward wedge and the step-like
downward trough, thereby substantially compromising the
frictionally engaging surface area. In such a case, the vessel,
organ or tissue would be suspended between adjacent step-like
ridges. A substantially greater height will also result in a
substantially thicker clamp, which can compromise utility in
endoscopic procedures.
[0089] Alternative Clamping Surfaces
[0090] Referring now to FIG. 4, portions of arms 105 and 110
featuring an alternative configuration of clamping surfaces is
shown. A plurality of spaced apart step-like "staircase" pillars
protruding 220 from the clamping side surface 130 of the first
clamping arm 105. Spaces 230 are provided between adjacent
"staircase" pillars 220. In this example, each staircase-shaped
pillar protrusion 220 comprises chamfered (i.e., right-angled)
surfaces 235 that converge at a vertex 225. Correspondingly, a
wedge shaped a step-like pattern resembling a pyramid 210 protrude
from the clamping surface 140 of the second clamping arm 110. The
pyramid-shaped wedge protrusion 210 is comprised of chamfered
(i.e., right-angled) surfaces 255 that converge at a vertex 250.
The staircase-like pillars 220 are aligned with the pyramid-shaped
wedge segments 210. Thus, when the arms 105 and 110 are urged
together in locking configuration, the pyramid-shaped wedge 210
receives corresponding staircase-like pillar protrusions 220. When
the arms are urged together to close the clip arms 105 and 100, the
top ridge or apex 211 of the pyramid-shaped wedge will be
approximated to the floor 213 of the other arm 105. This
configuration increases the pressure applied to vessels, organs or
tissue sandwiched between the triangle-shaped pyramid-like wedge
210 and the corresponding staircase-shaped pillar protrusions
220.
[0091] In yet another alternative embodiment, the protrusions are
of a size, shape and arrangement so that the protrusions of
opposing arms interdigitate with one another when the opposing arms
are moved toward one another. By interdigitate it is meant that the
protrusions of one arm extend into spaces between counterpart
protrusions of the other arm when the arms are moved towards one
another. Once the arms are brought together, vessels, organ or
other tissue engaged between the arms will be forced under clamping
pressure to wind around the protrusions and into the interdigital
spaces. The displacement into the interdigital spaces increases the
traction and gripping force of the arms upon the engaged vessel,
organ or tissue and increases the force required to move the
gripped vessel, organ or tissue relative to the arms. In addition,
protrusions having gripping features (e.g., ribs) provide
additional traction and further resist movement of the gripped
vessel, organ or tissue in directions transverse to the gripping
edges.
[0092] Arm Shape
[0093] The shapes of the arms may vary from straight to concave or
convex. Referring now to FIG. 5, a configuration 300 with a
substantially straight arm 310 and a corresponding curved (i.e.,
convex) arm 305 is shown. Another embodiment 400 with a pair of
curved (i.e., convex) arms 405, 410 is shown. In yet another
embodiment 500 a configuration with a pair of substantially
straight arms 505, 510 is shown. Another embodiment 600 includes a
pair of curved (i.e., convex) arms 605, 610, and a severable hinge
615. In that embodiment, the hinge 615 extends from the converging
ends of the arms 605, 610. These and other arm configurations that
allow clamping of vessels, organs or tissue between the arms are
feasible and come within the spirit and scope of the invention.
Thus, two concave surfaces may define a lens shaped space
therebetween. A concave and convex surface may define a lune shaped
space therebetween. Crescent, circular segment and triangular
shapes may also be defined using various combinations of curved and
straight arms.
[0094] Tissue Spreading Head and Head Mating Element
[0095] Referring now to FIGS. 6A, 6B, 7A and 7B, a clip according
to principles of the invention includes a male and female locking
mechanism, wherein the male component consists of a male head
element 800 configured to penetrate an engaged tissue or organ. As
shown in FIGS. 6A and 6B, the head mating element 900 comprises a
resilient aperture 930 in the second arm 110, aligned with the male
head element 800. A tapered ridge section 940, flexible tab or
other snap fit feature in the receptacle 900 resists withdrawal of
the fully inserted male head element 800. As shown in FIGS. 7A and
7B, the male head element 800 includes a base 820 which extends
from the first arm 105, a shank 830 that extends from the base 820,
and a head 840 that extends from the shank 830.
[0096] As shown in FIGS. 7A and 7B, an example head 800 includes a
sharpened and/or pointed leading edge 840 suitable for penetrating
an engaged portion of an organ or tissue. The head may be rigid
biocompatible plastic, reinforced biocompatible plastic, or
biocompatible metal.
[0097] The head 800 is configured to pass through the opening in
the head mating element 930, yet resist withdrawal. The head 800,
the head mating element 900 or both may exhibit resiliency to allow
passage of the head for locking. The bulbous portion, arrow-shape,
flanged edge, detents or cone-shape of the head resist or prevent
withdrawal of the head after it has been urged through the head
mating element.
[0098] Clip Alignment Guides
[0099] Adjacent to the distal (free) ends of the first and second
arms and adjacent to the male head element 800 and head mating
element 900, a pair of cylindrical bosses 145, 150 are formed
coaxially on the opposed lateral surfaces of the first and second
arms 105, 110. The bosses 145, 150 project outwardly beyond the
outer surfaces of the arms 105, 110. An applicator engages the clip
100 using the bosses 145, 150. An alternative design of the bosses
145, 150 to prevent undesired angulation of the clip 100 during use
with the applicator 900 is depicted in FIG. 19. Adjacent to the
circular bosses 145, 150, there are rectangular-shaped alignment
guides 147, 157 located on each arm 105, 110 of the clip. These
rectangular-shaped alignment guides 147, 157 provide stability of
the clip. Rectangular-shaped alignment guides 147, 157 maintain the
alignment of the clip 100 within the arms of the applicator 900
while it is applied onto tissue, preventing the proximal end of the
clip 115 (the hinge region) from angulating out of the jaws of the
applicator 900. The applicator tip may engage the front portion of
alignment guides 147 and 157 to prevent lateral movement of the
clip. The applicator may also include fixture elements for engaging
the rear portions of alignment guides 147 and 157 to retain the
rear portion of the clip in alignment with the applicator tip.
[0100] Materials
[0101] Clips according to principles of the invention may be
comprised, in whole or in part of metals such as stainless steel,
titanium, tantalum, or alloys thereof. Bioabsorbable and
radiolucent versions may be comprised of a one-piece integral
polymeric body formed from a suitable strong biocompatible
engineering plastic such as the type commonly used for surgical
implants. Examples of suitable plastics include acetal
polyoxymethylene (POM), polyethylene terephthalate (PET),
polybutylene terephthalate (PBT), polyoxymethylene,
polyetheretherketone (PEEK), polypropylene, and polyethylene or
other thermoplastic materials having similar properties that can be
injection-molded, or other thermoplastic materials having similar
properties that can be injection-molded, extruded or otherwise
processed into like articles.
[0102] Clip Application
[0103] In use, the clip 100 is typically positioned and compressed
into a locked position using an applicator. An applicator includes
a forceps-type applier having a conformal jaw assembly used to grip
and maintain alignment of the clip during placement and compressive
deformation. The proximal end of the applicator includes a handle
assembly with a stationary element and a movable (e.g., pivoting)
element. A linkage contained within an elongated tubular shaft
operably couples the movable handle element to the conformal jaw
assembly. The shaft preferably fits through a 10-15 mm trocar. The
distal end of applicator generally comprises the conformal jaw
assembly having opposing pivotable jaws which have respective jaw
recesses adapted to engage and retain bosses 145, 150 of the clip
100. Closure of the jaws of the applicator compresses the held clip
100. This causes the first and second arms 105, 110 of the clip 100
to close around a vessel, organ or tissue with clamping sides of
the first and second arms 105, 110 contacting the outer surface of
the engaged vessel, organ or tissue.
[0104] Head Penetration and Lock
[0105] As the clip is compressed, any portion of the engaged
vessel, organ or tissue or surrounding tissue in the path of the
male head element will be penetrated by spreading tissue laterally
as depicted in FIGS. 20A and 20B. In one invention model of the
clip in FIGS. 6A, 6B, 7A and 7B, as compression continues, the male
head element 800 enters the head mating element 930 and begins to
contact the female ridge 940. Further pivotal movement by the
applicator urges the pin 800 into the aperture created by two
parallel pillars or columns 910 and 920 until the head of the pin
840 is forced through the aperture 930 and passes adjacent to the
tapered ridge section 940, flexible tab or other snap fit feature
in the receptacle. Thereafter, the shank 830 of the male head
element is matingly seated in the head mating element opening 930
and resting on the tapered ridge section 940, flexible tab or other
snap fit feature to resist withdrawal of the fully inserted male
head element 800. This is the locked position. Upon release of the
applicator instrument, the clip remains in the locked position.
Once in the locked position, reference to FIGS. 2A, 2B, 11A and
11B, the male head element 800 resists withdrawal from the head
mating element 930 by allowing the shank 830 to engage the tapered
tab 940 or other snap fit feature in a one-way forward fashion.
[0106] In this example, the tissue spreading head 840 includes a
leading edge 842, a tip 841, and a latch surface 830. The latch
surface 840 engages a catch surface 950 on the head mating element
900. The pillars 910 and 920 include sharp edges 914 and 916, front
walls 918, and bottoms 920.
[0107] As depicted in FIGS. 20A and 20B, the clip penetrates tissue
by spreading the fibers of the tissue laterally or aside to allow
the male head element 840 to penetrate the tissue atraumatically
and without cutting into the tissue. All endovascular tissue in the
human body is made of organized collagen fibers--not random
placement of cells; these fibers 970 are organized layers of cells
that create cylindrical-shaped fibers. These collagen fibers 970
are assembled in organized fashion to create connective tissue 960.
Connective tissue 960 is the backbone of every organ and blood
vessel in the human body; it surrounds organs and vessels to give
it structure, shape and substance. The male head element 840 is
designed to separate these organized layers of collagen fibers 970
laterally as it penetrates tissue 960.
[0108] Alternate Hinges
[0109] With reference to FIGS. 8A through 8D, various exemplary
embodiments of a clip 100 according to principles of the invention
are illustrated. The hinged sections of the clips vary. In each
case, the width and/or thickness of the hinge section 115 is equal
to, less than, or greater than the average thickness of a clamping
arm 105, 110. In each case the hinged section 115 includes one or
more apertures 119, 120 to facilitate bending. The hinged section
may also include a hinge boss in proximity to the hinge on each
side of the clip to maintain alignment. The hinge boss is a
protruding feature that can be gripped by the applicator during
insertion. The shape and position of the hinge boss may vary within
the scope of the invention.
[0110] An alternative design of the hinge is shown in FIG. 8D; the
hinge 115 resembles a star-shaped or fan-shaped configuration with
multiple finger-like projections 119 radiating outwards. The radial
cut-outs 119 at the hinge area 115 allows the clip 100 to
accommodate various tissue thicknesses as the clip arms 105, 110
are reapproximated to each other during the clip closure process.
The star-like configuration 119 of the hinge 115 allows the hinge
to act as an "accordion" to accommodate various tissue thicknesses
within its arms 105, 110 while maintaining ample pressure on the
clamped tissue to prevent slippage under high pressures.
[0111] Bosses
[0112] Thus, the clip may include a unique arrangement of bosses.
As discussed above, there may be bosses at the free end of the
arms. There may also be one or more hinge bosses. The applicator
will hold the clip by its bosses until the clip is released from
the applicator. Gripping the boss at the hinge until the clip is
released provides enhanced control and stability of the clip while
applying to tissue. Specifically, gripping the boss at the hinge
may prevent unwanted angulation of the clip.
[0113] Clip Size
[0114] A clip according to principles of the invention can be sized
to accommodate various vessels. In an exemplary embodiment, the
clips are sized to work with laparoscopic procedures, meaning that
it preferably can fit through a 10-15 mm trocar. It may pass
through the trocar in a partially clamped state. After passing
through the trocar, if the clip was partially compressed, then the
jaws of the applicator and the clip will expand into a fully opened
state. Thus, other than being sized for use with a laparoscopic
procedure, the size of the clip may vary considerably to
accommodate various vessels.
[0115] Tissue Piercing Head
[0116] Referring now to FIGS. 9 through 11B, alternative exemplary
male and female locking mechanisms are illustrated, wherein the
male head element 805 comprises an arrow-like or cone-shaped lance
815 configured to penetrate an engaged tissue or organ. The lance
800 in FIG. 9 includes a sharp tip 842 for penetrating tissue,
extending outwardly from a shank 832. The shank extends from a base
820 to a sharp tip 842. The leading edges 818 of the tip may be
sharp.
[0117] As shown in FIGS. 10 through 11B, the head mating element
905 comprises an aperture 932 near the free end of an arm 110,
aligned with the male head element 805 and head 815. The apertures
may be generally aligned with bosses 145 and 150. The receptacle in
FIG. 10 includes a one-way catch 952 that engages the resilient
male head element 805 when the two arms 105, 100 are urged together
via an applicator. A tapered ridge section 942, flexible tab, catch
or other snap fit feature in the receptacle 932 of FIG. 10 resists
withdrawal of the fully inserted male head element 805 and head
810. The mated male lance and head mating element are illustrated
in FIGS. 2A, 2B, 11A and 11B.
[0118] In one example, the head mating element 905 comprises two
parallel pillars or columns 910 and 912 extending from the clamping
arm 110 via a base 922. The two columns 910 and 912 create an
opening or aperture 932 to allow the male head element 805 of one
arm 105 to engage the tapered ridge 942 of the second arm 110.
[0119] In this example, the tissue piercing head 815 includes a
leading edge 818, a tip 842, and a latch surface 832. The latch
surface 832 engages a catch surface 952 on the head mating element
905. The pillars 910 and 912 include sharp edges 914 and 916, and
front walls 918.
[0120] The two parallel pillars 910 and 912 have distinct sharp
edges that provide counter-traction of the tissue being clamped as
the male head element 800 penetrates the tissue. The male tissue
piercing head 815 shears or scissors tissue as it passes adjacent
to the sharp pillars 910 and 912, thus allowing the male head
element 805 to penetrate the tissue. As the male head element 805
passes through the aperture 932, it locks into the closed position
when the shank 8332 is resting on the ridge 942 within the aperture
932.
[0121] The head mating element 905 is surrounded by two pillars 910
and 912 with sharp edges that are parallel to each other, creating
the aperture 932 between its columns. These two sharp pillars are
arranged in parallel fashion to create a valley 932 where the male
head element 805 will rest when the two clip arms 105, 110 are
urged together. The top of the pillars comprise sharp edges 914 and
916, designed to provide counter-traction of the tissue as the male
head element 805 advances through the tissue and into the head
mating element 905. The sharp edges of the pillars enhance the
tissue penetrating capability of the male head element 805 and head
815 when advancing it through thick tissue.
[0122] The head of the lance 815 includes a sharp and/or pointed
leading edge 818 suitable for penetrating an engaged portion of an
organ or tissue. The head 815 may be rigid biocompatible plastic,
reinforced biocompatible plastic, or biocompatible metal. The head
815 is configured to pass through the opening or valley in the head
mating element 932, yet resist withdrawal. The head 815, the head
mating element 905, or both may exhibit resiliency to allow passage
of the head for locking. The bulbous portion, arrow-shape, flanged
edge, detents or cone-shape of the head resist or prevent
withdrawal of the head after it has been urged through the head
mating element and locked into the closed position when the shank
832 rests on the female ridge 942. The tip of the head 840 of the
lance should not extend beyond the margins of the female arm 110
when the clip is closed. Thus the tissue penetrating tip will not
rub against, abrade, puncture, pinch or otherwise harm adjacent
structures.
[0123] Tissue Gripping
[0124] FIG. 12 provides a cross-section view from the clip in FIGS.
1A through 11B. As shown, tissue (i.e., tissue or a vessel,
collectively "tissue") 620 is folded and sandwiched between the
ridge 210 of one arm 110 and the trough 185 of the other arm 105. A
substantial portion of tissue is wedged into the trough 201. The
surface area of tissue that contacts gripping surfaces of the clamp
100 is significantly greater than in the case of a substantially
planar clamping surface. The peak of the ridges 185, 215, 225, 235,
250, 255 substantially increases the frictional gripping force
resisting lateral movement of the tissue. This configuration
resists dislodgement of the clip.
[0125] Referring now to FIGS. 13 through 15, various views of arms
600, 605 of an exemplary surgical clip with interdigitating teeth
610 according to principles of the invention, are conceptually
illustrated. Straight arms 600, 605 are illustrated. However, the
invention is not limited to straight arms. Rather, curved arms may
be used within the scope of the invention. While the teeth 610 are
shown with a generally rectangular shape, teeth with other shapes
may be used without departing from the invention. For example, the
teeth may be v-shaped, u-shaped, or some other shape, or have
beveled or filleted edges. The teeth fit into corresponding gaps
615 in the opposite arm. The gaps are shaped and sized to receive
the teeth as well as portions of a clamped tissue or vessel 620
urged into the gaps by the teeth. The number, size and
configuration of teeth and gaps on the clamping surfaces may vary
without departing from the invention. The interdigitating or
interfitting teeth bend the clamped tissue or vessel and provide
increased surface area for frictional engagement.
Counter-intuitively, a clamping surface with teeth may damage
tissue less than a smooth surface because the toothed surface can
grasp with less overall pressure.
[0126] Other Gripping Features
[0127] Referring now to FIGS. 16 through 18, various views of arms
700, 705 of an exemplary surgical clip with interdigitating conical
teeth 710, 715 according to principles of the invention. Straight
arms 700, 705 are illustrated. However, the invention is not
limited to straight arms. Rather, curved arms may be used within
the scope of the invention. While the teeth 710, 715 are shown with
generally pointed tips, teeth with other shapes may be used without
departing from the invention. For example, the tip may be slightly
dulled or rounded. The teeth fit into corresponding gaps or spaces
between teeth in the opposite arm. The gaps are shaped and sized to
receive the teeth. In this embodiment, the tips of the teeth may
actually penetrate slightly into the surface of the gripped tissue
or vessel, without penetrating so deeply as to cause puncturing and
hemorrhaging. While three rows of teeth 715, 716, 717 are shown,
the invention is not limited to any number of rows or teeth aligned
in rows. The number, size and configuration of teeth and gaps on
the clamping surfaces may vary without departing from the
invention. The interdigitating or interfitting teeth penetrate into
the surface of the tissue or vessel to provide enhanced resistance
to dislodging.
[0128] While an exemplary embodiment of the invention has been
described, it should be apparent that modifications and variations
thereto are possible, all of which fall within the true spirit and
scope of the invention. With respect to the above description then,
it is to be realized that the optimum relationships for the
components and steps of the invention, including variations in
order, form, content, function and manner of operation, are deemed
readily apparent and obvious to one skilled in the art, and all
equivalent relationships to those illustrated in the drawings and
described in the specification are intended to be encompassed by
the present invention. The above description and drawings are
illustrative of modifications that can be made without departing
from the present invention, the scope of which is to be limited
only by the following claims. Therefore, the foregoing is
considered as illustrative only of the principles of the invention.
Further, since numerous modifications and changes will readily
occur to those skilled in the art, it is not desired to limit the
invention to the exact construction and operation shown and
described, and accordingly, all suitable modifications and
equivalents are intended to fall within the scope of the invention
as claimed.
* * * * *