U.S. patent application number 14/082201 was filed with the patent office on 2014-08-14 for tissue severing devices with sliding support and methods.
The applicant listed for this patent is Oscar R. Polo. Invention is credited to Oscar R. Polo.
Application Number | 20140228872 14/082201 |
Document ID | / |
Family ID | 47519334 |
Filed Date | 2014-08-14 |
United States Patent
Application |
20140228872 |
Kind Code |
A1 |
Polo; Oscar R. |
August 14, 2014 |
TISSUE SEVERING DEVICES WITH SLIDING SUPPORT AND METHODS
Abstract
Tissue severing devices and methods are provided operable to be
inserted through small surgical openings and advanced to tissue to
be severed. The tissue severing device includes a cutting element
that extends from a tube member during use. A slidable support
ribbon is operable to support the cutting element at an angle to an
axis of the tube member.
Inventors: |
Polo; Oscar R.; (Portland,
OR) |
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Applicant: |
Name |
City |
State |
Country |
Type |
Polo; Oscar R. |
Portland |
OR |
US |
|
|
Family ID: |
47519334 |
Appl. No.: |
14/082201 |
Filed: |
November 18, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13495023 |
Jun 13, 2012 |
8585727 |
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14082201 |
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PCT/US2010/024210 |
Feb 14, 2010 |
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13495023 |
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Current U.S.
Class: |
606/171 ;
606/170 |
Current CPC
Class: |
A61B 17/22012 20130101;
A61B 2017/003 20130101; A61B 17/32002 20130101; A61B 2017/320024
20130101; A61B 17/32056 20130101; A61B 2018/141 20130101; A61B
2018/00559 20130101; A61B 17/320016 20130101; A61B 2018/00994
20130101; A61B 2018/00595 20130101 |
Class at
Publication: |
606/171 ;
606/170 |
International
Class: |
A61B 17/32 20060101
A61B017/32 |
Claims
1-27. (canceled)
28. A tissue severing device comprising: a handle; a tube member
including an elongated tube having a tube member proximal end
extending into the handle and a tube member distal end opposite the
tube member proximal end, the tube member defining a tube member
lumen that extends through the tube member proximal end to the tube
member distal end and defining a tube member axis; an inner member
including an elongated body having an inner member proximal end
extending through the tube member lumen and into the handle and an
inner member distal end opposite the inner member proximal end, the
inner member being operable to be received within the tube member
lumen; a cutting element including a cutting element proximal end
and a cutting element distal end opposite the cutting element
proximal end, the cutting element proximal end extending into the
inner member distal end, the cutting element distal end extending
from the inner member distal end, the tube member distal end being
operable to move distally over and receive the inner member distal
end and the inner member distal end therein, and the tube member
distal end being operable to move in a proximal direction to expose
the cutting element distal end; and a slidable support ribbon
operable for supporting the inner member distal end in a curved
position when the inner member distal end is at least partially
exposed by the withdrawal of the tube member distal end, the
slidable support ribbon comprising an elongated body including a
slidable support ribbon proximal end and a slidable support ribbon
distal end opposite the slidable support ribbon proximal end, the
slidable support ribbon proximal end extending through the tube
member lumen from about the tube member proximal end to about the
tube member distal end and adjacent the inner member, the slidable
support ribbon distal end positioned adjacent the inner member
distal end and the cutting element distal end.
29. The tissue severing device of claim 28, wherein the slidable
support ribbon proximal end is positioned generally adjacent the
handle and may be operably engaged by a user.
30. The tissue severing device of claim 28, wherein the slidable
support ribbon distal end is operable to support the inner member
distal end into a curved shape when the tube member distal end is
withdrawn therefrom, the slidable support ribbon being operable to
substantially prevent the inner member distal end from extending
toward the tube member axis when the cutting element distal end is
pulled through tissue to be severed.
31-35. (canceled)
36. The tissue severing device of claim 30, wherein the slidable
support ribbon distal end is operably coupled to the tube member so
as to begin withdrawing proximally from being adjacent the cutting
element distal end as the cutting element distal end begins to be
exposed by the withdrawing tube member distal end, the slidable
support ribbon distal end operable to be exposed substantially
concurrently with the exposure of the inner member distal end by
the tube member distal end.
37. (canceled)
38. The tissue severing device of claim 30, wherein the tube member
distal end is operable to be withdrawn so as to expose a portion of
the inner member distal end, the slidable support ribbon distal end
is operable to be withdrawn from adjacent the cutting element
distal end and operably engage the inner member distal end so as to
support the inner member distal end into an angle to the tube
member axis.
39. The tissue severing device of claim 30, wherein the slidable
support ribbon distal end is slidingly coupled to the inner member
distal end, wherein when the inner member distal end is exposed by
withdrawing the tube member distal end, a user may pull the
slidable support ribbon proximal end in the proximal direction so
as to withdraw the slidable support ribbon distal end from adjacent
the cutting element distal end and flex the inner member distal end
into a desired angle to the tube member axis.
40. The tissue severing device of claim 30, further comprising an
engagement ring coupled to the inner member distal end, the
slidable support ribbon distal end and the inner member distal end
are slidingly coupled by cooperative engagement of the inner member
distal end and the engagement ring, the slidable support ribbon
distal end comprising a substantially uniform width body portion
and a flared portion at about the inner member distal end, wherein
the flared portion has a width that is larger than the body
portion, the engagement ring comprising a shape of a partial loop
coupled to the inner member distal end transverse to an inner
member axis, the engagement ring being operable to slidingly
receive the body portion of the slidable support ribbon distal end
and is undersized so as to not be able to receive the flared
portion therethrough, the flared portion operable as a catch such
that there is no further axial movement of the slidable support
ribbon distal end relative to the engagement ring when the flared
portion engages the engagement ring, wherein the engagement of the
flare portion with the engagement ring is operable to provide a
means for pulling the inner member distal end proximally and thus
flex the inner member distal end to present the cutting element
distal end to an angle to the tube member axis, wherein the
engagement ring being operable to be slidingly received within the
tube member lumen.
41-42. (canceled)
43. The tissue severing device of claim 40, wherein the slidable
support ribbon distal end further comprises a cutting element
engagement element operable to engage the cutting element distal
end about the inner member distal end, operable to open and
stabilize the cutting element distal end when the cutting element
engagement element engages the cutting element distal end about the
about the inner member distal end.
44-46. (canceled)
47. The tissue severing device of claim 28, wherein the slidable
support ribbon proximal end is cooperatively engaged with the tube
member proximal end such that when the tube member proximal end is
moved axially, the slidable support ribbon is operable to be moved
axially as well.
48. The tissue severing device of claim 28, wherein the slidable
support ribbon proximal end further comprising a snare extending at
an angle from the slidable support ribbon proximal end operable to
engage the tube member proximal end such that when the tube member
proximal end is moved axially, the slidable support ribbon is
operable to be moved axially.
49. The tissue severing device of claim 43, wherein the cutting
element engagement element is a flange extending at an acute angle
from the slidable support ribbon distal end and extending into the
loop formed by the cutting element distal end when adjacent
thereto.
50. (canceled)
51. The tissue severing device of claim 28, wherein the cutting
element comprises a cutting element proximal end and a cutting
element distal end opposite the cutting element proximal end, the
cutting element proximal end and the inner member distal end
removably coupled therebetween, the cutting element distal end
including at least a portion operable to cut and sever tissue.
52. (canceled)
53. The tissue severing device of claim 28, wherein the cutting
element distal end defines a loop, at least a portion of the
cutting element distal end including one or more sharp portions
that are suitable for severing tissue.
54. The tissue severing device of claim 53, wherein the loop is
operable to be biased to expand when the tube member distal end is
withdrawn therefrom, and wherein the cutting element distal end
being elastically deformed under the impinging force of the tube
member distal end so as to enter and be contained by the tube
member lumen when the tube member is advanced over the cutting
element distal end.
55. (canceled)
56. The tissue severing device of claim 28, wherein the inner
member further comprises at least one inner member lumen extending
through the inner member proximal end and the inner member distal
end, the cutting element proximal end extending through the inner
member lumen and coupled within the handle.
57. The tissue severing device of claim 56, wherein the cutting
element comprises a ribbon defining a flat-sided elongated member
that defines a loop at the cutting element distal end and two ends
forming the cutting element proximal end, the cutting element
proximal end received within the inner member lumen and extending
from the inner member proximal end.
58. The tissue severing device of claim 28, wherein the cutting
element distal end has a bias to form an angle to the tube member
axis.
59. The tissue severing device of claim 28, further comprising an
energy source coupled to the cutting element and operable to assist
the cutting element proximal end in cutting and severing
tissue.
60-63. (canceled)
64. The tissue severing device of claim 59, wherein the energy
source is a mechanical oscillator that is operable to rapidly and
alternatively pull on the two ends of the cutting element proximal
end so as to impart a sawing motion to the cutting element distal
end.
65-66. (canceled)
67. The tissue severing device of claim 28, wherein the inner
member proximal end is coupled to a mechanical oscillator that is
operable to rapidly push-pull on the inner member proximal end so
as to impart motion to the cutting element distal end.
68-118. (canceled)
Description
RELATED APPLICATIONS
[0001] This application is a continuation of and claims priority to
U.S. patent application Ser. No. 13/495,023, now U.S. Pat. No.
8,585,727, which is a continuation of and claimed priority to PCT
patent application Serial Number PCT/US10/24210, filed Feb. 14,
2010, entitled TISSUE SEVERING DEVICES AND METHODS, incorporated
herein in its entirety by reference.
FIELD
[0002] The present invention is related generally to the field of
medical devices. More particularly, the present invention involves
devices and methods that enable accurate dissection of tissue such
as associated with a patient undergoing surgery.
BACKGROUND
[0003] During surgical procedures and, more particularly, tissue
removal procedures, it is desirable to limit the size of the entry
incision to minimize the trauma experienced by the patient. In the
past, efforts to minimize entry incision size have generally been
limited due to the size of the tissue to be removed and the need
for access to the tissue.
[0004] However, in modern surgery access to the tissue cite is
provided by inserting one or more trocar and cannula. Thereafter,
one or more laparoscopes are used to view the tissue to be removed,
and additional port sites are used to gain access to the tissue to
sever it from tissue which is to remain. However, the entry
incision must still be sized to allow removal of the severed tissue
and, therefore, the reduction in entry incision size is rather
limited even in more modern or recently developed surgical
procedures.
[0005] Morcellators are devices that morcellate or cut tissue into
smaller pieces to allow for easier removal through small surgical
access sites. Morcellators that require a pushing or downward
traction operation to cut the tissue present a danger of over
extension into tissue that is not to be injured. By way of example,
but not limited thereto, in a laparoscopic subtotal hysterectomy,
one way of minimizing the danger of this over extension is to
amputate the body of the uterus from the cervix prior to
morcellation. The amputation of the uterus presents an added risk
of injury to other organs, such as the rectum and bowel, as they
lie behind the uterus and are difficult to see during uterus
amputation. Also, amputation is commonly performed using
electrocautery or harmonic scalpel which may cause lateral spread
of heat or other energy and can inadvertently cause a burn to the
bowel or bladder that may not be realized until days after surgery.
Further, amputation of the uterus requires the use of one surgical
instrument to amputate the uterus and another surgical instrument
to morcellate the uterus with their associated cost and complexity
of use.
[0006] Some known laparoscopic supracervical hysterectomy
instruments utilize graspers that pull tissue into a spinning
tubular blade or the spinning blade is pushed into the tissue.
These types of instruments have their limitations and dangers
associated with their use, such as, but not limited to, the exposed
sharp blade possibly injuring surrounding tissue not intended to be
morcellated, discharge of the tissue in a spinning tool, and the
difficulty and dangers of placing downward traction into the target
tissue.
[0007] There exists a need in the art for surgical devices and
methods that allow for more effective tissue severing and
morcellating and which allow for morcellation without the need to
first amputate the tissue.
SUMMARY
[0008] In accordance with an embodiment, a tissue severing device
comprises a handle, a tube member, and inner member, and a cutting
element. The tube member includes an elongated tube having a tube
member proximal end extending into the handle and a tube member
distal end opposite the tube member proximal end. The tube member
defines a tube member lumen that extends through the tube member
proximal end to the tube member distal end and defining a tube
member axis. The inner member includes an elongated body having an
inner member proximal end extending through the tube member lumen
and into the handle and an inner member distal end opposite the
inner member proximal end. The inner member is operable to be
received within the tube member lumen. The cutting element includes
a cutting element proximal end and a cutting element distal end
opposite the cutting element proximal end. The cutting element
proximal end extends into the inner member distal end. The cutting
element distal end extends from the inner member distal end. The
tube member distal end is operable to move distally over and
receive the inner member distal end and the inner member distal end
therein. The tube member distal end is operable to move in a
proximal direction to expose the cutting element distal end.
[0009] In accordance with another embodiment, the handle further
comprises an engagement means in operable engagement with the tube
member proximal end operable to permit the tube member to be moved
proximally and distally over the inner member.
[0010] In accordance with another embodiment, the tissue severing
device is operable to present the cutting element distal end at an
angle to the tube member axis when the tube member distal end is
withdrawn from the cutting element distal end and at least a
portion of the inner member distal end.
[0011] In accordance with another embodiment, at least a portion of
the inner member distal end is biased to form a curve of a
predetermined angle with respect to the tube member axis when the
tube member distal end is withdrawn from at least a portion of the
inner member distal end, and is elastically deformable operable to
extend under the urging engagement of the tube member distal end
when advanced over the inner member distal end.
[0012] In accordance with another embodiment, the tissue severing
device further comprises a supporting means operable to support the
inner member distal end in a curved position when the inner member
distal end is at least partially exposed by the withdrawal of the
tube member distal end.
[0013] In accordance with another embodiment, the supporting means
comprises a fixed support ribbon. The fixed support ribbon
comprises an elongated body including a fixed support ribbon
proximal end and a fixed support ribbon distal end opposite the
fixed support ribbon proximal end. The fixed support ribbon
proximal end is coupled to the tube member distal end within the
tube member lumen and the fixed support ribbon distal end is
coupled to the inner member distal end. The tube member distal end
is operable to advance over and receive the inner member distal
end, the cutting element distal end, and the fixed support ribbon.
The fixed support ribbon has a length that is operable to pull the
inner member distal end into a curve with respect to the tube
member axis when the tube member distal end is moved in a proximal
direction and to substantially retain that curve when tissue is
severed by the cutting element distal end.
[0014] In accordance with another embodiment, the inner member
distal end is biased to a substantially straight orientation along
the tube member axis. The fixed support ribbon is operable to
provide a pulling force necessary to flex the inner member distal
end into a curve as well as provide support to prevent the inner
member distal end from significantly extending toward the tube
member axis when the cutting element distal end is pulled through
tissue to be severed.
[0015] In accordance with another embodiment, the tissue severing
device further comprises a slidable support ribbon operable for
supporting the inner member distal end in a curved position when
the inner member distal end is at least partially exposed by the
withdrawal of the tube member distal end. The slidable support
ribbon comprises an elongated body including a slidable support
ribbon proximal end and a slidable support ribbon distal end
opposite the slidable support ribbon proximal end. The slidable
support ribbon proximal end extends through the tube member lumen
from about the tube member proximal end to about the tube member
distal end and adjacent the inner member. The slidable support
ribbon distal end is positioned adjacent the inner member distal
end and the cutting element distal end.
[0016] In accordance with another embodiment, the tissue severing
device further comprises an engagement ring coupled to the inner
member distal end. The slidable support ribbon distal end and the
inner member distal end are slidingly coupled by cooperative
engagement of the inner member distal end and the engagement ring.
The slidable support ribbon distal end comprises a substantially
uniform width body portion and a flared portion at about the inner
member distal end, wherein the flared portion has a width that is
larger than the body portion. The engagement ring comprising a
shape of a partial loop coupled to the inner member distal end
transverse to an inner member axis. The engagement ring is operable
to slidingly receive the body portion of the slidable support
ribbon distal end and is undersized so as to not be able to receive
the flared portion therethrough. The flared portion is operable as
a catch such that there is no further axial movement of the
slidable support ribbon distal end relative to the engagement ring
when the flared portion engages the engagement ring. The engagement
of the flare portion with the engagement ring is operable to
provide a means for pulling the inner member distal end proximally
and thus flex the inner member distal end to present the cutting
element distal end to an angle to the tube member axis. The
engagement ring is operable to be slidingly received within the
tube member lumen.
[0017] In accordance with another embodiment, the cutting element
comprises an elongated member that forms a contiguous element that
defines a loop at the cutting element distal end and two ends at
the cutting element proximal end.
[0018] In accordance with another embodiment, the cutting element
distal end comprises a substantially elastic material such that the
cutting element distal end comprises a diameter somewhat larger
than the inner diameter of the tube member lumen. When the tube
member distal end is advanced in the distal direction, the cutting
element distal end substantially elastically deforms and is
slidingly received within the tube member lumen and when the tube
member distal end is advanced in the proximal direction, the
cutting element distal end exits the tube member lumen and
substantially elastically expands therefrom.
[0019] In accordance with another embodiment, the tissue severing
device further comprises an energy source coupled to the cutting
element and operable to assist the cutting element proximal end in
cutting and severing tissue.
[0020] In accordance with another embodiment, the energy source is
housed within the handle. The inner member further comprises at
least one inner member lumen extending through the inner member
proximal end and the inner member distal end. The cutting element
comprises an elongated member that forms a contiguous element that
defines a loop at the cutting element distal end and two ends at
the cutting element proximal end. The cutting element proximal end
extends through the inner member lumen to the handle and the two
ends of the cutting element proximal end are coupled to the energy
source.
[0021] In accordance with another embodiment, the tissue severing
device further comprises an engagement means operable for moving
the tube member proximally and distally over the inner member.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] Embodiments are illustrated by way of example and not by way
of limitation in the figures of the accompanying drawings, in which
like references may indicate similar elements throughout the
various figures unless otherwise specified.
[0023] FIGS. 1A and 1B are perspective views of embodiments of
tissue severing devices comprising a handle, a tube member, an
inner member, and a cutting element;
[0024] FIG. 2A is a side view of the device distal end showing the
cutting element distal end extending from the tube member distal
end of an embodiment of the tissue severing device of FIG. 1A;
[0025] FIG. 2B is a side view of the device distal end showing the
inner member distal end and the cutting element distal end
extending from the tube member distal end of an embodiment of the
tissue severing device of FIG. 1A;
[0026] FIG. 3 is a side cut-away view of the device distal end
showing the tube member distal end extending over and containing
the inner member distal end and the cutting element distal end of
an embodiment of the tissue severing device of FIG. 1A;
[0027] FIGS. 4A-4C are side views of the device distal end showing
a progression of position of the inner member distal end in
accordance with embodiment;
[0028] FIGS. 5A and 5B are side cut-away views of the device distal
end showing an embodiment of a supporting means comprising a fixed
support ribbon of an embodiment of the tissue severing device of
FIG. 1B;
[0029] FIGS. 6A-6C are side views of the device distal end showing
a progression of positions of the inner member distal end, in
accordance with an embodiment;
[0030] FIG. 7A is a side, partial cut-away view of a tissue
severing device 10 in accordance with an embodiment;
[0031] FIGS. 7B-7C are perspective and top views, respectively, of
the device distal end showing a slidable support ribbon as another
embodiment of a supporting means operable for supporting the inner
member distal end in a curved position when the inner member distal
end is at least partially exposed by the withdrawal of the tube
member distal end;
[0032] FIG. 7D is a perspective view of a device distal end
comprising a slidable support ribbon and a plurality of engagement
rings, in accordance with another embodiment;
[0033] FIG. 8 is a cross-sectional view of the inner member distal
end, a portion of the body portion of the slidable support ribbon
distal end, and an engagement ring, in accordance with an
embodiment;
[0034] FIGS. 9A-9D are side views of an embodiment of a mechanism
for controlling the movement of the slidable support ribbon under
the influence of the movement of the tube member;
[0035] FIGS. 10A and 10B are perspective and side views,
respectively, of a distal end of another embodiment of a slidable
support ribbon;
[0036] FIGS. 11A-11C are top, perspective, and top views,
respectively, of the device distal end with the slidable support
ribbon, in accordance with an embodiment;
[0037] FIG. 12 is a side view of a cutting element engagement
element comprising a U-shaped flange, in accordance with an
embodiment;
[0038] FIG. 13 is a side, partial cut-away view of an inner member,
in accordance with an embodiment;
[0039] FIG. 14 is a top view of the device distal end showing a
bifurcated inner member distal end, in accordance with the
embodiment of FIG. 13;
[0040] FIG. 15 is a top, partial cut-away view of the device distal
end showing the inner member distal end, in accordance with another
embodiment;
[0041] FIG. 16 is a side view of the device distal end showing a
slidable support ribbon wherein the slidable support ribbon distal
end is fixedly coupled to the inner member distal end, in
accordance with an embodiment;
[0042] FIG. 17 is a side cross-sectional view of an embodiment of a
cutting element proximal end and an inner member distal end that
are operable for removable coupling engagement therebetween;
[0043] FIG. 18 is a partial cut-away view of an embodiment of a
cutting element and an inner member, in accordance with an
embodiment;
[0044] FIG. 19A is a top view of an embodiment of a cutting
element, in accordance with an embodiment;
[0045] FIG. 19B is a perspective view of an embodiment of a cutting
element, in accordance with an embodiment;
[0046] FIGS. 19C and 19D are top views, expanded and compresses,
respectively, of an embodiment of a cutting element, in accordance
with an embodiment;
[0047] FIG. 19E is a top view showing an embodiment of a cutting
element, in accordance with an embodiment;
[0048] FIG. 19F is a top view showing another embodiment of a
cutting element, in accordance with an embodiment;
[0049] FIG. 20 is a side partial cut-away view of the device distal
end wherein the cutting element distal end has a bias to an angle
beta to the tube member axis, in accordance with an embodiment;
[0050] FIG. 21 is a side cut-away view of a tissue severing device
in accordance with an embodiment;
[0051] FIG. 22 is a side view of the distal region of an embodiment
of the tissue severing device as presented to tissue, in accordance
with an embodiment;
[0052] FIG. 23 is a side view of the distal region of an embodiment
of the tissue severing device as cutting through tissue, in
accordance with an embodiment;
[0053] FIG. 24 is a side view of the distal region of an embodiment
of the tissue severing device as presented to tissue, in accordance
with an embodiment
[0054] FIG. 25 is a perspective view of a device distal end
including an inner member distal end that is operable to allow for
articulation, in accordance with an embodiment; and
[0055] FIG. 26 is a perspective view of a device distal end
including another inner member distal end that is operable to allow
for articulation, in accordance with an embodiment.
DETAILED DESCRIPTION
[0056] In the following description, embodiments of apparatus and
methods will be disclosed. For purposes of explanation, specific
numbers, materials, and/or configurations are set forth in order to
provide a thorough understanding of the embodiments. However, it
will also be apparent to those skilled in the art that the
embodiments may be practiced without one or more of the specific
details, or with other approaches, materials, components, etc. In
other instances, well-known structures, materials, and/or
operations are not shown and/or described in detail to avoid
obscuring the embodiments. Accordingly, in some instances, features
are omitted and/or simplified in order to not obscure the disclosed
embodiments. Furthermore, it is understood that the embodiments
shown in the figures are illustrative representations and are not
necessarily drawn to scale.
[0057] Reference throughout this specification to "one embodiment"
or "an embodiment" means that a particular feature, structure, or
characteristic described in connection with the embodiment is
included in at least one embodiment of claimed subject matter.
Thus, the appearances of the phrase "in one embodiment" or "an
embodiment" in various places throughout this specification are not
necessarily all referring to the same embodiment. Furthermore, the
particular features, structures, or characteristics may be combined
in one or more embodiments.
[0058] Reference will now be made to embodiments illustrated in the
drawings and specific language which will be used to describe the
same. It will nevertheless be understood that no limitation of the
scope of the invention is thereby intended. Alterations and further
modifications of the illustrated embodiments and further
applications of the principles of the invention, as would normally
occur to one skilled in the art to which the invention relates, are
also within the scope of the invention.
[0059] Tissue severing devices as provided in embodiments herein
are operable to be inserted through small surgical openings, such
as, but not limited to, being inserted through a trocar sleeve at a
laparoscopic port site and advanced to tissue to be severed or
morcellated. The tissue severing device is operable to directly
sever or morcellate tissue within a patient's body.
[0060] FIGS. 1A and 1B are perspective views of tissue severing
devices 10 comprising a handle 50, a tube member 20, an inner
member 30, and a cutting element 40, in accordance with two
embodiments. The tube member 20 comprises an elongated relatively
stiff tube having a tube member proximal end 22 extending into the
handle 50 and a tube member distal end 24 opposite the tube member
proximal end 22. The tube member 20 defines a tube member lumen 26
that extends through the tube member proximal end 22 to the tube
member distal end 24 defining a tube member axis X. The inner
member 30 comprises an elongated body having an inner member
proximal end 32 (hidden from view) extending through the tube
member lumen 26 and into the handle 50 and an inner member distal
end 34 opposite the inner member proximal end 32. The inner member
30 is operable to be received within the tube member lumen 26.
[0061] The cutting element 40 comprises a cutting element proximal
end 42 (hidden from view) that enters the inner member distal end
34, shown in FIG. 18, and a cutting element distal end 44 opposite
the cutting element proximal end 42. The cutting element distal end
44 extends from the inner member distal end 34.
[0062] The tissue severing device 10 includes a device proximal end
14 that generally includes the handle 50 and a device distal end 16
that generally includes the tube member distal end 24, the inner
member distal end 34, and the cutting element distal end 44.
[0063] FIG. 2A is a side view of the device distal end 16 showing
the cutting element distal end 44 extending from the tube member
distal end 24. FIG. 2B is a side view of the device distal end 16
showing the inner member distal end 34 and the cutting element
distal end 44 extending from the tube member distal end 24. FIG. 3
is a side cut-away view of the device distal end 16 showing the
tube member distal end 24 extending over and containing the inner
member distal end 34 and the cutting element distal end 44. The
tube member distal end 24 is operable to move in a distal direction
(away from the handle 50) over and with the tube lumen 26 operable
to receive the inner member distal end 34 and the cutting element
distal end 44 therein, as shown in FIG. 3. The tube member distal
end 24 is also operable to move in a proximal direction (toward the
handle 50) to expose the cutting element distal end 44, as shown in
FIG. 2A, and, in other embodiments, also expose at least a portion
of the inner member distal end 34, as shown in FIGS. 1A, 1B and 2B,
so as to present the cutting element distal end 44 to tissue to be
cut or severed.
[0064] Referring again to FIGS. 1A and 1B, in accordance with an
embodiment, the tube member proximal end 22 includes an engagement
means in cooperative engagement with the handle 50 operable to
permit the tube member 20 to be moved proximally and distally over
the inner member 30. It is anticipated that there are many
engagement means that may be used to provide the function for
permitting the movement of the tube member 20 proximally and
distally over the inner member 30, some of which are described
below.
[0065] The tube member 20 may comprise any suitable material,
including, but not limited to, stainless steel, plastic, PTFE,
polymer, and composite materials. In addition, the interior and/or
exterior surfaces of the inner member 30 and tube member 20 may be
coated with a low friction material such as, but not limited to,
PTFE, Teflon.RTM., polyvinylidene fluoride, polyethylene, or
another polymeric material to facilitate movement of the tube
member 20 with respect to the inner member 30 and cutting element
distal end 44.
[0066] In accordance with an embodiment, the tissue severing device
10 is operable to present the cutting element distal end 44
extending from the tube member distal end 24 substantially parallel
with the tube member axis X, as shown in FIG. 2A. The tube member
distal end 24 is operable to move proximately such that the cutting
element distal end 44 is exposed so as to be available for use to
cut or sever tissue. In accordance with an embodiment, the inner
member 30 may be relatively stiff so as to support the cutting
element 40 from deflecting during use to cut or sever tissue.
[0067] In accordance with another embodiment, the tissue severing
device 10 is operable to present the cutting element distal end 44
at an angle alpha to the tube member axis X when the tube member
distal end 24 is withdrawn from the cutting element distal end 44
and at least a portion of the inner member distal end 34, as shown
in FIG. 2B. In accordance with an embodiment, the inner member
distal end 34 is operable to curve away from and form an angle
alpha with the tube member axis X when the inner member distal end
34 is exposed by the withdrawal of the tube member distal end 24
therefrom. FIGS. 4A-4C are side views of the device distal end 16
showing a progression of position of the inner member distal end
34. As the tube member distal end 24 withdraws from the inner
member distal end 34, the angle alpha becomes progressively larger
to a final predetermined angle alpha. In accordance with
embodiments, the predetermined angle alpha may be any angle to the
tube member axis X. In accordance with an embodiment, the
predetermined angle alpha may be up to and including 90 degrees to
the tube member axis X.
[0068] The tube member distal end 22, by being moved proximally or
distally, may be used, among other things, to control the angle
alpha of the cutting element distal end 44 and the cutting depth
into the tissue as the tissue is being cut or severed.
[0069] In accordance with an embodiment, at least a portion of the
inner member distal end 34 is biased to form a curve of a
predetermined angle alpha when the tube member distal end 24 is
withdrawn from over the inner member distal end 34. The means for
providing the bias that affects the curve in the inner member
distal end 34 may include one or a combination of the elastic
properties of the tube member distal end 24 and a support means, as
further described below.
[0070] In accordance with an embodiment, the at least a portion of
the inner member distal end 34 that is elastically biased to form a
curve of a predetermined angle alpha is elastically deformable so
as to extend (straighten) under the urging engagement of the tube
member distal end 24 advancing distally over the inner member
distal end 34. The inner member distal end 34 and the cutting
element distal end 44 are operatively stiff so as to prevent
substantial extension or deflection of either or both of the inner
member distal end 34 and the cutting element distal end 44 toward
the tube member axis X under the forces encountered when the
cutting element distal end 44 penetrates, cuts, and/or severs
tissue, but not so stiff so as to prevent the extension of the
inner member distal end 34 and the cutting element distal end 44
under the force of the tube member distal end 24 moving distally
thereover.
[0071] In accordance with embodiments, the at least a portion of
the inner member distal end 34 comprises any suitable material or
assembly so as to be elastically deformable as well as either
biased to be substantially straight or biased to form a curve of a
predetermined angle alpha. Suitable materials include, but are not
limited to, heat-set and cold-formed stainless steel and alloys
thereof, super-elastic shape memory alloys including
nickel-titanium alloys, preferentially-braided tubing and sleeves,
and heat set or cold formed polymer and composite materials, among
others, in forms such as, but not limited to, wires, ribbons, rods,
sleeves, and tubes.
[0072] It is appreciated that there may be many apparatus that may
be utilized to affect articulation of the inner member distal end
34. Such apparatus to affect articulation may include, but not
limited to, one or more pivots, joints, extensible tubing, and
rigid segments coupled by flexible or elastic interconnects.
Embodiments representative of examples of such apparatus are
provided in the discussion of FIGS. 25 and 26.
[0073] It is understood that the inner member 30 and the tube
member 20 may comprise more than one material along the length of
or at different portions of the inner member 30 and tube member 20
suitable for a particular purpose. By way of example, the inner
member distal end 34 may be elastically deformable wherein the
inner member proximal end 32 may be relatively stiffer as compared
with the inner member distal end 34.
[0074] In accordance with other embodiments, and as an alternative
to relying entirely on the elastic properties of the inner member
distal end 34 to affect the suitable balance of stiffness for the
particular purpose as described above, the tissue severing device
10 further comprises a support means. As also provided below, the
support means may be used to the advantage of guiding tissue to be
severed into the cutting element distal end 44 and controlling the
depth of the cut, regardless of the support means' contribution to
establishing the curve of the inner member distal end 34 or
controlling extension of the inner member distal end 34 toward the
tube member axis X while the cutting element distal end 44 is
pulled through tissue to be severed.
[0075] In accordance with embodiments of the tissue severing device
10, the tissue severing device 10 further comprises supporting
means for supporting the inner member distal end 34 in a curved
position when the inner member distal end 34 is at least partially
exposed by the withdrawal of the tube member distal end 24
therefrom. The supporting means may be used in combination with or
in lieu of any bias to a predetermined curvature that may be
present in the inner member distal end 34 as described above.
[0076] FIGS. 5A and 5B are side cut-away views of the device distal
end 16 showing an embodiment of a supporting means comprising a
fixed support ribbon 60, also shown in the embodiment of FIG. 1B.
The fixed support ribbon 60 comprises an elongated body including a
fixed support ribbon proximal end 62 and a fixed support ribbon
distal end 64 opposite the fixed support ribbon proximal end 62.
The fixed support ribbon proximal end 62 is coupled to the tube
member distal end 24 within the tube member lumen 26 and the fixed
support ribbon distal end 64 is coupled to the inner member distal
end 34.
[0077] The tube member distal end 24 is operable to advance over
and receive the inner member distal end 34, the cutting element
distal end 44, and the fixed support ribbon 60, as shown in FIG.
5A. The tube member distal end 34 may be moved in the proximal
direction so as to withdraw from the cutting element distal end 44,
the inner member distal end 34, and a portion of the fixed support
ribbon 60, as shown in FIG. 5B. The fixed support ribbon 60 has a
length that is operable to pull the inner member distal end 34 into
a curve and to substantially retain that curve as tissue is severed
by the cutting element distal end 44.
[0078] FIGS. 6A-4C are side views of the device distal end 16
showing a progression of positions of the inner member distal end
34. When the tube member distal end 24 covers the cutting element
distal end 44, as shown in FIG. 6A, the fixed support ribbon 60 is
generally slack and does not exhibit a significant force on the
inner member distal end 34. As the tube member distal end 24 is
moved proximally (toward the handle as shown in FIG. 1B), and
moving the fixed support ribbon proximal end 62 proximally,
exposing at least a portion of the inner member distal end 34, the
fixed support ribbon 60 becomes taught and begins to exert a
pulling force on the inner member distal end 34 which bends the
inner member distal end 34 to an angle alpha to the tube member
axis X dependent on the distance that the tube member distal end 24
has moved proximally, as shown in FIGS. 6B and 6C.
[0079] As the tube member distal end 24 is moved distally to
progressively cover the inner member distal end 34, the fixed
support ribbon proximal end 62 moves distally with the tube member
distal end 24 allowing the inner member distal end 34 to extend
toward the tube member axis X. In an embodiment wherein the inner
member distal end 34 has a curve bias, that is, is biased to a
predetermined curve, the fixed support ribbon 60 in combination
with the tube member distal end 24 provides support to prevent the
inner member distal end 34 from extending significantly toward the
tube member axis X when the cutting element distal end 44 is pulled
through tissue to be severed which may present forces that may
overcome the curve bias of the inner member distal end 34 were it
not for the fixed support ribbon 60. In addition, or in the
alternative, the fixed support ribbon 60 assists in controlling the
depth of cut of the cutting element distal end 44 by impinging on
and guiding the tissue into the cutting element distal end 44, as
will be discussed further below.
[0080] The fixed support ribbon 60 is operable to control the depth
of cut into the tissue by the cutting element distal end 44. During
use, the fixed support ribbon 60 slides along the tissue edge
substantially preventing the cutting element distal end 44 from
sinking into the tissue to a depth greater than the length of the
cutting element distal end 44.
[0081] In an embodiment wherein the inner member distal end 34 has
a straight bias, that is, is biased to a substantially straight
orientation along the tube member axis X, the fixed support ribbon
60 in combination with the tube member distal end 24 provides the
pulling force necessary to bend the inner member distal end 34 into
a curve as well as provide support to prevent the inner member
distal end 34 from significantly extending toward the tube member
axis X when the cutting element distal end 44 is pulled through
tissue to be severed. Additionally, the fixed support ribbon 60
assists in controlling the depth of cut of the cutting element
distal end 44 by guiding the tissue to be severed into the cutting
element distal end 44, as will be discussed further below.
[0082] The tube member distal end 24, by being moved proximally or
distally, in combination with the fixed support ribbon 60, may be
used, among other things, to control the angle alpha of the cutting
element distal end 44 and the cutting depth into the tissue as the
tissue is being cut or severed.
[0083] FIG. 7A is a side, partial cut-away view of a tissue
severing device 10 and FIGS. 7B-7C are perspective and top views,
respectively, of the device distal end 16 showing a slidable
support ribbon 160 as another embodiment of a supporting means
operable for supporting the inner member distal end 34 in a curved
position when the inner member distal end 34 is at least partially
exposed by the withdrawal of the tube member distal end 24. The
slidable support ribbon 160 may be used in combination with or in
lieu of any bias to a predetermined curvature that may be present
in the inner member distal end 34.
[0084] The slidable support ribbon 160 comprises an elongated body
including a slidable support ribbon proximal end 162 and a slidable
support ribbon distal end 164 opposite the slidable support ribbon
proximal end 162. The slidable support ribbon proximal end 162
extends through the tube member lumen 26 from about the tube member
proximal end 22 to the tube member distal end 24 and adjacent the
inner member 30. The slidable support ribbon distal end 164 is
positioned adjacent the inner member distal end 34 and the cutting
element distal end 44 and is operably engaged therewith as detailed
below.
[0085] The slidable support ribbon proximal end 162 is positioned
generally adjacent the handle 50 and may be operably engaged by the
user or elements of the tissue severing device 10 as detailed
below.
[0086] In accordance with an embodiment, the slidable support
ribbon distal end 164 is operable to support the inner member
distal end 34 into a curved shape when the tube member distal end
24 is withdrawn therefrom. The slidable support ribbon 160 is
operable to substantially prevent the inner member distal end 34
from extending toward the tube member axis X when the cutting
element distal end 44 is pulled through tissue to be severed. The
slidable support ribbon 160 is also operable to, among other
things, control the depth of cut into the tissue by guiding the
tissue toward the cutting element distal end 44.
[0087] In another embodiment, the slidable support ribbon distal
end 164 is also operable to, among other things, protect the tube
member lumen 26 from being damaged by a sharp edge 45 of the
cutting element distal end 44 by acting as a barrier therebetween.
In accordance with an embodiment, the slidable support ribbon
distal end 164 comprises a relatively flat profile so as to cover
at least a portion of the cutting element distal end 44 when the
slidable support ribbon distal end 164 is extended there over. The
slidable support ribbon distal end 164 is operable to extend
between a sharp edge 45, shown in FIG. 7C, of the cutting element
distal end 44 and a portion of the tube member lumen 26 when the
tube member distal end 24 is extended over the cutting element
distal end 44. The slidable support ribbon distal end 164 is
operable to withdraw from adjacent the sharp edge 45 of the cutting
element distal end 44 when the tube member distal end 24 is
withdrawn from over the cutting element distal end 44.
[0088] In accordance with an embodiment, the slidable support
ribbon distal end 164 is operable to begin withdrawing proximally
from being adjacent the cutting element distal end 44 as the
cutting element distal end 44 begins to be exposed by the
withdrawing tube member distal end 24. In this embodiment, the
slidable support ribbon distal end 164 is exposed substantially
concurrently with the exposure of the inner member distal end 34 by
the tube member distal end 24. In other words, the slidable support
ribbon distal end 164 is not adjacent the portion of the cutting
element distal end 44 that is exposed by the withdrawing tube
member distal end 24 such that the cutting element distal end 44
may begin severing tissue immediately upon withdrawal of the tube
member distal end 24.
[0089] In accordance with another embodiment, the slidable support
ribbon distal end 164 is operable to at least partially be adjacent
the cutting element distal end 44 as the cutting element distal end
44 and the slidable support ribbon distal end 164 are exposed by
the withdrawing tube member distal end 24. In this embodiment, the
slidable support ribbon distal end 164 is withdrawn from adjacent
the cutting element distal end 44 after the cutting element distal
end 44 is at least substantially exposed by the withdrawing tube
member distal end 24. The slidable support ribbon distal end 164
may come between at least a portion of the sharp edge 45 of the
cutting element distal end 44 and adjacent tissue near which it is
placed. The user may withdraw the slidable support ribbon distal
end 164 into the tube member lumen 26 in which the cutting element
distal end 44 may then sever tissue.
[0090] In another embodiment, as the tube member distal end 24 is
further withdrawn so as to expose a portion of the inner member
distal end 34, the slidable support ribbon distal end 164 is
withdrawn from adjacent the cutting element distal end 44 and
operably engages the inner member distal end 34 so as to provide at
least one of the following functions, including, but not limited
to, support the inner member distal end 34 into an arc shape, to
substantially prevent the inner member distal end 34 from extending
toward the tube member axis X while the cutting element distal end
44 is pulled through tissue to be severed, and control the depth of
cut into the tissue by guiding the tissue toward the cutting
element distal end 44.
[0091] The slidable support ribbon 160 is operable to control the
depth of cut into the tissue by the cutting element distal end 44.
During use, the slidable support ribbon 160 slides along the tissue
edge substantially preventing the cutting element distal end 44
from sinking into the tissue to a depth greater than the length of
the cutting element distal end 44.
[0092] As discussed above, the slidable support ribbon distal end
164 and the tube member distal end 24 are operably engaged to
provide the desired functions. In accordance with the embodiments
of FIGS. 7A-7C, the slidable support ribbon distal end 164 is
slidingly coupled to the inner member distal end 34. As the inner
member distal end 34 is exposed by the withdrawing tube member
distal end 24, the user may pull the slidable support ribbon
proximal end 162 in the proximal direction so as to withdraw the
slidable support ribbon proximal end 162 from adjacent the cutting
element distal end 44 and bend the inner member distal end 34 into
a desired arc to present the cutting element distal end 44 to the
tissue at an angle alpha to the tube member axis X. The user may
control the slidable support ribbon proximal end 162 in a desired
position by pulling or pushing the slidable support ribbon proximal
end 162.
[0093] In accordance with an embodiment, the slidable support
ribbon distal end 164 and the inner member distal end 34 are
slidingly coupled by cooperative engagement of the inner member
distal end 34 and an engagement ring 168 coupled to the inner
member distal end 34. The slidable support ribbon distal end 164
comprises a substantially uniform width body portion 165 and a
flared portion 167 at the slidable support ribbon distal end 164,
wherein the flared portion 167 has a width that is larger than the
body portion 165.
[0094] The engagement ring 168 comprises a shape of a partial loop
and is coupled to the inner member distal end 34 transverse to an
inner member axis X2. The engagement ring 168 is operable to
slidingly receive the body portion 165 of the slidable support
ribbon distal end 164 but is undersized so as to not be able to
receive the flared portion 167 therethrough. The flared portion
167, thus, functions as a catch such that there is no further axial
movement of the slidable support ribbon distal end 164 relative to
the engagement ring 168 when the flared portion 167 engages the
engagement ring 168. Therefore, the engagement of the flare portion
167 with the engagement ring 168 provides a means for pulling the
inner member distal end 34 proximally and thus flex the inner
member distal end 34 into a desired arc to present the cutting
element distal end 44 at an angle alpha to the tube member axis
X.
[0095] FIG. 7D is a perspective view of the device distal end 16
comprising a slidable support ribbon 160 and a plurality of
engagement rings 168a, 168b in accordance with another embodiment.
The plurality of engagement rings 168a, 168b are operable to
support the slidable support ribbon 160 in conformance with the
curved position of the inner member distal end 34 when the inner
member distal end 34 is at least partially exposed by the
withdrawal of the tube member distal end 24.
[0096] The engagement ring 168 is operable to be slidingly received
within the tube member lumen 26. FIG. 8 is a cross-sectional view
of the inner member distal end 34, a portion of the body portion
165 of the slidable support ribbon distal end 164, and an
embodiment of the engagement ring 168. To assist in guiding the
tube member distal end 24 over the engagement ring 168 so as to
contain the engagement ring 168, the engagement ring 168 comprises
a proximal edge 163 that is sloped facing proximally so as to guide
the tube member distal end 24 over the engagement ring 168.
[0097] The engagement ring 168 is operable to slidingly receive the
body portion 165 of the slidable support ribbon distal end 164. In
accordance with an embodiment, the engagement ring 168 comprises an
inner surface 161 that has a convex shape facing distally so as to
assist in guiding the body portion 165 of the slidable support
ribbon distal end 164 between the engagement ring 168 and the inner
member distal end 34. This may be particularly advantageous when
the slidable support ribbon distal end 164 is caused to flex at an
angle so as to pull and/or support the inner member distal end 34
at an angle to the tube member axis X.
[0098] In accordance with an embodiment, the pullback of the
slidable support ribbon 160 in the proximal direction so as to bend
the inner member distal end 34 into a desired curve to present the
cutting element distal end 44 at an angle alpha to the tube member
axis X, and visa versa, may be done in a manual operation by the
user or an automatic operation by the tissue cutting device 10. In
accordance with an embodiment wherein the slidable support ribbon
160 is manually controlled, the slidable support ribbon proximal
end 162 is operable to be manipulated by the user. In accordance
with an embodiment, as shown in FIG. 7A, the slidable support
ribbon proximal end 162 extends from the handle 50 such that the
slidable support ribbon proximal end 162 may be grasped by the
user. The slidable support ribbon proximal end 162 and the handle
50 may also comprise an engagement element such that the slidable
support ribbon proximal end 162 may be releasably coupled to the
handle 50 when the slidable support ribbon 160 is extended or
retracted to a desired position. The engagement element allows for
temporarily fixating the position of the slidable support ribbon
proximal end 162.
[0099] It is anticipated that there are many suitable engagement
elements that provide the function for releasably coupling the
slidable support ribbon proximal end 162 to the handle 50. In an
embodiment of an engagement element, by way of example only and not
limited thereto, as shown in FIG. 7A, a ratchet 150 may be operably
engaged between the slidable support ribbon proximal end 162 and
the handle 50. The ratchet 150 allows for motion in the proximal
direction while preventing motion in the distal direction until
controlled release. As is known in the art, a ratchet 150 may
comprise many devices, such as, but not limited to, a pair of racks
with intermeshing teeth, and a toothed gear and pawl.
[0100] It is appreciated that the movement of the slidable support
ribbon 160 may also be controlled by an electrical device, such as,
but not limited to, an electric motor. In accordance with an
embodiment, the slidable support ribbon proximal end 162 is engaged
with a motor that is automatically or manually controlled operable
to move the slidable support ribbon 160 proximally and
distally.
[0101] In accordance with an embodiment wherein the slidable
support ribbon 160 is automatically controlled by the tissue
severing device 10, the slidable support ribbon proximal end 162 is
operable to be manipulated by an interaction of elements of the
tissue severing device 10.
[0102] In accordance with an embodiment wherein the slidable
support ribbon 160 is automatically controlled, the slidable
support ribbon proximal end 162 is cooperatively engaged with the
tube member proximal end 22 such that when the tube member proximal
end 22 is moved axially, the slidable support ribbon 160 may be
moved axially as well. It is anticipated that there are many
apparatus that may affect cooperation between the slidable support
ribbon proximal end 162 and the tube member proximal end 22.
[0103] FIGS. 9A-9D are side views of an embodiment of a mechanism
for controlling the movement of the slidable support ribbon 160
under the influence of the movement of the tube member 20. The
slidable support ribbon proximal end 162 further comprises a snare
166 extending at an angle from the slidable support ribbon proximal
end 162 operable to catch a tube member proximal edge 21 of the
tube member proximal end 22.
[0104] FIG. 9A shows a simplified view of the tube member 20 in the
distal position wherein the cutting element 40 is contained within
the tube member lumen 26. The snare 166 is spaced a predetermined
distance from the tube member proximal edge 21. The predetermined
distance may be substantially the same as the length of the cutting
element 40 such that when the tube member distal end 24 has
retracted from the cutting element distal end 44, the tube member
proximal edge 21 may engage the snare 166, as shown in FIG. 9B. As
the tube member 20 is moved further in the proximal direction, the
tube member proximal edge 21 engages the snare 166 so as to pull
the slidable support ribbon 160 in the proximal direction and thus
move the slidable support ribbon distal end 164 from adjacent the
cutting element distal end 44, as shown in FIG. 9C. As the tube
member 20 is moved further in the proximal direction, the slidable
support ribbon 160 is moved further in the proximal direction and
thus the slidable support ribbon distal end 164 engages the inner
member distal end 34 so as to support the cutting element distal
end 44 at an angle alpha to the tube member axis X. In accordance
with an embodiment, the slidable support ribbon distal end 164 may
be coupled to a biasing element 265 such that the slidable support
ribbon 160 is urged to move in the distal direction when the tube
member 20 is moved in the distal direction.
[0105] FIGS. 10A and 10B are perspective and side views,
respectively, of a distal end 1164 of another embodiment of a
slidable support ribbon 1160. The slidable support ribbon 1160 is
an embodiment of a supporting means that is operable for supporting
the inner member distal end 34 in a curved position when the inner
member distal end 34 is at least partially exposed by the
withdrawal of the tube member distal end 24 and operable to support
the cutting element distal end 44 in an open position. The slidable
support ribbon 1160 may be used in combination with or in lieu of
any bias to a predetermined curvature, including straight, that may
be present in the inner member distal end 34.
[0106] The slidable support ribbon 1160 comprises an elongated body
including a slidable support ribbon proximal end 162, a slidable
support ribbon distal end 1164 opposite the slidable support ribbon
proximal end 162, and a ribbon body portion 1161 therebetween. The
slidable support ribbon distal end 1164 comprises a cutting element
engagement element 1170 operable to engage the cutting element
portions 144a, 144b of the cutting element distal end 44 about the
inner member distal end 34 as shown in FIGS. 11B-11C and discussed
below. In accordance with the embodiment of FIGS. 10A-10B, the
cutting element engagement element 1170 comprises a flange 1168
depending at about a 90 degree angle from the ribbon body portion
1161. The flange 1168 is operable to be received within the loop
formed by the cutting element distal end 44.
[0107] Substantially similar to the embodiment of the slidable
support ribbon 160 of FIG. 7A, the slidable support ribbon proximal
end 162 of the slidable support ribbon 1160 extends through the
tube member lumen 26 from about the tube member proximal end 22 to
the tube member distal end 24 and adjacent the inner member 30.
FIGS. 11A-11C are top, perspective, and top views, respectively, of
the device distal end 16 with the slidable support ribbon 1160 in
accordance with an embodiment. The slidable support ribbon distal
end 1164 is positioned adjacent the inner member distal end 34 and
the cutting element distal end 44 and is operably engaged therewith
as detailed below.
[0108] As shown in FIG. 11A, when the cutting element distal end 44
is positioned within the tube member distal end 24, the flange 1168
of the slidable support ribbon distal end 1164 is positioned within
the loop formed by the cutting element distal end 44 and does not
substantially engage the cutting element distal end 44. As shown in
FIGS. 11B-11C, when the cutting element distal end 44 is exposed by
the withdrawal of the tube member distal end 24, the slidable
support ribbon 1160 may be moved proximally such that the flange
1168 engages the cutting element portions 144a, 144b of the cutting
element distal end 44 assisting in spreading apart the cutting
element portions 144a, 144b and thus assisting in opening and
stabilizing the loop formed by the cutting element distal end 44.
The flange 1168 helps to stabilize, or hold-open, the cutting
element distal end 44 during subsequent tissue severing. The flared
portion 167 of the slidable support ribbon distal end 1164 engages
the engagement ring 168 reducing any further traction on the
cutting element distal end 44 by the flange 1168.
[0109] The slidable support ribbon distal end 1164 is also operable
to support the inner member distal end 34 into a curved shape at an
angle alpha to the tube member axis X when the tube member distal
end 24 is withdrawn therefrom. The slidable support ribbon 1160 is
operable to substantially prevent the inner member distal end 34
from extending toward the tube member axis X when the cutting
element distal end 44 is pulled through tissue to be severed. The
slidable support ribbon 1160 is also operable to, among other
things, control the depth of cut into the tissue by guiding the
tissue toward the cutting element distal end 44.
[0110] Substantially similar to the embodiment of FIG. 7A, the
slidable support ribbon distal end 1164 is slidingly coupled to the
inner member distal end 34 by an engagement ring 168. The slidable
engagement of the slidable support ribbon 1160 of FIGS. 11A-11C is
substantially the same as the slidable engagement of the
embodiments of FIGS. 7A-7C. In accordance with an embodiment, the
slidable support ribbon distal end 1164 is flared so as to engage
the engagement ring 168 so as to position the cutting element
distal end 44 as described above and shown in FIG. 11B. The
slidable support ribbon distal end 1164 is flared also so as to
provide a broader flange 1168 so as to more greatly engage and
spread apart the cutting element portions 144a, 144b of the cutting
element distal end 44.
[0111] It is appreciated that the cutting element engagement
element 1170 of the slidable support ribbon distal end 1164 that is
operable to engage the cutting element portions 144a, 144b of the
cutting element distal end 44 may have a shape suitable for a
particular purpose. FIG. 12 is a side view of a cutting element
engagement element 1170 comprising a U-shaped flange 1169 operable
to engage and substantially wrap around the cutting element
portions 144a, 144b of the cutting element distal end 44. The
U-shaped flange 1169 is operable to contain a portion of the
cutting element portions 144a, 144b therein so as to prevent the
cutting element portions 144a, 144b from slipping from the
engagement of the U-shaped flange 1169.
[0112] It is appreciated that direct contact of the cutting element
engagement element 1170 with the cutting element portions 144a,
144b may not be suitable for every purpose. By way of example, but
not limited thereto, direct contact may reduce freedom of movement
of the cutting element distal end 44 when energized by an energy
source as discussed below. By way of another example, but not
limited thereto, direct contact may cause electrical conductivity
issues when the cutting element distal end 44 is energized by an
electrical source such as in electrocautery. It is appreciated that
there are many ways to prevent the direct contact between the
cutting element engagement element 1170 and the cutting element
portions 144a, 144b themselves when the cutting element engagement
element 1170 is moved proximally so as to assist in spreading apart
the cutting element portions 144a, 144b and thus opening or making
more circular the loop formed by the cutting element distal end
44.
[0113] FIG. 13 is a side, partial cut-away view of an inner member
30 further comprising two inner member lumens 36a,b that are
substantially parallel and that extend from the inner member
proximal end 32 to the inner member distal end 34 therethrough, in
accordance with an embodiment. The inner member distal end 34
further comprises a slit 135 between the two inner member lumens
36a,b, that extends from the inner member distal end 34 to a
predetermined distance proximally operable to produce a bifurcation
of the inner member distal end 34 defining two branch portions
234a,b each containing one of the two inner member lumens 36a,b.
The two inner member lumens 36a,b are operable such that each of
the cutting element portions 144a, 144b of the cutting element
distal end 44 may be received and extend into one of the two inner
member lumens 36a,b.
[0114] FIG. 14 is a top view of the device distal end 16 showing a
bifurcated inner member distal end 34 in accordance with the
embodiment of FIG. 13. The inner member distal end 34 is bifurcated
along the slit 135, the bifurcation being formed under the urging
engagement of one or more of the spring bias of the cutting element
44 and the cutting element engagement element 1170 of the slidable
support ribbon distal end 1164. In the case of the cutting element
engagement element 1170, the cutting element engagement element
1170 engages the two branch portions 234a,b of the inner member
distal end 34 about the cutting element portions 144a, 144b of the
cutting element distal end 44 effectively creating and/or
supporting the bifurcation of the inner member distal end 34. The
cutting element engagement element 1170 engages the two branch
portions 234a,b as shown in FIG. 14 rather than the cutting element
portions 144a, 144b themselves as shown in FIG. 11B.
[0115] FIG. 15 is a top, partial cut-away view of the device distal
end 16 showing the inner member distal end 34, in accordance with
another embodiment. The tissue severing device 10 further comprises
two cutting element sleeves 230a,b. Each cutting element sleeve
230a,b comprises an elongated body having a cutting element sleeve
proximal end 232a,b extending through the inner member lumen 36 and
into the handle 50 and a cutting element sleeve distal end 234a,b
opposite the cutting element sleeve proximal end 232a,b. Each of
the two cutting element sleeves 230a,b further comprises a sleeve
lumen 236a,b that extends from the cutting element sleeve proximal
end 232a,b to the cutting element sleeve distal end 234a,b
therethrough. The cutting element portions 144a, 144b of the
cutting element distal end 44 are operable to be received within
the sleeve lumen 236a,b.
[0116] The two cutting element sleeves 230a,b spread apart from
each other under the urging engagement of one or more of the spring
bias of the cutting element 44 and the cutting element engagement
element 1170 of the slidable support ribbon distal end 1164. In the
case of the cutting element engagement element 1170, the cutting
element engagement element 1170 engages the two cutting element
sleeve distal ends 234a,b about the cutting element portions 144a,
144b of the cutting element distal end 44 effectively assisting in
spreading apart the cutting element portions 144a, 144b and thus
opening or making more circular the loop formed by the cutting
element distal end 44, the two cutting element sleeves 230a,b
preventing direct contact between the cutting element engagement
element 1170 and the cutting element portions 144a, 144b.
[0117] FIG. 16 is a side view of the device distal end 16 showing a
slidable support ribbon 2160 wherein the sliding support ribbon
distal end 164 is fixedly coupled to the inner member distal end
34, in accordance with an embodiment. When the inner member distal
end 34 is exposed by the withdrawing tube member distal end 24, the
user may pull the sliding support ribbon proximal end 162 in the
proximal direction so as to flex the inner member distal end 34
into a desired curve to present the cutting element distal end 44
at an angle alpha to the tube member axis X. The user may control
the sliding support ribbon distal end 164 in a desired position by
pulling or pushing a snare 166 at the sliding support ribbon
proximal end 162. It is appreciated that the slidable support
ribbon 2160 may also be moved proximally and distally by the
apparatus presented for the other embodiments herein or by
apparatus known in the art.
[0118] As previously discussed, the cutting element 40 is operable
for cutting and severing tissue. The cutting element 40 comprises a
cutting element proximal end 42 that engages the inner member 30
and a cutting element distal end 44, at least a portion of which is
used to cut and sever tissue.
[0119] Various embodiments of the cutting element proximal end 42
are anticipated. In general, embodiments of the cutting element
proximal end 42 are anticipated that either couple with the inner
member distal end 34 or pass through the inner member 30 to couple
with other elements within the handle 50. It is appreciated that
there are many coupling elements that may be used to provide fixed
or removable coupling between the inner member distal end 34 and
the cutting element proximal end 42.
[0120] In accordance with an embodiment, a cutting element 40 is
provided that may be removably coupled with the inner member distal
end 34. FIG. 17 is a side cross-sectional view of an embodiment
wherein the cutting element proximal end 42 and the inner member
distal end 34 are operable for removable coupling engagement
therebetween. The cutting element proximal end 42 comprises a
mating element 37 and the inner member distal end 34 comprises a
receiving element 35. The mating element 37 and the receiving
element 35 are operable for removable coupling therebetween,
wherein the mating element 37 is received and coupled to the
receiving element 35.
[0121] In accordance with an embodiment, a plurality of cutting
elements 40 may be provided, each suitable for a particular purpose
such that one cutting element 40 may be interchanged on the inner
member distal end 34 with another cutting element 40 of a same or
different configuration. By way of example, cutting elements 40 of
differing sizes and shapes may be provided suitable for a
particular purpose. Further, as the cutting element 40 becomes
dull, a replacement cutting element 40 may replace the first.
[0122] In accordance with other embodiments, a cutting element 40
is provided that comprises a cutting element proximal end 42 that
passes through the inner member 30 and is operable for coupling
with elements within the handle 50. FIG. 18 is a side, cut-away
view of an inner member 30 further comprising at least one inner
member lumen 36 that extends from the inner member proximal end 32
to the inner member distal end 34 therethrough. In accordance with
the embodiment of FIG. 18, the cutting element 40 comprises an
elongated member that forms a contiguous element that defines a
loop 46 at the cutting element distal end 44 and two ends 48 at the
cutting element proximal end 42. In accordance with an embodiment,
the cutting element 40 is a wire. In another embodiment, the
cutting element 40 is a ribbon, that is, a flat-sided elongated
member that defines a loop 46 at the cutting element distal end 44
with the two ends 48 of the ribbon forming the cutting element
proximal end 42. The cutting element proximal end 42 is operable to
be received within the inner member lumen 36 and extend from the
inner member proximal end 32 suitable for a particular purpose
discussed below.
[0123] Various embodiments of the cutting element distal end 44 are
anticipated. In accordance with an embodiment, the cutting element
distal end 44 comprises a blade that is operable for cutting and
severing tissue. In accordance with other embodiments, the cutting
element distal end 44 comprises a loop 46, such as, but not limited
to a loop of wire and ribbon. At least a portion of the cutting
element distal end 44 comprises one or more sharp portions 45 that
are suitable for severing tissue. FIG. 18 shows an embodiment of a
cutting element distal end 44, in accordance with an embodiment.
The cutting element distal end 44 comprises a wire in the form of a
loop 46 including a sharp edge 45 that is preferentially sharp so
as to cut tissue. The sharp edge 45 is operable such that it may
cut into adjacent tissue as it is released by the tube member
distal end 24 and as the tissue severing device 10 is pulled
proximally toward the user.
[0124] FIG. 19A is a top view showing an embodiment of a cutting
element 40a, in accordance with an embodiment. The cutting element
distal end 44 comprises a ribbon in the form of a loop 46 including
a sharp edge 45 that is preferentially sharp so as to cut tissue. A
broad surface 41 of the cutting element 40a is generally parallel
to a plane defined by the loop 46 so as to present the sharp edge
45 also generally parallel with the plane defined by the loop
46.
[0125] FIG. 19B is a perspective view showing an embodiment of a
cutting element 40b, in accordance with an embodiment. The cutting
element distal end 44 comprises a ribbon in the form of a loop 46
including a sharp edge 45 that is preferentially sharp so as to cut
tissue, and a dull edge 47 that is not sharp relative to the sharp
edge 45, such that it may not cut tissue. A broad surface 41 of the
cutting element 40b is generally perpendicular to a plane defined
by the loop 46 so as to present the sharp edge 45 also generally
perpendicular with the plane defined by the loop 46.
[0126] The sharp edge 45 is operable to cut into adjacent tissue as
it is released by the tube member distal end 24, as shown in FIG.
11B, and as the tissue severing device 10 is pulled proximally
toward the user. The sharp edge 45 is presented on the edge of the
cutting element distal end 44 that faces proximally when it is
released by the tube member distal end 24. In other embodiments,
the sharp edge 45 may comprise serrations so as to assist in
severing tissue.
[0127] Various sizes and configurations of embodiments of the
cutting element distal end 44 are anticipated. In the embodiment of
FIG. 3, the cutting element distal end 44 is operable to fit within
the tube member lumen 26 without elastic deformation of the cutting
element distal end 44.
[0128] In the embodiment of FIGS. 5A-5B, the cutting element distal
end 44 comprises a substantially elastic material such that the
loop 46 may have a diameter somewhat larger than the inner diameter
of the tube member lumen 26. When the tube member distal end 24 is
advanced in the distal direction, the cutting element distal end 44
is operable to substantially elastically deform and be slidingly
received within the tube member lumen 26 as shown in FIG. 5A. When
the tube member distal end 24 is advanced in the proximal
direction, the cutting element distal end 44 is operable to exit
the tube member lumen 26 and substantially elastically expand
therefrom. In accordance with an embodiment, the cutting element
distal end 44 is in the form of a substantially oval loop 46 when
released from the tube member lumen 26. The loop 46 is operable to
be biased to open up when the tube member distal end 24 is
withdrawn therefrom. When the tube member 20 is advanced over the
cutting element distal end 44, the cutting element distal end 44 is
operable to elastically deform under the impinging force of the
tube member distal end 24 into a substantially closed or
pinched-down oval shape so as to enter the tube member lumen 26. In
accordance with an embodiment, and by way of example and not
limited thereto, the loop 46 of the cutting element distal end 44
may have a diameter of about 12 mm, wherein the tube member may
have an inner diameter of about 5 mm.
[0129] It is appreciated that the cutting element 40 may be
constructed from many typed of materials, such as, but not limited
to, stainless steel and shape-memory metals or metal alloys such
as, but not limited to, nickel-titanium alloy.
[0130] In accordance with an embodiment, the cutting element distal
end 44 is substantially uniformly elastically deformable. In
accordance with other embodiments, the cutting element distal end
44 comprises one or more elastic regions operable to provide
elastic deformation of the cutting element distal end 44.
[0131] In accordance with an embodiment, the cutting element distal
end 44 is formed as a single element. In accordance with another
embodiment, the cutting element distal end 44 may be formed by
integrating or joining separate components comprising one or more
materials, at least some of which have elastic properties. FIGS.
19C and 19D are top views showing an embodiment of a cutting
element 40c, in accordance with an embodiment. The cutting element
distal end 44 comprises a ribbon in the form of a loop 46
comprising two stainless steel portions 141 coupled together by a
super-elastic nickel-titanium alloy portion 241, wherein the
nickel-titanium portion 241 provides a significant portion of the
elasticity of the cutting element distal end 44 to a collapsed
shape as shown in FIG. 19C and the stainless steel portions 141
providing generally the bias to the expanded shape as shown in FIG.
19D.
[0132] It is also appreciated that the cutting element 40 may be
constructed with geometric features that assist in forming a loop
at the cutting element distal end 44. FIG. 19E is a top view
showing an embodiment of a cutting element 40e, in accordance with
an embodiment. The cutting element distal end 44 comprises a ribbon
defining a crease 341 across the width of the ribbon. The crease
341 is operable to allow for preferential bending to assist in
compressing the cutting element distal end 44 into an elongated
loop for the cutting element distal end 44 to be received within
the tube member lumen 26.
[0133] FIG. 19F is a top view showing another embodiment of a
cutting element 40f, in accordance with an embodiment. The cutting
element distal end 44 comprises a ribbon defining a necked-down
portion 441. The necked-down portion 441 is operable to allow for
preferential bending to assist in compressing the cutting element
distal end 44 into an elongated loop for the cutting element distal
end 44 to be received within the tube member lumen 26.
[0134] FIG. 20 is a side partial cut-away view of the device distal
end 16 wherein the cutting element distal end 44 has a bias to an
angle beta to the tube member axis X, in accordance with an
embodiment. The bias of the cutting element distal end 44 is
operable such that the sharp edge 45 is presented to tissue when
the device distal end 16 is placed along side and adjacent to
tissue to be severed as will be discussed below. In accordance with
this embodiment, the tissue may begin to be severed prior to the
emergence of the inner member distal end 34 from the tube member
distal end 24.
[0135] In accordance with an embodiment, the inner member 30 and
thus the cutting element 40 may be operable to be assembled in the
tube member lumen 36 such that the cutting element distal end 44
may be retained at one or more predetermined angles with respect to
the handle 50. By way of example, in accordance with an embodiment,
the cutting element distal end 44 may be operable to be assembled
to extend from the tube member distal end 24 at one of four
directions, such as up, right, down, or left, as viewed along the
tube member axis X from the handle 50.
[0136] In accordance with embodiments of the tissue cutting device
10, an energy source is provided to assist the cutting element
proximal end 44 in cutting and severing tissue. FIG. 21 is a side
partial cut-away view of a tissue severing device 10 comprising an
energy source 90, in accordance with an embodiment. The cutting
element proximal end 42 comprises two ends 48, such as shown in the
embodiment of FIG. 18. The cutting element proximal end 42 extends
through the inner member lumen 36 to the handle 50. Within the
handle 50, the two ends 48 of the cutting element proximal end 42
are coupled to the energy source 90 operable to assist in severing
tissue. It is appreciated that the energy source 90 may employ one
or more energy modes that are operable to assist in cutting and
severing tissue, such as, but not limited to, mechanical, radio
frequency, thermal, ultrasonic, and any other suitable energy.
[0137] In accordance with an embodiment, the energy source 90 is a
radio frequency energy source 90, and the cutting element 40 may
function as a component of a monopolar or a bipolar system. The
radio frequency energy source 90 may be operable as an
electrocautery instrument so as to provide, among other things,
coagulation of small bleeding vessels that may be encountered
during the severing process.
[0138] In accordance with another embodiment, the two ends 48 of
the cutting element proximal end 42 are coupled to an energy source
90 that is mechanical in operation. In accordance with an
embodiment, the energy source 90 is an ultrasonic source that is
operable to impart a vibratory action to the cutting element distal
end 44 to assist in severing the tissue. In another embodiment, the
energy source 90 is a mechanical oscillator that is operable to
rapidly and alternatively pull on the two ends 48 of the cutting
element proximal end 42 so as to impart a sawing motion to the
cutting element distal end 44 to assist in severing the tissue.
[0139] In another embodiment, the energy source 90 is a mechanical
oscillator, such as, but not limited to, a motor, that is operable
to rapidly and alternatively push-pull on the two ends 48 of the
cutting element proximal end 42 so as to provide a rapid in and out
movement of the cutting element distal end 44 to assist in severing
tissue. In accordance with another embodiment, the inner member
lumen 36 comprises a track that is operable to guide the movement
of the cutting element distal end 44 which is coupled to a trolley
that is adapted to couple with the track.
[0140] In yet another embodiment, the energy source 90 is a thermal
source that is operable to heat the cutting element distal end 44
to assist in severing the tissue.
[0141] In accordance with embodiments wherein the cutting element
proximal end 42 couples with the inner member distal end 34, the
cutting element distal end 44 may be energized with energy by
coupling the energy source 90 to the inner member proximal end 32.
The energy from the energy source 90 is communicated to the cutting
element distal end 44 via the inner member 30. It is appreciated
that many energy sources may be used to communicate energy to the
cutting element distal end 44 via the inner member 30. It is also
appreciated that a mechanical energy source may be particularly
effective. In accordance with an embodiment, the inner member
proximal end 32 is coupled to a mechanical oscillator that is
operable to rapidly push-pull on the inner member proximal end 32
so as to impart motion to the cutting element distal end 44 to
assist in severing the tissue. In accordance with an embodiment,
the energy source 90 is an ultrasonic source that is operable to
impart a vibratory action to the inner member 30 that is
communicated to the cutting element distal end 44 to assist in
severing tissue.
[0142] In accordance with and embodiment, by way of example, the
energy source 90 is a variable speed drive operable to induce
oscillatory motion to the cutting element distal end 44 either
directly or via the inner member 30. Referring again to FIG. 21,
the drive includes a motor 92, a transmission 93, and a switch 94.
The switch 94 comprises a first contact 95 housed in the handle 50
adjacent a button contact 96.
[0143] When the button contact 96 is in an initial position, the
switch 94 represents an open electrical circuit. Thus, no current
is supplied to the motor 92, and the cutting element distal end 44
is stationary. The motor 92 is electrically connected to power via
the switch 94 and a control 99 when the button contact 96 is in the
inward most position so as to make electric coupling with the first
contact 95, as will be described more fully hereafter.
[0144] The control 99 includes a rotary pot 97 operable to allow a
user to control the power available to the motor 92 and, thus, the
speed of the cutting element distal end 44. Appropriate lengths of
electrical conductors 91 electrically interconnect the control 99,
the switch, 94, and the motor 92.
[0145] The button contact 96 nests within a track (not shown)
defined by the handle 50. A button return spring (not shown), which
may be mounted between the button contact 96 and a portion of the
handle 50, biases the button contact 96 in an outward position away
from the first contact 95 and out of electrical communication
therewith. The transmission 93 is operable to convert rotational
motion from the motor 92 to an oscillatory motion that is
communicated to the cutting element distal end 44 by coupling the
transmission 93 to either the cutting element proximal end 42 or
the inner member proximal end 32.
[0146] In accordance with embodiments of the tissue cutting device
10, and referring to FIGS. 1A and 1B, the tissue cutting device 10
further comprises an engagement means 70 being operable for moving
the tube member 20 proximally and distally over the inner member
30. It is anticipated that there are many engagement means 70 that
may be used to provide the function for moving the tube member 20
proximally and distally, including unpowered, powered, manual and
automatic means, some of which will be described further below. In
accordance with an embodiment, wherein the handle 50 comprises the
engagement means 70 as a slidable engagement element, and the tube
member 20 is operable to be moved proximally and distally over the
inner member 30 by a user grasping the tube member 20 and sliding
the tube member 20 through the slidable engagement element within
the handle 50.
[0147] The tissue severing device 10, shown in FIGS. 1 and 21,
further comprises an engagement means 70 in the form of a tube
member moving element 170 operable to engage the tube member
proximal end 22 for moving the tube member 20 proximally and
distally over the inner member 30. In accordance with an embodiment
as shown in FIG. 21, the tube member moving element 170 that is
operable for axially moving the tube member 20 includes a rack 56
and pinion 57. It is understood that there are many rack and pinion
configurations in the art suitable for a particular purpose. For
example, but not limited thereto, in accordance with an embodiment,
the rack 56 comprises a plurality of spaced notches or grooves
located at the tube member proximal end 22. The rack 56 may be an
integral feature of the tube member 20 or an element that is
coupled to the tube member proximal end 22. The pinion 57 comprises
an engagement wheel having teeth that operably engage the spaced
notches of the rack 56. In operation, when the pinion 57 is rotated
in a clockwise direction, the rack 56 is engaged to advance the
tube member 20 axially in a proximal direction. When the pinion 57
is rotated in the opposite direction, the rack 56 is engaged to
move the tube member 20 axially in a distal direction.
[0148] A tube member moving element 170 for axially moving the tube
member 20 relative to the inner member 30 and cutting element 40
may be provided by many known means, such as, but not limited to a
rack and pinion drive system wherein the pinion comprises helical
threads and is operable by rotating the pinion along the tube
member axis X, such as shown in the embodiment of FIGS. 1A and 1B.
Other linear actuators may also be used, suitable for a particular
purpose. It is appreciated that the tube member moving element 170
may be electrically and manually operated.
[0149] It is appreciated that the tube member moving element 170
for axially moving the tube member 20 relative to the inner member
30 and cutting element 40 may be operably coupled to the energy
source 90 for energizing the cutting element distal end 44. By way
of example, but not limited thereto, in accordance with an
embodiment, the energy source 90 for energizing the cutting element
distal end 44 is activated only when the tube member 20 has been
moved proximally by a predetermined amount. Such a configuration
may prevent the activation of the energy source 90 prior to the
withdrawal of the cutting element distal end 44 from the cutting
element distal end 44.
[0150] It is appreciated that other elements may be incorporated
into the tissue severing device 10. By way of example, but not
limited thereto, the tube member 20 may include one or more
accessory lumens such as, but not limited to, for suction,
irrigation, inflation. Gas, liquid, or a combination thereof from
an external source may be administered through a communications
lumen 225, shown in FIG. 21, and coupled to the tube member lumen
26 at the tube member proximal end 22. For example, but not limited
thereto, an aqueous solution may be employed for irrigation
purposes or a local anesthetic, such as lidocaine, may be
administered through the tube member lumen 26 so as to exit the
tube member distal end 24. In addition, the tube member lumen 26
may be operatively connected to an external vacuum source. The
external vacuum source may provide suction to, for example, but not
limited to, remove from the patient, fluids, such as, but not
limited to, blood, irrigation fluid or smoke generated during use
of the cutting element 40 or other device.
[0151] In using the tissue severing device 10 of an embodiment
shown in FIG. 21, the cutting element 40 and inner member 30 are
first contained within the tube member lumen 26 of the tube member
20. The tube member distal end 24 may be passed through a trocar
sleeve that has been placed within a patient and placed along side
and adjacent to tissue 80 to be severed as shown in FIG. 22. FIG.
22 is a side view of the device distal end 16 placed along side
tissue 80 to be severed. The tube member 20 is moved axially
proximally so as to withdraw from and expose the cutting element
distal end 44 and the inner member distal end 34. The cutting
element distal end 44 is operable to impinge and cut into the
adjacent tissue 80 substantially laterally or laterally and
proximally (toward the handle 50) so as to create an arc-shaped cut
86 into the tissue 80, as shown in FIG. 22. Once the cutting
element 40 is exposed the desired amount, the handle 50, as shown
in FIG. 1B, is pulled proximally so as to pull the extended cutting
element distal end 44 through the tissue 80, severing the tissue
80, with the severed tissue 85 extruding through the loop 46 of the
cutting element distal end 44, as shown in FIG. 23.
[0152] The support ribbon 60 substantially prevents the inner shaft
distal end 34 from extending distally toward the tube member axis X
during the cutting operation as well as prevents the cutting
element distal end 44 from cutting too deeply. The support ribbon
60 guides the tissue 80 into the loop 46 of the cutting element
distal end 44 and therefore limits the depth of the cut 86. Were
the cutting element distal end 44 to cut too deeply, the cutting
element distal end 44 may get stuck during the cutting operation.
Severed tissue 85 may be removed from the patient by another
device.
[0153] Additional severing operations may be performed by moving
the exposed cutting element distal end 44 to another portion of
tissue 80 to be severed and impinging the cutting element distal
end 44 into the tissue 80. Alternatively, after each cutting
operation, the tube member 20 may thereafter be moved distally so
as to advance over the inner member distal end 34 and the cutting
element distal end 44. The tube member distal end 24 is again
placed along side tissue 80 to be severed and the process is
repeated.
[0154] It is appreciated that the angle of the cutting element
distal end 44 to the tissue 80 may be changed by the selective
positioning of the tube member distal end 24 with respect to the
cutting element distal end 44 or the inner member distal end 34.
The user may adjust the angle of the cutting element distal end 44
at any time during the cutting operation so as to control the
cutting operation. By way of example, but not limited thereto, less
tissue 80 may be severed by reducing the exposure of the cutting
element distal end 44. By way of another non-limiting example, the
initiation of the cutting operation may be done at first by
limiting the exposure of the cutting element distal end 44 and
subsequently increasing the exposure of the cutting element distal
end 44 as the tissue severing device 10 is pulled proximally during
the cutting operation.
[0155] It is appreciated that by virtue of the cutting element
distal end 44 being operable to impinge and cut into the adjacent
tissue 80 substantially laterally or combination laterally and
proximally (toward the handle 50) so as to create an arc-shaped cut
86 into the tissue 80, the cutting element distal end 44 may be
placed and the cut initiated closer to vital organs and tissue that
is to remain unsevered. In embodiments of the tissue severing
device 10 disclosed herein, the uterus may be morcellated while the
uterus is still attached to the cervix. The lateral cutting action
of the embodiments of the tissue severing device 10 greatly reduce
the risk of injuring adjacent tissue and organs as compared with
uterus amputation procedures, particularly for those embodiments of
the tissue severing device 10 that do not incorporate heat in the
cutting operation. Further, since no amputation of the uterus prior
to morcellation is required, only one device, the tissue severing
device 10, is required for both the separation of the uterus from
the cervix and morcellating the uterus for removal, reducing the
cost and complexity of the surgery. It is evident that embodiments
of the tissue severing device 10 disclosed herein presents a
significant improvement over prior art devices, as, among other
things, downward (distal) traction is not employed and uterus
amputation and the corresponding amputation surgical device is not
required.
[0156] It may be necessary for the surgeon to rest the device
distal end 16 in the patient while other operations are performed.
The tube member 20 may be moved distally so as to advance over the
inner member distal end 34 and the cutting element distal end 44 so
as to prevent the cutting element distal end 44 from injuring the
patient while resting in the patient.
[0157] In accordance with another method of using the tissue
severing device 10, the tube member distal end 24 is moved
proximately so as to withdraw from the cutting element distal end
44 and the inner member distal end 34. The cutting element distal
end 44 is placed beyond a leading edge 82 of the tissue 80 with the
sharp portion 45 of the cutting element distal end 44 placed
adjacent tissue 80 to be severed, as shown in FIG. 24. Cutting of
the tissue 80 is affected by pulling proximally on the tissue
severing device.
[0158] Referring again to the ability of the inner member distal
end 34 to deform or flex from a substantially straight
configuration to a curved or angled configuration, it is
appreciated that articulation apparatus operable to allow for
articulation of the inner member distal end 34 may be provided by
many apparatus, such as, but not limited to, nested ring sections,
sliding corrugated sections, pivots, movable joints, and extensible
tubing, such as, but not limited to, bellows-type tubing. It is
also appreciated that means for providing control of, movement of,
and/or a bias to the segments into a predetermined configuration,
such as substantially straight or to form a curve of a
predetermined angle, may be provided by many apparatus, such as,
but not limited to, elastic elements, such as, but not limited to,
springs and spine members, and mechanical elements, such as, but
not limited to, a slidable support ribbon 165 and pull-wires and
rods.
[0159] FIG. 25 is a perspective view of a device distal end 16
including an inner member distal end 34 that is operable to allow
for articulation, in accordance with an embodiment. At least a
portion of the inner member distal end 34 comprises two or more
segments 34a, 34b that are interconnected by a bellows joint 37
supported by one or more spine members 39. The one or more spine
members 39 may be operable to provide a predetermined bias on the
segments 34a, 34b, so as to present the inner member distal end 34
in a straight or curved configuration suitable for a particular
purposes.
[0160] FIG. 26 is a perspective view of a device distal end 16
including another inner member distal end 34 that is operable to
allow for articulation, in accordance with an embodiment. At least
a portion of the inner member distal end 34 comprises two or more
segments 34a, 34b that are interconnected by a pivot joint 37. The
movement of the pivot joint 37 may be controlled, at least in part,
by the engagement of the slidable support ribbon 165 with the
engagement ring 168 so as to present the inner member distal end 34
in a straight or curved configuration. The pivot joint 37 is
located between the inner member proximal end 32 and the engagement
ring 168.
[0161] It is appreciated that the tube member distal end 24 may
have a tube flare portion 29 to guide the engagement of the
slidable support ribbon 165 and/or the inner member distal end 34
as shown in FIG. 25. The tube flare portion 29 is operable to
provide a smooth bend radius for the components that may engage
it.
[0162] In operation, when the tube member distal end 24 is advanced
over the cutting element distal end 44, the slidable support ribbon
165 and the inner member distal end 34 lie substantially parallel
with each other within the tube member distal end 24. As the tube
member distal end 24 is withdrawn, the cutting element distal end
44 expands into an open position. As the tube member distal end 24
is further withdrawn, the cutting element engagement element 1170
engages the cutting element portions 144a, 144b of the cutting
element distal end 44 to stabilize, or hold-open, the cutting
element distal end 44 during subsequent tissue severing. The flared
portion 167 of the slidable support ribbon distal end 164 engages
the engagement ring 168 reducing any further traction on the
cutting element distal end 44 by the cutting element engagement
element 1170. The crease 1141 preferentially bends so as to reduce
engagement of the slidable support ribbon distal end 164 on the
tube member distal end 24.
[0163] While the invention has been described in connection with
specific embodiments thereof, it will be understood that it is
capable of further modification, and this application is intended
to cover any variations, uses, or adaptations of the invention
following, in general, the principles of the invention and
including such departures from the present disclosure as come
within known or customary practice in the art to which the
invention pertains and as may be applied to the essential features
hereinbefore set forth, and as fall within the scope of the
invention and the limits of the appended claims.
* * * * *