U.S. patent application number 16/666484 was filed with the patent office on 2020-06-04 for bi-directional articulating surgical shaver.
The applicant listed for this patent is Acclarent, Inc.. Invention is credited to Fatemeh Akbarian, Itzhak Fang, Jetmir Palushi, Henry F. Salazar.
Application Number | 20200170659 16/666484 |
Document ID | / |
Family ID | 70849806 |
Filed Date | 2020-06-04 |
United States Patent
Application |
20200170659 |
Kind Code |
A1 |
Akbarian; Fatemeh ; et
al. |
June 4, 2020 |
BI-DIRECTIONAL ARTICULATING SURGICAL SHAVER
Abstract
A surgical instrument for cutting a tissue and related methods
includes a shaft, a cutting member, and an axial adjustment
coupling. The shaft and the cutting member are configured to
articulate from a first configuration toward a second configuration
and respectively have distal and proximal shaft ends distal and
proximal member ends. The cutting member is disposed within the
shaft and configured to cyclically move relative to the shaft. The
axial adjustment coupling is configured to longitudinally move the
proximal member end relative to the proximal shaft end while
articulating the shaft and the cutting member from the first
configuration toward the second configuration. Thereby, the axial
adjustment coupling inhibits movement of the distal member end
relative to the distal shaft end for maintaining alignment between
a shaft window opening in the shaft and a cutting window opening in
the cutting member.
Inventors: |
Akbarian; Fatemeh; (Rancho
Palos Verdes, CA) ; Fang; Itzhak; (Irvine, CA)
; Palushi; Jetmir; (Irvine, CA) ; Salazar; Henry
F.; (Pico Rivera, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Acclarent, Inc. |
Irvine |
CA |
US |
|
|
Family ID: |
70849806 |
Appl. No.: |
16/666484 |
Filed: |
October 29, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62775135 |
Dec 4, 2018 |
|
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|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/32002 20130101;
A61B 2017/003 20130101; A61B 17/24 20130101; A61B 2217/005
20130101; A61B 2017/320032 20130101; A61B 2017/00309 20130101; A61B
2017/00327 20130101 |
International
Class: |
A61B 17/32 20060101
A61B017/32; A61B 17/24 20060101 A61B017/24 |
Claims
1. A surgical instrument, comprising: (a) a shaft configured to
articulate from a first configuration toward a first articulated
configuration, including: (i) a distal shaft end, (ii) a proximal
shaft end, (iii) a shaft sidewall extending from the distal shaft
end to the proximal shaft end and configured to move the distal
shaft end relative to the proximal shaft, and (iv) a shaft window
opening extending through the shaft sidewall; (b) a cutting member
disposed within the shaft and configured to cyclically move
relative to the shaft, wherein the cutting member is further
configured to articulate within the shaft from the first
configuration toward the second configuration, including: (i) a
distal member end, (ii) a proximal member end, (iii) a member
sidewall extending from the distal member end to the proximal
member end and configured to move the distal member end relative to
the proximal member end, (iv) a cutting window opening extending
through the member sidewall and configured to align with the shaft
window during cyclical movement relative thereto and receive a
tissue for cutting, and (c) an axial adjustment coupling
longitudinally securing the shaft relative to the cutting member
and configured to longitudinally move the proximal member end
relative to the proximal shaft end while articulating the shaft and
the cutting member from the first configuration toward the second
configuration to inhibit movement of the distal member end relative
to the distal shaft end for maintaining alignment between the shaft
window opening and the cutting window opening.
2. The surgical instrument of claim 1, wherein the cutting member
further includes a suction lumen extending longitudinally
therethrough and in fluid communication with the cutting window
opening, wherein the cutting window opening is configured to align
with the shaft opening during cyclical movement relative thereto
such that the cutting window opening and the shaft opening are in
fluid communication for suctioning the tissue therethrough.
3. The surgical instrument of claim 1, wherein the axial adjustment
coupling longitudinally biases the distal member end toward the
distal shaft end.
4. The surgical instrument of claim 1, further comprising at least
a portion of a motorized drive assembly, wherein the axial
adjustment coupling rotatably secures the cutting member relative
to the at least the portion of the motorized drive assembly to
inhibit relative rotation therebetween.
5. The surgical instrument of claim 1, wherein the shaft is
configured to articulate from the first configuration toward a
third configuration, and wherein the cutting member is further
configured to articulate within the shaft from the first
configuration toward the third configuration.
6. The surgical instrument of claim 5, wherein the first
configuration is a first straight configuration, wherein the second
configuration is a first articulated configuration, and wherein the
third configuration is a second articulated configuration, and
wherein the second articulated configuration is bent opposite from
the first articulated configuration.
7. The surgical instrument of claim 1, further comprising an
articulation mechanism operatively connected to the shaft and the
cutting member and configured to articulate the shaft and the
cutting member from the first configuration toward the second
configuration.
8. The surgical instrument of claim 7, wherein the articulation
mechanism includes a elongate member connected to the shaft, and
wherein the elongate member is configured to be pulled and thereby
articulate the shaft from the first configuration toward the second
configuration.
9. The surgical instrument of claim 8, wherein the shaft sidewall
is configured to engage the member sidewall while moving from the
first configuration toward the second configuration to urge the
cutting member from the first configuration toward the second
configuration.
10. The surgical instrument of claim 8, further comprising a body
assembly having the shaft and the cutting member distally extending
therefrom, wherein the articulation mechanism further includes an
articulation input positioned on the body assembly and operatively
connected to the elongate member, wherein the articulation input is
configured to selectively urge the elongate member to direct the
shaft from the first configuration toward the second
configuration.
11. The surgical instrument of claim 1, wherein at least a portion
of the shaft configured to articulate is formed from a flexible
material.
12. The surgical instrument of claim 1, wherein at least a portion
of the shaft configured to articulate has a plurality of gaps
positioned longitudinally therealong, wherein the plurality of gaps
are respectively configured to at least partially close together in
the second configuration.
13. The surgical instrument of claim 1, further comprising a body
assembly including a motorized drive assembly, wherein the shaft
and the cutting member distally extend from the body assembly.
14. The surgical instrument of claim 13, wherein the motorized
drive assembly includes a drive output member, and wherein the
axial adjustment coupling rotatably secures the cutting member
relative to the drive output member to inhibit relative rotation
therebetween.
15. The surgical instrument of claim 1, wherein the shaft is a
shaft tube and the cutting member is a cutting member tube.
16. A surgical instrument, comprising: (a) a body assembly
including a motorized drive assembly having a drive output member;
(b) a shaft distally extending from the body assembly and
configured to articulate from a straight configuration toward an
articulated configuration, including: (i) a distal shaft end, (ii)
a proximal shaft end, (iii) a shaft sidewall extending from the
distal shaft end to the proximal shaft end and configured to move
the distal shaft end relative to the proximal shaft, and (iv) a
shaft window opening extending through the shaft sidewall; (c) a
cutting member disposed within the shaft and configured to
cyclically move relative to the shaft, wherein the cutting member
is further configured to articulate within the shaft from the
straight configuration toward the articulated configuration,
including: (i) a distal member end, (ii) a proximal member end,
(iii) a member sidewall extending from the distal member end to the
proximal member end and configured to move the distal member end
relative to the proximal member end, (iv) a cutting window opening
extending through the member sidewall and configured to align with
the shaft window during cyclical movement relative thereto and
receive a tissue for cutting, and (d) an axial adjustment coupling
longitudinally securing the shaft relative to the cutting member
and rotatably securing the cutting member relative to the drive
output member, wherein the axial adjustment coupling biases the
distal member end toward the distal shaft end and is configured to
longitudinally move the proximal member end relative to the
proximal shaft end while articulating the shaft and the cutting
member from the straight configuration toward the articulated
configuration to inhibit movement of the distal member end relative
to the distal shaft end for maintaining alignment between the shaft
window opening and the cutting window opening.
17. The surgical instrument of claim 16, further comprising an
articulation mechanism having an elongate member connected to the
shaft, and wherein the elongate member is configured to be pulled
and thereby articulate the shaft from the straight configuration
toward the articulated configuration.
18. A method of accessing a tissue with a surgical instrument,
wherein the surgical instrument includes a shaft extending from a
distal shaft end to a proximal shaft end and a cutting member
extending from a distal member end to a proximal member end, the
cutting member disposed within the shaft and configured to
cyclically move relative to the shaft, wherein the shaft and the
cutting member are configured to articulate from a straight
configuration toward an articulated configuration, the method
comprising: (a) articulating the shaft and the cutting member from
the straight configuration toward the articulated configuration;
(b) longitudinally moving the proximal member end relative to the
proximal shaft end with an axial adjustment coupling thereby
maintaining a longitudinal position of the distal member end
relative to the distal shaft end throughout articulation from the
straight configuration toward the articulated configuration; and
(c) accessing the tissue with the shaft and the cutting member in
the articulated configuration.
19. The method of claim 18, further comprising biasing the distal
member end of the cutting member toward the distal shaft end of the
shaft.
20. The method of claim 18, further comprising rotating the cutting
member relative to the shaft within the shaft while inhibiting
rotation of the cutting member relative to a drive output member of
a motorized drive assembly with the axial adjustment coupling
connected therebetween.
Description
PRIORITY
[0001] This application claims priority to U.S. Provisional Pat.
App. No. 62/775,135, entitled "Bi-Directional Articulating Surgical
Shaver," filed Dec. 4, 2019, the disclosure of which is
incorporated by reference herein.
BACKGROUND
[0002] Surgical cutting instruments configured for removal of
lesions, polyps and fibroids within the nasal cavity are known.
Some configurations may include an elongated inner member rotatably
coaxially disposed within a tubular outer member. The distal end of
the outer member includes an opening, and the distal end of the
inner member includes cutting edges. The proximal ends of the two
members may be connected to a handle directly or via a detachable
hub. The inner member may be hollow and in communication with an
aspiration port so that severed tissue, etc. can be aspirated out
through the hollow member. The cutting edges can have any various
configurations suitable for the particular type of tissue, such as
bone tissue, to be done, with the opening configured to cooperate
with the specific cutting edge configuration.
[0003] To use such surgical cutting instrument to address such
tissues, the opening/cutting edge is advanced to the target
surgical site, and the opening positioned adjacent the tissue to be
removed. The opening may be repositioned to address tissue which
could not be accessed with the instrument in the previous position.
Surgical cutting instruments with a fixed opening allow surgeons to
cut only in the direction of the fixed opening cutting. To access,
cut and remove tissue at various locations, surgeons have to
reposition the instrument at various angles; or in some instances,
change to other instruments having a more appropriately arranged
opening.
[0004] It may be desirable to access, cut and remove tissue, such
as bone tissue, at various locations without having to reposition
or change the surgical instrument. While several different surgical
instruments and methods of use have been made for tissue removal
within the nasal cavity, it is believed that no one prior to the
inventors has made or used the invention described in the appended
claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] While the specification concludes with claims which
particularly point out and distinctly claim the invention, it is
believed the present invention will be better understood from the
following description of certain examples taken in conjunction with
the accompanying drawings, in which like reference numerals
identify the same elements and in which:
[0006] FIG. 1 depicts a perspective view of a first exemplary
surgical cutting instrument having a handle assembly and a shaft
assembly;
[0007] FIG. 2 depicts an exploded perspective fragmentary view of
the shaft assembly of FIG. 1 having a shaft and a cutting
member;
[0008] FIG. 3 depicts a schematic side view of a second exemplary
surgical cutting instrument having a handle assembly, a deflectable
shaft assembly with an articulation mechanism, and an axial
adjustment coupling;
[0009] FIG. 4 depicts an enlarged, proximal perspective view of the
deflectable shaft assembly and a portion of the axial adjustment
coupling of the surgical cutting instrument of FIG. 3;
[0010] FIG. 5A depicts a schematic, sectional view of the
deflectable shaft assembly taken along a centerline thereof with
the articulation mechanism of FIG. 3 in a straight
configuration;
[0011] FIG. 5B depicts the schematic, sectional view of the
deflectable shaft assembly similar to FIG. 5A, but showing the
shaft assembly with the articulation mechanism in an upward
articulated configuration;
[0012] FIG. 5C depicts the schematic, sectional view of the
deflectable shaft assembly similar to FIG. 5B, but showing the
shaft assembly with the articulation mechanism in a downward
articulated configuration;
[0013] FIG. 6A depicts an enlarged, perspective view of a distal
end portion of the deflectable shaft assembly of FIG. 3 in the
straight configuration having various features hidden for greater
clarity;
[0014] FIG. 6B depicts the enlarged, perspective view of the distal
end portion of the deflectable shaft assembly similar to FIG. 6A,
but showing the shaft assembly in the upward articulated
configuration;
[0015] FIG. 7A depicts an enlarged, schematic side view of the
axial adjustment coupling connected to a portion of the shaft
assembly in the straight configuration of FIG. 6A;
[0016] FIG. 7B depicts the enlarged, schematic side view of the
axial adjustment coupling connected to a portion of the shaft
assembly similar to FIG. 7A, but showing the shaft assembly in the
upward articulated configuration of FIG. 6B; and
[0017] FIG. 8 depicts a perspective view of an alternative
deflectable shaft assembly having a plurality of gaps and
positioned in an upward articulated configuration.
[0018] The drawings are not intended to be limiting in any way, and
it is contemplated that various embodiments of the invention may be
carried out in a variety of other ways, including those not
necessarily depicted in the drawings. The accompanying drawings
incorporated in and forming a part of the specification illustrate
several aspects of the present invention, and together with the
description serve to explain the principles of the invention; it
being understood, however, that this invention is not limited to
the precise arrangements shown.
DETAILED DESCRIPTION
[0019] The following description of certain examples of the
invention should not be used to limit the scope of the present
invention. Other examples, features, aspects, embodiments, and
advantages of the invention will become apparent to those skilled
in the art from the following description, which is by way of
illustration, one of the best modes contemplated for carrying out
the invention. As will be realized, the invention is capable of
other different and obvious aspects, all without departing from the
invention. Accordingly, the drawings and descriptions should be
regarded as illustrative in nature and not restrictive.
[0020] It will be appreciated that the terms "proximal" and
"distal" are used herein with reference to a clinician gripping a
handpiece assembly. Thus, an end effector is distal with respect to
the more proximal handpiece assembly. It will be further
appreciated that, for convenience and clarity, spatial terms such
as "upward," "downward," "side," "axial," and "longitudinal" also
are used herein for reference to relative positions and directions.
However, surgical instruments are used in many orientations and
positions, and these terms are not intended to be limiting and
absolute.
[0021] It is further understood that any one or more of the
teachings, expressions, versions, examples, etc. described herein
may be combined with any one or more of the other teachings,
expressions, versions, examples, etc. that are described herein.
The following-described teachings, expressions, versions, examples,
etc. should therefore not be viewed in isolation relative to each
other. Various suitable ways in which the teachings herein may be
combined will be readily apparent to those of ordinary skill in the
art in view of the teachings herein. Such modifications and
variations are intended to be included within the scope of the
claims.
[0022] I. Exemplary Surgical Cutting Instrument
[0023] FIG. 1-2 show a first exemplary surgical cutting instrument
(10) that may be used to remove tissue, such as bone tissue, from
the nasal cavity, as well as from any other suitable location.
Surgical cutting instrument (10) of the present example includes a
handle assembly (12), a hub (14), and a shaft assembly (16)
extending distally from handle assembly (12). Handle assembly (12)
has a handle (18) which may be of any suitable configuration.
Handle (18) may include controls for the operation of surgical
cutting instrument (10), or the controls may be located remotely.
Surgical cutting instrument (10) further includes a suction port
(20) operatively connected to a vacuum source (22) and configured
to enable aspiration of tissue, such as a bone tissue, from a
surgical site. Rotational motion is delivered by a motorized drive
assembly (24) within handle assembly (12) to shaft assembly (16) in
the present example, although any suitable rotational or
oscillatory motion source may be utilized. For example, such motion
source may be housed within handle assembly (12) or may be external
and connectable to handle assembly (12). A power source (26)
connects to motorized drive assembly (24) to power surgical cutting
instrument (10) for use. In addition or alternatively, handle
assembly (12) may house a battery (not shown).
[0024] Shaft assembly (16) generally includes an outer shaft (28)
and an inner cutting member (30) collectively configured to receive
and remove tissue from the surgical site. Cutting member (30),
which is illustrated as a tube, is disposed within a longitudinally
extending lumen (32) of shaft (28). Cutting member (30) is
configured to be rotated about a longitudinal axis (42) of shaft
assembly (16) at a distal portion. Although shaft assembly (16) is
depicted as rigid, all or a portion of shaft assembly (16) may be
flexible, with longitudinal axis (42) comprising a series of
cross-sectional centers. Cutting member (30) defines a lumen and
extends proximally to handle assembly (12) and connects to
motorized drive assembly (24), which rotatably drives cutting
member (30) relative to shaft (28). In the present example, shaft
(28) is formed of polycarbonate and cutting member (30) is formed
of stainless steel. Of course, shaft (28) and cutting member (30)
may be formed of one or more alternative materials in accordance
with the invention described herein. The invention is thus not
intended to be unnecessarily limited to manufacture with
polycarbonate and stainless steel. While the present example of
cutting member (30) is a hollow tube, cutting member (30) is not
limited to being tubular and defining its own lumen (32).
[0025] Shaft (28) includes a window region (48) having a shaft
opening, such as a shaft window opening (50), at a distal portion
thereof. Distal portion includes a tubular sidewall (51) that
distally terminates in a curved end, such as a generally
hemispherical end (52). Shaft window opening (50) extends through
tubular sidewall (51) of shaft (28) into lumen (32) and is in fluid
communication with the environment surrounding shaft (28). Shaft
window opening (50) faces radially outward relative to longitudinal
axis (42) such that tissue is configured to be radially received
through shaft window opening (50) into a central suction lumen (60)
of cutting member (30) in a radially inward direction. Shaft window
opening (50) is surrounded by a relatively dull edge (61).
[0026] Cutting member (30) includes a cutting window opening (54)
at distal portion of cutting member (30). Cutting window opening
(54) is configured to longitudinally align with shaft window
opening (50) and includes a cutting edge (58) extending therealong.
It is noted that less than the entirety of cutting edge (58) may be
configured for cutting tissue against an opposing edge (61) of
shaft (28). At least a portion of cutting edge (58) is disposed to
move adjacent to and across at least a portion of window region
(48) when cutting member (30) is rotated or oscillated about
longitudinal axis (42). By way of example, as cutting member (30)
moves in a clockwise direction, edge (61) of window region (48)
provides an opposing surface to cutting edge (58) whereby tissue
may be severed to remove a cut tissue portion therefrom. Cutting
edge (58) and edge (61) may have any configuration which suitably
cooperates with the other to sever tissue, such as a knife edge, a
serrated edge, bipolar, monopolar or harmonic energy modality, or
laser activated cutting edge.
[0027] The extent of movement and position of cutting edge (58)
relative to edge (61) is sufficient to separate tissue, whether by
severing, tearing or any other mechanism. For example, cutting edge
(58) may cyclically move across at least a portion of window region
(48). Further clockwise movement of cutting member (30) will
advance cutting edge (58) past edge (61), such as results from
oscillation about longitudinal axis (42) or from full rotation
about longitudinal axis (42).
[0028] With continued reference to FIGS. 1-2, vacuum source (22)
generates suction in a proximal direction along suction lumen (60)
and longitudinal axis (42) toward suction port (20). Suction lumen
(60) is defined by a tubular sidewall (62) of cutting member (30)
in the present example and is in direct fluid communication with
cutting window opening (54). Without tissue blocking cutting window
opening (54), such suction proximally withdraws a window airflow
therethrough along suction lumen (60). However, once tissue is
respectively introduced into window opening (54), suction
effectively draws tissue into window opening (54) for resection
while tissue blocks airflow along suction lumen (60). Airflow
through suction lumen (60) essentially terminates such that vacuum
source (22) accumulates the vacuum within suction lumen (60). Such
termination of airflow may generally be referred to as a stalled
airflow within lumen. Additional details regarding airflow through
lumen and aspiration vents for improving such airflow are discussed
in alternative examples described in U.S. patent application Ser.
No. 15/795,473, entitled "Tissue Shaving Instrument," filed Oct.
27, 2017, the disclosure of which is incorporated by reference
herein.
[0029] Furthermore, surgical cutting instrument (10) may be used in
conjunction with an image-guide surgery (IGS) navigation system,
medical procedure chair, and displays described alone or in any
combination according to the following: U.S. Pat. Pub. No.
2016/0008083, entitled "Guidewire Navigation for Sinuplasty,"
published Jan. 14, 2016; U.S. Patent App. No. 62/555,824, entitled
"Apparatus to Secure Field Generating Device to Chair," filed Sep.
8, 2017; U.S. Pat. Pub. No. 2016/0008083, entitled "Guidewire
Navigation for Sinuplasty," published Jan. 14, 2016; U.S. Pat. Pub.
No. 2016/0310042, entitled "System and Method to Map Structures of
Nasal Cavity," published Oct. 27, 2016; U.S. Pat. No. 8,702,626,
entitled "Guidewires for Performing Image Guided Procedures,"
issued Apr. 22, 2014; U.S. Pat. No. 8,320,711, entitled "Anatomical
Modeling from a 3-D Image and a Surface Mapping," issued Nov. 27,
2012; U.S. Pat. No. 8,190,389, entitled "Adapter for Attaching
Electromagnetic Image Guidance Components to a Medical Device,"
issued May 29, 2012; U.S. Pat. No. 8,123,722, entitled "Devices,
Systems and Methods for Treating Disorders of the Ear, Nose and
Throat," issued Feb. 28, 2012; U.S. Pat. No. 7,720,521, entitled
"Methods and Devices for Performing Procedures within the Ear,
Nose, Throat and Paranasal Sinuses," issued May 18, 2010; U.S. Pat.
Pub. No. 2014/0364725, entitled "Systems and Methods for Performing
Image Guided Procedures within the Ear, Nose, Throat and Paranasal
Sinuses," published Dec. 11, 2014; U.S. Pat. Pub. No. 2014/0200444,
entitled "Guidewires for Performing Image Guided Procedures,"
published July 17, 2014; U.S. Pat. No. 9,198,736, entitled "Adapter
for Attaching Electromagnetic Image Guidance Components to a
Medical Device," issued Dec. 1, 2015; U.S. Pat. Pub. No.
2011/0060214, entitled "Systems and Methods for Performing Image
Guided Procedures within the Ear, Nose, Throat and Paranasal
Sinuses," published March 10, 2011; U.S. Pat. No. 9,167,961,
entitled "Methods and Apparatus for Treating Disorders of the Ear
Nose and Throat," issued Oct. 27, 2015; and U.S. Pat. Pub. No.
2007/0208252, entitled "Systems and Methods for Performing Image
Guided Procedures within the Ear, Nose, Throat and Paranasal
Sinuses," published Sep. 6, 2007, the disclosures of each of the
these references being incorporated by reference herein.
[0030] II. Deflectable Shaft Assembly and Axial Adjustment Coupling
for a Surgical Cutting Instrument
[0031] While surgical cutting instrument (10) is configured to
remove a target tissue as discussed above in greater detail, a
particular position of such target tissue within the patient will
likely vary, to at least some extent, depending on the patient and
the tissue identified for removal. For example, in some instances,
the target tissue may be positioned along a relatively linearly
extending cavity in the patient or, in other instances, may be
positioned along more complex, winding cavities within the patient.
In order to access target tissue within such complex, winding
cavities, the surgeon may attempt to reposition surgical cutting
instrument (10) at one or more awkward angles or even discard
surgical cutting instrument (10) for a more suitable instrument
depending on the circumstance. Thus, manipulating the position of
shaft window opening (50) and cutting window opening (54) for
greater access to the target tissue generally provides for greater
comfort and enhanced outcomes for the patient.
[0032] With respect to FIGS. 3-4, a second exemplary surgical
cutting instrument (110) has a deflectable shaft assembly (116)
distally extending from a handle assembly (112) and operatively
connected thereto via an axial adjustment coupling (170). Surgical
cutting instrument (110) further includes an articulation mechanism
(172) operatively connected to deflectable shaft assembly (116).
Articulation mechanism (172) selectively articulates deflectable
shaft assembly (116) between a straight configuration, an upward
articulated configuration, and a downward articulated configuration
for deflecting distal portions of deflectable shaft assembly (116)
relative to proximal portions of deflectable shaft assembly (116)
and accessing the target tissue. More particularly, an outer shaft
(128) and an inner cutting member (130) of deflectable shaft
assembly (116) each respectively articulate along a common
longitudinal axis (177) (see FIG. 5A). Such articulation varies the
lengths of cutting member (130) and shaft (128) along common
longitudinal axis, with the greatest difference being between the
straight configuration and the most articulated upward and downward
configurations in the present example. Axial adjustment coupling
(170) secures cutting member (130) relative to shaft (128) to allow
cutting member (130) to longitudinally move along common
longitudinal axis (177) (see FIG. 5A) during articulation of
deflectable shaft assembly (116) for maintaining alignment between
shaft window opening (50) and cutting window opening (54) during
use. Various features of surgical cutting instruments (10, 110) may
be readily incorporated into each other such that the invention is
not intended to be unnecessarily limited to the particular examples
shown herein. In any case, like numbers provided below indicate
like features discussed above in greater detail.
[0033] Handle assembly (112) has a handle body (118) that may
include controls for the operation of surgical cutting instrument
(110), or the controls may be located remotely. One such control is
an activation control (not shown) configured to selectively power
motorized drive assembly (24) via power source (26). Vacuum source
(22) fluidly connects to suction port (20) (see FIG. 1) to draw a
vacuum through suction lumen (60) (see FIG. 4) of cutting member
(130) rotatably disposed within shaft (128). Motorized drive
assembly (24) rotatably drives cutting member (130) within shaft
(128) such that cutting member (130) rotates cyclically and
repeatedly through an open state and a closed state in relation to
shaft (128). In the open state, cutting window opening (54) aligns
with shaft window opening (50) to fluidly communicate the vacuum
throughout to the environment for receiving and suctioning tissue
therein. In contrast, in the closed state, a tubular sidewall (162)
of cutting member (130) aligns with and covers shaft window opening
(50) to inhibit further suctioning.
[0034] In the present example, shaft (128) is longitudinally and
rotationally fixed to handle body (118). Axial adjustment coupling
(170) mechanically couples cutting member (130) to a drive output,
including a drive output gear (174), such that cutting member (130)
rotatably locks to drive output gear (174) while being
simultaneously configured to translate relative to drive output
gear (174). In turn, cutting member (130) similarly rotates and
selectively translates relative to handle body (118) and shaft
(128) to accommodate articulation of cutting member (130) relative
to articulation of shaft (128) as selectively directed by an
articulation input (176) of articulation mechanism (172). While
articulation input (176) is shown as a knob in the present example,
it will be appreciated that alternative inputs configured to be
selectively manipulated by the surgeon may be similarly used.
[0035] To this end, FIG. 5A shows one example of deflectable shaft
assembly (116) in a straight configuration such that common
longitudinal axis (177) of shaft (128) and cutting member (130) is
generally linear. At least a portion of shaft (128) and at least a
portion of cutting member (130) are each formed of one or more
flexible materials configured to flexibly deform from this linearly
extending common longitudinal axis (177). In addition, at least
such portions of cutting member (130) are further configured to
transmit sufficient torque during use to cut the target tissue as
described above. In one example, cutting member (130) may include
an intermediate section having a braided steel material extending
from drive output gear (174) (see FIG. 3) to cutting window opening
(54) for flexibility therealong. In another example, cutting member
(130) may include an intermediate section having a torsional drive
cable for similar flexibility. Furthermore, the flexible portion of
cutting member (130) in one example may be along an entire
longitudinal length of cutting member (130) up to cutting window
opening (54) or such flexible portion in another example may be
limited to a shorter longitudinal length of cutting member (130)
that longitudinally aligns with the flexible portions of shaft
(128).
[0036] Articulation mechanism (172) includes articulation input
(176) connected to a pair of elongate members, such as a pair of
cables (178), each connected to a distal end portion (180) of shaft
(128). More particularly, cables (178) extend along respective
longitudinal channels (182) on angularly opposing sides of a
tubular sidewall (151) of shaft (128) about common longitudinal
axis (177). Cables (178) are secured to distal end portion (180) of
shaft (128) within respective longitudinal channels (182) and
proximally extend therefrom into handle body (118) (see FIG. 3) to
operatively connect to articulation input (176). In the present
example, cables (178) are push-pull cables (178) configured
transmit force in tension and compression for more easily
articulating deflectable shaft assembly (116). While the present
example shows longitudinal channels (182) formed within tubular
sidewall (151) of shaft (128), an alternative example may have
cables (178) longitudinally extending along an outer surface of
tubular sidewall (151) and, in addition, may be positioned in an
outer radial groove extending along the outer surface of tubular
sidewall (151). An outer sheath (not shown) may further cover
cables (178) positioned on the outer surface of shaft (128).
Alternatively, rather than dedicated longitudinal channels (182) as
discussed above, cables (178) may longitudinally extend in an
annular gap between cutting member (130) and shaft (128).
[0037] Upon articulation of deflectable shaft assembly (116), a
distal shaft end (184) of shaft (128) and a distal member end (186)
of cutting member (130) respectively deflect relative to a proximal
shaft end (188) of shaft (128) and a proximal member end (190) of
cutting member (130). Manipulating articulation input (176) one
direction, as shown in FIG. 5B, pulls one cable (178) in tension
and pushes the other cable (178) in compression to articulate
deflectable shaft assembly (116) from the straight configuration to
the upward articulated configuration. More particularly, distal
shaft end (184) deflects upward relative to proximal shaft end
(188) such that tubular sidewall (151) of shaft (128) similarly
urges tubular sidewall (162) of cutting member (130) to follow
along the arcuately extending common longitudinal axis (177). Thus,
distal member end (186) also deflects upward relative to proximal
member end (190) while maintaining longitudinal alignment between
shaft window opening (150) and cutting window opening (154) from
the straight configuration to the upward articulated
configuration.
[0038] With respect to FIG. 5C, manipulating articulation input
(176) the opposite direction pushes one cable (178) in compression
and pulls the other cable (178) in tension to articulate
deflectable shaft assembly (116) from the straight configuration to
the downward articulated configuration. More particularly, distal
shaft end (184) deflects downward relative to proximal shaft end
(188) such that tubular sidewall (151) of shaft (128) similarly
urges tubular sidewall (162) of cutting member (130) to follow
along the arcuately extending common longitudinal axis (177). Thus,
distal member end (186) also deflects downward relative to proximal
member end (190) while maintaining longitudinal alignment between
shaft window opening (150) and cutting window opening (154) from
the straight configuration to the downward articulated
configuration. While the above description initiates articulation
from the straight configuration to each of the upward and downward
articulated configurations in the present example, it will be
appreciated that such articulation may initiate from any
configuration of deflectable shaft assembly (116) and terminate in
any configuration of deflectable shaft assembly (116). The
invention is thus not intended to be unnecessarily limited to
initiate and terminate articulation as shown and described herein.
Furthermore, while the present example of deflectable shaft
assembly (116) selectively articulates via articulation mechanism
(172), an alternative shaft assembly may having one or more
portions of cutting member (130) and shaft (128) be formed of a
malleable material. Rather than selectively directing articulation
input (176), the surgeon may grip and physically manipulate such
malleable cutting member and malleable shaft by hand to a desirable
shape for use. Thus, the surgeon may manipulate malleable
deflectable shaft assembly to at least any articulation as shown in
FIGS. 5A-5C.
[0039] FIGS. 6A-6B show the distal end portion of deflectable shaft
assembly (116) in greater detail with distal shaft end (184) of
shaft (128) and distal member end (186) of cutting member (130)
respectively in the straight and upward articulated configurations.
FIG. 6A shows distal member end (186) a predetermined longitudinal
distance (D) from distal shaft end (184) in the straight
configuration, whereas FIG. 6B shows distal member end (186) the
same predetermined longitudinal distance (D) from distal shaft end
(184) in the upward articulated configuration. To this end, shaft
window opening (150) remains longitudinally aligned with cutting
window opening (154) in each of the straight and upward articulated
configurations and, indeed, remains similarly aligned in any
configuration.
[0040] As shown in FIGS. 7A-7B, axial adjustment coupling (170)
mechanically couples with cutting member (130) to maintain the
predetermined longitudinal distance (D) between distal shaft end
(184) and distal member end (186) regardless of the configuration
of deflectable shaft assembly (116). In the straight configuration
of FIG. 7A, axial adjustment coupling (170) extends between and
mechanically couples cutting member (130) to drive output gear
(174) of motorized drive assembly (124). More particularly, axial
adjustment coupling (170) mechanically locks rotation of drive
output gear (174) to proximal member end (190) and transmits torque
therethrough such that drive output gear (174) rotatably drives
cutting member (130) relative to shaft (128) (see FIG. 3).
[0041] While rotatably securing drive output gear (174) to proximal
member end (190), axial adjustment coupling (170) has a spline
coupling (191) that simultaneously allows for longitudinal
translation of proximal member end (190) relative to drive output
gear (174) for maintaining the predetermined longitudinal distance
(D) (see FIGS. 6A-6B) during articulation. With respect to FIG. 7B,
articulating cutting member (130) to the upward articulated
configuration causes distal shaft end (184) (see FIG. 6B) to
longitudinally engage distal member end (186) and urge cutting
member (130) proximally toward drive output gear (174) as indicated
by arrow (192). In the present example, proximal member end (190)
compresses against a spring (194) such that cutting member (130) is
distally biased toward distal shaft end (184). Alternatively or in
addition, axial adjustment coupling (170) may include a wave spring
assembly and/or bearings to accommodate such longitudinal movement
and bias. By way of further example, axial adjustment coupling
(170) may include a longitudinal drive mechanism in place of at
least spring (194) to actively position cutting member (130)
relative to shaft (128). In this respect, the invention is not
intended to be unnecessarily limited to passive adjustment, such as
by biasing cutting member (130) with spring (194) as shown in the
present example. Returning deflectable shaft assembly (116) from
the upward biased configuration to the straight configuration will
reverse the longitudinal movement of cutting member (130) away from
drive output gear (174). Such proximal movement indicated by arrow
(192) would similarly occur upon articulating deflectable shaft
assembly (116) from the straight configuration to the downward
articulated configuration.
[0042] Axial adjustment coupling (170) of the present example is
connected inline with drive output gear (174) and, indeed, a
remainder of motorized drive assembly (124), such that axial
adjustment coupling (170) is generally distally positioned relative
to drive output gear (174). In another example, axial adjustment
coupling (170) may be coaxial with common longitudinal axis (177)
(see FIG. 5A) and drive output gear (174) may be positioned on
another axis offset from common longitudinal axis (177) (see FIG.
5A). In such an alternative example, one or more portions of axial
adjustment coupling (170), such as spring (194), may be proximally
positioned relative to drive output gear (174), which is positioned
alongside proximal member end (190) of cutting member (130). A
driven gear member (not shown) may be coupled to proximal member
end (190) to laterally engage drive output gear (174) to drive
rotation of cutting member (130). Driven gear member (not shown)
would thus remain engaged with drive output gear (174) while
longitudinally sliding relative to drive output gear (174) thereby
allowing for longitudinal translation of proximal member end (190)
relative to drive output gear (174) in order to maintain the
predetermined longitudinal distance (D) (see FIGS. 6A-6B) as
discussed above.
[0043] In another example, FIG. 8 shows an alternative deflectable
shaft assembly (216), which has an outer shaft (228) with an inner
cutting member (230) similarly configured to deflectable shaft
assembly (116) (see FIG. 3) discussed above. However, in addition
to or alternatively, shaft (228) has a plurality of gaps (296)
positioned longitudinally through tubular sidewall (251) along an
inner radius of deflection, such as upward articulated
configuration. Gaps (296) are generally opened in the straight
configuration and close, to at least some extent, as shaft (228)
articulates toward the upward articulated configuration. Gaps (296)
provide space for the material of shaft (228) to more easily and
predictably deflect during use. Such gaps (296) may be similarly
positioned on an opposing side of sidewall (251) to create a
similar downward articulated configuration and/or positioned on
cutting member (230) for similar deflection thereof Alternative
materials or structures for flexing deflectable shaft assembly
(216) may be similarly used, and the invention is not intended to
be unnecessarily limited to the flexible materials and structures
as shown and described herein.
[0044] In order to further aid alignment between an inner, cutting
member (130) and an outer shaft, another alternative shaft assembly
may include a longitudinally elongated shaft window opening (not
shown) configured to remain in communication with cutting window
opening (154) as cutting member (130) longitudinally moves within
outer shaft. Such elongated shaft window opening (not shown)
longitudinally extends further than shaft window opening (50),
discussed above, while cutting window opening (154) may remain the
same. The additional elongation of elongated shaft window opening
(not shown) is sized to accommodate the longitudinal movement of
cutting window opening (154) to maintain consistent communication
therethrough in any of the configurations shown in FIGS. 5A-5C.
[0045] In use, with respect to FIGS. 3-5C, surgeon introduces the
distal end portion of deflectable shaft assembly (216) into the
nasal cavity of the patient toward the target tissue while the
deflectable shaft assembly (216) is in the straight configuration.
The surgeon manipulates the articulation input (176) to articulate
deflectable shaft assembly (216) from the straight configuration
toward either the upward or downward articulated configurations as
desired for accessing the target tissue with the shaft and cutting
window openings (50, 54). During the articulation shown in FIGS.
5A-5C, cables (178) push and pull on distal end portion (180) of
shaft (128) such that shaft (128) urges cutting member (130) along
common longitudinal axis (177) to collectively articulate
deflectable shaft assembly (116).
[0046] With respect to FIGS. 6A-7B, distal shaft end (184) engages
distal member end (186) and proximally translates cutting member
(130) to urge proximal member end (190) relative to proximal shaft
end (188) (see FIG. 3) and toward drive output gear (174). Axial
adjustment coupling (170) biases distal member end (186) toward
distal shaft end (184), but spring (194) resiliently compresses to
accommodate the longitudinal translation of cutting member (130),
while spline coupling (191) simultaneously remains rotatably locked
to cutting member (130). The translation of proximal member end
(190) thereby retains the predetermined longitudinal distance (D)
between distal shaft end (184) and distal member end (186) to
maintain longitudinal alignment of shaft and cutting window
openings (50, 54) regardless of the particular configuration of
deflectable shaft assembly (116).
[0047] Once shaft window opening (50) accesses the target tissue,
the surgeon selectively powers motorized drive assembly (124) to
transmit torque from drive output gear (174) and through axial
adjustment coupling (170) to rotatably drive cutting member (130)
to cut and remove the target tissue against cutting edge (58) (see
FIG. 2) as discussed above. While the above description first
articulates deflectable shaft assembly (116) and then rotatably
drives cutting member (130) to cut the target tissue, the surgeon
may alternatively drive cutting member (130) while simultaneously
articulating deflectable shaft assembly (116) in other
examples.
[0048] III. Exemplary Combinations
[0049] The following examples relate to various non-exhaustive ways
in which the teachings herein may be combined or applied. It should
be understood that the following examples are not intended to
restrict the coverage of any claims that may be presented at any
time in this application or in subsequent filings of this
application. No disclaimer is intended. The following examples are
being provided for nothing more than merely illustrative purposes.
It is contemplated that the various teachings herein may be
arranged and applied in numerous other ways. It is also
contemplated that some variations may omit certain features
referred to in the below examples. Therefore, none of the aspects
or features referred to below should be deemed critical unless
otherwise explicitly indicated as such at a later date by the
inventors or by a successor in interest to the inventors. If any
claims are presented in this application or in subsequent filings
related to this application that include additional features beyond
those referred to below, those additional features shall not be
presumed to have been added for any reason relating to
patentability.
EXAMPLE 1
[0050] A surgical instrument, comprising: (a) a shaft configured to
articulate from a first configuration toward a first articulated
configuration, including: (i) a distal shaft end, (ii) a proximal
shaft end, (iii) a shaft sidewall extending from the distal shaft
end to the proximal shaft end and configured to move the distal
shaft end relative to the proximal shaft, and (iv) a shaft window
opening extending through the shaft sidewall; (b) a cutting member
disposed within the shaft and configured to cyclically move
relative to the shaft, wherein the cutting member is further
configured to articulate within the shaft from the first
configuration toward the second configuration, including: (i) a
distal member end, (ii) a proximal member end, (iii) a member
sidewall extending from the distal member end to the proximal
member end and configured to move the distal member end relative to
the proximal member end, (iv) a cutting window opening extending
through the member sidewall and configured to align with the shaft
window during cyclical movement relative thereto and receive a
tissue for cutting, and (c) an axial adjustment coupling
longitudinally securing the shaft relative to the cutting member
and configured to longitudinally move the proximal member end
relative to the proximal shaft end while articulating the shaft and
the cutting member from the first configuration toward the second
configuration to inhibit movement of the distal member end relative
to the distal shaft end for maintaining alignment between the shaft
window opening and the cutting window opening.
EXAMPLE 2
[0051] The surgical instrument of Example 1, wherein the cutting
member further includes a suction lumen extending longitudinally
therethrough and in fluid communication with the cutting window
opening, wherein the cutting window opening is configured to align
with the shaft opening during cyclical movement relative thereto
such that the cutting window opening and the shaft opening are in
fluid communication for suctioning the tissue therethrough.
EXAMPLE 3
[0052] The surgical instrument of any one or more of Examples 1
through 2, wherein the axial adjustment coupling longitudinally
biases the distal member end toward the distal shaft end.
EXAMPLE 4
[0053] The surgical instrument of any one or more of Examples 1
through 3, further comprising at least a portion of a motorized
drive assembly, wherein the axial adjustment coupling rotatably
secures the cutting member relative to the at least the portion of
the motorized drive assembly to inhibit relative rotation
therebetween.
EXAMPLE 5
[0054] The surgical instrument of any one or more of Examples 1
through 4, wherein the shaft is configured to articulate from the
first configuration toward a third configuration, and wherein the
cutting member is further configured to articulate within the shaft
from the first configuration toward the third configuration.
EXAMPLE 6
[0055] The surgical instrument of Example 5, wherein the first
configuration is a first straight configuration, wherein the second
configuration is a first articulated configuration, and wherein the
third configuration is a second articulated configuration, and
wherein the second articulated configuration is bent opposite from
the first articulated configuration.
EXAMPLE 7
[0056] The surgical instrument of any one or more of Examples 1
through 6, further comprising an articulation mechanism operatively
connected to the shaft and the cutting member and configured to
articulate the shaft and the cutting member from the first
configuration toward the second configuration.
EXAMPLE 8
[0057] The surgical instrument of Example 7, wherein the
articulation mechanism includes an elongate member connected to the
shaft, and wherein the elongate member is configured to be pulled
and thereby articulate the shaft from the first configuration
toward the second configuration.
EXAMPLE 9
[0058] The surgical instrument of Example 8, wherein the shaft
sidewall is configured to engage the member sidewall while moving
from the first configuration toward the second configuration to
urge the cutting member from the first configuration toward the
second configuration.
EXAMPLE 10
[0059] The surgical instrument of Example 8, further comprising a
body assembly having the shaft and the cutting member distally
extending therefrom, wherein the articulation mechanism further
includes an articulation input positioned on the body assembly and
operatively connected to the elongate member, wherein the
articulation input is configured to selectively urge the elongate
member to direct the shaft from the first configuration toward the
second configuration.
EXAMPLE 11
[0060] The surgical instrument of any one or more of Examples 1
through 10, wherein at least a portion of the shaft configured to
articulate is formed from a flexible material.
EXAMPLE 12
[0061] The surgical instrument of any one or more of Examples 1
through 11, wherein at least a portion of the shaft configured to
articulate has a plurality of gaps positioned longitudinally
therealong, wherein the plurality of gaps are respectively
configured to at least partially close together in the second
configuration.
EXAMPLE 13
[0062] The surgical instrument of any one or more of Examples 1
through 12, further comprising a body assembly including a
motorized drive assembly, wherein the shaft and the cutting member
distally extend from the body assembly.
EXAMPLE 14
[0063] The surgical instrument of Example 13, wherein the motorized
drive assembly includes a drive output member, and wherein the
axial adjustment coupling rotatably secures the cutting member
relative to the drive output member to inhibit relative rotation
therebetween.
EXAMPLE 15
[0064] The surgical instrument of any one or more of Examples 1
through 14, wherein the shaft is a shaft tube and the cutting
member is a cutting member tube.
EXAMPLE 16
[0065] A surgical instrument, comprising: (a) a body assembly
including a motorized drive assembly having a drive output member;
(b) a shaft distally extending from the body assembly and
configured to articulate from a straight configuration toward an
articulated configuration, including: (i) a distal shaft end, (ii)
a proximal shaft end, (iii) a shaft sidewall extending from the
distal shaft end to the proximal shaft end and configured to move
the distal shaft end relative to the proximal shaft, and (iv) a
shaft window opening extending through the shaft sidewall; (c) a
cutting member disposed within the shaft and configured to
cyclically move relative to the shaft, wherein the cutting member
is further configured to articulate within the shaft from the
straight configuration toward the articulated configuration,
including: (i) a distal member end, (ii) a proximal member end,
(iii) a member sidewall extending from the distal member end to the
proximal member end and configured to move the distal member end
relative to the proximal member end, (iv) a cutting window opening
extending through the member sidewall and configured to align with
the shaft window during cyclical movement relative thereto and
receive a tissue for cutting, and (d) an axial adjustment coupling
longitudinally securing the shaft relative to the cutting member
and rotatably securing the cutting member relative to the drive
output member, wherein the axial adjustment coupling biases the
distal member end toward the distal shaft end and is configured to
longitudinally move the proximal member end relative to the
proximal shaft end while articulating the shaft and the cutting
member from the straight configuration toward the articulated
configuration to inhibit movement of the distal member end relative
to the distal shaft end for maintaining alignment between the shaft
window opening and the cutting window opening.
EXAMPLE 17
[0066] The surgical instrument of Example 16, further comprising an
articulation mechanism having an elongate member connected to the
shaft, and wherein the elongate member is configured to be pulled
and thereby articulate the shaft from the straight configuration
toward the articulated configuration.
EXAMPLE 18
[0067] A method of accessing a tissue with a surgical instrument,
wherein the surgical instrument includes a shaft extending from a
distal shaft end to a proximal shaft end and a cutting member
extending from a distal member end to a proximal member end, the
cutting member disposed within the shaft and configured to
cyclically move relative to the shaft, wherein the shaft and the
cutting member are configured to articulate from a straight
configuration toward an articulated configuration, the method
comprising: (a) articulating the shaft and the cutting member from
the straight configuration toward the articulated configuration;
(b) longitudinally moving the proximal member end relative to the
proximal shaft end with an axial adjustment coupling thereby
maintaining a longitudinal position of the distal member end
relative to the distal shaft end throughout articulation from the
straight configuration toward the articulated configuration; and
(c) accessing the tissue with the shaft and the cutting member in
the articulated configuration.
EXAMPLE 19
[0068] The method of Example 18, further comprising biasing the
distal member end of the cutting member toward the distal shaft end
of the shaft.
EXAMPLE 20
[0069] The method of any one or more of Examples 18 through 19,
further comprising rotating the cutting member relative to the
shaft within the shaft while inhibiting rotation of the cutting
member relative to a drive output member of a motorized drive
assembly with the axial adjustment coupling connected
therebetween.
[0070] IV. Miscellaneous
[0071] It should be understood that any of the examples described
herein may include various other features in addition to or in lieu
of those described above. By way of example only, any of the
examples described herein may also include one or more of the
various features disclosed in any of the various references that
are incorporated by reference herein.
[0072] It should be understood that any one or more of the
teachings, expressions, embodiments, examples, etc. described
herein may be combined with any one or more of the other teachings,
expressions, embodiments, examples, etc. that are described herein.
The above-described teachings, expressions, embodiments, examples,
etc. should therefore not be viewed in isolation relative to each
other. Various suitable ways in which the teachings herein may be
combined will be readily apparent to those of ordinary skill in the
art in view of the teachings herein. Such modifications and
variations are intended to be included within the scope of the
claims.
[0073] It should be appreciated that any patent, publication, or
other disclosure material, in whole or in part, that is said to be
incorporated by reference herein is incorporated herein only to the
extent that the incorporated material does not conflict with
existing definitions, statements, or other disclosure material set
forth in this disclosure. As such, and to the extent necessary, the
disclosure as explicitly set forth herein supersedes any
conflicting material incorporated herein by reference. Any
material, or portion thereof, that is said to be incorporated by
reference herein, but which conflicts with existing definitions,
statements, or other disclosure material set forth herein will only
be incorporated to the extent that no conflict arises between that
incorporated material and the existing disclosure material.
[0074] Versions of the devices disclosed herein can be designed to
be disposed of after a single use, or they can be designed to be
used multiple times. Versions may, in either or both cases, be
reconditioned for reuse after at least one use. Reconditioning may
include any combination of the steps of disassembly of the device,
followed by cleaning or replacement of particular pieces, and
subsequent reassembly. In particular, versions of the device may be
disassembled, and any number of the particular pieces or parts of
the device may be selectively replaced or removed in any
combination. Upon cleaning and/or replacement of particular parts,
versions of the device may be reassembled for subsequent use either
at a reconditioning facility, or by a surgical team immediately
prior to a surgical procedure. Those skilled in the art will
appreciate that reconditioning of a device may utilize a variety of
techniques for disassembly, cleaning/replacement, and reassembly.
Use of such techniques, and the resulting reconditioned device, are
all within the scope of the present application.
[0075] By way of example only, versions described herein may be
processed before surgery. First, a new or used instrument may be
obtained and if necessary cleaned. The instrument may then be
sterilized. In one sterilization technique, the instrument is
placed in a closed and sealed container, such as a plastic or TYVEK
bag. The container and instrument may then be placed in a field of
radiation that can penetrate the container, such as gamma
radiation, x-rays, or high-energy electrons. The radiation may kill
bacteria on the instrument and in the container. The sterilized
instrument may then be stored in the sterile container. The sealed
container may keep the instrument sterile until it is opened in a
surgical facility. A device may also be sterilized using any other
technique known in the art, including but not limited to beta or
gamma radiation, ethylene oxide, or steam.
[0076] Having shown and described various versions of the present
invention, further adaptations of the methods and systems described
herein may be accomplished by appropriate modifications by one of
ordinary skill in the art without departing from the scope of the
present invention. Several of such potential modifications have
been mentioned, and others will be apparent to those skilled in the
art. For instance, the examples, versions, geometrics, materials,
dimensions, ratios, steps, and the like discussed above are
illustrative and are not required. Accordingly, the scope of the
present invention should be considered in terms of the following
claims and is understood not to be limited to the details of
structure and operation shown and described in the specification
and drawings.
* * * * *