U.S. patent application number 15/216310 was filed with the patent office on 2016-11-10 for aspirators, components thereof, and assembly and fit thereof.
This patent application is currently assigned to SurgiMark, Inc.. The applicant listed for this patent is SurgiMark, Inc.. Invention is credited to David John Yarger.
Application Number | 20160325026 15/216310 |
Document ID | / |
Family ID | 57222194 |
Filed Date | 2016-11-10 |
United States Patent
Application |
20160325026 |
Kind Code |
A1 |
Yarger; David John |
November 10, 2016 |
ASPIRATORS, COMPONENTS THEREOF, AND ASSEMBLY AND FIT THEREOF
Abstract
In part, the disclosure relates to an aspirator having a handle
that includes a suction connector extending from a proximal end
face, a substantially cylindrical sleeve mount having an outer
surface and a shoulder. A tubular member defining a bore and having
flared end disposed in a suction head having one or more
cantilevered protuberances can extend from the sleeve mount. The
substantially cylindrical sleeve mount is in relief with respect to
the shoulder and extends distally therefrom. The substantially
cylindrical sleeve mount defines an aperture. The suction connector
bore, bore of tubular member, inner cavity of handle and suction
head bore define a fluid flow path or cavity. The aspirator can
include a sleeve that receives the suction head. The sleeve engages
and interferes with the sleeve mount. The suction head and sleeve's
inner wall have one or more engineered clearances between them to
enhance assembly.
Inventors: |
Yarger; David John; (Hood
River, OR) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SurgiMark, Inc. |
Yakima |
WA |
US |
|
|
Assignee: |
SurgiMark, Inc.
Yakima
WA
|
Family ID: |
57222194 |
Appl. No.: |
15/216310 |
Filed: |
July 21, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62364653 |
Jul 20, 2016 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2205/582 20130101;
A61M 1/0086 20140204; A61M 1/008 20130101; A61M 1/0039
20130101 |
International
Class: |
A61M 1/00 20060101
A61M001/00 |
Claims
1. An aspirator comprising: an elongate handle defining a fluid
flow cavity, the elongate handle comprising a proximal end face, a
suction connector extending from the proximal end face, a
substantially cylindrical sleeve mount comprising an outer surface,
and a shoulder, wherein the substantially cylindrical sleeve mount
is in relief with respect to the shoulder and extends distally
therefrom, wherein the substantially cylindrical sleeve mount
defines an aperture, wherein the suction connector defines a
suction connector bore, the suction connector bore in fluid
communication with the aperture and the fluid flow cavity.
2. The aspirator of claim 1 further comprising: a tubular member
extending from the aperture, wherein the tubular member comprises a
proximal tube end and a distal tube end, wherein the proximal tube
end is disposed in and secured by the handle, the tubular member
defining a tubular member bore, wherein the distal tube end is
flared.
3. The aspirator of claim 1 further comprising: an elastic sleeve,
the elastic sleeve defining a plurality of vent holes, a sleeve
lumen and a sleeve inner wall, the elastic sleeve comprising a
sleeve tip and a sleeve rim, wherein the sleeve rim defines a
sleeve opening.
4. The aspirator of claim 3 wherein substantially cylindrical
sleeve mount comprises a mount thickness and a mount length,
wherein the mount thickness and mount length are sized such that
during sleeve installation on the sleeve mount the sleeve inner
wall interferes with the outer surface of the sleeve mount upon the
substantially cylindrical sleeve mount entering the sleeve
lumen.
5. The aspirator of claim 4 wherein interference between sleeve
inner wall and the outer surface continues along the mount length
during the installation, wherein the installation is complete when
the sleeve rim contacts the shoulder.
6. The aspirator of claim 2 further comprising: an elastic sleeve,
the elastic sleeve defining a plurality of vent holes, a sleeve
lumen and a sleeve inner wall, the elastic sleeve comprising a
sleeve tip and a sleeve rim, wherein the sleeve rim defines a
sleeve opening, wherein the sleeve lumen is sized to receive the
tubular member and to interfere with the outer surface of the
sleeve mount upon the sleeve mount entering the sleeve lumen.
7. The aspirator of claim 6 wherein interference between sleeve
inner wall and the outer surface continues along an engagement
length during installation, wherein the installation is complete
when the sleeve rim contacts at the shoulder.
8. The aspirator of claim 1 wherein the substantially cylindrical
sleeve mount has a longitudinal axis, wherein an angle of taper of
the outer surface of the substantially cylindrical sleeve mount
measured relative to the longitudinal axis is less than about 2
degrees.
9. The aspirator of claim 3 wherein a sleeve engagement zone is
defined by a region of overlap between outer surface and sleeve
inner wall wherein interference between the elastic sleeve and
substantially cylindrical sleeve mount occurs in the sleeve
engagement zone.
10. The aspirator of claim 2 further comprising: a suction head
comprising a body, a distal suction head end face and a proximal
suction head end face, the suction head attached to the distal tube
end; the body defining a primary opening and a suction head bore,
the distal suction head end face surrounding the primary opening,
the proximal suction head end face defining an output aperture, the
output aperture in fluid communication with the suction head bore
and the primary opening; and a plurality of protuberances disposed
radially around the primary opening, each protuberance comprising a
first region and a second region, the first region cantilevered
relative to the distal end face and extending distally relative to
the primary opening, the second region extending from body to
define a ridge.
11. The aspirator of claim 2 further comprising: a suction head
defining an opening and a suction head bore, the opening in fluid
communication with the suction head bore, the suction head attached
to the distal tube end, the suction head comprising a plurality of
protuberances symmetrically arranged around the opening, each of
the protuberances being an extension of a surface of the suction
head in one or more directions.
12. The aspirator of claim 2 wherein the fluid flow cavity is
further defined by the suction connector bore; an elongate section
of the tubular member bore disposed in the handle and in fluid
communication with the suction connector bore; and a transitional
cavity disposed between the suction connector bore and the elongate
section of the tubular member bore, the transitional cavity
disposed within the handle.
13. The aspirator of claim 12 wherein a diameter of the
transitional cavity is less than a diameter of the suction
connector bore at interface of transitional cavity and suction
connector bore.
14. The aspirator of claim 3 further comprising: a tubular member
extending from the aperture, wherein the tubular member comprises a
proximal tube end and a distal tube end, and a suction head
attached to a distal tube end, wherein an engineered clearance
distance is defined between a surface of the suction head and an
inner surface of the sleeve such that a skewing angle is
constrained when elastic sleeve is installed on handle, wherein the
tubular member comprises a bend.
15. The aspirator of claim 14 wherein the skewing angle is defined
by longitudinal axis of the tubular member proximal to the bend and
longitudinal axis of sleeve distal to the bend.
16. The aspirator of claim 2 further comprising a tubular member
defining a bend, the tubular member comprising a proximal tube end
and a distal tube end, the proximal tube end disposed in the
handle, the tubular member extending from substantially cylindrical
sleeve mount, wherein a section of the tubular member distal to the
bend defines a tubular longitudinal axis, wherein the substantially
cylindrical sleeve mount is sized to receive an elastic sleeve such
that the bend is disposed within the sleeve.
17. The aspirator of claim 14 wherein a section of the elastic
sleeve distal to the bend defines a sleeve longitudinal axis,
wherein a clearance is defined between a sleeve inner surface of
the elastic sleeve and an outer surface of the tubular member by a
skewing angle between the longitudinal axis and the sleeve
longitudinal axis.
18. The aspirator of claim 5 wherein the interference is a nominal
interference of the sleeve inner wall to a mating diameter of the
outer surface of the sleeve mount, wherein the nominal interference
ranges from about 0.010 inches to about 0.020 inches.
19. The aspirator of claim 7 wherein the engagement length ranges
from about 0.400 to about 0.800 inches.
20. A method of providing tactile feedback for an aspirator
comprising: providing an aspirator sleeve comprising a sleeve wall,
the sleeve wall defining a sleeve cavity and a proximal sleeve end
face; providing an aspirator handle comprising a substantially
cylindrical sleeve mount and a tubular member, the tubular member
extending from the substantially cylindrical sleeve mount;
initiating interference between sleeve wall and substantially
cylindrical sleeve mount when sleeve mount enters the sleeve
cavity; and maintaining interference between sleeve wall and
substantially cylindrical sleeve mount from initiation of
interference until the aspirator sleeve is installed.
21. The method of claim 20 wherein maintaining interference further
comprises varying level of interference while maintaining
interference over a first portion of an engagement distance along
the sleeve mount.
22. The method of claim 21 wherein varying level of interference
further comprises increasing the level of interference in response
to a first range of assembly forces over the first portion of
engagement distance along the sleeve mount.
23. The method of claim 22 wherein varying level of interference
further comprises increasing level of interference in response to a
second range of assembly forces over a second portion of engagement
distance along the sleeve mount.
24. The method of claim 23 wherein a first rate of increasing
assembly force for the first portion of the engagement distance is
greater than a second rate of increasing assembly force for the
second portion of the engagement distance.
25. The method of claim 24 wherein the first portion of the
engagement distance includes a region of the outer surface that
initially interferes with substantially cylindrical sleeve
mount.
26. The method of claim 24 wherein the second portion of the
engagement distance includes a region of the outer surface that is
bounded proximally by a shoulder of the handle.
27. The method of claim 20 further comprising moving substantially
cylindrical sleeve mount into sleeve cavity over an engagement
distance until aspirator sleeve is installed on substantially
cylindrical sleeve mount, wherein interference occurs over the
engagement distance.
28. The method of claim 20 further comprising, in response to
installation of sleeve on sleeve mount by a user, providing the
tactile feedback to the user during installation until the sleeve
is fully engaged relative the sleeve mount.
29. The method of claim 20 wherein the tactile feedback is an
assembly force, wherein the assembly force provided to the user is
increasing until the sleeve reaches a shoulder disposed around the
sleeve mount.
30. The method of claim 20 wherein the interference is maintained
over an engagement length that ranges from about 0.400 to about
0.800 inches.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of priority under 35
U.S.C. 119(e) from U.S. Provisional Application No. 62/364,653
filed on Jul. 20, 2016, the disclosure of which is herein
incorporated by reference in its entirety.
BACKGROUND
[0002] A number of different devices may be used to remove fluids
from a cavity, or other region of a patient, during a medical
procedure. Often these devices will implement removal via suction.
In general, devices used for producing suction, moving material by
suction, or collecting material by suction, such as various types
of aspirators, have remained largely the same since their initial
development. Typically, a hollow tubular instrument is connected to
a partial vacuum. The partial vacuum creates suction through the
tubular instrument, thus removing fluid, tissue, or other material
from a cavity or region of the body.
[0003] An aspirator typically includes a tip that is inserted into
a surgical site, wound, or other bodily hole. The tip is generally
elongated in shape and may include a handheld or grip section to
facilitate using the aspirator. The proximal end of the tip is
connected to a tube connected to a suction pump, providing the
partial vacuum and thus suction to the tip. During use, the distal
end of the aspirator tip is inserted into the patient. This distal
end may have one or more openings into which gases, fluids, and
materials may flow.
[0004] During operation, pieces of tissue and other debris may be
suspended in the bodily fluid, thus clogging the aspirator. In
addition, as is typically the case, surgical irrigation is used to
wash a wound, tissues, organs and surgical cavities as part of
various medical procedures. As a result, irrigation solution is
introduced into the body, which is typically removed at a later
stage. Various materials can also become entrained in the
irrigation solution. There are various ways in which fluid flow can
be interrupted or aspirator ports can be clogged during aspirator
operation.
[0005] For example, openings at an end of the aspirator, the
location where fluid first enters the device, are particularly
vulnerable to clogging. One solution to this problem involves
covering the distal end of the aspirator with a sleeve formed with
a plurality of small holes. The plurality of small holes may
prevent the tissue from reaching the opening of the aspirator.
However, the plurality of small holes may still allow the fluid
sleeve to become clogged. As the fluid sleeve becomes clogged,
suction is no longer distributed uniformly among the remaining
unclogged holes. This condition may create additional undesirable
suction in a particular area, thus pulling surrounding tissue into
the holes of the sleeve and simultaneously blocking or otherwise
reducing the suctioning of unwanted material during the
procedure.
[0006] One solution to this problem of clogging involves including
additional holes in the end of the aspirator, near the connection
between the sleeve and the aspirator. Because these additional
holes are spaced from the wound, bodily hole, or surgical site, the
additional holes are less likely to become clogged with tissue or
debris. However, these holes are often vulnerable to obstruction by
the hands or fingers of the user (e.g., by the hand holding the
aspirator). Likewise, these holes may be obstructed or blocked when
resting the aspirator and sleeve combination against another
object, such as the patient's body, a table, or dressings
surrounding the surgical site. Further, given the introduction of
an irrigation solution and the entrainment of material therein, the
potential exists for unintentionally suction applied to tissue and
tearing at tissue surface or otherwise damaging it through the
process of removing unwanted material from a surgical site using a
suction device.
[0007] Therefore, a need exists for improved surgical aspirator and
sleeve combinations that address these challenges and others
relating to a user's tactile user experience when using such
combinations and as otherwise described in more detail herein.
SUMMARY
[0008] In part, the disclosure relates to an aspirator having a
handle that includes a suction connector extending from a proximal
end face, a substantially cylindrical sleeve mount having an outer
surface and a shoulder. A tubular member defining a bore and having
flared end disposed in a suction head having one or more
cantilevered protuberances can extend from the sleeve mount. The
substantially cylindrical sleeve mount is in relief with respect to
the shoulder and extends distally therefrom. The substantially
cylindrical sleeve mount defines an aperture. The suction connector
bore, bore of tubular member, inner cavity of handle and suction
head bore define a fluid flow path or cavity. The aspirator can
include a sleeve that receives the suction head. The sleeve engages
and interferes with the sleeve mount. The suction head and sleeve's
inner wall have one or more engineered clearances between them to
enhance assembly. In one embodiment, the disclosure relates to a
sleeve and aspirator combination or assembly. In one embodiment,
the disclosure relates to a sleeveless actuator or suction
device.
[0009] In part, the disclosure relates to various aspirator
interference fit and assembly features and related embodiments.
[0010] In part the disclosure relates to an aspirator. The
aspirator includes an elongate handle defining an fluid flow
cavity, the elongate handle includes a proximal end face, a suction
connector extending from the proximal end face, a substantially
cylindrical sleeve mount includes an outer surface, and a shoulder,
wherein the substantially cylindrical sleeve mount is in relief
with respect to the shoulder and extends distally therefrom,
wherein the substantially cylindrical sleeve mount defines an
aperture, wherein the suction connector defines a suction connector
bore, the suction connector bore in fluid communication with the
aperture and the fluid flow cavity.
[0011] The aspirator may also include a tubular member extending
from the aperture, wherein the tubular member includes a proximal
tube end and a distal tube end, wherein the proximal tube end is
disposed in and secured by the handle, the tubular member defining
a tubular member bore, the tubular member bore in fluid
communication with the flow cavity and suction connector bore. The
aspirator may also include an elastic sleeve, the elastic sleeve
defining a plurality of vent holes, a sleeve lumen and a sleeve
inner wall, the elastic sleeve includes a sleeve tip and a sleeve
rim, wherein the sleeve rim defines a sleeve opening.
[0012] In one embodiment, the substantially cylindrical sleeve
mount includes a mount thickness and a mount length, wherein the
mount thickness and mount length are sized such that during sleeve
installation on the sleeve mount the sleeve inner wall interferes
with the outer surface of the sleeve mount upon the substantially
cylindrical sleeve mount entering the sleeve lumen. In one
embodiment, interference between sleeve inner wall and the outer
surface continues along the mount length during the installation,
wherein the installation is complete when the sleeve rim contacts
the shoulder. In one embodiment, the aspirator may also include an
elastic sleeve, the elastic sleeve defining a plurality of vent
holes, a sleeve lumen and a sleeve inner wall, the elastic sleeve
includes a sleeve tip and a sleeve rim, wherein the sleeve rim
defines a sleeve opening, wherein the sleeve lumen is sized to
receive the tubular member and to interfere with the outer surface
of the sleeve mount upon the sleeve mount entering the sleeve
lumen.
[0013] In one embodiment, the interference between sleeve inner
wall and the outer surface continues along an engagement length
during installation, wherein the installation is complete when the
sleeve rim contacts at the shoulder. In one embodiment, the
substantially cylindrical sleeve mount has a longitudinal axis,
wherein an angle of taper of the outer surface of the substantially
cylindrical sleeve mount measured relative to the longitudinal axis
is less than about 2 degrees. In one embodiment, a sleeve
engagement zone is defined by a region of overlap between outer
surface and sleeve inner wall wherein interference between the
elastic sleeve and substantially cylindrical sleeve mount occurs in
the sleeve engagement zone. In one embodiment, the distal tube end
is flared.
[0014] The aspirator may also include a suction head includes a
body, a distal suction head end face and a proximal suction head
end face, the suction head attached to the distal tube end; the
body defining a primary opening and a suction head bore, the distal
suction head end face surrounding the primary opening, the proximal
suction head end face defining an output aperture, the output
aperture in fluid communication with the suction head bore and the
primary opening; and a plurality of protuberances disposed radially
around the primary opening, each protuberance includes a first
region and a second region, the first region cantilevered relative
to the distal end face and extending distally relative to the
primary opening, the second region extending from body to define a
ridge.
[0015] The aspirator may also include a suction head defining an
opening and a suction head bore, the opening in fluid communication
with the suction head bore, the suction head attached to the distal
tube end, the suction head includes a plurality of protuberances
symmetrically arranged around the opening, each of the
protuberances being an extension of a surface of the body in or
more directions. In one embodiment, the fluid flow cavity
transports one or more fluids including, without limitation,
liquids, gases, and the foregoing with one or more solid materials
disposed therein.
[0016] In one embodiment, the flow cavity of the handle is also
defined by a proximal cavity, a distal cavity, and a middle cavity
disposed between the distal cavity and the proximal cavity. In one
embodiment, a diameter of the middle cavity is less than diameter
of proximal cavity at interface of middle cavity and proximal
cavity. The aspirator may also include a suction head attached to
the distal tube end, wherein an engineered clearance distance is
defined between a surface of the suction head and an inner surface
of the sleeve such that a skewing angle is constrained when elastic
sleeve is installed on handle, wherein the tubular member includes
a bend.
[0017] In one embodiment, the fluid flow cavity is further defined
by the suction connector bore; an elongate section of the tubular
member bore disposed in the handle and in fluid communication with
the suction connector bore; and a transitional cavity disposed
between the suction connector bore and the elongate section of the
tubular member bore. The transitional cavity is disposed within the
handle in one embodiment. In one embodiment, a diameter of the
transitional cavity is less than a diameter of the suction
connector bore at interface of transitional cavity and suction
connector bore.
[0018] In one embodiment, the skewing angle is defined by
longitudinal axis of the tubular member proximal to the bend and
longitudinal axis of sleeve distal to the bend. The aspirator may
also include a tubular member defining a bend, the tubular member
includes a proximal tube end and a distal tube end, the proximal
tube end disposed in the handle, the tubular member extending from
substantially cylindrical sleeve mount, wherein a section of the
tubular member distal to the bend defines a tubular longitudinal
axis, wherein the substantially cylindrical sleeve mount is sized
to receive an elastic sleeve such that the bend is disposed within
the sleeve.
[0019] In one embodiment, a section of the elastic sleeve distal to
the bend defines a sleeve longitudinal axis, wherein a clearance is
defined between a sleeve inner surface of the elastic sleeve and an
outer surface of the tubular member by a skewing angle between the
longitudinal axis and the sleeve longitudinal axis.
[0020] In one embodiment, the interference is a nominal
interference of the sleeve inner wall to a mating diameter of the
outer surface of the sleeve mount, wherein the nominal interference
ranges from about 0.010 inches to about 0.020 inches. In one
embodiment, the engagement length ranges from about 0.400 to about
0.800 inches.
[0021] In part, the disclosure relates to a method of providing
tactile feedback for an aspirator. The method includes providing an
aspirator sleeve includes a sleeve wall, the sleeve wall defining a
sleeve cavity and a proximal sleeve end face; providing an
aspirator handle includes a substantially cylindrical sleeve mount
and a tubular member, the tubular member extending from the
substantially cylindrical sleeve mount; initiating interference
between sleeve wall and substantially cylindrical sleeve mount when
sleeve mount enters the sleeve cavity; and maintaining interference
between sleeve wall and substantially cylindrical sleeve mount from
initiation of interference until the aspirator sleeve is
installed.
[0022] In one embodiment of the method, maintaining interference
may also include varying level of interference while maintaining
interference over a first portion of an engagement distance along
the sleeve mount. In one embodiment of the method, varying level of
interference may also include increasing the level of interference
in response to a first range of assembly forces over the first
portion of engagement distance along the sleeve mount. In one
embodiment of the method, varying level of interference may also
include increasing level of interference in response to a second
range of assembly forces over a second portion of engagement
distance along the sleeve mount.
[0023] In one embodiment of the method, a first rate of increasing
assembly force for the first portion of the engagement distance is
greater than a second rate of increasing assembly force for the
second portion of the engagement distance. In one embodiment of the
method, the first portion of the engagement distance includes a
region of the outer surface that initially interferes with
substantially cylindrical sleeve mount. In one embodiment of the
method, the second portion of the engagement distance includes a
region of the outer surface that is bounded proximally by a
shoulder of the handle. In one embodiment of the method, the method
may also include moving substantially cylindrical sleeve mount into
sleeve cavity over an engagement distance until aspirator sleeve is
installed on substantially cylindrical sleeve mount, wherein
interference occurs over the engagement distance.
[0024] In one embodiment of the method, the method may also include
selecting sleeve and selecting handle such that when sleeve is
installed on substantially cylindrical sleeve mount, a combination
of sleeve and handle has appearance of a Poole suction device. In
one embodiment of the method, the method may also include in
response to installation of sleeve on sleeve mount by a user,
providing tactile feedback to the user during installation until
the sleeve is fully engaged relative to the sleeve mount.
[0025] In one embodiment of the method, the method may also
include, in response to installation of sleeve on sleeve mount by a
user, providing tactile feedback to the user during installation
until the sleeve is fully engaged relative the sleeve mount. In one
embodiment of the method, the tactile feedback is an assembly
force, wherein the assembly force provided to the user is
increasing until the sleeve reaches a shoulder disposed around the
sleeve mount. In one embodiment of the method, the interference is
a nominal interference of the sleeve wall to a mating diameter of
the substantially cylindrical sleeve mount, wherein the nominal
interference ranges from about 0.010 inches to about 0.020 inches.
In one embodiment of the method, the interference is maintained
over an engagement length that ranges from about 0.400 to about
0.800 inches. In one embodiment, the method is a method of
assembling a suction device.
[0026] In part, the disclosure relates to various suction head
features and related embodiments.
[0027] In part, the disclosure relates to a suction apparatus, the
suction apparatus includes a suction head includes a body, a distal
end face and a proximal end face; the body defining a primary
opening and a suction head bore, the distal end face surrounding
the primary opening, the proximal end face defining an output
aperture, the output aperture in fluid communication with the
suction head bore and the primary opening; and a plurality of
protuberances disposed around the primary opening, each
protuberance includes a first region and a second region, the first
region cantilevered relative to the distal end face and extending
distally relative to the primary opening, the second region
extending from body distally from one of the four lobes. In one
embodiment, the second region is a ridge, fin, or other shaped
structure. In one embodiment of the suction apparatus, the
plurality of protuberances is two protuberances. In one embodiment
of the suction apparatus, the plurality of protuberances is four
protuberances.
[0028] In one embodiment of the suction apparatus, the suction head
includes four lobes, wherein the plurality of protuberances is two
or more protuberances, at least one protuberance extends distally
from one of the four lobes. In one embodiment of the suction
apparatus, the suction apparatus may also include a tubular member,
the tubular member includes a flared distal tip, the flared distal
tip disposed in the body in fluid communication with the primary
opening and suction head bore, the tubular member extending from
the output aperture. In one embodiment of the suction apparatus,
the flared distal tip includes a flaring angle, the flaring angle
extending from longitudinal axis of tubular member to inner surface
of flared distal tip, wherein the flaring angle is greater than
about 2 degrees and less than about 40 degrees. In one embodiment
of the suction apparatus, one or more of the first regions
extending distally relative to the primary opening define one or
more flow paths in fluid communication with the output
aperture.
[0029] In one embodiment of the suction apparatus, the one or more
flow paths are also defined relative to a tissue surface, the
tissue surface tented, by one or more of the first regions, to form
at least a portion of the one or more flow paths. In one embodiment
of the suction apparatus, the suction apparatus may also include a
handle includes a substantially cylindrical sleeve mount, wherein
the tubular member includes a proximal tubular member end face,
wherein the proximal tubular member end face is disposed with the
handle, wherein the tubular member extends from the substantially
cylindrical sleeve mount.
[0030] In part, the disclosure relates to a suction apparatus, the
suction apparatus includes a housing includes a distal end face and
a proximal end face, the housing includes a first shape, a central
bore defined by the housing and spanning the proximal end face and
the distal end face, the central bore defining a longitudinal axis
of the suction head, N vent ports arranged in a first configuration
relative to the longitudinal axis, wherein each of the N vent ports
is defined by the housing, and M protuberances arranged in a second
configuration relative to the longitudinal axis wherein each of the
protuberances is defined by the housing, wherein a first portion of
one or more of the M protuberances is cantilevered relative to the
proximal end face.
[0031] In one embodiment of the suction head, one or more of the M
protuberances extend from the housing such that upon tissue contact
the one or more protuberances at least partially define one or more
fluid flow paths. In one embodiment of the suction head, the
suction head may also include a handle member and a tubular member
defining a tubular bore, the tubular member includes a flared end
and a proximal tubular end face, the flared end disposed in the
suction head and in fluid communication with the central bore, the
handle member attached to the proximal tubular end face.
[0032] In one embodiment of the suction head, a flaring angle of
the flared end is less than about 40 degrees. In one embodiment of
the suction head, the housing, the tubular member, and the handle
member are of a unitary construction. In one embodiment of the
suction head, one or more of the M protuberances include a second
region cantilevered relative to and extending radially from a
surface of the housing. In one embodiment of the suction head, the
housing includes two or more lobes, wherein one of the M
protuberances extend from at least one of the two or more lobes. In
one embodiment of the suction head, the second configuration of M
protuberances includes a symmetric arrangement of each of the
protuberances relative to the longitudinal axis.
[0033] In one embodiment of the suction head, M is even, and
wherein a channel is disposed between each pair of protuberances,
the channel defined by the housing, wherein one or more of the N
vent ports is disposed in each channel. In one embodiment of the
suction head, the housing includes four lobes arranged around the
central bore in a cruciform arrangement, wherein M is 2 and the
second configuration includes one of the protuberances extending
distally from at least one of the lobes. In one embodiment of the
suction head, the M protuberances protrude from the proximal end
face of the housing, and wherein the housing defines a plurality of
recessed regions at the proximal end face. In one embodiment of the
suction head, N is a natural number and M is a natural number less
than or equal to eight. In one embodiment of the suction head, the
first shape is selected from the group consisting of a bulb, a
knob, ellipsoidal, a conic section, a frustum, a sphere, a
truncated ellipsoid, a half sphere, and a shape defined by a
surface of revolution.
[0034] In one embodiment of the suction head, the second end of the
housing tapers to a substantially elliptical opening, the
substantially elliptical opening defined by the housing and in
fluid communication with the central bore. In one embodiment of the
suction head, the suction head may also include a tubular member,
the tubular member disposed in the housing and extending through
the substantially elliptical opening, the tubular member in fluid
communication with the central bore and the N vent ports. In one
embodiment of the suction head, the suction head may also include a
handle includes a substantially cylindrical sleeve mount, a tubular
member extending from the handle and having a flared proximal end
face, wherein the housing is secured to the proximal end face.
[0035] In part, the disclosure relates to a suction apparatus, the
suction apparatus includes a body defining a bore, the bore
defining a longitudinal axis, the body having a proximal end and a
distal end, the bore in fluid communication with a central opening,
one or more protuberances arranged around the longitudinal axis,
each of the one or more protuberances being an extension of a
surface of the body in or more directions, wherein a distal end of
each protuberance extends beyond the central opening a distance D;
and a plurality of trenches arranged around the longitudinal axis,
each of the trenches being a deformation of the surface of the
body, wherein the plurality of trenches define a plurality of vent
holes. In one embodiment of the suction apparatus, D ranges from
about 0.002 inches to about 0.1 inches. In one embodiment of the
suction apparatus, the suction head has a cruciform cross-sectional
shape defined by the central opening and four surface extensions of
the housing, wherein the one or more protuberances is two
protuberances or four protuberances.
[0036] In one embodiment of the suction apparatus, the body
includes a ring-shaped distal end face encircling the bore and the
distal end of each protuberance cantilevered relative to the
ring-shaped distal end face. In one embodiment of the suction
apparatus, the distal end of each protuberance is arranged relative
to the central bore such that upon tissue contact the distal end
protuberances define one or more fluid flow paths relative to the
central bore. In one embodiment of the suction apparatus, the one
or more fluid flow paths are also defined by one or more tissue
regions.
[0037] In part, the disclosure relates to various internal
geometric features of a suction handle, associated flow paths and
related embodiments.
[0038] In one aspect, the disclosure relates to an aspirator that
includes: a metal tubular member includes a flared end and a
proximal tubular end, the tubular member defining a bore, the
proximal tubular end includes an inner diameter and an outer
diameter; and an elongate handle includes a distal end face
defining an aperture, the metal tubular member extending from the
aperture, wherein the proximal tubular end, an elongate section of
the bore and the metal tubular member are disposed in the handle, a
suction connector extending from the proximal end face, the suction
connector and the elongate handle defining a first flow cavity, the
elongate handle defining a second flow cavity, the second flow
cavity disposed within the handle, the second flow cavity adjacent
to and in fluid communication with the first flow cavity, the
second flow cavity adjacent to the proximal tubular end and in
fluid communication with the bore, wherein the first flow cavity,
the second flow cavity and the elongate section of the bore define
an inner flow path within the handle.
[0039] The aspirator may also include a suction head defining a
third flow cavity in fluid communication with the inner flow path,
the suction head attached to the flared end. In one embodiment, the
suction head and the handle include a polymer material. In one
embodiment of the aspirator, the first flow cavity has a truncated
cone shape, wherein a diameter of the second flow cavity is less
than diameter of the first flow cavity at an interface of the first
flow cavity and the second flow cavity. In one embodiment of the
aspirator, the distal end face of handle includes a substantially
cylindrical sleeve mount.
[0040] In one embodiment of the aspirator, a diameter of second
flow cavity is greater than the outer diameter. In one embodiment
of the aspirator, interface between first flow cavity and second
flow cavity includes a stepped transition. In one embodiment of the
aspirator, the metal tubular member is a cylindrical tube or a
tapered tube. In one embodiment of the aspirator, the flared end
has a flared outer diameter, wherein the ratio of the flared outer
diameter to the outer diameter of the proximal tubular end is less
than about 1.4. In one embodiment of the aspirator, a length of the
second flow cavity is less than a length of the first flow cavity.
In one embodiment of the aspirator, a length of the elongate
section of the bore in the handle is greater than the length of the
second flow cavity.
[0041] In one embodiment of the aspirator, an inner diameter of the
bore is less than or equal to a diameter of the second flow cavity.
In one embodiment of the aspirator, a curved transition is defined
at a junction of an inner surface of the third flow cavity of the
suction head and the flared end. In one embodiment of the
aspirator, the curved transition is a radius or smooth curve. In
one embodiment of the aspirator, the outer diameter of the tubular
member is greater than or equal to a diameter of the second flow
cavity. In one embodiment of the aspirator, a diameter of first
flow cavity is less than about 0.5 inches, wherein the diameter of
the first flow cavity is widest dimension of inner flow path of
handle.
[0042] In one aspect, the disclosure relates to an aspirator that
includes: a metal tubular member includes a flared end and a
proximal tubular end, the tubular member defining a bore, the
proximal tubular end includes an inner diameter and an outer
diameter; a suction head attached to the flared end, the suction
head defining a suction head bore, the suction head bore in fluid
communication with the bore; and an elongate handle includes a
suction connector, and a section of the tubular member disposed
within the handle, the handle defining a proximal flow cavity
adjacent to and in fluid communication with the suction connector,
the handle defining a transitional flow cavity between the section
of the tubular member and the proximal flow cavity; the section of
the tubular member, the transitional flow cavity and the proximal
flow cavity defining an inner flow cavity in fluid communication
with the bore of the metal tubular member and the suction head
bore, wherein a diameter of transitional flow cavity is less than
diameter of proximal flow cavity at interface of transitional flow
cavity and proximal flow cavity.
[0043] In one embodiment of the aspirator, the flared end has a
flared outer diameter, wherein the ratio of the flared outer
diameter to the outer diameter of the first end is less than about
1.4. In one embodiment of the aspirator, the diameter of
transitional cavity is greater than the outer diameter. In one
embodiment of the aspirator, the interface between transitional
flow cavity and proximal flow cavity includes a stepped transition.
In one embodiment of the aspirator, the tubular member is a
cylindrical tube or a tapered tube.
[0044] In one embodiment of the aspirator, the proximal flow cavity
is a truncated cone. In one embodiment of the aspirator, a curved
transition is defined at a junction of an inner surface of the
suction head bore and the flared end. In one embodiment of the
aspirator, the curved transition is a radius or smooth curve. In
one embodiment of the aspirator, the outer diameter of the tubular
member is greater than or equal to a diameter of the transitional
flow cavity. In one embodiment of the aspirator, the inner diameter
of the tubular member is less than a diameter of the transitional
flow cavity
[0045] In part, the disclosure relates to various suction head,
sleeve and aspirator clearances, skewing angles constrained thereby
and related embodiments.
[0046] In one aspect, the disclosure relates to an aspirator that
includes: a handle includes a shoulder and a sleeve coupler, the
sleeve coupler defining an aperture, the handle and the sleeve
coupler includes a longitudinal axis, wherein the sleeve coupler is
in relief relative to the shoulder; a tubular member defining a
bend, the tubular member includes a proximal tube end and a distal
tube end, the proximal tube end disposed in the handle, the tubular
member extending from the sleeve coupler and the aperture; and a
suction head includes a distal end face, the suction head attached
to the tubular member, wherein a clearance is defined between a
sleeve inner surface of the elastic sleeve and the suction
head.
[0047] In one embodiment of the aspirator, the clearance ranges
from about 0.080 inches to about 0.11 inches, wherein the clearance
is between the distal end face of the suction head and the sleeve
inner surface. In one embodiment of the aspirator, the clearance
ranges from about 0.001 inches to about 0.020 inches, wherein the
clearance is between a side of the suction head and the sleeve
inner surface. In one embodiment of the aspirator, the clearance
ranges from about 0.005 inches to about 0.100 inches, wherein the
clearance is between the distal end face of the suction head and
the sleeve inner surface. In one embodiment of the aspirator, a
section of the tubular member distal to the bend defines a tubular
longitudinal axis, wherein the sleeve coupler is sized to receive
an elastic sleeve such that the bend is disposed within the sleeve,
wherein a section of the elastic sleeve distal to the bend defines
a sleeve longitudinal axis.
[0048] In one embodiment of the aspirator, the clearance constrains
a first skewing angle range between the longitudinal axis and the
sleeve longitudinal axis. In one embodiment of the aspirator, the
first skewing angle range is from about 24.degree. to about
32.degree.. In one embodiment of the aspirator, the first skewing
angle range is from about 33.5.degree. to about 41.5.degree.. In
one embodiment of the aspirator, the first skewing angle range is
from about 32.degree. to about 40.degree.. In one embodiment of the
aspirator, the clearance constrains a second skewing angle range
between a portion of the sleeve and a portion of the tubular member
after the bend.
[0049] In one embodiment of the aspirator, the second skewing angle
range is from about 5.degree. to about 15.degree.. In one
embodiment of the aspirator, the second skewing angle range is from
about 2.degree. to about 6.degree.. In one embodiment of the
aspirator, the elastic sleeve defines a plurality of vent holes, a
sleeve lumen and the sleeve inner surface, the elastic sleeve
includes a sleeve tip and a sleeve rim, wherein the sleeve rim
defines a sleeve opening. In one embodiment of the aspirator, a
distal end face of the sleeve is next to the shoulder, wherein
combination of sleeve and aspirator resembles a Poole suction
device. In one embodiment of the aspirator, a surface of the
tubular member at the bend contacts the sleeve inner surface at one
or more regions.
[0050] In one aspect, the disclosure relates to an aspirator that
includes: an elastic sleeve includes a proximal sleeve end, a
distal sleeve end and an inner sleeve wall, the proximal sleeve end
and inner sleeve wall defining an elongate tapered cavity, wherein
the elongate tapered cavity defines a handle coupling region, a
bend region, a suction head receiving region; and a first clearance
region; and a suction head defining a suction head bore, a distal
suction head end face and an output aperture; a handle includes a
sleeve coupler and a suction connector barb, the handle defining an
elongate cavity, the sleeve coupler defining a handle opening, the
elongate cavity in fluid communication with the handle opening and
the suction connector barb; and a hollow tubular member includes a
flared end, a proximal tubular end and a bend disposed between the
flared end and the proximal tubular end, the flared end extending
from the output aperture, the proximal tubular end extending from
the sleeve coupler, wherein a first clearance distance normal to
distal suction head end face is present in the first clearance
region when sleeve coupler is disposed in the handle coupling
region.
[0051] In one embodiment of the aspirator, the first clearance
ranges from 0.080 inches to about 0.11 inches. In one embodiment of
the aspirator, the elongate tapered cavity defines a second
clearance region, wherein a second clearance distance normal to
surface of tubular member is present in the second clearance region
when sleeve coupler is disposed in the handle coupling region. In
one embodiment of the aspirator, the second clearance region is
disposed between the first clearance region and the bend region. In
one embodiment of the aspirator, the second clearance ranges from
about 0.001 inches to about 0.020 inches.
[0052] In one embodiment of the aspirator, the elastic sleeve has a
first longitudinal axis and a portion of the tubular member after
the bend has a second longitudinal axis, wherein the skewing angle
between the first longitudinal axis and the second longitudinal
axis is greater than about 2 degrees and less than about 10
degrees. In one embodiment of the aspirator, the first clearance
ranges from about 0.005 inches to about 0.100 inches. In one
embodiment of the aspirator, combination of elastic sleeve, suction
head, hollow tubular member and sleeve coupler resembles a Poole
suction device.
[0053] In part, the disclosure relates to a method. The method
includes providing an aspirator includes a sleeve mount and a
tubular member extending therefrom, the tubular member includes a
bend; providing an elastic sleeve defining an opening, an inner
sleeve wall and a lumen to receive the sleeve mount and tubular
member; and skewing the elastic sleeve relative to a portion of the
tubular member distal to the bend by a skewing angle greater than 2
degrees after sleeve mount is installed within the lumen. In one
embodiment, a distal end of the tubular member terminates in a
suction head includes a distal end face, and may also include
maintaining a clearance between the distal end face and the inner
sleeve wall. In one embodiment, the clearance is less than or equal
to about 0.11 inches. In one embodiment, the method is a method to
provide tactile feedback to and end user and ease assembly of
sleeve and sleeve mount. In one embodiment, the method is a method
of assembling a suction device.
Additional Embodiments and Features
[0054] In one embodiment, the aspirators and aspirator components
described herein comprise a polymer. In one embodiment, the
aspirators and aspirator components described herein comprise a
metal. In one embodiment, the aspirators and aspirator components
described herein comprise a polymer and a metal. In one embodiment,
the sleeves described herein comprise and elastic material. In one
embodiment, an aspirator as described herein includes a tubular
member or tube such as a cannula. The tubular member can comprise a
metal. In one embodiment, an aspirator as described herein includes
metal suction head. In one embodiment, an aspirator as described
herein includes a polymer suction head. In one embodiment, the
aspirators described herein comprise a tubular member that includes
a flared end having a flared outer diameter and an inner diameter
and an end having a circular cross-section with an outer diameter
less than the flared outer diameter. In one embodiment, the tube,
the aspirator, and the sleeve are manufactured using one or more
polymers.
[0055] Although, the invention relates to different aspects and
embodiments, it is understood that the different aspects and
embodiments disclosed herein can be integrated together as a whole
or in part, as appropriate. Thus, each embodiment disclosed herein
can be incorporated in each of the aspects to varying degrees as
appropriate for a given implementation. Further, the various
aspirators, sleeves, components, and parts of the foregoing can be
used for medical applications and other applications for fluid
suction and fluid delivery without limitation.
[0056] Other features and advantages of the disclosed embodiments
will be apparent from the following description and accompanying
drawings.
BRIEF DESCRIPTION OF DRAWINGS
[0057] The figures depicted and described herein are not
necessarily to scale, emphasis instead generally being placed upon
illustrative principles. The figures are to be considered
illustrative in all aspects and are not intended to limit the
invention, the scope of which is defined only by the claims.
[0058] FIG. 1 is a side elevational view depicting an aspirator and
an aspirator sleeve suitable for combination, in accordance with an
illustrative embodiment of the disclosure.
[0059] FIG. 2A is a side elevational view depicting the aspirator
of FIG. 1, in accordance with an illustrative embodiment of the
disclosure.
[0060] FIG. 2B is a side elevational view depicting the aspirator
sleeve of FIG. 1, in accordance with an illustrative embodiment of
the disclosure.
[0061] FIG. 3 is a front view depicting an aspirator combined with
an aspirator sleeve, in accordance with an illustrative embodiment
of the disclosure.
[0062] FIG. 4 is a multi-cutaway view depicting aspirator handle
engagement with an aspirator sleeve, in accordance with an
illustrative embodiment of the disclosure.
[0063] FIGS. 5A, 5B, 5C and 5D are a series of multi-perspective
views depicting a suction head suitable for use with an aspirator
and other medical suction devices in accordance with an
illustrative embodiment of the disclosure.
[0064] FIG. 6A is a cutaway side view depicting a distal end of an
aspirator that includes a tubular member and suction head, in
accordance with an illustrative embodiment of the disclosure.
[0065] FIG. 6B is a perspective view depicting a suction head
semi-transparently relative to a tubular member having a flared
tip, in accordance with an illustrative embodiment of the
disclosure.
[0066] FIG. 6C is a side elevational view depicting a tubular
member having a flared tip suitable for use with a suction head, in
accordance with an illustrative embodiment of the disclosure.
[0067] FIG. 6D is a cross-section view depicting an aspirator
engaging an aspirator sleeve, in accordance with an illustrative
embodiment of the disclosure.
[0068] FIG. 7A is a front view depicting an aspirator sleeve, in
accordance with an illustrative embodiment of the disclosure.
[0069] FIG. 7B is a front cutaway view depicting the suction head
of the aspirator, configured to engage with the aspirator sleeve of
FIG. 7A, in accordance with an illustrative embodiment of the
disclosure.
[0070] FIG. 7C is a back view depicting an aspirator sleeve and
inner matting surface thereof, in accordance with an illustrative
embodiment of the disclosure.
[0071] FIG. 8A is a front view depicting the aspirator and
aspirator sleeve, inserted into a wound or surgical incision, in
accordance with an illustrative embodiment of the disclosure.
[0072] FIG. 8B is a front view depicting the suction head of an
aspirator in a sleeveless configuration, inserted into a wound, in
accordance with an illustrative embodiment of the disclosure.
[0073] FIG. 9A is a perspective view depicting an aspirator, in
accordance with an illustrative embodiment of the disclosure.
[0074] FIG. 9B is a perspective view depicting a handle of an
aspirator and the sleeve coupler or mount portion thereof with a
tubular member extending from it, in accordance with an
illustrative embodiment of the disclosure.
[0075] FIG. 10A is a schematic view of a curve in a plane with a
longitudinal axis of rotation in the plane by which a surface or
solid of revolution can be generated to define a flow path within a
handle or other member, in accordance with an illustrative
embodiment of the disclosure.
[0076] FIGS. 10B and 10C are cutaway views depicting an elongate
member such as a handle that includes a fluid flow path that is
suitable for use with various medical devices in accordance with an
illustrative embodiment of the disclosure.
[0077] FIG. 10D is a side cutaway view depicting a suction head
defining a bore attached to a flared tubular member in accordance
with an illustrative embodiment of the disclosure.
[0078] FIGS. 11A, 11B and 11C are cutaway views depicting
engagement of aspirator handle embodiments, two sleeve coupler
embodiments, and sleeve deformation for each of the two coupler
embodiments, in accordance with an illustrative embodiment of the
disclosure.
[0079] FIGS. 12A and 12B are side cutaway views showing the
engagement of an aspirator sleeve and the interference therewith
over an engagement length in accordance with an illustrative
embodiment of the disclosure.
[0080] FIG. 13 is a graph depicting an overview of certain
generalized force-engagement trends to provide context for certain
design features relating to an installation or combination of a
sleeve with an aspirator, in accordance with an illustrative
embodiment of the disclosure.
[0081] FIGS. 14A and 14B are cutaway views depicting bending of an
aspirator after assembly and combination with an aspirator sleeve
and various engineered clearances, in accordance with an
illustrative embodiment of the disclosure.
[0082] FIGS. 15A, 15C and 15D are cutaway views depicting
engagement of a tubular member and suction head of various
aspirator embodiments while engaging with an aspirator sleeve and
various axial and angular relationships, permitted in part based on
an engineered clearance, in accordance with an illustrative
embodiment of the disclosure.
[0083] FIG. 15B is a schematic representation that depicts some of
the various axial and angular relationships of FIG. 15A without the
aspirator and sleeve in accordance with an illustrative embodiment
of the disclosure.
[0084] FIG. 16 is a cutaway view depicting a tubular member and
suction head of an aspirator while engaging with the aspirator
sleeve, in accordance with an illustrative embodiment of the
disclosure.
[0085] FIGS. 17A and 17B are perspective views of two alternative
suction head embodiments suitable for use with an aspirator and
other medical suction devices in accordance with an illustrative
embodiment of the disclosure.
DETAILED DESCRIPTION
[0086] Embodiments of an aspirator will now be described. The
aspirator can be used in combination with or without an elastic
sleeve in various embodiments. Although embodiments of the present
disclosure will be depicted generally as Yankauer or Andrews
aspirators, Poole suction devices, surgical suction catheters and
other suction devices and component devices thereof one skilled in
the relevant art will appreciate that the disclosed embodiments are
illustrative in nature, and therefore, should not be construed as
limited in application or its construction and mechanical and
geometric properties with either a Yankauer or Andrews-type
aspirator, a Poole suction device, other suction devices, other
medical devices and variants of the foregoing.
[0087] The embodiments of the present disclosure have wide
application, and may be used on any similar aspirator and sleeve
combination or as an aspirator without a sleeve, such as a Frazier
aspirator and sleeve combination and other aspirators, surgical
suction catheters, fluid transport devices and components thereof.
Some embodiments of aspirators and aspirator sleeve assemblies are
suitable for use as disposable handheld suction devices. The
suction head described herein can be used in any suitable suction
or spraying application. Further, although generally described in
the context of surgical procedures and medical devices, in part,
the devices and methods described herein also generally relate to
fluid transport and suction devices and thus have applications
outside of the medical field as such devices can be adapted or
configured, whole or in part.
[0088] Accordingly, the following descriptions and illustrations
herein should be considered illustrative in nature, and not
limiting the scope of the invention, as claimed. As used herein,
fluid such as in fluid communication refers to flow paths for
liquids, gases and other materials entrained therein which can flow
through the aspirators described herein.
Introduction to Design Features of Various Embodiments
[0089] In part, the disclosure includes features that relate to an
aspirator having a suction head that can be used with or without
sleeve and various improvements relating to components of the
aspirator and the combination of the sleeve with the aspirator. In
one embodiment, the sleeve is sized and configured to manually
engage a handle member and also secure to the handle and remain
secured during use of the handle-sleeve combination. Thus, in part,
the disclosure relates to improving the process of fitting a sleeve
onto a handle when converting a first handheld suction device into
a combination suction device via the installation of a flexible
sleeve. In one embodiment, the assembly process of engaging and
securing a sleeve and a handheld member converts a first suction
device to a Poole suction device or a variation of a Poole suction
device.
[0090] In one embodiment, installing a sleeve on a handle member is
designed to provide tactile feedback to the user and result in a
gradually increasing engagement and securement rather than
negligible or zero engagement initially followed by an abrupt
engagement and securement as the end of the engagement length. The
sleeve mating area handle is substantially cylindrical in one
embodiment. The method of installation includes fitting a sleeve
over a handle surface such as a sleeve coupler or sleeve mount that
has a substantially cylindrical shape.
[0091] As a result, interference between sleeve and sleeve coupler
of handle occurs upon engagement and continues as sleeve moves
along engagement length of sleeve coupler. The substantially
cylindrical shape is selected to avoid a conical shape and other
undesirable sleeve coupler shapes. In general, the undesirable
sleeve coupler shapes result in an abrupt force increase during the
final steps of the sleeve and handle combination process which is
undesirable to an end user.
[0092] In one embodiment, the nominal interference of the sleeve to
the mating diameter of sleeve coupler ranges from about 0.010 to
about 0.020 inches. In one embodiment, the nominal interference of
the sleeve to the mating diameter of sleeve coupler ranges from
about 0.012 to about 0.040 inches as another embodiment. Prior to
engagement of sleeve and sleeve coupler, and the associated
interference between the two during assembly, it is worthwhile to
consider the engineering of the interference for its tactile
feedback and other advantages. In part, such interference is
defined by the geometry of both the sleeve and the handle mating
areas in their relaxed, never-assembled states. The engagement
length, which includes the mating length, for various aspirator
designs, such as without limitation, the designs shown and
described herein, ranges from about 0.400 to about 0.800 inches. In
one embodiment, the elastic sleeve includes an elastic vinyl or
other elastic polymer suitable for use in a medical application. In
one embodiment, the substantially cylindrical sleeve mount/coupler
includes a rigid plastic. Other rigid polymer-based materials and
other rigid materials can be used in various embodiments.
[0093] In addition, in one embodiment, whether a suction device is
used alone or in combination with a sleeve, the suction devices are
configured to include improvements while retaining familiar shapes
reminiscent of classic suction instrument designs. In one
embodiment, when installing an elastic sleeve relative to or on a
sleeve coupler of the handle of a suction device, the elastic
sleeve conforms to the curvilinear profile of the tubular member
and takes on the appearance of a Poole suction device.
[0094] The shape, sizes, groove and other features of the elastic
sleeve and the handles, tubular members and suction heads and the
associated bends and contours or lack thereof for each of the
foregoing described and depicted herein can vary such that the
appearance and functionality thereof are adapted to a particular
application. In addition, the shapes, sizes, grooves and other
features of a given sleeve and aspirator can be tailored to
replicate those of existing medical devices while incorporating one
or more of the various design improvements described herein.
[0095] In some configurations a sleeve is not used with an
aspirator and the aspirator is used as a medical suction catheter
with handle, a cannula or tubular member, and a suction head. An
exemplary suction head includes a primary opening and a plurality
of protuberances arranged relative thereto. A plurality of vent
holes is defined by the suction head and arranged relative to the
primary opening in one embodiment. In addition, a plurality of
protuberances is arranged relative to the vent holes in a
cantilevered configuration relative to the body of the suction head
and disposed in a geometric pattern such as a symmetric pattern
relative to the primary opening. The suction head embodiments can
be used as a component of an aspirator as described herein. In
addition, the suction head embodiments can be used with any
suitable medical device to provide suction, irrigation, or any
other fluid directing functionality.
[0096] The suction head includes a body such as a housing or
workpiece and can be of various shapes and includes smooth surfaces
that define holes, cavities, ridges, or other suction head
structures or voids. The suction head can include one or more
protrusions to help prevent obstruction of a fluid transport
channel or port of the suction head.
[0097] In one embodiment, the suction devices described herein
include a handle, a tube, a crowned or cruciform suction head, and
a sleeve. Each of the respect foregoing components of a suction
device can be manufactured using polymers, metals, resins,
laminates, printable materials and combinations and variations of
the foregoing. In one embodiment, two or more of the foregoing
components of a suction device are unitary.
[0098] In various depictions of embodiments in the figures, a
distal direction D and a proximal direction P are shown with arrows
to provide a reference frame. Additional details relating to these
exemplary embodiments and various other embodiments are described
in more detail herein.
Aspirator, Sleeve and Combination Suction Device Features
[0099] FIGS. 1 and 2A show an aspirator 13. An elastic sleeve 40
suitable for use with the aspirator 13 is shown in FIGS. 1 and 2B.
The aspirator 13 can be introduced into a sleeve 40 to form the
surgical aspirator and sleeve combination 30 as shown in FIG. 3.
The sleeve 40 is flexible and includes an inner surface sized to
mate with a sleeve coupler 26, which is a portion of handle 20. The
sleeve coupler 26 is the portion of the handle to which the sleeve
attaches. The sleeve 40 and sleeve coupler interfere upon the start
of engagement when the sleeve facing end face cross the plane of
the proximal end face of sleeve 40a.
[0100] In one embodiment, the handle is a body that includes a
hollow or cavity that spans the length of the handle and is in
fluid communication with a proximal handle opening and a distal
handle opening. This cavity of the handle is formed from one or
more cavities in one embodiment which form a fluid transport path
or channel. A tubular member 14 is attached to a suction head 18.
The combination of sleeve 40 and aspirator 13 is referred to as a
suction set or a combination suction device 30 in one embodiment.
The term suction catheter generally refers to an aspirator which
can include a sleeve or be sleeveless in various embodiments.
[0101] FIG. 2A depicts the surgical aspirator 13. The aspirator 13
generally includes a hollow tubular member 14 that is inserted into
a wound, bodily orifice, or surgical site. Still referring to FIGS.
1 and 2A, the aspirator 13 further includes an enlarged hollow
medial section, or elongated handle member 20. The handle member 20
includes a grip member 22 for gripping the aspirator 13, a barb or
suction tube coupling member 24 that is used to attach the
aspirator 13 to a tube that in turn is connected to a source of
suction (not shown), a sleeve coupler 26 for attaching a sleeve 40
(see FIG. 1) to the aspirator 13. The sleeve coupler can also be
referred to as a sleeve mount or as a male coupling portion of
handle.
[0102] In one embodiment, the sleeve coupler is configured as a
male coupler which is introduced into the lumen of the sleeve at
the sleeve opening but other coupling designs are possible. In one
embodiment, interference between sleeve and sleeve coupler occurs
upon engagement of the sleeve with the substantially cylindrical
shape of the sleeve coupler. In one embodiment, the sleeve coupler
receives and interferes with the inner surface of the sleeve along
an engagement length. Sleeve coupler 26 extends distally from
handle 20 and terminates at a sleeve coupler end face. In one
embodiment, a shoulder 37 is also a component or portion of the
handle 20. The shoulder extends beyond, surrounds the sleeve
coupler, and provides a surface for the sleeve to abut when
combination with the aspirator is complete.
[0103] The handle member 20 and tubular member 14 are constructed
from one or more materials. The materials are a rigid or
semi-rigid, resiliently deformable material that is adaptable for
use in the medical arts. In one embodiment, polymeric or resinous
plastic is used. In one embodiment, a metal is used. Suitable
metals can include stainless steel, nickel plated brass, steel
alloys, brass alloys, nickel allows, and any other metal or
combinations or alloys of metal suitable for a given medical use or
having desirable mechanical properties. The tubular member 14 can
include without limitation a tube, a cannula, a tubular member, a
ferrule, and other elongate objects and combinations thereof.
[0104] The tubular member includes one or more bends 17 in one
embodiment. Any number of combinations of bends 17 can be formed
along the length of tubular member 14. The one or more bends 17 can
include one or more kinks, elbows, corners, and other bends and
directional changes in the tubular member. In one embodiment, the
one or more bends are disposed between the handle and the suction
head. Each bend 17 can vary over any angle range as is desirable
for a given aspirator application. In one embodiment, the bend is
absent or slight such that the tubular member 14 is substantially
straight.
[0105] As shown in FIGS. 1 and 2A, for example, a suction head 18
is disposed at the end of the tubular member 14 in various
embodiments. The suction head embodiments described herein such as
suction head 18 and other generalized embodiments in which a
suction head 180 is shown are not limited to a particular suction
device, sleeve, handle or tubular but can be used as part of any
fluid transport medical device without limitation.
[0106] The sleeve coupler 26 can have a continuous smooth or
patterned surface or it can be formed from ridges or plates or
subsections such that gaps and grooves are present in its surface.
In one embodiment, sleeve alignment grooves 56 may be formed on the
sleeve coupler 26. The sleeve alignment grooves 56 are formed in
the proximal end of the sleeve coupler 26, and extend a
predetermined distance toward the distal end of the sleeve coupler
26. The sleeve alignment grooves 56 are formed on opposite sides of
the sleeve coupler 26. The sleeve alignment grooves 56 may have any
cross-sectional shape, but preferably have a cross-sectional shape
that is generally U-shaped, V-shaped, W-shaped, X-shaped, arcuate
or other suitable groove shape without limitation. In some
embodiments, no such grooves are present. The outside surface 28
has a cross-sectional profile.
[0107] In one embodiment, the cross-sectional profile is
substantially cylindrical. This cross-sectional profile extends
between the shoulder of the handle and the end face of the sleeve
coupler in one embodiment such that the sleeve coupler has a
substantially cylindrical shape. In one embodiment, the sleeve and
handle are designed such that a portion of the sleeve fits within a
portion of the handle. In one embodiment, the sleeve and handle are
designed such that the sleeve is secured to the handle by a clasp
or another securing device. In one embodiment, the handle includes
an annular fence such that the sleeve fits in between the inner and
outer fence sections of such a fence or is otherwise attached
thereto. Typically, the use of a substantially cylindrical sleeve
mount or coupler is preferred for receiving an elastic sleeve.
[0108] Referring to FIG. 2B, the sleeve 40 may include grooves or
ridges along its external surface as desired to aid in attaching or
removing the sleeve 40. In one embodiment, the sleeve includes one
or more bearing flats on its interior surface. These flats are
configured to align or track with the geometry of the suction head
or any disks or other bodies disposed or suspended relative to the
tubular member 14. In various embodiments, bearing flats are not
used. In one embodiment, the sleeve exterior surface includes
ridges 47 and 52 that extend longitudinally along the length of the
sleeve 40 on both the upper and lower surfaces of the sleeve
40.
[0109] In one embodiment, two center ridges 47 are formed
proximally to one another along the center of both the upper and
lower surfaces of the sleeve 40, wherein such center ridges 47 are
disposed between two lateral ridges 52. In FIG. 7A, a dotted region
80 is shown. This region 80 is an exemplary location where an
optional contact feature can be incorporated in the sleeve 40 or
where the sleeve itself provides contact. The contact feature, in
most cases, is the inside of the sleeve. In various embodiments,
region 80 is simply the inner surface of the sleeve. In one
embodiment, the regions 80 are where the lobes of the suction touch
the inner surface. The region 80 follows the inner, natural contour
of the sleeve.
[0110] In one embodiment, the sleeve 40 may include additional
ribs, ridges, and other projections as well as grooves and
depressions on the sleeve exterior surface to lend structural
support and aid in conducting gases, fluids, and materials into the
interior of the sleeve 40. The sleeve has an inner surface, which
can mate, or couple with member 26 at final position 43 as shown in
FIG. 4. The sleeve coupler 26 enters the volume or lumen of the
sleeve V and thereby interferes with the inner wall of the
sleeve.
[0111] In this way, the sleeve end face 40a contacts or is in close
proximity with shoulder 37 such that engagement stops at final
position 43. The sleeve is stopped from advancing further along the
member 26 because of shoulder 37 in one embodiment. In some
embodiments, such as a sleeve coupler with a conical profile the
sleeve can get stuck before reaching the shoulder 37. As a result,
a substantially cylindrical profile for sleeve couplers is
preferred in various embodiments. The edge of the shoulder 37
completely or partially extends around the border of member 26 in
various embodiments. The sleeve coupler 26 is in relief relative to
the shoulder 37 of the handle.
[0112] In one embodiment, the shoulder effectively operates as a
break that terminates movement of a sleeve when being combined with
a handle via member 26 that has a substantially cylindrical
configuration. In other configurations, such as when member 26 is
designed to have a conical configuration, the increasing force
resulting from the delayed onset of interference during the
sleeve-handle combination process often results in the sleeve
becoming stuck along a length of the conical sleeve mount. As a
result, for a conical sleeve mount, the shoulder often does not
contact the sleeve after combing a sleeve with a handle. In a
preferred embodiment, when sleeve is fully engaged on sleeve
coupler and contacts the shoulder, this provides tactile feedback
to user to indicate that assembly is complete.
[0113] As shown in FIG. 2B, the sleeve 40 includes an elongate,
nominally straight sleeve tubular body that defines an internal
channel having an open, proximal sleeve end face 43 and an enclosed
distal sleeve end portion 45. The end face 43 includes or is
bounded by a lip or rim of the sleeve 40 in one embodiment. End
face 43 of the sleeve includes an annular band or rim, which bounds
the inner surface and lumen of the sleeve. The lip of the sleeve
abuts the shoulder, which presents further sleeve movement during
installation on the aspirator. The sleeve defines a volume or lumen
of the sleeve V that facilitates fluid transport and engagement
with the sleeve coupler 26 at the inner sleeve wall.
[0114] The sleeve 40 also contains a plurality of spaced orifices
or vent holes 62 that allow gases, fluids, and materials to flow
into the interior of the sleeve 40. The orifices or vent holes are
defined by the material(s) of which the sleeve is made. The
orifices or vent holes can include holes, channels, cavities and
other voids or bores that allow fluids to be suctioned or expelled
relative thereto. The orifices 62 are preferably round or ovoid but
other shapes may be used. In one embodiment, the orifices are
opening, hole, aperture, slot, slit, cleft or channel.
[0115] In one embodiment, the orifices or vent holes 62 are sized
to permit the inflow of gases, fluids, and materials of a size that
will not clog the opening 16 in the tubular member 14 (e.g., a
suction head 18) when the tubular member is enclosed by the sleeve
40. Larger materials, on the other hand, such as body tissue, are
unable to pass through the orifices 62 and may clog them. The
suction head 18 is configured to prevent clogging when used without
a sleeve in some embodiments through its various protuberances 17.
In one embodiment, the suction head has a bulbous geometry that
includes two or more groupings of symmetric features defined by the
material used to form the suction head 18.
[0116] In one embodiment, the orifices or vent holes 62 are formed
between the center ridges 47 and the lateral ridges 52 on each side
of the sleeve 40 so that the ridges 47 and 52 may engage the tissue
and form a gap between the tissue and the orifices or vent holes
62, thereby preventing clogging. The orifices 62 on one side of
sleeve 40 are in alignment with orifices or vent holes 62 on the
opposite side of the sleeve.
[0117] The sleeve 40 is preferably constructed from a material
suitably flexible to conform to the shape of tubular member 14
inserted therein and bend as sleeve 40 engages with coupler 26 of
the handle. Suitable materials to construct the sleeve include
rigid or semi-rigid, resiliently deformable materials adaptable for
use in the medical arts such as polymeric or resinous plastic or
other elastic materials. Alternatively, the sleeve 40 may instead
be contoured to match the contours present in the tubular member
14.
[0118] Referring back to FIG. 2A, the sleeve coupler 26 includes an
outside surface 28. The sleeve coupler 26 may be formed in the
distal portion of the handle member 20 or attached to the handle
member 20 as a separate component. Alternatively, the sleeve
coupler 26 may be attached to the tubular member 14 and not
attached to the handle member 20. In a one embodiment, the sleeve
coupler 26 is between about 20 and about 70 mm long in the
longitudinal direction. In one embodiment, the sleeve coupler 26 is
substantially cylindrical.
[0119] Additional details relating to an exemplary substantially
cylindrical coupling member 260 and a non-cylindrical member 265,
which is a conical member in this example, are shown in FIGS. 11A
and 11B and described in further detail below. The associated
deforming effects of such members on a sleeves 1200, 1205 are shown
in FIGS. 11A and 11C with regard to sleeve 1205 (engagement with
substantially non-cylindrical/conical sleeve mount 265) compared
relative to sleeve 1200 (engagement with substantially cylindrical
sleeve mount 260). The left side of FIGS. 11A-11C show a combined
sleeve and sleeve coupler, a sleeve coupler and a deformed sleeve
for a sleeve coupler 260 having a substantially cylindrical
profile. The right side of FIGS. 11A-11C show a combined sleeve and
sleeve coupler, a sleeve coupler and a deformed sleeve for a sleeve
coupler 265 having a conical profile.
[0120] In one embodiment, the coupling member 26 has a
substantially cylindrical shape and generally has the same
cross-section or substantially the same cross-section along its
longitudinal axis. Although some slight tapering is permitted. In
one embodiment, the degree of tapering of a substantially
cylindrical object of the disclosure has an angle of taper of less
than about three degrees measured relative to the longitudinal axis
of the object. In one embodiment, the angle of taper is less than
about 2 degrees measured relative to the longitudinal axis of the
object.
[0121] In alternate embodiments, the cross-sectional areas of the
proximal and distal ends may be approximately equal (e.g.,
substantially cylindrical configuration). In a preferred
embodiment, along its lateral axis, the cross-sectional diameter of
the proximal end of the sleeve coupler 26 is between about 4 and
about 20 mm and the cross-sectional diameter of the distal end is
between about 4 and about 20 mm. The cross-sectional area of the
proximal end sleeve coupler 26 is preferably less than the
cross-sectional area of the distal end of the grip member 22.
[0122] In one embodiment, substantially cylindrical, in the context
of interference fit of an elastic sleeve and sleeve coupling member
means that the fit (e.g., fit between the handle member 20 and the
sleeve 40) mechanically behaves as if the mating surfaces are
approximately cylindrical. As used herein, the term "substantially
cylindrical" means generally having the shape of a cylinder or a
cylindrical shape such that the object resembles a cylinder, but
can have one or more deviations from a true cylinder, either with
or without a contour, as explained herein.
[0123] As reference frame, the cylinder or cylindrical shape of
sleeve coupler 26 can include a longitudinal axis. In one
embodiment, the deviations from a true cylinder are in the radial
direction and can vary along the longitudinal axis. In addition,
due to manufacturing constraints, there may be a conical taper to
the surfaces that are herein referred to as substantially
cylindrical as described herein and may be constrained by angle of
taper or a draft angle. In one embodiment, the draft angle for a
substantially cylindrical object is greater than zero and less than
about 3 degrees. In one embodiment, the angle by which the
substantially cylindrical object tapers relative to a longitudinal
axis thereof ranges from greater than about 0 degrees to about 3
degrees. In one embodiment, a substantially cylindrical sleeve
coupler is a sleeve coupler that avoids the assembly force profile
of a conical or substantially conical sleeve coupler as described
herein.
[0124] The cross-sectional shape of the sleeve coupler 26 may
remain constant or vary (as depicted in FIG. 2A) along the
longitudinal axis within certain thresholds. In one embodiment, the
draft angle of the sleeve coupler is less than or equal to about 4
degrees. The sleeve coupler 26, excluding longitudinal exterior
grooves 74 (described below), may have any cross-sectional shape,
but preferably has a cross-sectional shape that is substantially
cylindrical. The sleeve coupler can have a cross-sectional shape
that is generally round, ovoid, square, rectangular, triangular,
hexagonal, or other closed shape.
[0125] Still referring to FIG. 2A, handle member 20 includes at
least one longitudinal exterior groove 74 extending longitudinally
along the outside surface of handle member 20. In one embodiment,
longitudinal exterior grooves 74 extend from the proximal to the
distal end of sleeve coupler 26. It is appreciated that the grooves
74 may extend from the proximal end of the sleeve coupler 26 and
along only a portion of the sleeve coupler 26. In addition, the
longitudinal exterior grooves 74 extend onto a section of the grip
member 22 from its distal end. Alternatively, separate grooves may
be included in the grip member 22 that are in communication or
intersect with longitudinal exterior grooves 74 on the sleeve
coupler 26. Preferably, longitudinal exterior grooves 74 are
between about 1 and about 7 mm deep and about 1 and about 10 mm
wide, and have any cross-sectional shape such as U-shaped,
V-shaped, M-shaped, or other suitable groove shape.
[0126] The longitudinal grooves 74 may extend along the entire
length of the grip member 22, or, alternatively, may extend along
only a portion of the grip member 22. Referring to FIG. 2A, a first
set 75 of longitudinal grooves 74 are preferably formed along the
top of the grip member 22 and a second set 77 of longitudinal
grooves 74 are formed along the bottom of the grip member 22. Each
set of longitudinal grooves 75 and 77 is shown having three
longitudinal exterior grooves 74; however, fewer or more than three
grooves 74 may instead be used. The first set 75 of longitudinal
grooves preferably extend along only a portion of the grip member
22, and the second set 77 of longitudinal grooves preferably extend
along the entire length of the grip member 22.
[0127] As shown in FIG. 2A, the grip member 22 of the handle 20 may
also include a lateral groove 76 formed along each side of the grip
member 22 lateral to the longitudinal exterior grooves 74. The
lateral grooves 76 may extend along the entire length of the grip
member 22 or only a portion thereof. The lateral grooves 76 provide
traction on the grip member 22 to aid in holding the grip member,
especially when attaching or removing the sleeve 40.
[0128] Still referring to FIG. 2A, the grip member 22 is suitably
sized to be received into an average sized hand but larger or
smaller grip sections may be constructed for larger or smaller
hands respectively. When being held in a typical manner by a user,
the top side of the grip member 22 can be engaged with a user's
thumb, and the bottom side of the grip member 22 is can be engaged
with the remaining fingers. FIG. 1, for example, illustrates a
typical manner of holding the grip member 22 by a user. However, it
should be appreciated that the grip member 22 may be held in any
comfortable, effective manner.
[0129] For instance, the user may instead wrap his entire hand
around the grip member 22 such that the user's fingers engage the
top side of the grip member 22. Generally, the grip member 22 may
be between about 35 and 80 mm long and have a cross-sectional width
between about 12 and about 30 mm and a cross-sectional height
between about 12 and about 30 mm. The grip member 22 may also be
tapered or include contours along its longitudinal axis for a more
comfortable grip.
[0130] In one embodiment depicted in FIG. 3, the combination of an
exemplary embodiment of a sleeve 40 combined with a handle member
20 is shown as combination suction device 30. As shown a
substantially cylindrical sleeve coupler 26 of handle 20 is
disposed within sleeve 40. In one embodiment the device 30 is
designed to resemble a Poole suction device with the bending of the
sleeve being reduced such the sleeve is straightened to the extent
possible. With regard to the device 30 shown, the installation of
the sleeve 40 is achieved by engaging the sleeve's inner surface
with a substantially cylindrical mating region of the handle
member.
[0131] In further detail, the distal end of the grip member 22
abuts the proximal end of the sleeve coupler 42 of the sleeve 40.
Longitudinal exterior grooves extend onto grip member 22 from the
distal end. Air flows through the portion of longitudinal exterior
grooves located in handle member 22 into venting channels. This
configuration may prevent air flow interference by either the hand
of the user or the distal end of the grip member 22; air can freely
flow through the venting channels.
[0132] With the sleeve 40 in place, the distal end of the aspirator
13 and sleeve 40 combination device 30 may be inserted into the
wound, surgical site, or bodily orifice to remove fluids therein.
Suction flows from the suction source, such as a suction pump,
through a tube and into the handle member 20 (as shown in FIG. 1).
The suction head (not shown) provides suction within the sleeve 40
which pulls liquid in through the various orifices of the sleeve.
As shown in FIG. 2A, the barb or suction tube coupling member 24
may include a tiered section that is coupled to the tube and
associated suction source by inserting one or more of the tiers
having a smaller cross-sectional area into the tube. Generally, any
tube coupling mechanism may be used. The tube may be constructed
from any tubular material suitable for transmitting suction forces
to a surgical aspirator and gases, fluids and materials from a
surgical site known in the medical arts.
[0133] Handle member 20 defines one or more bores therein (not
shown in FIG. 3). In one embodiment, the bores are in stacked
arrangement of segments of varying lengths and diameters to define
a fluid flow path or channel. The cavity within the handle 20 can
be defined as a surface of rotation as described in more detail
below. For example, the curve 175a in FIG. 10A can be rotated
relative to a longitudinal axis L.sub.axis such that the fluid flow
path or cavity 175b of FIG. 10B is defined. In one embodiment, the
arrangement of segments resembles the adjacent sections of a
telescope with the diameter of the smaller segment being sized to
fit within the larger diameter of the adjoining section. These bore
segments or elongate cavities are in fluid communication with
suction tube coupling member 24 and suction head 18 in various
embodiments. Additional details relating to this arrangement of
elongate cavity sections to form fluid transport channels are
discussed with regard to FIGS. 10A, 10B and 10C.
[0134] In addition, further details relating to the suction head
and these elongate cavity sections including the interface of the
suction head bore 110d, flared tube end, bore segment disposed in
handle, suction connector bore, and a transitional flow cavity in
between the suction connector bore and the tube bore, and suction
head housing is shown in FIGS. 10B, 10C and 10D. FIG. 10D is a side
cutaway view depicting a suction head defining a bore attached to a
flared tubular member in accordance with an illustrative embodiment
of the disclosure.
[0135] Suction traverses the handle member 20 and into the tubular
member 14. In various embodiments, the suction traverses the
stepped or tiered arrangement of cavities in handle 20. Suction
travels up the tubular member and pulls gases, fluids, and small
materials into the opening 16. The gases, fluids, and materials
inside the sleeve 40 flow from the wound, surgical site, or bodily
orifice into the sleeve 40 through the plurality of orifices 62 and
opening 16. If the orifices 62 become clogged, such that the flow
of gases, fluids, and materials into the interior of the sleeve 40
is at least partially restricted, air flow is available to the
sleeve through the venting channels. Air provided by the venting
channels may prevent uneven distribution of suction forces over any
unclogged orifices 62. Otherwise, if the suction force is
concentrated over too few orifices 62, the tissue surrounding the
wound could be pulled into the orifices 62 in the sleeve 40 causing
discomfort, pain, and injury to the patient.
Engagement Between Surgical Aspirator Handle and Sleeve
[0136] Referring now to FIGS. 3 and 4, the sleeve 40 slides over
the tubular member 14 of the aspirator 13 so that the tubular
member 14 is encased by the sleeve 40. Generally, the sleeve 40 is
attached to the aspirator 13 at the handle member 20 by a coupling
device. The coupling device includes a sleeve coupling member such
as the sleeve coupler 26, shown in FIGS. 2A, 4 and 11A and 11B, and
a sleeve coupling member such as the sleeve coupler. The sleeve
coupler 26 is received into the proximal end face of the sleeve,
which has an inner lumen or receiving volume V to receive the
suction head and tubular next member.
[0137] As shown in FIG. 3, a coupled region 70 is formed where the
sleeve coupler 26 is inserted into the sleeve coupler 26 and span
an engagement length EL along the coupler 26. In one embodiment,
the sleeve 40 and the sleeve coupler 26 of the handle are designed
such that interference commences as soon as the outer surface of
the sleeve coupler 26 enters the cavity of the sleeve 40 or
otherwise is aligned with and initially contacts the inner wall or
rim of the sleeve 40. As depicted in FIG. 4, the sleeve 40 is
attached to the handle member 20 at the proximal sleeve end face 43
of the sleeve 40. Likewise, the sleeve 40 may include a plurality
of orifices 62.
[0138] In one embodiment, members 26 and 40 couple or engage
together such that the elastic sleeve grips and expands to a
substantially cylindrical coupler 26 as the sleeve 40 and sleeve
coupler 26 of the handle interfere over an engagement length of the
coupler. These features are shown in FIG. 3, on the left side of
FIGS. 11A-11C, respectively and in FIGS. 12A and 12B. This process
of installing the sleeve relative to the handle's coupling or
mounting member provides tactile feedback to an end user without
abrupt changes in the installation force profile as shown in FIG.
13. This has the advantage of allowing an end user to securely
couple the sleeve and the aspirator as they move relative to each
other over a distance. This overcomes certain disadvantages with a
conical profile.
[0139] In general, a conical profile is an example of a
non-cylindrical profile. A conical profile of a sleeve mating or
couple member 26 can be used in some embodiments, but this design
has various design limitations that can be overcome using a
substantially cylindrical profile. These can be seen on the
embodiments on the rights side of FIGS. 11A-11C for coupler 265.
Specifically, with a non-substantially cylindrical coupler, an
abrupt spike or increase in the force needed to secure a sleeve to
a conical member occurs during engagement and is jarring to the
touch. Further, the force needed to achieve the majority of the
friction fitting over the remaining short coupling distance
consistent with coupling a sleeve to a conical member, may exceed
the hand strength of various end users.
[0140] In contrast, as disclosed herein pairing of an elastic
sleeve with a substantially cylindrical coupling member of an
aspirator requires less hand strength to complete the friction fit
of the sleeve onto the handle and the tactile experience during the
combination is gradual and less jarring than in the case of a
conical member to sleeve coupling. As a result, substantially
cylindrically shaped sleeve couplers, such as couplers 26, 260 are
preferred in one embodiment. As a related point with regard to the
assembly of the elastic sleeve relative to the handle over the
sleeve coupler, there is hysteresis in the sleeve. Although the
sleeve is not being plastically deformed during assembly, the
interference with the sleeve mount over an engagement distance can
change the shape of the sleeve. Accordingly, after assembly and
removal, the sleeve does not necessarily return to its as-molded
state.
[0141] As shown in FIGS. 5A-5D, an enlarged suction head 180, open
at its distal end, is formed on the distal end of the tubular
member 14. The suction head 18 includes a body or housing 27. The
suction head 180 defines a distal opening or orifice 16 into which
gases, fluids, and materials can flow. The suction head has a
protective role in various embodiments and generally includes
smooth surfaces to avoid cutting or otherwise damaging tissue. In
general, smooth or non-sharp surfaces and surface contours and
transitions are used in a given aspirator and sleeve design.
[0142] The suction head 180 includes one or more flow maintaining
features to avoid tissue damage under various suction scenarios by
pushing tissue out of the way to maintain flow to opening 16 or
other vent holes in the suction head 180. In one embodiment, the
housing is made from a polymer, metal, glass, or other material.
The housing is formed by injection molding in one embodiment. The
body of the suction head is unitary in one embodiment. Other
manufacturing processes can be used in various embodiments. In one
embodiment, tubular member includes a flared end that the suction
head surrounds. This can be achieved via a printing or molding
process or a dip and ablate process in one embodiment.
[0143] In one embodiment, the housing tapers to a substantially
elliptical end opening 16, the substantially elliptical opening
defined by the housing and in fluid communication with the central
bore. The substantially elliptical end opening can be a circle or
substantially circular in one embodiment. With regard to the
various embodiments disclosed herein, a taper can be a curvilinear
taper, a straight taper, or combinations of differing taper
configurations. In one embodiment, the suction head has a shape
corresponding to the revolution of a curve about a longitudinal
axis as shown in FIG. 10A and described herein. In one embodiment,
the suction head has a shape such as for example a cross-sectional
shape that includes one or more of the following shapes: a tear, a
pear, an elliptical shape, a spherical shape, a hemispherical
shape, a conical shape, others shape that lacks sharp edges, an
organic shape similar to the forgoing and combinations of the
foregoing and subsets thereof.
[0144] In one embodiment, the suction head 180 includes
protuberances 17 that are disposed on, extend from, or otherwise
part of the suction head 180. The protuberances are arranged
relative to an end face of the suction head such as a rim or
annular band that surround opening 16. Various types of
protuberances 17 can be incorporated into the suction head to
maintain one or more fluid flow paths even in the event of tissue
or other material blocking other flow paths into opening 16. In one
embodiment, the suction head includes a plurality or protuberances
that are cantilevered from the forward face of the suction head.
This forward face is also referred to herein as a distal end face
and includes the rim or lip of the central opening 16. In one
embodiment, each protuberance can include various surfaces,
regions, or ends. In one embodiment, the distal end of each
protuberance extends beyond the central opening a distance D. D
ranges from about 0.002 inches to about 0.1 inches in one
embodiment.
[0145] In one embodiment, the protuberances 17 form suction head
grooves 21 there between. The suction head 180 is preferably formed
with two or four suction protuberances 17 such as ridges that are
generally the same size and shape and equidistant from one another,
each ridge 17 being diametrically opposite another ridge 17. The
suction head ridges are used to abut the sleeve 40 to form a gap
between the suction head 180 and the sleeve 40. However, if the
aspirator 13 is used without the sleeve 40, the suction head
protuberances 17 are capable of bridging the adjacent soft tissue
and maintaining the channels in the grooves 21 open for the flow of
fluid, gas, and materials through the channels.
[0146] The suction head 180 may include additional vent ports or
apertures 19. The suction head apertures 19 are formed in suction
head grooves 21, and each suction head aperture 19 extends
laterally through the suction head from a first suction head groove
21 to an adjacent suction head groove 21. FIGS. 5A-5C illustrate
three rows of suction head apertures 19a-19c formed between
adjacent suction head grooves 21a and 21c. Each row of suction head
apertures 19a-19c is positioned approximately parallel to the other
rows. In one embodiment, the suction head apertures have a central
channel that passes all the way through the housing. The central
axis of this channel is approximately perpendicular to the
longitudinal axis of the suction head that passes through opening
16. The suction head apertures 19 intersect the suction head
opening 16, such that the suction head apertures 19 are in
communication with the suction head opening 16. In FIG. 5C, two
protuberances are shown. In other embodiments, three or more
protuberances can be used.
[0147] In this manner, gases, fluids, and materials may flow within
the grooves 21, through the suction head orifices 19, and into the
opening 16 in the distal end of the tubular member 14. Although
three rows of orifices are shown, it is to be understood that other
numbers of rows of orifices 19, either fewer or greater in number,
can be utilized. Also, the orifices are shown as round in
cross-section, but the orifices can be of other cross-sectional
shapes, such as oval, hexagonal, octagonal, etc.
[0148] FIGS. 17A and 17B are perspective views of two alternative
suction head embodiments 186, 188. These suction head embodiments
186, 188 are suitable for use with an aspirator and other medical
suction devices in accordance with an illustrative embodiment of
the disclosure. Each suction head 186, 188 is attached to a tubular
member 14 which can include one or more bends. In one embodiment,
suction head 186 is formed using plastic or other materials as
described herein. In one embodiment, suction head 188 is formed by
insert molding. The suction heads 186, 188 include bores that
terminate at a primary opening 16. Each suction head also includes
one or more surface features such as the protuberances 17 shown.
The protuberances 17 are cantilevered relative to the opening and
radially extend around the bore. A protuberance can range from
about 0.002 inches to about 0.1 inches. In another embodiment, a
protuberance can range from about 0.001 inches to about 0.2
inches.
[0149] The suction heads 186, 188 include a body, which can be
formed from plastic or other materials. The body of each suction
head defines various orifices 19. In one embodiment, the orifices
19 are formed in suction head grooves 21. In one embodiment, each
suction head orifices 19 extends laterally through the suction head
portion from a first suction head groove 21 to an adjacent suction
head groove 21. The open 16 is surrounded by a distal end face
which can be various shapes such as a ring or annular region or an
irregular or rectilinear shape. Various suction heads can be used
with the aspirators described herein and vary in size and
individual dimensions based on the particular suction device design
and application thereof. The suction heads 186, 188 are provided as
further exemplary embodiments.
Fluid Transport and Suction Promoting Tip Embodiments
[0150] As noted herein, various embodiments of suction devices
improve the performance of suction when the surgical aspirator 13
(particularly the suction head 18, 180) is used alone (e.g.,
without the sleeve 40, 1200). In addition, the various types of
suction heads described herein can be used with different aspirator
and other fluid flow directing devices without limitation. In FIG.
6A, as a general embodiment, a bulbous suction head 190 is showed
with a tubular member 140 partially surrounded by the suction head
190. Additional details of various thickness associated with the
flow path of the handle 200 that are in fluid communication with
tubular member 140 are shown in FIGS. 10B and 10C. Still referring
to FIG. 6A, the outer diameter OD of the tubular member 140 is also
depicted herewith.
[0151] The inner diameter of the bore of tubular member 140 is
shown by thickness T3. In general, the thickness of the tubular
member bore T3 is the smallest diameter thickness relative to the
thickness of the suction head bore T4, and the thickness of the
transitional cavity T2 and the thickness T1 of the proximal cavity.
The transitional cavity and the proximal cavity can generally be
referred to as first and second fluid flow cavities (and vice
versa) in one embodiment. The flared lip or edge 102 of the
terminus of the tubular member is shown relative to a dotted
longitudinal axis.
[0152] In one embodiment, the inner flared edge of 102 of member
140 is flared by an angle F relative to the longitudinal axis of
the tubular member. In one embodiment, flaring angle F ranges from
greater than or equal to 0 to about 36 degrees in one embodiment.
In one embodiment, the flaring angle F ranges from about 10 degrees
to about 45 degrees. In one embodiment, the flaring angle F ranges
from about 25 degrees to about 38 degrees. In one embodiment, the
flaring angle F ranges from about 30 degrees to about 37 degrees.
The flaring angle F is selected to provide an attachment site at
the end of tubular member for plastic or other materials to form
around as part of a molding process. In one embodiment, this
process is used to attach a metal tubular member having a flared
end to a suction head such that the suction head surrounds the
flared end and is mechanically fastened thereto. This can be seen
in the partially transparent view of FIG. 6B in which suction head
180 has flared end of tubular member 140 with flaring angle F
disposed therein.
[0153] In addition as shown in FIG. 6A, the bore of the suction
head 193 has a thickness T4. The bore of the suction head 193
terminates at opening 16. The thickness of the bore 193 is greater
than the tube thickness 140. The bore 193 can be defined as a
surface of revolution or a revolute and have various shapes and
configurations. The bore 193 is in fluid communication with the
elongate fluid flow path of the handle of the aspirator. With
regard to FIGS. 10A and 10B, the bore 193 is in fluid communication
with elongates sections 110a, 110b, and 110c. The elongate section
110c defined by the handle is a proximal cavity or fluid flow
cavity 110a. This cavity can include the bore of the suction
connector 250 bore in one embodiment.
[0154] In one embodiment, elongate cavity 110c is defined by the
inner surface of the tubular member 140 and is the bore of that
member 140. This tubular member bore or fluid flow cavity extends
through the tubular member 140 until it undergoes a transition when
it interfaces with flared region 122 of the tubular member as shown
in FIG. 10D. The flared region 122 is part of the suction head,
which also includes a fluid flow cavity in the form of the suction
head bore 110d. The thickness T4 of the suction head bore 193 is
selected to be greater than the thickness of tubular member 140. In
one embodiment, with respect to the zone or region at which the
flared tubular member expands into the suction head 190, a radius
can be defined relative to the bore 193 and the flared lip 102 of
the tubular member 140.
[0155] In one embodiment, the disclosure relates to a suction head
that includes an opening and a plurality of vent holes arranged
relative thereto. In one embodiment, the opening is a central or
primary opening 16. Such an opening is positioned relative to a
distal end face and is the widest opening, port or aperture in the
suction head. The central or primary opening is in fluid
communication with a distal end face and is at least partially
defined by a lip or rim. The distal end face can include an annular
region of the suction head that bounds the primary opening of the
suction head. The suction head can include various protuberances
17, as shown in FIGS. 6B and 7B for example. The protuberances 17
can be aligned to orient with the vent holes, ridges 47 and 52 and
other components of the sleeve. The protuberances 17 are
cantilevered relative to one or more features of the suction head
28 in one embodiment. The plurality of protuberances are disposed
radially around the primary opening in one embodiment. The
plurality of protuberances is 2 in one embodiment. The plurality of
protuberances is 4 in one embodiment. The plurality of
protuberances is one or more in one embodiment. The suction head
body can include one or more lobes.
[0156] In one embodiment, one or more of the lobes is aligned with
or terminates at a protuberance. Two protuberances aligned with two
lobes of a suction head can be seen in the embodiment of FIG. 5C.
In one embodiment, the suction head includes two or four
second-region protuberances and two or more lobes. In one
embodiment, the top and bottom lobes have first region
protuberances. The first region protuberances are cantilevered
relative to the primary opening in one embodiment. The second
region protuberances extend outward from suction head such as ribs
or fins in one embodiment.
[0157] In one embodiment, a pair of protuberances are aligned along
a diameter of the bore of the suction head. In one embodiment, a
pair of lobes of suction head is aligned along a diameter of the
bore of the suction head. In one embodiment, a first pair of lobes
is aligned along a first diameter of the bore of the suction head.
In one embodiment, a second pair of lobes is aligned along a second
diameter of the bore of the suction head. The first and second
diameters can be arranged at an angle such as a 90 degree, 45
degree or another angle. In one embodiment, the first and second
diameters are orthogonal such that the lobes form a cruciform
configuration. In one embodiment, the suction head includes four
lobes and has a cross shape, which each lobe corresponding to an
arm of a cross.
[0158] In one embodiment, the suction head has a crowned feature
formed from a plurality of protuberances, for example, as
illustrated by the exemplary suction head embodiments in FIGS.
5A-5D, 6A and 6B. Specifically, the crowned suction head includes
protuberances or protrusions 17 that prevent the primary suction
hole from being closed off by debris and tissues during use. The
suction head 18 is bulbous and in communication with a tubular
member such as tubular member 14. FIG. 6B shows a suction head 180
with the addition of a tubular member 140. As shown, the flared
portion of tubular member is potted in the suction head to form a
mechanical strong attachment. In one embodiment, the suction head
180 is a bulbous housing or workpiece having one or more
protuberances such as the crown or cruciform embodiments described
herein.
[0159] A protuberance 17 is shown on the top of suction 180 in a
cantilevered configuration relative to opening 16. As shown, the
protuberance 17 extends outward at end 177 past the end face 83 of
the suction head 180. This extension of the protuberance 17
relative to end face 83 helps create a flow channel relative to
opening 16 and tissue as described with regard to FIG. 8B.
Effectively, a protuberance acts like a tent pole that raises the
tissue surface in contact with the suction head during a procedure.
In this way, the portion of the protuberance in contact with the
tissue defines at least a portion of a flow path. Absent the
protuberances, the suction head would apply suction to the tissue
surface and adhere to the tissue when suction is applied via the
barb.
[0160] FIG. 6C illustrates a side elevational view of an exemplary
tubular member 14. The tubular member can include various bends and
curves (not shown) in an embodiment. In the embodiment illustrated
in FIG. 6C, the tubular member 14 has a flared profile. The flaring
angle F is shown. The inner and outer thicknesses of the unflared
portion of the member 14 are T3 and OD as shown. The flared end
face 300 has an outer diameter ODF and an inner diameter IDF.
[0161] The ratio of the outer diameter of flared end of tubular
member (ODF) to the outer diameter of the tubular member OD is less
than or equal to about 1.4. This ratio can also be represented as a
fraction as ODF/OD. This ratio has been determined to be an
advantageous design constraint for various embodiments. The flared
end face 300 helps lock or fasten the suction head 18 (not shown in
FIG. 6C) to the tubular member 14. In one embodiment, the suction
head is molded around end face 300.
[0162] For example, the suction head 18 may include suction head
orifices 19. The suction head orifices 19 are formed in suction
head grooves 21, and each suction head orifices 19 extends
laterally through the suction head portion from a first suction
head groove 21 to an adjacent suction head groove 21. The suction
head protrusions 17 provide adequate spacing between the suction
head orifices 19 on the suction head groove 21 and the surface of
the sleeve 40.
[0163] Referring to FIG. 6C, sleeve 40 may include sleeve alignment
ribs 50 formed along a portion of the interior surface 41 of the
sleeve 40 in the space between the orifices 62. The cross-section
of fluid transport channel or bore is disposed centrally in FIG.
6C. In region 60, fluids or gases are flowing during operation of a
combined sleeve and suction set. The sleeve alignment ribs 50
extend from the proximal end of the sleeve 43 toward the distal tip
sleeve end portion 45. Preferably, two sleeve alignment ribs 50 are
formed on the interior surface of the sleeve 41 on opposite sides
of the sleeve 40. The sleeve alignment ribs 50 taper in height as
the ribs 50 extend toward the distal tip sleeve end portion 45.
[0164] In one embodiment, the sleeve alignment ribs 50 conform or
partially conform to the shape of the sleeve alignment grooves 56,
such that the sleeve alignment grooves 56 may engage with and
receive the sleeve alignment ribs 50 when the sleeve 40 receives
the aspirator 13, as shown in FIG. 3. The sleeve alignment ribs 50
are tapered at the proximal end of the sleeve to form lead-in
portions. The lead-in portions aid in securing the sleeve 40 to the
aspirator 13 by guiding the sleeve alignment ribs 50 into the
sleeve alignment grooves 56.
[0165] The sleeve alignment ribs 50 engage and move relative to the
sleeve alignment grooves 56 so that the sleeve 40 is properly
aligned and coupled to the aspirator 13. In one embodiment, the
sleeve alignment grooves orient the sleeve relative to the handle
and metal tube and the suction head at the end of the tube. The
orientation of the suction head and ridges 17 are set with regard
to the handle and thus can be oriented relative to the alignment
grooves in the handle. When mated or coupled, in one embodiment,
the suction head projections align with the four suction head
protuberances or ridges 17 to form a gap between the suction head
18 and the sleeve 40.
[0166] As discussed with regard to various embodiments, the sleeve
40 and the sleeve coupler 26 of the handle of a given aspirator
embodiment are sized in a plurality of dimensions to cause
interference when combined together. Several zones or regions of
interference 65 are shown in the figure. They are distributed
circumferentially around the inner sleeve wall surface and the
surface of the sleeve mount in one embodiment. As shown, the sleeve
coupler 26 has a surface that has a substantially cylindrical
profile but the surface is not continuous as a result of the
grooves or ridges used to form its structure.
[0167] FIGS. 6D and 7A-7B depict sleeve 40 engagement with the
suction head 18 of the sleeve 40. Additionally, cross-holes remain
properly aligned with longitudinal exterior grooves to ensure
proper venting and air flow into the sleeve 40. Moreover, when the
sleeve alignment ribs 50 are received by and interfere with the
sleeve alignment grooves 56, the sleeve 40 is locked into place and
will not rotate about aspirator 13. Thus, while the aspirator 13 is
being used, the bearing flats will remain abutted to the four
suction protuberances 17, and the cross-holes will remain properly
aligned with longitudinal exterior grooves. In FIG. 6D, alignment
grooves 56 are sized with an engineered clearance relative to the
alignment ribs or tongues 50 such that the two components can align
and mate without interfering.
[0168] To further aid in proper alignment, indicator designs or
indicia may be formed on the sleeve 40 and handle member 20,
respectively. Preferably, the indicator designs comprise an arrow
or other suitable design or indicia. For example, the indicator
design may be in alignment with the center ridges of the sleeve 40
and be in the form of an arrow, with the arrow pointing toward the
proximal end of the sleeve 40. Likewise, for example, the indicator
design may be formed on both sides of the sleeve 40. A similar
indicator design may be formed on the top of the grip member 22, in
alignment with the first set of longitudinal exterior grooves, with
the arrow pointing toward the sleeve coupler 26.
[0169] Either of the two arrows on the sleeve 40 may be aligned
with the arrow on the grip member 22 when inserting the aspirator
13 into the sleeve 40, such that the sleeve may be rotated
180.degree. and still properly mate with the aspirator. The
indicator designs may facilitate proper alignment of the sleeve
alignment ribs 50 with the sleeve alignment grooves 56, thereby
ensuring that the suction head projections align and/or abut the
four suction head ridges 17.
[0170] It should be appreciated that any suitable design or indicia
may be used to guide the insertion of the aspirator 13 into the
sleeve 40. The indicator design is formed in alignment with the
first set 75 of longitudinal grooves 74 on the top of the grip
member 22 such that the first set 75 of longitudinal grooves
extends only partially along the grip member 22 from the distal end
of the grip member 22. It should be appreciated that the indicator
design may instead be formed within the first set of longitudinal
grooves 75 such that the continuity of the longitudinal grooves 75
is not interrupted, and the grooves 75 instead extend along the
entire length of the grip member 22 or a portion thereof.
[0171] FIG. 7C is a back view depicting a surgical aspirator sleeve
40 of FIG. 7A, an exemplary sleeve alignment rib 50, and an inner
matting surface thereof 85. As described herein with regard to
other embodiments, when the handle member engages the sleeve such
that the groove on the handle member aligns with groove 50, the
contacting points C1, C2 of the suction head shown in FIG. 7B are
disposed within the lumen of the sleeve 40 or make contact with the
inner sleeve wall or a feature extended therefrom. In one
embodiment, mating flats or another projection of the inner sleeve
surface can be present at region 80. Thus, alignment at the handle
with respect to the sleeve facilitates suction head alignment. In
turn, this offers advantages in terms of facilitating the aspirator
and metal tube being positioned in the sleeve 40 at a predetermined
position or with a predetermine clearance.
[0172] In one embodiment, as shown in FIG. 7B, the suction head 180
includes a body with various protuberances 17. In one embodiment,
the body includes a bore which provides a fluid transport function.
The body is bulbous fluid flow directing member in one embodiment.
The body can be of various shapes without limitation. Further, as
shown the suction head includes an annular or ring-shaped distal
end face 83 encircling or surrounding the primary suction head
opening or bore 16. To provide greater stability, in one
embodiment, one or protuberances 17 are cantilevered relative to
the ring-shaped distal end face 83 and disposed around opening 16
in a symmetric or patterned arrangement.
Draft Features Relating to Suction Head Embodiments
[0173] In one embodiment, one or more of the components of a given
suction device are formed using a molding process such as injection
molding. For example, in one embodiment the handle component is
molded with two parts of a mold coming together. Because of the
molding process, a parting line is aligned with a plane that
bisects the suction handle. This line and associated plane can
effectively be seen when a witness line is visible on the molded
part. This line on some embodiments of the handle and other molded
parts is referred to as a parting line. The parting line indicates
the plane where the mold separates. A given molded part typically
drafts from this plane. That is, the part has a suitable positive
draft angle so that it can be removed from the mold.
[0174] In one embodiment, there is one parting line or plane that
bisects the handle 20. There is another parting line that is
perpendicular to the axis of the tube inset from the outer most set
of protuberances by a distance of about 0.005 inches to about 1
inches. In one embodiment, the parting line is moved away from
suction head opening 16 to reduce the possibility of any tissue
snagging because of parting line or material arranged or extending
with respect to it from the molding process. In one embodiment,
with regard to the suction head and its associated vent holes, the
draft-axis of a plurality of vent holes is perpendicular to the
parting line.
[0175] Additionally, in a preferred embodiment, the parting line is
not at the rim of the primary opening 16. Rather, the parting line
is back toward the handle 20. By their nature, parting lines may be
sharp. The location of the parting line prevents any kind of sharp
edge on the most used surface of the aspirator 13.
Exemplary Surgical Aspirator and Sleeve Uses
[0176] FIG. 8A depicts a surgical aspirator 13 and surgical
aspirator sleeve 40 that includes one or more of the features and
implementations described herein. In particular, the aspirator 13
and sleeve are shown in a typical application such as a medical
procedure. For example, the surgical aspirator 13 and surgical
aspirator sleeve 40 may be assembled to form a combined suction
device 30. The combined suction device 30 is inserted into a wound
800 of a patient. As shown, the substantially straight orientation
of the device 30 causes it to resemble a Poole suction device. An
example scenario when a crown or cruciform suction head (or other
suction maintaining geometry of suction head configuration) is
suitable for use as part of a medical procedure in is depicted and
described herein with regard to FIG. 8B.
[0177] Referring back to FIG. 1 and FIG. 2A, it should be
appreciated that the longitudinal grooves 74 may be covered with
portions of the hand. For instance, the user may wrap his or her
hand around the grip member 22 such that the palm of the hand
engages the second set 77 of longitudinal grooves 74 and the user's
fingers engage the first set 75 of longitudinal grooves 74.
Moreover, the suction may be varied by using an adjustable sleeve
or other mechanism (not shown) that can be coupled to the grip
member 22 and is adapted to cover at least a portion of the
longitudinal grooves 74 of sets 75 and/or 77.
[0178] For example, the user adjusts the position of his or her
hand as various levels of suction are needed. When the aspirator 13
and sleeve 40 are deep within a patient's body (e.g., wound 800)
such that a majority of the orifices 62 and the cross-holes are
covered by a portion of the patient's body, air flow into the
sleeve 40 is decreased. This may also occur if some of the orifices
62 and/or cross-holes become clogged. Without sufficient venting
into the sleeve 40, the suction level within the interior of the
sleeve 40 increases, and tissue may collapse around the aspirator
and sleeve combination device. To relieve some of the pressure
within the sleeve 40, the user can hold the grip member 22 to cover
only a minimal portion of the longitudinal grooves 74 of sets 75
and 77, thereby allowing air to flow into the sleeve 40 and relieve
some of the pressure on the tissue.
[0179] If, on the other hand, the aspirator 13 and sleeve 40 is
only partially enclosed within the patient's body such that a
majority of the orifices 62 and the cross-holes are exposed to the
atmosphere, air can flow freely into the sleeve 40 to relieve the
pressure within the sleeve 40. As such, the suction level within
the interior of the sleeve 40 may decrease below a threshold level
of interest to a user. To increase the suction within the sleeve
40, the longitudinal grooves 74 of sets 75 and/or 77 can be
increasingly covered by the user's hand until the desired level of
suction is attained.
[0180] Likewise, for example, the aspirator 13 may be used without
the sleeve 40 to accurately and efficiently drain fluids from a
specific area, such as a surgical site such as shown in FIG. 8B.
When placing the suction head 18 within a body cavity, the suction
head protrusions or ridges 17 bridge the adjacent soft tissue and
maintain the channels open in the grooves 21. Thus, if the suction
head opening 16 is clogged, fluid, gas, and materials may flow into
the channels defined by grooves 21 and into the orifices 19. The
suction head opening 16 also can refer to the bore of the suction
head which is in fluid communication with a tubular member in some
embodiments. In one embodiment, the protuberances disposed around
the opening 16 are sized and arranged to form a flow channel in the
presence of tissue that drapes or otherwise contacts the
protuberances during a medical procedure. In one embodiment, tissue
is pinned or isolated away from the suction head and one or more
regions of the tissue cooperate with opening 16 to form a flow
channel.
[0181] If the aspirator 13 is placed within a cavity so that is
oriented substantially orthogonally to a tissue wall, the suction
head opening 16, as well as the orifices 19 adjacent the end
opening, may be elevated from the tissue wall using one or more
protrusions extending from the suction head. In addition, in some
circumstances, the fluid, gas, and materials may flow into the
channels defined by grooves 21 and into the uncovered orifices 19
located father away from the opening 16. In one embodiment, opening
16 is referred to as a main or primary opening.
[0182] FIG. 8B depicts an embodiment of a suction head having a
crowned configuration with the various protuberances shown disposed
in a tissue 805 and fluid 810 containing environment such as cavity
being accessed due to a surgical incision. Various arrows are also
show in FIG. 8B. The arrows indicate the direction of fluid flow or
the application of suction from a remote vacuum source or other
device. A viscous film, semi-liquid layer, or a small pool of
liquid is depicted by a bold curved line 805. When using an
aspirator in suction head-only mode (no sleeve attached), the
suction head and its associate protuberances pushes flexible tissue
away from the main opening of the suction head 16. A crown or
cruciform arrangement of protuberances is suitable for achieving
this as other arrangements of protuberances from a suction
head.
[0183] The pushing away of or gap maintaining of tissue draping
relative to a protrusion or ridge extending from the suction head
is achieved using various protrusions. In one embodiment,
maintaining suction and fluid flow occurs by one or more
protrusions 17 interfacing with tissue or other material to avoid a
planar or continuously smooth contacting surface in favor of
creating gaps and arcuate flow paths on purpose. FIG. 6B shows an
exemplary protrusion 17 relative to end face 83 that can displace
tissue to maintain a flow channel. The gaps and protrusions 17
interfacing with tissue create a frontal area for the fluid to flow
relative to end face 83 and opening 16. Traditional aspirator
suction tips do not have protuberances, and the flexible tissues
surround the hole in the suction tip and seal it much like a
flapper valve or reed valve. The tissue is deformed due to the
presence of the suction head; however, you can also see that the
protuberances keep a path open (frontal area) for fluid flow.
[0184] In one embodiment, the length, width, and height of an
exemplary protuberance range from about 0.001 inches to about 0.20
inches. The protuberances disposed on or formed from or otherwise
constituting a component of the suction head can be any suitable
shape and dimension suitable for use with a suction head. As
examples, protuberances can include, without limitation, bumps,
knobs, tangs, bosses, non-sharp elements, ridges, spheres,
hemispheres, rounded projections and other objects and members. In
one embodiment, the protuberances are sized and shaped to create a
flow channel when in use relative to organs, tissue and other
biological materials and structures.
Assembly Fit Profile/Substantially Cylindrical Configuration
Embodiments
[0185] In one embodiment, the mating surface and associated areas
of the handle member 20 and sleeve 40 may have conical type
configurations (e.g., truncated cone potion with an
increasing/decreasing cross-sectional area along an axis). Conical
configurations, however, often mean that the friction force joining
the handle member 20 and sleeve 40, as an assembly, does not occur
until engagement of the sleeve 40 and handle member 20 is nearly
complete. Also, in certain instances, the aspirator 13 of the
handle member 20 interferes with the end (e.g., distal sleeve end
portion 45) of the sleeve 40 before the sleeve 40 is completely
engaged on the handle member 20.
[0186] One or more features, such as grooves, ribs, struts, or
other structures can be disposed or formed at the distal end of the
sleeve 40 to contact certain areas of the aspirator 13 of the
handle member 20 for engagement purposes. However, these features
may serve to diminish the fluidic performance of the device and
care in their selection and alignment is important. In some
embodiments, these features at the distal end of the sleeve are
avoided because they do not yield a practical benefit, while
simultaneously complicating the manufacturing of the assembly.
[0187] Likewise, these features may introduce tactile ambiguity
during the assembly process (e.g., the engagement) of the sleeve
40. For example, the sleeve 40 is made of a material whereby
shrinkage during injection molding is difficult to predict.
Therefore, it is often the case that the manufactured sleeve 40 is
slightly shorter than initially intended. A short sleeve 40 may
ruin any anticipated assembly tactile feedback. Further, for
features at the closed end of the sleeve, the distal end, to
perform as desired, the sleeve 40 would have to meet the shoulder
37 on the handle 20. In addition, features at the distal end of the
sleeve disposed within the lumen of the sleeve would have to be
contacted simultaneously; given a sleeve 40 that is slightly
shorter than intended, this may be impossible to implement.
[0188] Despite these shortcomings, proper fit engagement between
the sleeve 40 and handle member 20 is possible using various
implementations and constraints. The sleeve 40 is designed to mate
or couple with the handle member 20 at a substantially cylindrical
sleeve coupler 26, 260 and be secured thereby during use of the
handle-sleeve combination such that interference commences with and
continues through sleeve and sleeve coupler engagement.
Accordingly, once the sleeve is secured to the handle, the
frictional forces are such that the two components will not
disengage during a medical procedure unless pulled apart by a
person or device. Additionally, it is preferred that the assembly
process (e.g., the engagement) provide tactile feedback to the
user.
[0189] For example, when the sleeve 40 and handle member are
engaged via a sleeve coupler to form a combined secure assembly of
both components, the user is able to feel or otherwise sense the
gradually increasing friction associated with the mating or
coupling of the components. This relationship is illustrated
graphically by FIG. 13, depicting the force-engagement
relationships for two different coupling member profiles and thus
indicative of a user's tactile experience with such a sleeve and
aspirator combination process. The two force profiles of FIG. 13
also track the engage of the two sleeve coupler designs and
associated sleeves shown on the right (substantially conical) and
left (substantially cylindrical) sides of FIGS. 11A-11C.
[0190] Given the conditions of a procedure room and the prevalence
of fluids, having a comfortable and satisfying process when forming
a suction device by combing an aspirator and sleeve is important.
The embodiments described herein relating to a substantially
cylindrical sleeve coupler design allow a user to complete the
combination of both components and have a level of confidence that
a secure fit has been achieved. This is an advantageous design
feature. In addition, a high level of strength is not required for
a substantially cylindrical sleeve coupler which is unlike various
substantially conical sleeve couplers as illustrated by the
assembly force spikes of FIG. 13.
[0191] The designs disclosed herein address many of the assembly
shortcomings relating to a substantially conical sleeve coupler
such as coupler 265 shown on the right side of FIGS. 11A-11C in
conjunction with sleeve 1205 and handle 1255. In contract, as
illustrated in FIGS. 9A, 9B, and the left side of FIG. 11B,
preferably the mating areas of the sleeve 1200 and sleeve coupler
260 of the aspirator are now substantially cylindrical. FIGS. 12A
and 12B are side cutaway views showing the engagement of an
aspirator sleeve 1200 and the interference therewith over an
engagement length EL that follows which correspond to the sleeve
1200 and sleeve coupler 260 shown on the left side of FIGS.
11A-11C. More particularly, FIGS. 9A and 9B illustrates the
substantially cylindrical profile of the sleeve coupler 260 (e.g.,
the mating area) of the handle member 1250.
[0192] FIG. 9A is a perspective view depicting an aspirator 130
that includes a suction head 18, a tubular member 14, a shoulder
37, a barb 24 for a suction source, a handle 1250 and a sleeve
coupler 260. FIG. 9B is a perspective view depicting the interface
of a tubular member 14 and a handle member of an aspirator 130 and
sleeve coupler 260 and handle 1250. The sleeve coupler 260 and
handle 1250 are also described with regard to the embodiment shown
on the left side of FIGS. 11A-11C and sleeve 1200.
[0193] The handle member 1250, as illustrated in FIGS. 9A, 9B, 12A
and 12B, includes the sleeve coupler 260 and has a shoulder 37. The
handle member 1250 additionally includes tube coupling member 260.
The aspirator may include additional features, as disclosed above,
such as the tubular member 14 and the suction head 18.
[0194] Particular details relating to the engagement of a
substantially cylindrical profile of the sleeve coupler 260 of the
handle member 1250 relative to an alternative embodiment is
illustrated by FIGS. 11A-11C and FIGS. 12A and 12B. FIGS. 11A-11C
includes cutaway views of both a substantially cylindrical
configuration (left) and a substantially conical configuration of
sleeve couplers or mounts 260, 265. The left hand portion of each
of FIGS. 11A-11C shows features relating to an embodiment that
includes a substantially cylindrical sleeve mount or coupler. The
right hand portion of each of FIGS. 11A-11C shows features relating
to an embodiment that includes a non-substantially cylindrical
sleeve mount or coupler such as a conical sleeve mount or coupler.
In one embodiment, an outer surface of the sleeve coupler 260
portion of the handle, which is the portion that contacts the
sleeve, has a cross-sectional profile that is substantially
cylindrical along its length.
[0195] The left side of FIG. 11B shows an exemplary sleeve coupler
260 having a substantially cylindrical profile over an engagement
length EL with an initial engagement point P1 and the end of
engagement occurring at point P2. In FIG. 12A, engagement has
started and sleeve 1200 is interfering with coupler 260 in zone Z1.
The engagement length EL has an initial zone or region Z1 and a
terminal zone or region Z2. The assembly force remains
substantially the same or gradually increases as the sleeve 1200 is
engaged to enter zone Z2 and have engagement terminate at point P2.
FIG. 11C shows a sleeve 1200 having a volume V on the left side.
The sleeve 1200 is slightly deformed by the substantially
cylindrical coupler 260. FIG. 11C shows a sleeve 1205 having a
volume V.sub.con on the right side as significantly and
asymmetrically deformed by substantially conical coupler 265.
[0196] The substantially cylindrical shape of the sleeve coupler
260 is chosen such that the engagement force between the sleeve and
the coupler is gradually increasing as the two are paired with
interference being present through the engagement length EL in both
Z1 and Z2. That said, the assembly force in Z1 and Z2 are not
significantly different so that a sudden force spike does not occur
in Z2. This follows because interference starts from the time of
engagement of the sleeve with the sleeve coupler but the profile of
coupler 260 generally conforms to that of cylinder without
significant deviations.
[0197] In FIG. 11B, the start of this engagement of a sleeve with
substantially cylindrical coupler 260 starts at point P1 with the
sleeve coupler having a thickness H1. Interference starts upon
engagement at P1. With thickness H1, the sleeve 1200 and couple 260
interfere. In contrast with a conical coupler 265 interference does
not commence with engagement at thickness H.sub.2 which is less
than H.sub.1. Instead, with the conical sleeve coupler 265, sleeve
1205 does not interfere with the sleeve coupler 265 over the zone
Z3 at thickness H2, as shown on right side of FIG. 11B, even though
the sleeve 1205 has received the coupler 265. The thickness H2 of
sleeve coupler 265 is not thick enough to engage the sleeve 1205
over region Z3. As a result, given the conical taper of sleeve
coupler 265, any interference and tactile feedback is delayed. When
interference does start, at the end of Z3 or after Z3, the conical
profile causes the forces to suddenly increase.
[0198] A strong assembly force occurs in Z4 as engagement
terminates. Engagement can terminate with coupler 265 prior to
reaching the shoulder because of the high assembly force which must
be overcome to push the sleeve 1255 through Z3. As shown, in FIGS.
11A and 11C, the sleeve 1205 and coupler 265 are trumpet shaped
such that interference does not occur in Z3 and strong assembly
forces are required in Z4. In one embodiment, a substantially
cylindrical sleeve coupler is a sleeve coupler that avoids the
assembly force profile of a conical or substantially conical sleeve
coupler as described herein. This type of coupler can be identified
in like of the description provided herein and the associated force
behavior and unwanted force spikes which are avoided while still
providing tactile feedback over EL.
[0199] FIGS. 12A and 12B are side cutaway views showing the
engagement of an aspirator sleeve and the interference therewith
over an engagement length EL and generally track the substantially
cylindrical assembly of sleeve 1200 and coupler 260 of FIGS.
11A-11C and the related non-quantified assembly force relationship
of FIG. 13. As shown, the sleeve 1200 buts against the shoulder 37
of the handle 20 when engaged (e.g., complete engagement). With a
substantially cylindrical sleeve mount 260 as part of the handle
design, the interference of the sleeve 1200 and handle member 260
increases the separation force with increased engagement as the
sleeve moves along a member of the handle, from the point of first
contact to complete assembly. The assembly force transitions as
sleeve 1200 interferes with sleeve coupler 260 from zone Z1 to zone
Z2 along engagement length EL is a gradual transition and in one
non-limiting embodiment can track the curve G1 shown in FIG. 13. As
noted below, the disclosure is not limited to the relationships of
FIG. 13, but provides them as informative guidance to distinguish
substantially cylindrical and substantially conical sleeve coupler
profiles.
[0200] To further summarize the benefits of using a substantially
cylindrical sleeve coupler some general assembly force versus
sleeve-handle engage are illustrated graphically by FIG. 13. Any
theory, mechanism of operation, proof, or finding stated herein is
meant to further enhance understanding of principles of the present
disclosure and is not intended to make the present disclosure in
any way dependent upon such theory, mechanism of operation,
illustrative embodiment, proof, or finding. With being held to any
particular theory or mechanism, the forces displayed in FIG. 13
relating to combining an elastic sleeve with either a substantially
cylindrical sleeve coupler G1 and a substantially conical sleeve
coupler G2 are meant to illustrate general trends relating to
differences between the respective assembly processes and not
detailed quantitative date.
[0201] The graph shows a plot of assembly force versus
sleeve-handle engagement, comparing substantially conical G2 and
substantially cylindrical G2 profiles for these two types of sleeve
couplers. As illustrated by FIG. 13, with substantially cylindrical
sleeve coupler profile G1, a significant assembly force exists if
there is any engagement (e.g., high initial slope near the start of
engagement). This follows because interference commences with
engagement as discussed herein for such a profile G1. By
comparison, with substantially conical sleeve coupler profiles G2,
for much of the perceived engagement there is negligible force
(e.g., low initial slope near the start of engagement). In
addition, the force near complete engagement for the G2 profile is
significantly larger than that at the start of engagement. This
follows because the thickness of the conical sleeve coupler
typically does not interfere with the sleeve when it first crosses
into the sleeve lumen. In one embodiment, profile G1 is has a force
profile that increases during sleeve engagement and then levels off
as engagement is completed. In contrast, profile G2, has a
gradually increasing force during assembly and then the assembly
force increases significantly at the end of the assembly process.
This results in a user of a substantially conical profile (G2
profile) having excessive force feedback at the end of the process.
This high force profile at the end of assembly may even result in
making assembly impossible. In part, this demonstrates the tactile
feedback and assembly benefits of the substantially cylindrical
profile G1.
Internal Geometry of Handle and Internal Fluid Flow Path Design
Embodiments
[0202] In part, the disclosure relates to an aspirator or other
medical device that includes a flow path through which liquids,
gases, debris, and other material can flow through. In particular,
a handle or other support for a suction device that includes a flow
path disposed therein is one aspect of the disclosure. For some
embodiments, a flow path is formed from one or more cavities or
volumes that are defined by the geometry of the inner walls and
structures of a given handle or other support member. In some
embodiments, the handle or support member are formed by a molding
process. The handle or support member are formed with proximal and
distal end faces that are in fluid communication with a flow path
that is in fluid communication with an aperture or hole defined by
each respective end face. These apertures can be used to connect a
tubular member and a barb, respectively, in one embodiment. The
flow path allows for fluid, gas or other material transport and
spans the inner region of a given handle or support member between
the proximal and distal end faces and their respective
apertures.
[0203] FIG. 10A is a schematic view of a curve 175a in a plane with
a longitudinal axis of rotation in the plane by which a surface or
solid of revolution can be generated to define a flow path within a
handle or other member. The arrows show a direction of rotation
about which the curve can be rotated relative to the longitudinal
axis L.sub.axis. In some embodiments, the flow path is designed to
have a geometric shape that can be defined by a surface of
revolution. A surface of revolution is one or more surfaces of a
solid of revolution. Given that the flow path is one or more
cavities defined by the material of a handle or support member, the
surfaces that define the cavity of the flow path can be surfaces of
revolution. The term revolute can also be used to refer to a
surface of revolution or the shape of the fluid flow path within a
handle or other member.
[0204] The curve used to generate a given surface or solid of
revolution (also referred to as a revolute) can include straight
line segments or curved segments without limitation. The curve 175a
includes linear and curved sections. The surface that results from
rotating the curve 175a about the longitudinal axis is shown as
fluid flow path 175b of handle 240 in FIG. 10B. This flow path
includes the section of the tubular member 140 disposed in the
handle as shown in FIG. 10B. In one embodiment, there is an even
number of cavities defined from the barb 240 to the suction head
180. These are depicted and described in various ways with regard
to FIGS. 10A-10D. These cavities can include the suction head bore
110d, cavity defined by section of tubular member bore disposed in
the handle, and a second flow cavity adjacent thereto and a first
flow cavity that includes the bore of the barb or suction
connector. These cavities are in fluid communication with each
other and define a flow path. A portion of this flow path is
internal to the handle 260. Another portion of this flow path is
external to the handle. The external path includes the section of
the tubular member not disposed in the handle and the suction head
bore as shown in FIG. 10D. FIGS. 10B and 10C illustrate cutaway
views of the handle member 200 and include details relating to the
inner flow path 175b defined by curve 175a and the portion of the
tubular member bore disposed in the handle.
[0205] In one embodiment, the inner flow path 175b can also be
defined by a combination or sum of three elongate adjacent cavities
having differing dimensions. The handle 200 can include a
substantially cylindrical sleeve coupler 260 in one embodiment.
Alternatively, for other support members for other medical devices
that include an inner flow path, a substantially cylindrical sleeve
coupler may or may not be included. The regions of fluid flow shown
relative to the suction head 190 in FIG. 6A such as bore 193 are in
fluid communication with fluid flow path 175b in one
embodiment.
[0206] In FIG. 10B, various subsections of flow path 175b of the
handle member 200 are shown. In one embodiment, the flow path 175b
is a cavity defined by a surface of revolution 175a. In one
embodiment, the flow path 175b is a cavity defined by stacked
arrangement of elongate cavities. Three cavities (proximal/first
fluid flow cavity) 110a, (transitional or second fluid flow cavity)
110b, and segment of bore 110c of tubular member in the handle are
in fluid communication with one another and each have a respective
length L1, L2, L3 and a respective inner thickness T1, T2, and T3.
These three cavities 110a, 110b, and 110c define a flow path. This
flow path continues with the suction head bore 110d that has a
thickness T4. Elongate cavity 110a is a truncated cone in one
embodiment. The material used to make the handle 260 is a polymer
such as a plastic in one embodiment. The handle can be formed
through various molding processes. In addition, the suction head
180 can be formed through various molding processes. In one
embodiment, one or both of the suction head and the handle can be
printed using a 3D printer or other similar manufacturing
process.
[0207] In one embodiment, elongate cavity 110c is either defined by
handle 200 or by a tubular member 140 disposed in the handle 200.
As shown in FIG. 10B, elongate cavity 110c is the inner bore of
tubular member 140. The outer diameter OD of the tubular member 140
is also depicted herewith. The outer diameter OD is selected to be
less than the diameter T4 of the suction head 190 in one
embodiment. Typically, the elongate cavity 110c is defined by a
tubular member 140 having an inner diameter T3 such that the
tubular member 140 is disposed within the handle 200 a distance L3.
In embodiments that do not include a tubular member 140, the length
of cavity 110C is also L3.
[0208] In one embodiment, the transition between elongate cavity
110c and elongate cavity 110b is a junction between a cavity
defined by handle and an inner bore 110c of member 140. In this
way, the handle includes a junction between dissimilar materials in
one embodiment. This junction is formed at the proximal end of the
tubular member 140 and the distal end of elongate cavity 110b. In
one embodiment, the thickness T2 of elongate cavity 110b is
approximately the same distance as the outer diameter of tubular
member 140. In one embodiment, inner diameter of elongate cavity
110b is greater than inner diameter of elongate cavity 110c.
[0209] In the aggregate, from a cross-sectional view, these three
cavity sections 110a, 110b, and 110c form a composite shape. The
composite shape is approximated, from a cross-sectional view, as
three rectangular shapes. The inner diameter of the tubular member
T3 is less than the thickness T2 in one embodiment. As shown in
FIG. 10B, L1 is greater than or equal to L2. L2 is greater than or
equal to L3. L1 is greater than L3. The thicknesses of each section
110a, 110b, and 110c are also increasing when moving from the
tubular member 140 to elongate member 240--that is moving distally
to proximally. In one embodiment, elongate hollow member 240 is
suction port or barb. As shown, T1 is greater than or equal to T2
which in turn is greater than or equal to T3. In one embodiment,
the handle 260 as shown in FIG. 10B includes a metal tubular member
such as tubular member 140. The tubular member has a bore, which
acts as a flow cavity or flow path.
[0210] Inside the handle, this is a fluid flow path. The flow path
can extend through the tubular member bore to the bore of the
suction head in one embodiment. In addition, the handle portion
which surrounds the tubular member effectively defines a tubular
cavity 289 that surrounds and secures the tubular member 140. The
proximal end (right side) has the barb 240 and a proximal cavity or
fluid flow cavity 110a. The tubular cavity 289 is not typically a
flow cavity, with the flow of fluid being carried through the
tubular member 140 disposed in the tubular cavity of the handle
260. [0208] In one embodiment, the stepped or stacked arrangement
of adjacent and continuous cavities 110a, 110b, and 110c is
referred to as a spyglass configuration or spyglass shaped
cavity.
[0211] In one embodiment, the elongate cavities form or define an
internal fluid flow path. The longitudinal axis of the handle,
which is disposed along the internal flow path, is the axis about
which a stepped curve or line is rotated to define a volume within
the handle. This volume is an exemplary internal flow path in one
embodiment. The geometry of the internal flow path is a stepped
revolute in one embodiment. These cylindrical segments effectively
have a spyglass or telescoping or nested arrangement such that each
subsequent segment can nest or fit within the preceding segment
even though the shapes define cavities, which are fixed in the
handle and bounded by the inner surface geometry of the handle 200.
In one embodiment, the handle defines a region of two or more
elongate cavities arranged along a central longitudinal axis or
shifted relative thereto.
[0212] In one embodiment, the stepped features of the flow path
175b of a handle 200 become successively smaller, from proximal end
to distal end, until the last sections of the flow path meets the
tube 140 which has a cylindrical diameter and bore 193 of suction
head (if a suction head is part of the design). Each cavity section
110a, 110b, and 110c can have various cross-sections and need not
be cylindrical. The stepped revolute features of the flow path 175b
may include draft (taper). Flow path section 110a includes a
positive draft angle, and section 110b can optionally include a
positive draft angle. At the junction between 110a and 110b, a
sharp corner or turn or stepped transition 233 is present.
[0213] This in contrast to corner 122a in which a radius or curve
is present and a sharp edge is avoided. T2 is generally a smaller
distance than T1. From the barb end 240, typically there will two
or more cavities. In one embodiment, only three cavities are used
to define the flow path. Also, the diameter of the mouth at the
barb 240 is T1 in some embodiments. The thickness of T1 and the
wall of barb 240 is configured to provide sufficient wall thickness
to allow coupling to a suction source via a conduit or tube that
attaches to barb 240.
[0214] FIG. 10D shows the suction head 180 which is in fluid
communication with the bore 110c of the tubular member 140.
Additional details relating to the suction head 180 and the
elongate cavity sections of handle including the interface of the
suction head bore 110d, flared tube end 122, and suction head
housing is shown. Elongate cavity 110c, which is the inside of the
tubular member 140, is defined by the inner surface of the tubular
member 140. The inner surface of the suction head 179 defines the
suction head bore 110d. The suction head bore 110d is a cavity that
is in fluid communication with elongate cavity 110c of the tubular
member, which the bore of the tubular member. The thickness of the
suction head bore is shown as T4 in FIG. 10D. These two cavities,
179 and 110c come together at a flared region 122 of the tubular
member that has a flaring angle.
[0215] As shown in FIG. 10D, the flared region has a corner 122a or
surface junction 122a that is where inner suction head surface 179
terminates at the flared end of the tubular member which is
disposed in the body of the suction head 180. This corner 122a is a
transitional region and is engineered to be a smooth curve in one
embodiment. With respect to FIG. 10B, in one embodiment, cavity
110d is a cylinder or a cylinder with a taper. The taper can be
greater than or equal to about 0.5 degrees in one embodiment. The
diameter of cavity 110d is greater than the cavity 110c in one
embodiment. Elongate cavity 110a and elongate cavity 110b have a
cavity interface or junction 245. This interface 245 is a
transition from thickness T1 to thickness T2. Elongate cavity 110c
and elongate cavity 110c have a cavity interface or junction 247.
This interface 247 is a transition from thickness T2 to thickness
T4 and T3. Thickness T3, the inner tube diameter, is typically less
than thickness T2.
[0216] In one embodiment, the corner 122a has a curve such a
circular section or sector having a radius, an elliptical section
having an elliptical curve, or another curve. The corner 122a near
the flared region 122 is constrained to avoid a sharp edge or
abrupt transition or step.
Engineered Clearance of Aspirator Sleeve Combination
[0217] After a sleeve is assembled with the aspirator, the proximal
end of the elastic sleeve conforms to the profile of the handle and
is approximately aligned with the handle over a distance from the
shoulder until a bend is encountered along the tubular member. In
one embodiment, as part of the design of the combined sleeve and
aspirator, one more clearances have been engineered into the distal
end or tip of the sleeve. The one or more clearances in this sleeve
area allow the sleeve to have a more gradual bend because of the
skew angle between an axis of the bent sleeve tip and an axis of
the bent distal portion of the tubular member. By constraining this
skewing angle and optionally other skewing angles and clearances,
the angle by which the sleeve bends relative to the longitudinal
axis of the handle is reduced such that the sleeve appears
straighter even though it contains a tubular member with a bend. In
one embodiment, this gradual bend of the sleeve allows the
combination of sleeve and aspirator to more closely follow the
shape of a straight, traditional, Poole suction device.
[0218] Various embodiments of the aspirators described herein
benefit from including an engineered clearance between the suction
head and the inner sleeve wall. For example, this clearance is
typically a gap between the end face of the suction head and the
terminal end of the inner sleeve wall near the end of the elastic
sleeve. This clearance SC is shown in FIGS. 14A, 14B, and 15A, 15C
and 15D. Although SC can also include any clearance distance
between the suction head and the sleeve wall at the distal end of
the sleeve when the suction head is disposed therein after
aspirator sleeve assembly, as shown in FIG. 14A, preferably, SC is
the distance between the inner sleeve wall end portion and an end
face or end region of the suction head or a side clearance relative
to the side of the suction head as shown in FIGS. 14B and 15A, 15C
and 15D. The clearance between the suction head to the inner sleeve
wall SC is advantageous relative to aspirators that lack such a
clearance.
[0219] In various embodiments, as shown for example in FIGS. 14A,
14B, and 15A-15D and other embodiments described and depicted
herein, including a clearance between the suction head and the
inner sleeve wall permits the various skewing angles described
herein. In contrast, for an aspirator and sleeve system that lacks
such a clearance and the associated possible ranges of skewing
angles, there is interference between the suction head and the end
portion of the sleeve. This creates problems such as sticking and
unwanted sleeve bending or extreme hooking when the sleeve and
aspirator are combined to form an assembly.
[0220] In one embodiment, one or more engineered clearances at the
tip area of sleeve allows the axis of the tubular member of the
aspirator after a bend in the tubular member to be askew with the
axis of the sleeve in that area. FIGS. 15A, 15C and 15D show
various embodiments of sleeve and aspirator combinations 500. The
region R1 shows a tubular member and a sleeve aligned before the
bend B. The region R2, after region R1, includes the bending sleeve
and the bend B of the tubular member. In some embodiments, the
sleeve bending occurs before or after the tubular member bend B.
Although discussed in more detail herein, this can be seen with the
axis passing through the bent tubular member shown by line segment
JK as compared to the axis through line segment LN that corresponds
to an axis of the bent sheath 40.
[0221] An exemplary engineered clearance SC associated with the
suction head 18 and its respective engagement with sleeve 40 as
well as various clearances D.sub.fy between the bent tubular member
14 and the inner sleeve wall 143 are shown in FIGS. 14A and 14B.
The engineered clearance SC near the suction head clearance
improves suction and fluid transfer through the sleeve and into
tubular member 14 and results in less friction between the suction
head 18 and the sleeve 40 during sleeve and aspirator coupling. In
one embodiment, the engineered clearances described herein are
greater than about zero to about 0.2 inches.
[0222] In one embodiment, there is an engineered clearance SC,
which is a distance, from a point on suction head, such as a point
on distal end face of suction head, to the distal terminus of the
inner wall of the sleeve. This clearance within the sleeve near its
distal tip as measured from a normal from the distal end face of
the suction head can range from about 0.080 to about 0.11 inches.
In one embodiment, the clearance ranges from about 0.005 inches to
about 0.100 inches, wherein the clearance is between the distal end
face of the suction head and the sleeve inner surface. In one
embodiment, the clearance between inner sleeve wall and a point of
suction head or tubular member ranges from about 0.005 inches to
about 0.100 inches.
[0223] In one embodiment, there is radial engineered clearance SC
extending from a normal to the surface of the tubular member to the
inner sleeve wall of the sleeve. This radial clearance can range
from about 0.001 inches to about 0.020 inches. The various
engineered clearances SC can vary relative to the tubular member,
the suction head, and otherwise within the sheath as space or
clearance is set which permits or constrains various skewing
angles, alone or in combination as design parameters.
[0224] In addition to the generalized clearance SC which include
radial or axial clearances as described herein without limitation,
other clearances or spaces can be described relative to the
aspirator and sleeve designs. As a result of these two axes being
shifted relative to each, there are various clearances such as
clearances D.sub.fy that are present by design. These clearances
are shown in a y directional relative to a range or distance
D.sub.fx. The distance D.sub.fx is an offset relative to the
longitudinal axis of the sleeve 40. D.sub.fx provides one reference
frame to measure the various D.sub.fy clearance or deflection
values, which vary along the D.sub.fx range.
[0225] In one embodiment, a relative extremum such as the maximum
D.sub.fy value of the set of D.sub.fy values that range of distance
D.sub.fx can be identified as the maximum engineered clearance
value. This is but one exemplary measurement of clearances. As
discussed below, the various angles that constrain the relationship
of the tubular member, suction head and inner sleeve wall 143 are
selected by design to create clearances between these various
components. The angle LMJ is one skewing angle that can be
constrained to allow one or more clearances such as the D.sub.fy
clearances shown. Other skewing angles can also be constrained as
described herein. Example skewing angles, as can be seen with
regard to FIGS. 15A and 15B, include without limitation one or more
of the following angles: angle ABL, angle ABJ, angle LMJ, angle
ABJ, angle ACL, angle ACJ and other combinations of angles shown in
FIGS. 15A and 15B.
[0226] Angle ACJ corresponds to the bend angle of distal portion
(upper portion) of tubular member relative to the handle and is one
skewing angle that can be used to constrain one or more clearances.
Angle LMJ corresponds to the skewing between the upper portion of
the sleeve and the upper portion of the tubular member after the
bend is another skewing angle that can be used to constrain one or
more clearances. Angle ACL corresponds to the bend angle of sleeve
relative to the handle and is one skewing angle that can be used to
constrain one or more clearances. In one embodiment, the angles,
ACL and ACJ range from about 10 degrees to about 45 degrees.
[0227] The engineered clearance between the tubular member and the
sleeve D.sub.fy results in a sleeve that is less sharply bent as
would be the case if D.sub.fy were removed. With D.sub.fy removed,
the sleeve and the tubular member 14 would closely track and
conform to each other and the sleeve would appear considerably more
bent and hooked. Such bending and hooking make the combination
sleeve and aspirator combination harder to assemble and also make
the combination look less like other suction devices with a
straighten sleeve end portion such as a Poole suction device.
[0228] As a result, the clearances engineered between an elastic
sleeve and a tubular member, when both are combined together,
address these problems. As discussed herein, the various clearances
between the sleeve and elements disposed within the sleeve
constrain skewing angles between the various axes described herein
constrain and establish ranges for these angles. Additional details
relating to the engineered clearance is discussed herein with
regard to FIGS. 14A-16.
[0229] In one embodiment, the arrangement of two combinable
components of a suction system are sized and arranged relative to
other components to provide an amount of clearance. In one
embodiment, clearance refers to a distance between two objects or
an amount of clear space. A given clearance SC can be described in
terms of a distance in one or more directions relative to the
objects at issue such as a suction head surface, inner sleeve wall
surface, tubular member surface and other distances measured
relative to sleeve inner wall and a surface point of the tubular
member or suction head in distal region of sleeve. Clearance SC can
also be described in terms of one or more volume elements in which
object pairs do not collide or only selectively collide at certain
points, lines angles or surfaces. In one embodiment, various
angular ranges of intersecting or offset axes are described herein
which provide constraints for the axial and angular positions of a
sleeve relative to the tubular member of an aspirator. These
angular and axial constraints or parameters are suitable for
achieving various engineering clearances of interest.
[0230] As illustrated in FIGS. 14A, 14B, 15A, 15B, and 16, the
suction head 18 and tubular member 14 may include one or more
predetermined clearances such as a threshold clearance. The
foregoing clearances can be engineered to address various design
and user interactions with a suction device such as assembly a
sleeve with an aspirator. A clearance is interposed between a
sleeve and the suction head and or the tubular member to which it
is attached in one embodiment. This clearance functions to more
easily allow aspirator 13, 130 to combine with a sleeve 40, 120 and
provides one or more offset distances between the tubular member,
the suction head and the inner wall of the sleeve in various
embodiments. The various axis such as the longitudinal axis of each
of the tubular member and sleeve, for the respective bent and
unbent portions as well as the longitudinal axis of the handle and
any offset axis relating to the foregoing can be described as a
first, second, third, . . . . Nth axis without limitation.
[0231] More particularly, FIGS. 14A and 14B illustrate exemplary
clearance associated with the suction head 18 and its respective
engagement with sleeve 40. The inner surface 143 of the sleeve 40
is shown. A bend angle 145 can be measured relative to a tangent to
inner surface 143. The sleeve can be positioned relative to a
suction head with a clearance D between them. The sleeve 40 can be
positioned relative to a suction head with a clearance D between
them. In one embodiment, D ranges from about 0.005 inches to about
0.050 inches.
[0232] FIG. 15A illustrates a cutaway view of engineering clearance
SC relative to the suction head 18 attached to a tubular member 14
having a bending disposed within the sleeve 40. D.sub.fy can range
along various values along the bent section of the sleeve. In one
embodiment, an average of these values can be used to measure the
engineered clearance. In other embodiments, the maximum D.sub.fy
value from tubular surface to inner sleeve wall is used as the
engineered clearance.
[0233] FIG. 15B is a schematic representation that depicts some of
the various axial and angular relationships of FIG. 15A without the
aspirator and sleeve to allow the various angles, axis, and
distances to be more easily viewed. FIGS. 15C and 15D show
additional embodiments 520, 530 of aspirator and sleeve
combinations that include clearances SC that vary relative to the
SC of combination 500 in FIG. 15A. The angles, line segments and
coordinate system of FIG. 15A are also used to depict similarly
oriented segments and angles for aspirator assemblies 520, 530 in
FIGS. 15C and 15D even though the distances and angles in
embodiments 520, 530 differ based on changes to one or more design
parameters such as differing SC values. The assembly of these
elements, sleeve and tubular member, 500, 520, 520 relative to the
distal end of the sleeve can be described in terms of various
axial, angular and other metrics to describe certain features
relating to engineered clearances within the sleeve 40.
[0234] In one embodiment, the skewing angles for FIG. 15A vary
based on one or more parameters for combination device 500
including an engineered clearance SC. For example, in one
embodiment angle ABJ ranges from about 24.degree. to about
32.degree.. In one embodiment angle ABJ is 28.degree..+-.4.degree..
For example, in one embodiment angle LMJ ranges from about
5.degree. to about 15.degree.. In one embodiment angle LMJ is
10.degree..+-.5.degree..
[0235] In one embodiment, the skewing angles for FIG. 15C vary
based on one or more parameters for combination device 520
including an engineered clearance SC. For example, in one
embodiment angle ABJ ranges from about 33.5.degree. to about
41.5.degree.. In one embodiment angle ABJ is
37.5.degree..+-.4.degree.. For example, in one embodiment angle LMJ
ranges from about 2.degree. to about 6.degree.. In one embodiment
angle LMJ is 4.degree..+-.2.degree..
[0236] In one embodiment, the skewing angles for FIG. 15D vary
based on one or more parameters for combination device 530
including an engineered clearance SC. For example, in one
embodiment angle ABJ ranges from about 32.degree. to about
40.degree.. In one embodiment angle ABJ is 36.degree..+-.4.degree..
For example, in one embodiment angle LMJ ranges from about
5.degree. to about 15.degree.. In one embodiment angle LMJ is
10.degree..+-.5.degree..
[0237] In one embodiment, one or more clearances, such as a radial
and/or an axial clearance between inner sleeve wall and suction
head, is desirable because it constrains the shape of triangle BMC
as shown in FIGS. 15A, 15C, and 15D. The various clearances
selected constraining the skewing angles which in turn shift and
flatten triangle BMC such the sleeve is not tightly coupled against
the tubular member or otherwise interfering with it during and/or
after assembly. A tight fit between sleeve and tubular member
causes sharp bending and makes assembly the sleeve relative to the
tubular member, suction head and handle difficult or not possible
in some cases.
[0238] Prior to discussing some of the clearance features of the
disclosure it is informative to consider some geometric axial and
angular transformations that can occur as a result of using a
tubular member with one or more bends. The various sets of axis and
angles can be understood by considering an aspirator with a
straight tubular member and a straight sleeve. In such an example,
the longitudinal axis of the tubular member and the sleeve would be
substantially aligned such that there was a common longitudinal
axis for the tubular member, the handle of the aspirator and the
sleeve.
[0239] Now, if the straight sleeve and the straight tubular member
were simultaneously bent, the longitudinal axis shared by both
sleeve and tubular member would shift and deviate from the first
shared axis. In turn, the bent portion of the sleeve and the bent
portion of the tubular member would each have their own relative
axis through their respective portions. Skewing of various axis
because of tubular member bending and sleeve bending result in
different axes and angles which constrain the arrangement of device
components.
[0240] Constraining the arrangement and position of device
components via various angles and certain clearance distances SC
allows for a range of product designs that use a sleeve and an
aspirator that are easier to assemble and that can, in some
embodiments, have a more gradual sleeve bend in assembled form as a
result of the clearance selected. This more gradual sleeve bend
allows the assemble device to resemble a Poole suction device in
one embodiment. These angles are relevant when designing the
clearances associated with the interplay of sheath, suction head
and tubular member when the aspirator and sheath are combined. As a
result, the engineered clearances possible can be constrained by
these various angles, generally referred to as skewing angles.
[0241] As shown in FIGS. 15A, 15B 15C, and 15D, the aspirator has a
longitudinal axis L.sub.axis (unbent) that is disposed within the
tubular member 14 and the handle (not shown). On the various line
segments, alternatively described as axes, points A, B, C, D, L, M,
N, J and K are shown which define various line segments as end
points and also can be used to identify various angles. These
coordinates can be used to depict clearance SC and the skewing
angles in exemplary embodiments 500, 520 and 530 which correspond
to different exemplary product designs having differing SC values
or other differing angles or proportions. Three points of
intersection B, C, and M for segments or axis are shown. The bend
of the tubular member 14 that contacts or is otherwise closest to
the inner wall of the sleeve 40 occurs at point B. The line segment
AD and component line segments AB and BD thereof are disposed along
the longitudinal axis L.sub.axis. Line segment or axis LN includes
line segments LM, MC, and CN as component line segments. Line
segment or axis JK includes line segments JM, MB, and BK as
component line segments.
[0242] The portion of the aspirator (disposed on the distal side of
the figure) that includes the suction head 18 and the section the
tubular member that continues after the bend B has its own relative
longitudinal axis disposed along segment JB. The bending of the
tubular member 14 effectively transforms the unbent longitudinal
axis of segment AD (L.sub.axis) to a bent longitudinal axis JK.
Similarly, the bending of the sleeve 40 from a straight
longitudinal axis that tracks axis AD to a bent longitudinal axis
LCN results in a skewing of the bent distal sleeve portion and the
bent distal tubular member portion.
[0243] As a result, angles LMJ, ABL, ABJ, and ACL can vary over
different ranges and are constrained based on the engineered
clearance value for a particular aspirator and sleeve assembly
design. Thus, one or more skewing angles are a function or
otherwise permitted based on the engineered clearance SC for a
given embodiment such as 500, 520, 530 and others as suited for
particular aspirator and sleeve dimensions and relative clearances
associated with such dimensions and sleeve properties. This angle
and the other angles are permitted or constrained by the SC value
in one embodiment. Thus, in one embodiment, an engineered clearance
between inner wall of sleeve and the suction head, such as the side
of suction head or from the distal end face of the suction,
facilitates the assembly process, and reduces the sleeve skewing or
bending from the tubular member. In this way, the skewing angles
vary as a function of or are constrained by the engineered
clearances. This features works in conjunction with substantially
cylindrical sleeve mount to ease assembly.
[0244] FIG. 16 illustrates a partially cutaway view of engineering
clearance associated with the suction head 18 and its respective
engagement with sleeve 40, including bending of tubular member 14,
in a fully engaged configuration. For example, the substantially
cylindrical profile of the sleeve coupling area 26 (e.g., the
mating area) of the handle member 20 is mated with the sleeve
40.
[0245] Providing a clearance allows for utilization of familiar
product shapes and forms, reminiscent of classic suction instrument
designs. For example, the handle member 20 may be reminiscent to
the classic Andrews-Pynchon design. When the sleeve 40 is
assembled, the elastic sleeve conforms to the curvilinear profile
of the handle member 20 (e.g., the bending of tubular member 14).
In one embodiment, a clearance has been engineered, into the distal
area (e.g., the distal sleeve end portion 45 of the sleeve 40) to
allow the sleeve 40 to have a gradual bend. The gradual nature of
the bend and the degree of bending results in a combination of
sleeve 40 and handle member 20 that visually and tactilely more
closely approximate those of straight, traditional, Poole-type
suction handle. This gradual bend is obtained by setting one or
more skewing angles such that one or more skewing angle ranges from
greater than about 1 degree to about 3 degrees. In one embodiment,
the skewing angle is greater than about 2 degrees and less than
about 10 degrees. In another embodiment, the angle between the
longitudinal axis and the sleeve longitudinal axis, ranges from
greater than about 20 degrees to less than about 45 degrees.
[0246] In an example embodiment, gradual bending of the assembly
may further include bearing flats near the suction head 18 of the
sleeve 40. As shown in FIG. 7A, optionally bearing flats, a molded
rib or other structure that is part of the sleeve or another
component that is adhered to or otherwise incorporated as part of
the sleeve can optionally be disposed in region 80. In one
embodiment, bearing flats of the sleeve 40 are designed to
interface with the plurality of lobes or protuberances of a suction
head. Accordingly, the bearing flats are typically disposed closer
to the distal sleeve end portion 45 of the sleeve 40. In various
embodiments, these flats are not used.
[0247] The protrusions of the suction head form an exemplary
cruciform cross-section (e.g., the cross-section defined by suction
head projections 17 of the suction head 18 and aid the process of
sleeve assembly in some implementations. In one embodiment, the
assembled suction set/combination device is configured to have a
gradual bend with ribs or other elongate guides disposed within the
sleeve and near the opening of the sleeve at its base. These ribs
or guides or other bearing flats are designed to interface with the
cruciform cross-section of the suction head. In addition, the flats
can help simplify the process of sleeve assembly where the sleeve
is elastically deformed to accommodate a bent cannula and the
curvilinear profile of the suction handle.
[0248] In one embodiment, the bearing flats provide a degree of
structural support or reinforcement along certain regions of the
sleeve. As a result, the bearing flats provide additional support
and tactile feedback to a user combining the device when the sleeve
40 is elastically deforming to accommodate the curvilinear profile
of the suction handle. In one embodiment, four bearing flats are
utilized, one for each protrusion or lobe of the cruciform
cross-section of the suction head. In one embodiment, a bearing
flat is paired with each lobe or protrusion of the suction head. In
one embodiment, the bearing flats are sized and arranged to align
with a plurality of lobes of suction head having a cruciform
cross-section. The number of lobes and bearing flats are typically
less than about six.
[0249] By providing a set of components, such as an aspirator and a
sleeve, a clearance at the suction head area is deliberately formed
to accommodate degrees of skewing or deflection relative to one or
more axes. Specifically, the clearance accommodates skewing or
deflection of the axis of the suction head 18 and tubular member 14
relative to the axis of the sleeve 40 in that area. This skewing
differential between the tubular member 14 and the sleeve 40 is
illustrated by FIGS. 15A. 15C and 15D.
[0250] To provide an alternate reference frame relative to the line
segments and coordinates of FIGS. 15A-15, two directional
parameters D.sub.fx and D.sub.fy are shown with regard to the bent
sleeve and handle assembly and provide exemplary ranges or
distances over which a clearance can be formed relative to the
inner sleeve wall and a normal measure relative to a surface of a
suction head or the tubular member. In one embodiment, D.sub.fx and
D.sub.fy result from the clearances SC chosen near the suction
head, which limit how close it can come to the inner wall of the
sleeve.
[0251] In one embodiment, the installation of a sleeve relative to
a suction device can be configured such that a tight fit between
the terminus of the tubular member (e.g., suction head 18) and
sleeve (e.g., sleeve 40) in the suction head area of the assembly.
This tighter fit may force the axis of the suction head and tube to
be coincident with that of the sleeve in the suction head area.
Functionally, this leads to a noticeably bent suction device when
assembled for Poole-type suction. The tight fit of the sleeve and
suction head additionally leads to undesirable resistance during
assembly of the sleeve (e.g., mating of the sleeve).
Combination of Assembled Handle and Drainage Channels
[0252] The device discussed above improves the functionality of the
handle member 20 when the sleeve 40 is combined with the handle to
form a Poole-type suction device. Poole-type suction involves a
process of aspirating a volume of irrigation and body fluids from
an open-surgery wound (e.g., wound 800) as shown with regard to
FIG. 8A. A Poole-type suction device creates a drainage and suction
path, to a point of suction, via channels formed by interleaved
shells. Traditional Poole-type suction devices have a small handle
area that primarily functions to provide hardware to couple an
outer rigid sleeve. This rigid sleeve creates the drainage/suction
path. Therefore, the suction set may be referred to as a Poole-type
suction device when the sleeve 40 is assembled to the handle member
20. Effectively, one feature of the disclosure relates a method of
converting a handle-based suction device such as member 20 to a
Poole-type suction device. In general, the methods described herein
provide tactile feedback to a user with regard to a provided sleeve
and aspirator and also ease assembly thereof.
[0253] Some designs may not utilize the entire handle as is the
case for a typical Poole-type suction device. For example, designs
may completely ventilate one side of the handle into the internal
cavity formed by the sleeve and the suction handle. However, the
top side of the suction handle does not provide this functionality
entirely. For example, regions on the top of the handle are a
typical place at which ventilation is blocked.
[0254] By comparison, the device disclosed herein provides
channeling on both the top and bottom sides of the handle member
20. This integration, between the handle member 20 and the sleeve
40 effectively makes the entire assembly a Poole-type suction
device. Moreover, this assembly is not sensitive to orientation in
the wound (e.g., top side suction vs. bottom side suction). With
the straighter profile of the sleeve 40, there may be a tendency
for the operator to disregard orientation of the Poole-type suction
handle member 20 during use. By implementing complete double-sided
venting, Poole-type suction performance is improved regardless of
orientation and user actions.
[0255] In one embodiment, the aspirator is of a singular
construction or integral such that its components or subassemblies
are all a common material such as a molded polymer or metal. An all
polymer or all metal aspirators are examples of such constructions
and can be described as unitary in some embodiments. In some
embodiment, two or more of the components of a suction catheter can
be different materials or manufactured using different processes
and at different points in time. In some embodiments, an aspirator
or suction catheter includes two or more of, for example, a suction
head, a tubular member/cannula, an elastic sleeve and a handle
member.
[0256] More generally, as used herein, the term unitary
construction or unitary encompasses embodiments that are of a
singular construction as well as embodiments in two parts of
combined to form an assembly or combination. Thus, if a metal tube
is coupled to a plastic handle and plastic suction head in some
manner to form a device such as device can be referred to as
unitary suction catheter. As noted above, in other embodiments, the
term "unitary" can also refer to an object that is a single piece.
For example, an object formed from a single injection molding,
e.g., without assembly or addition of further parts can be
described as unitary or having a unitary structure.
[0257] In the description, the invention is discussed in the
context of surgical aspirators and sleeves; however, these
embodiments are not intended to be limiting and those skilled in
the art will appreciate that the invention can also be used for any
applications where fluid removal and/or partial vacuum applications
are required.
[0258] Although the preceding and following text sets forth a
detailed description of different embodiments of the invention, it
should be understood that the legal scope of the invention is
defined by the words of the claims set forth at the end of this
patent. The detailed description is to be construed as exemplary
only and does not describe every possible embodiment of the
invention since describing every possible embodiment would be
impractical, if not impossible. Numerous alternative embodiments
could be implemented, using either current technology or technology
developed after the filing date of this patent, which would still
fall within the scope of the claims defining the invention.
[0259] The aspects, embodiments, features, and examples of the
invention are to be considered illustrative in all respects and are
not intended to limit the invention, the scope of which is defined
only by the claims. Other embodiments, modifications, and usages
will be apparent to those skilled in the art without departing from
the spirit and scope of the claimed invention.
[0260] The use of headings and sections in the application is not
meant to limit the invention; each section can apply to any aspect,
embodiment, or feature of the invention.
[0261] Throughout the application, where compositions are described
as having, including, or comprising specific components, or where
processes are described as having, including or comprising specific
process steps, it is contemplated that compositions of the present
teachings also consist essentially of, or consist of, the recited
components, and that the processes of the present teachings also
consist essentially of, or consist of, the recited process
steps.
[0262] In the application, where an element or component is said to
be included in and/or selected from a list of recited elements or
components, it should be understood that the element or component
can be any one of the recited elements or components and can be
selected from a group consisting of two or more of the recited
elements or components. Further, it should be understood that
elements and/or features of a composition, an apparatus, or a
method described herein can be combined in a variety of ways
without departing from the spirit and scope of the present
teachings, whether explicit or implicit herein.
[0263] The use of the terms "include," "includes," "including,"
"have," "has," or "having" should be generally understood as
open-ended and non-limiting unless specifically stated
otherwise.
[0264] The use of the singular herein includes the plural (and vice
versa) unless specifically stated otherwise. Moreover, the singular
forms "a," "an," and "the" include plural forms unless the context
clearly dictates otherwise. In addition, where the use of the terms
"about" or "approximately" are before a quantitative value, the
present teachings also include the specific quantitative value
itself, unless specifically stated otherwise. As used herein, the
term "about" refers to a .+-.10% variation from the nominal value.
As used herein, the term "approximately" refers to a .+-.10%
variation from the nominal value.
[0265] It should be understood that the order of steps or order for
performing certain actions is immaterial so long as the present
teachings remain operable. Moreover, two or more steps or actions
may be conducted simultaneously.
[0266] Where a range or list of values is provided, each
intervening value between the upper and lower limits of that range
or list of values is individually contemplated and is encompassed
within the invention as if each value were specifically enumerated
herein. In addition, smaller ranges between and including the upper
and lower limits of a given range are contemplated and encompassed
within the invention. The listing of exemplary values or ranges is
not a disclaimer of other values or ranges between and including
the upper and lower limits of a given range.
* * * * *