U.S. patent application number 17/534151 was filed with the patent office on 2022-03-17 for method and device for delivery of a solution into a body orifice.
This patent application is currently assigned to Wiesman Holdings, LLC. The applicant listed for this patent is Wiesman Holdings, LLC. Invention is credited to Jon Wiesman.
Application Number | 20220080169 17/534151 |
Document ID | / |
Family ID | |
Filed Date | 2022-03-17 |
United States Patent
Application |
20220080169 |
Kind Code |
A1 |
Wiesman; Jon |
March 17, 2022 |
METHOD AND DEVICE FOR DELIVERY OF A SOLUTION INTO A BODY
ORIFICE
Abstract
A diffusing applicator is provided and generally includes a head
unit, and extension shaft, and a dispensing device. The head unit
includes a fluid receiving space and a plurality of dispensing
passageways in communication the fluid receiving space. The
extension shaft is securely connected to the head unit. The
dispensing device is for holding a fluid and is connected to the
extension shaft. The dispensing device is in communication with the
plurality of dispensing passageways and urges fluid through
extension shaft and through the dispensing passageways.
Inventors: |
Wiesman; Jon; (York,
PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Wiesman Holdings, LLC |
York |
PA |
US |
|
|
Assignee: |
Wiesman Holdings, LLC
York
PA
|
Appl. No.: |
17/534151 |
Filed: |
November 23, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16009887 |
Jun 15, 2018 |
11207509 |
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17534151 |
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62520156 |
Jun 15, 2017 |
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International
Class: |
A61M 31/00 20060101
A61M031/00; A61B 17/42 20060101 A61B017/42; A61M 3/02 20060101
A61M003/02 |
Claims
1. A diffusing applicator comprising: a head unit having a fluid
receiving space and a plurality of dispensing passageways in
communication the fluid receiving space; an extension shaft
securely connected to the head unit; and a dispensing device for
holding a fluid and connected to the extension shaft, the
dispensing device in communication with the plurality of dispensing
passageways and urging fluid through extension shaft and through
the dispensing passageways.
2. The diffusing applicator of claim 1, further comprising a slide
positioned over and moveable along the extension shaft.
3. The diffusing applicator of claim 2, wherein the slide is
positionable along the extension shaft to prevent the head unit
from advancing forward in an orifice.
4. The diffusing applicator of claim 2, wherein the slide is a ring
shaped member having an inner circumference sized to receive and
bias outer walls of the extension shaft.
5. The diffusing applicator of claim 2, further comprising a
dispensing device for holding a fluid and connected to the
extension shaft, the dispensing device in communication with the
dispensing passageway.
6. The diffusing applicator of claim 5, wherein the dispensing
passageway is a single forward frontal discharge tip having angled
outer sidewalls at an end thereof.
7. The diffusing applicator of claim 6, wherein the head unit
includes a rounded polished tip that sits flush with the extension
shaft.
8. The diffusing applicator of claim 5, wherein the dispensing
passageway is a side discharge passageway positioned on one side of
the head unit.
9. The diffusing applicator of claim 8, further comprising a second
side discharge passageway positioned on another side of the head
unit.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. Non-Provisional
patent application Ser. No. 16/009,887 dated Jun. 15, 2018 and
claims the benefit of U.S. Provisional Application No. 62/520,156,
filed Jun. 15, 2017.
FIELD OF THE INVENTION
[0002] The invention relates to a diffusing applicator and, more
particularly, a diffusing applicator for precisely delivering a
viscous and/or non-viscous solution to a target area in the human
body.
BACKGROUND
[0003] The incidence of preterm birth in the United States
increased from 1990 until an all-time high was observed in 2006.
Since that date, the rate of preterm birth has decreased 11.36% due
to public health campaigns and a greater reliance on objective data
to define the risk for preterm birth. Hamilton, B E, Martin J A,
Osterman M J K, Curtin S C, Brady E., Division of Vital Statistics.
Births: Preliminary Data for 2013, National Vital Statistics
Reports, Vol. 63, No. 2, May 29, 2014.
[0004] Despite a reduction in incidence, the cost surrounding
preterm birth remain staggering and the costs associated for one
(1) baby in the neonatal intensive care unit (NICU) now can exceed
$1,250,000.00. In 2006, the Institute of Medicine calculated the
national expenditure exceeded 25 billion dollars annually to
address the complication of preterm birth. Behrman R E, Stith
Butler A., Committee on understanding premature birth and assuring
healthy outcomes: causes, consequences, and prevention, Washington,
D.C.: National Academies Press, 2007. Studies have now defined the
most cost effective methods to reduce the frequency of preterm
birth, including the measurement of cervical length rather than
basing therapies upon obstetric history alone. Cahill A G, Odibo A
O, Caughey A B, Stamilio D, Hassan S, Macones G, et al., Universal
cervical length screening and treatment with vaginal progesterone
to prevent preterm birth: a decision and economic analysis, Am J
Obstet Gynecol; 2010:202:548.e1-8; also Werner E F, Hans C S,
Pettker C M, Buhimischi C S, Copel J, Funai E F, et al., Universal
cervical-length screening to prevent preterm birth: a
cost-effectiveness analysis, Ultrasound Obstet Gynecol 2011;
38:32-7. One method is directed to a prophylactic strategy in women
with a history of preterm birth, while another is directed to
utilizing a therapeutic approach in those with premature cervical
shortening. Of these two strategies, relying upon objective
evidence to define an indication for treatment is likely superior
as demonstrated in the largest randomized double-blind,
placebo-controlled trial performed to date in singletons. O'Brien J
M, DeFranco E A, Adair C D, Lewis D F, Hall D R, How H, et al.,
Effect of progesterone on cervical shortening in women at risk for
preterm birth: secondary analysis from a randomized, double-blind,
placebo-controlled trial, Ultrasound Obstet Gynecol 2009; 34:
653-59; also DeFranco E A, O'Brien J M, Adair C D, Lewis D F, Hall
D R, Fusey S, et al., Vaginal progesterone is associated with a
decreased risk of early preterm birth and improved neonatal outcome
in women with a short cervix, Ultrasound Obstet Gynecol 2007;
30:697-705.
[0005] In addition, there is a desire to reduce unnecessary
exposure to any intervention in in the population of pregnant women
as an inherent.
[0006] Ultrasound provides an opportunity to define cervical
integrity and performance by measurement of the cervical length.
This measurement in conjunction with progesterone supplementation
has shown to reduce the rate of preterm births. Romero R,
Nicolaides K H, Conde-Agudelo A, Tabor A, O'Brien J M, Cetingoz E,
et al., Vaginal progesterone in women with an asymptomatic
sonographic short cervix in the midtrimester decreases preterm
delivery and neonatal morbidity: a systematic review and
meta-analysis of individual patient data, Am J Obstet Gynecol 2012;
206: 124.e1-19. In fact, more data supports the use of this
strategy based on objective measurement, a biomarker for preterm
birth, than any other intervention in the history of
obstetrics.
[0007] The measurement of cervical length is performed by
ultrasound most commonly by either a transabdominal or transvaginal
method. The transvaginal method requires an invasive,
time-intensive procedure in addition to expertise. Therefore, the
translation of research findings may not be as well adopted as
needed if clinicians practicing in lower risk environments are not
provided with the tools to allow optimal means to evaluate cervical
contour and measure cervical length. Therefore, providing the
opportunity to visualize the cervix is important to further reduce
the rate of preterm birth.
[0008] Uniformity of any medical procedure is a desired goal as
quality and safety and outcomes are improved. The application of a
contrast into the vagina allows individuals with less expertise in
cervical imaging to better define cervical landmarks improving the
accuracy for measurement of cervical length.
[0009] This measurement is even more difficult when transabdominal
imaging is exclusively performed. The use of a contrast in
transabdominal, transperineal, or transvaginal imaging can improve
assessment of anatomy, as contrast has been demonstrated to improve
visualization with numerous other applications in radiology.
[0010] Therefore, there is a need for an improved method and device
to deliver a solution contrast to improve the clarity of evaluating
the cervix
SUMMARY
[0011] An object of the invention, among others, is to provide a
diffusing applicator 1 that improves the delivery of intravaginal
contrast to evaluate a cervix
[0012] Accordingly, a diffusing applicator is provided and
generally includes a head unit, and extension shaft, and a
dispensing device. The head unit includes a fluid receiving space
and a plurality of dispensing passageways in communication the
fluid receiving space. The extension shaft is securely connected to
head unit. The dispensing device holds a fluid and is connected to
the extension shaft. The dispensing device is in communication with
the plurality of dispensing passageways.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The present invention will be explained in greater detail
with reference to embodiments and referring to the appended
drawings, in which
[0014] FIG. 1 is a perspective view of a diffusing applicator 1
according to the invention, shown connected with a known dispensing
device;
[0015] FIG. 2 is a side view of a diffusing applicator 1 according
to the invention, showing an exemplary use therewith;
[0016] FIG. 3 is a close-up perspective view a diffusing applicator
1 according to the invention, showing a head unit with a head unit
with an extension shaft attached therewith;
[0017] FIG. 4 is a front view of the diffusing applicator 1 of FIG.
3;
[0018] FIG. 5 is a rear view of the diffusing applicator 1 of FIG.
3;
[0019] FIG. 6 is a side view of the diffusing applicator 1 of FIG.
3;
[0020] FIG. 7 is a sectional view of the diffusing applicator 1 of
FIG. 5 taken along line 7-7;
[0021] FIG. 8 is another sectional view of the diffusing applicator
1 of FIG. 5 taken along line 8-8;
[0022] FIG. 9 is another sectional view of the diffusing applicator
1 of FIG. 5 taken along line 7-7;
[0023] FIG. 10 is a sectional view of an extension shaft of a
diffusing applicator 1 according to the invention;
[0024] FIG. 11 is a close up view of a sliding stop and an
extension shaft of a diffusing applicator 1 according to the
invention;
[0025] FIG. 12 is a sectional view of the sliding stop and
extension shaft of FIG. 11
[0026] FIG. 13 is a perspective view of an adapter of a diffusing
applicator 1 according to the invention;
[0027] FIG. 14 is a top view of the adapter of FIG. 13;
[0028] FIG. 15 is a side view of the adapter of FIG. 13;
[0029] FIG. 16 is a front view of the adapter of FIG. 13;
[0030] FIG. 17 is a rear view of the adapter of FIG. 13;
[0031] FIG. 18 is a close-up sectional perspective view of an
adapter according to the invention, shown connected to a known
dispensing device
[0032] FIG. 19 is a perspective view of another diffusing
applicator 1 according to the invention;
[0033] FIG. 20 is a close-up sectional view of the diffusing
applicator 1 of FIG. 19, shown connected with a known dispensing
device;
[0034] FIG. 21 is perspective view of another head unit of a
diffusing applicator 1 according to the invention;
[0035] FIG. 22 is a sectional view of the head unit 10 unit of FIG.
21;
[0036] FIG. 23 is perspective view of another head unit and an
extension shaft of a diffusing applicator 1 according to the
invention; and
[0037] FIG. 24 is a sectional view of the head unit 10 unit and
extension shaft of FIG. 23.
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0038] Now with reference to the figures, a diffusing applicator 1
according to the invention will be described and generally includes
a head unit 10, an extension shaft 20, an adapter 30, and a
dispensing device 40.
[0039] The diffusing applicator 1 according to the invention allows
administration of a solution, such as a lubricant, anesthetic,
pharmaceutical or contrast, into a body orifice, such as vagina
uterus, urethra, rectum and/or nasal pharyngeal cavity.
[0040] As shown in FIGS. 1-9, the head unit 10 is a blunt shape
member having a distal end and a proximal end. As shown, the head
unit 10 is a is cylindrical shaped. However, one skilled in the art
should appreciate that other shapes are possible and may be refined
depending on the appropriate shape for the intended function of the
diffusing applicator 1.
[0041] The head unit 10 can be designed in a multiple of shapes
from a round structure to and oblong/oval structure, the primary
goal of the head unit 10 is to safely enter into, deliver and/or
place a solution, viscous and/or non-viscous medicated or
non-medicated into a mammalian body orifice, namely the vagina and
forward to and around the cervical os, but not limited to and/or
into the uterus, urethra, rectum and/or nasal pharyngeal cavity by
means of dispensing passageways 18 that can be positioned in any
angular format around the structure.
[0042] The primary factor that ensures the safety of the diffusing
applicator 1 is that the head unit 10 is rounded/smooth while being
a larger diameter than the rigid and/or flexible structure, namely
the extension shaft 20, that is incorporated into the structure
namely the head unit 10.
[0043] The head unit 10 should also include a bulbous shape, such
that the cervix or any membranes inadvertently encountered will at
minimal risk for complications related to the application of a
contrast agent which markedly differs from a syringe. Finally, the
volume of contrast placed can be altered without the need for
reinsertion of a device (syringe) which has edges and can be
painful. None of these advancement occurred during or as a result
of federally sponsored research.
[0044] The unique design of the head unit 10 may also be used for
additional lubrication to reduce excessive perineal stretching
aimed to reduce perineal lacerations and/or reducing trauma to the
pelvic floor and/or levator muscles in regards to the expediting
delivery of a child.
[0045] As shown, the head unit 10 generally includes outer walls
12, a shaft receiving opening 14, a fluid receiving space 16, and a
plurality of dispensing passageways 18.
[0046] The outer walls 12 are generally made of plastic, such as
rubber or resilient polymer, which are formed to include the shaft
receiving opening 14 positioned at a distal end thereof, a fluid
receiving space 16 positioned in a hollow center, and a plurality
of dispensing passageways 18 extending from the fluid receiving
space 16 toward a proximal end thereof.
[0047] The shaft receiving opening 14 is shaped and sized to
correspond with the extension shaft 20 such that the outer walls 12
frictionally engage the extension shaft 20. The outer walls 12 are
deformable and sized slightly smaller than the extension shaft 20
such that the extension shaft 20 is received through the shaft
receiving opening 14 and secured by the outer walls along the
distal end thereof. Therefore, when the extension shaft 20 is
positioned through the shaft receiving opening 14, the extension
shaft 20 is snug fit with the head unit 10 (see FIG. 7-9).
[0048] In an exemplary embodiment as illustrated, each dispensing
passageway 18 is a channel extending through the outer walls 12. As
shown in FIGS. 7-9, each dispensing passageway 18 leads from the
fluid receiving space 16 to on outer surface of the head unit
10.
[0049] As shown, the head unit 10 includes a primary dispensing
passageway 18a and a plurality of secondary dispensing passageways
18b. In an exemplary, the primary dispensing passageway 18a extends
laterally from the fluid receiving space 16 to on outer surface of
the head unit 10. More particularly, the primary dispensing
passageway 18a extends to a distal tip of the head unit 10. In
contrast, the secondary dispensing passageways 18b extend from the
fluid receiving space 16 to on outer surface of the head unit 10 at
an angle. More particularly, the secondary dispensing passageway
18b extends to a sides of the head unit 10 and are spaced apart
from the each other and positioned rearward of the primary
dispensing passageway 18a. As a result, the head unit 10 according
to the invention is provided with dispensing passageways 18 that
produce an angular and lateral flow of a solution, viscous and/or
non-viscous into a mammalian body orifice, for instance the vagina
and forward on to the cervical os. However, one skilled in the art
should appreciate that this design is not limited to this
application, but and could be used in other applications, such as
delivery of a the urethra, uterus, rectum and/or nasal pharyngeal
cavity.
[0050] As shown in FIGS. 7-9, in an exemplary embodiment, the head
unit includes three secondary dispensing passageways 18b extend at
an approximate 45.degree. degree angle and three secondary
dispensing passageways 18b extend at an approximate 30.degree.
degree angle and are offset from each other and are positioned
rearward of the secondary dispensing passageways 18b. As a result,
the secondary dispensing passageways 18b evenly deliver solution
about an outer surface of the outer walls 12. One skilled in the
art should appreciate that the secondary dispensing passageways 18b
could extend at various angles, including 90.degree. degree with
respect to the lateral placement of the primary dispensing
passageway 18a.
[0051] The placement of the passageways 18 is in direct correlation
to the safe placement of the solution, viscous and/or non-viscous
into a mammalian body orifice, namely the vagina and forward to and
around the cervical os, but not limited to and/or into the uterus,
urethra, rectum and/or nasal pharyngeal cavity arrives via a
syringe, but not limited to any structure, such as a bag/pouch or
cartridge so that damage does not occur to the organ and/or orifice
for which the device enters.
[0052] The head unit 10 design facilitates a specific and safe even
disbursement of the viscous and/or non-viscous solution into a body
cavity. In an alternative application, the head unit 10, as
described, could be used with common therapy for prostate cancer by
placing a lubricant void in the rectum ahead of radiation to reduce
damage of surrounding tissue. In yet another application, the head
unit 10 could be used for intravaginal brachytherapy.
[0053] Now with reference to FIG. 10, an extension shaft 20 for the
diffusing applicator 1 and, more particularly, for a head unit 10
according to the invention, is shown. The extension shaft 20 is
simply a known rigid and/or flexible structure "tube" to be
inserted into the head unit 10 and an adapter 30 for a dispensing
device 40, such as a syringe. The extension shaft 20 allows a
viscous and/or non-viscous solution to flow without obstruction
into the orifice and/or a cavity from the dispensing device through
the head unit 10 by a length of the extension shaft 20.
[0054] Now with reference to FIGS. 13-18, an adapter 30 for the
diffusing applicator 1 according to the invention is shown and
connects with a dispensing device 40, such as a common luer lock
syringe.
[0055] In an exemplary embodiment of the invention, the adapter 30
is a and/or attachment whereby the threads are present enabling a
dispensing type container namely a "syringe" but not limited to any
structure that can safely house a viscous and/or non-viscous
solution to be locked on and/or slid in place onto and/or into the
"receiver" assembly. Generally, the adapter 30 is made from a rigid
plastic and generally includes a shaft receiving end 32 positioned
at a proximal end, a dispensing unit receiving end 34 positioned at
a distal end, and a handle section 36 positioned between the shaft
receiving end 32 and the dispensing unit receiving end 34.
[0056] As shown, the adapter 30 is generally a tubular member
having a fluid receiving channel 38 extending there through. The
shaft receiving end 32 is a smooth tubular element such that a
rigid and/or flexible extension shaft 20 can be inserted into fluid
receiving channel 38 and the extension shaft 20 is frictionally
secured to the adapter 30. In contrast, in an exemplary embodiment
of the invention, the dispensing unit receiving end 34 is a tubular
element having threads positioned on an outer surface thereof. As
shown, this design would correspond with dispensing device 40
having matching threads along an inner surface thereof (see FIG.
18). However, one skilled in the art should appreciate that the
dispensing unit receiving end 34 could include threads along an
inner surface thereof, which would correspond with a dispensing
device 40 having threads along an outer surface thereof.
[0057] In an exemplary embodiment, the adapter 30 may include a
handle section 36. As shown, the handle section 36 include
protuberances to facilitate clasping of the adapter 30. In the
shown embodiment, the handle section 36 includes a pair of tabs 37
positioned on opposite sides thereof. As a result, the handle
section 36 facilitates precise connection of the adapter 30 with
the extension shaft 20 and the dispensing device 40. For instance,
the handle section 36 allows the adapter to be precisely screwed
onto a dispensing device 40 without compromising the integrity of
either member.
[0058] In alternative embodiment, as shown in FIGS. 19 and 20, the
adapter 30' may be a simple sleeve that connects the extension
shaft 20 and the dispensing device 40 through friction fit means.
The adapter 30' may be a tubular member formed from a resilient
plastic, such as rubber, and has in inner circumference slightly
smaller than the extension shaft 20 and dispensing device 40. Upon
assembly, the adapter 30' elastically deforms to first fit over the
extension shaft 20 with inner walls of the adapter 30' bias the
walls of the extension shaft 20 to secure the adapter 30' with the
extension shaft 20. Likewise, the adapter 30' elastically deforms
to then fit over the an end of the dispensing device 40 to secure
the adapter 30' with the dispensing device 40.
[0059] As shown through the Figures, the dispensing device 40 is
any known dispensing type container namely a "syringe", but not
limited to any structure that can safely house a viscous and/or
non-viscous solution to be locked on and/or slid in place onto
and/or into the "receiver" assembly.
[0060] Now, with reference to FIGS. 11 and 12, the diffusing
applicator 1 according to the invention may further includes a
slide 50 that is shaped and dimensions to forcibly slide up and
down the extension shaft 20 to prevent the head unit 10 from
advancing forward while allowing the practitioner to properly
anesthetized area in urethra where the procedure will take place.
The slide 50 has a primary function to prevent the advancement of
the diffusing applicator 1 further than deemed necessary to
properly perform the procedure by the practitioner (see FIG. 2).
However, the slide 50 may also act as a premeasuring device that
can be incorporated into the procedure especially if an ultrasound
has predetermined the specific area where the procedure is to be
conducted. The slide 50 can act as a safety stop for any procedure
to be used as a depth marker by the practitioner to prevent any
ancillary injury to the cervical os and/or mucosal tissue.
[0061] In an exemplary embodiment, the slide 50 is a ring shaped
member having an inner circumference sized to receive, but bias,
the outer walls of the extension shaft 20. As a result, the slide
50 can move up and down the extension shaft, but does so under
force. Likewise, the slide 50 has an outer circumference that is
larger than the head unit 10 such that when the head unit 10 is
positioned in a body orifice, the slide 50 will not fit.
[0062] Now with reference to FIGS. 21-24, in a further embodiment,
a diffusing applicator 1 according to the invention may be provided
and directed to transurethral surgical procedures.
[0063] In the shown embodiments, the diffusing applicator 1
according to the invention may include alternative head unit 10
designs.
[0064] In an exemplary embodiment shown in FIGS. 21 and 22, another
head unit 110 for a diffusing applicator 1 according to the
invention is shown and generally includes a single center discharge
tip for performing, for example, transurethral surgical
procedures.
[0065] As shown in FIG. 22, the head unit 110 may include a single
forward frontal discharge tip 112, which includes angled sides 114
at an end thereof that extend to a rounded polished tip 116 that
would be flush with the extension shaft 20 and prevent any
"snagging" of tissue when entering and/or exiting the urethra.
[0066] The diffusing applicator 1 according to the invention allows
the application and/or deposit of a viscous/non-viscous
medicated/non-medicated solution into the urethra providing an
advanced anesthetized area.
[0067] Prior to the diffusing applicator 1 according to the
invention, the medicated lubricant for transurethral surgical
procedures was offered for sale in a 5 mL syringe with a slightly
elongated tip. When administered, the medicated lubricant was only
able to enter into the urethra a short way due to the naturally
occurring vascular resistance in the urethra. As a result of this
phenomenon, an entirely new design with the same concept was
developed, most pertinently this device still diffuses/deliver a
medicated viscous and/or non-viscous solution into the urethra for
purposes of a low risk, non-invasive urological procedures.
[0068] Now with reference to FIGS. 23 and 24, yet another head unit
210 for a diffusing applicator 1 according to the invention is
shown and includes side discharge features for performing, for
example, transurethral surgical procedures.
[0069] As shown, the head unit 210 generally includes a fluid
discharge body 212 and insertion tip 220.
[0070] The fluid discharge body 212 generally includes a pair of
side discharge passageways 214, an attachment section 216, and
fluid receiving space 218.
[0071] The fluid discharge body 212 is a monolithic, generally
cylindrical member with the fluid receiving space 218 extending
through a center thereof. The side discharge passageways 214 are
openings extending through the walls and positioned on opposite
side s of the fluid discharge body 212. In the shown embodiment,
the side discharge passageways 214 are generally box or rectangular
shaped. However, one skilled in the art should appreciate that
other designs are possible, including circular or oval shaped
openings. As shown, in FIG. 24, the fluid receiving space 218
communicates with the side discharge opening 214.
[0072] The attachment section 216 is an elongated section of the
fluid discharge body 212 and includes a plurality of hose barbs 217
positioned on an outside thereof. However, one skilled in the art
should appreciate that other designs are possible. The
circumference of the attachment section should be such that the
fluid discharge body 212 would be substantially flush with the
extension shaft 20 and prevent any "snagging" of tissue when
entering and/or exiting the urethra.
[0073] The insertion tip 220 is a solid member and is secured to
the fluid discharge body 212. The insertion tip 220 has a general
spherical shape in the embodiment shown. The insertion tip 220 is
free to sharp edges and rigid to allow easy and unobstructed entry
into the body orifice.
[0074] The diffusing applicator 1 according to the invention allows
the application and/or deposit of a viscous/non-viscous
medicated/non-medicated solution into the urethra providing an
advanced anesthetized area.
[0075] Prior to the diffusing applicator 1 according to the
invention, the medicated lubricant for transurethral surgical
procedures was offered for sale in a 5 mL syringe with a slightly
elongated tip. When administered, the medicated lubricant was only
able to enter into the urethra a short way due to the naturally
occurring vascular resistance in the urethra. As a result of this
phenomenon, an entirely new design with the same concept was
developed, most pertinently this device still diffuses/deliver a
medicated viscous and/or non-viscous solution into the urethra for
purposes of a low risk, non-invasive urological procedures.
[0076] With reference to FIG. 1, assembly of a diffusing applicator
1 according to the invention will be described.
[0077] The slide 50 is positioned over the extension shaft 20 and
the extension shaft 20 is securely connected to the head unit 10.
The type of head unit 10, 110, 210 selected for the diffusing
applicator 1 will depend on application, such as use for insertion
into the vagina, uterus, urethra, rectum and/or nasal pharyngeal
cavity. The extension shaft 20 is then connected to the dispensing
device 40 with or without the adapter 30.
[0078] According to an embodiment of the invention, the diffusing
applicator 1 according to the invention has a length that ranges
anywhere from about 0.25'' to about 24'', with a diameter ranging
from about 0.025'' to about 0.50''. The extension shaft 20
flexibility of the extension shaft 20 depends upon the solution
chosen.
[0079] Now with reference to the Figure, uses of a diffusing
applicator 1 will be described.
[0080] For instance, the diffusing applicator 1 according to the
invention can provide contrast in the vagina to improve cervical
imaging utilized a syringe to apply the contrast agent (saline or
methylcellulose gel). The diffusing applicator 1 has addressed and
resolved the short comings of all of the previous devices used to
safely identify and measure the cervix.
[0081] For instance, the specific delivery and placement of a
sterile medical lubricant around the cervical os, using the
diffusing applicator 1, can reduce variation by allowing easier
identification of the external cervical os. The diffusing
applicator 1 allows for a volume of a viscous and/or non-viscous
solution to be safely deployed around the cervical os. The volume
of lubricant can be altered and provides the sonographer an
opportunity to optimize the scan depending upon the method
utilized.
[0082] The diffusing applicator 1 according to the invention is a
device that functions totally different and relays upon a totally
different methodology to arrive at a diagnosis of a shortened
cervix, which in fact this protocol allows the diagnosis to be more
uniform and this should be sufficient to differentiate between the
two devices, when compared to that of the art.
[0083] The diffusing applicator 1 allows for a solution of varying
viscosities namely a lubricant but not limited to any solution,
viscous and/or non-viscous used to facilitate a procedure, medical
and/or non-medical to facilitate a diagnosis so that a
practitioner, namely an sonographer, but not limited to any medical
technician, so that the volume of a solution, viscous and/or
non-viscous will engage as a couplant that will provide a
consistent resolution necessary to yield a uniform diagnosis.
[0084] The diffusing applicator 1 enables the solution viscous
and/or non-viscous to be inserted and/or deposited into one of the
above mentioned body orifices, of the volume of that solution,
viscous and/or non-viscous. The solution acts as a void and/or
couplant that in turn provides a medical practitioner a consistent
resolution for Ultrasound, 2D Ultrasound, 3D Ultrasound, 4D
Ultrasound, X-Ray, CAT Scan, C-Scope, MRI and/or any other
radiological imaging type device that requires a void and/or
couplant necessary to achieve a uniform diagnosis.
[0085] The diffusing applicator 1 according to the invention allows
for greater uniformity and accuracy for measurement of cervical
length and easier identification of the shortened cervix. The
diffusing applicator 1 according to the invention is designed to
enhance translation for preterm prevention into lower risk, lower
fidelity environments.
[0086] For instance, according to known practices, application of
intravaginal contrast has been commonly performed via a syringe,
but an improved methodology using the diffusing applicator 1
according to the invention can enhance translation of these
important research findings. The diffusing applicator 1 rectifies
previous short comings of known devices by delivering delivers a
viscous and/or non-viscous solution to and around the cervical
os.
[0087] In one exemplary aspect of the invention, the diffusing
applicator 1 permits contrast to extrude laterally (at an angle
away from the external os to minimize the potential for placement
of gel into the endocervical canal or lower uterine segment) rather
than through its most distal point like known devices.
[0088] Prior to the diffusing applicator 1 according to the
invention, a medicated lubricant was offered for sale in a 5 mL
syringe with a slightly elongated tip, when administered, the
medicated lubricant was only able to enter into the urethra a short
way due to the naturally occurring vascular resistance in the
urethra. As a result of this phenomenon, an entirely new design
with the same concept was developed, most pertinently this device
still diffuses/deliver a medicated viscous and/or non-viscous
solution into the urethra for purposes of a low risk, non-invasive
urological procedures.
[0089] The diffusing applicator 1 according to the invention can
appear in a numerous of designs depending upon the application
and/or orifice for which the device is to safely deliver a viscous
and/or non-viscous medicated and/or non-medicated solution to and
around the cervical os and/or into the urethra, see below.
[0090] The diffusing applicator 1 according to the invention now
allows for safer administration of a contrast to improve
visualization of the cervix. The applicator according to the
invention addresses and rectifies the short comings of the devices
previously used to deliver and deliver a sterile viscous and/or
non-viscous solution to and around the cervical os. The diffusing
applicator 1 according to the invention is specifically designed
such that contrast is extruded laterally (at an angle away from the
external os to minimize the potential for placement of gel into the
endocervical canal or lower uterine segment) rather than through
its most distal point. This safety feature minimizes the risk for
bacteria to be carried into the upper genital tract. The tip of the
device is also designed as bulbous such that the cervix or any
membranes inadvertently encountered will at minimal risk for
complications related to the application of a contrast agent which
markedly differs from a syringe. A smooth, rounded surface,
specifically without rough edges means the potential for rupture of
membranes due to inadvertent contact with fetal membranes is
minimized.
[0091] The diffusing applicator 1 according to the invention is
also designed for extrusion of contrast through multiple sites.
This feature enhances the potential for contrast to spread
throughout the desired location to improve visualization. In
addition, multiple exit ports enhance safety.
[0092] Finally, the diffusing applicator 1 according to the
invention also has features which enhance patient comfort. The use
of a rounded tips of the head units 10, 110, 210 minimize patient
pain and discomfort with application of a contrast. The volume of
contrast placed can also now be altered without the need for
reinsertion of a device such as a syringe and/or other rigid
structure which can be painful. Therefore, the diffusing applicator
1 according to the invention is an improvement compared to past
iterations used to place a solution, viscous and/or non-viscous
into a mammalian body orifice, namely the vagina and forward to and
around the cervical os, but not limited to and/or into the uterus,
urethra, rectum and/or nasal pharyngeal cavity.
[0093] The foregoing illustrates some of the possibilities for
practicing the invention. While certain embodiments of the
invention have been described above, these descriptions are given
for purposes of illustration and explanation. Variations, changes,
modifications, and many other embodiments of the systems and
methods disclosed may be adopted without departure from the scope
and spirit of the invention. It is, therefore, intended that the
foregoing description be regarded as illustrative rather than
limiting, and that the scope of the invention is given by the
appended claims together with their full range of equivalents.
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