U.S. patent application number 10/698714 was filed with the patent office on 2005-05-05 for laparoscopic spray device and method of use.
Invention is credited to Hagmann, Adam, Spero, Richard, Yardimci, Atif M..
Application Number | 20050096588 10/698714 |
Document ID | / |
Family ID | 34435500 |
Filed Date | 2005-05-05 |
United States Patent
Application |
20050096588 |
Kind Code |
A1 |
Hagmann, Adam ; et
al. |
May 5, 2005 |
LAPAROSCOPIC SPRAY DEVICE AND METHOD OF USE
Abstract
A laparoscopic spray device for selectively applying a multiple
component material dispensed from a multiple component material
applicator to a surgical site in vivo is disclosed. The device
comprises an interface member capable of engaging a multiple
component applicator, a body having at least two lumens therein,
and a detachable spray tip in fluid communication with the body.
The detachable spray tip includes a mixing chamber having at least
one flexible mixing member positioned therein which is capable of
creating a turbulent flow within a mixing chamber. In addition, the
at least one mixing member prevents a back flow of material from
the mixing chamber to the at least two lumens. The present
invention is particularly useful in remotely applying multiple
component tissue adhesives to an internal incision.
Inventors: |
Hagmann, Adam; (Brentwood,
CA) ; Spero, Richard; (Brentwood, CA) ;
Yardimci, Atif M.; (Northbrook, IL) |
Correspondence
Address: |
BAXTER INTERNATIONAL INC.
ONE BAXTER PARKWAY OF3-2E
DEERFIELD
IL
80015
US
|
Family ID: |
34435500 |
Appl. No.: |
10/698714 |
Filed: |
October 31, 2003 |
Current U.S.
Class: |
604/82 ;
604/500 |
Current CPC
Class: |
B05C 17/00506 20130101;
A61B 2017/00473 20130101; B05C 17/00516 20130101; A61B 17/00491
20130101; A61M 25/0032 20130101; A61B 2017/00495 20130101; A61M
25/003 20130101; A61M 2025/0037 20130101 |
Class at
Publication: |
604/082 ;
604/500 |
International
Class: |
A61M 037/00 |
Claims
1. A laparoscopic spray device for mixing and applying a multiple
component agent to a target site, comprising: a first fluid
reservoir containing a first component and a second fluid reservoir
containing a second component; an elongated delivery shaft having a
proximal end, a distal end, and at least two fluid delivery
channels in fluid communication with the first and second fluid
reservoirs, the fluid delivery channels having distal ports; a
spray tip assembly having a proximal end, a distal end, and a
discharge aperture disposed at the distal end, the spray tip
assembly detachably coupled to the distal end of the elongated
delivery shaft and having a sealing member disposed at the proximal
end of the spray tip assembly that seals the distal ports of the
fluid delivery channels of the elongated delivery shaft when the
sealing member is in a relaxed state and which allows fluid flow
from the distal ports when pressure is applied to the sealing
member; an elongated mixing chamber having a proximal end and a
distal end, the elongated mixing chamber in fluid communication
with the fluid delivery channels when pressure is applied to the
first and second components in the fluid delivery channels; at
least one lateral port disposed proximally of the distal end of the
elongated mixing chamber and in fluid communication with the
elongate mixing chamber; and at least one spiral mixing channel
proximal to the discharge aperture of the spray tip assembly, the
at least one spiral mixing chamber in fluid communication with the
elongated mixing chamber via the at least one lateral port and in
fluid communication with the discharge aperture of the spray tip
assembly.
2. (canceled)
3. The device of claim 1 wherein the elongated mixing chamber of
the spray tip assembly comprises an elongated cylindrical cavity
that tapers distally to a transverse dimension that is less than a
transverse dimension of the proximal end of the elongate mixing
chamber.
4. (canceled)
5. (canceled)
6. The device of claim 1 wherein the first and second fluid
reservoirs comprise syringes and wherein the device further
comprises a manifold disposed between and in fluid communication
with the syringes and the fluid delivery channels of the elongated
delivery shaft.
7. The device of claim 6 wherein the syringes are detachably
coupled to the manifold by a Luer-lock configuration.
8. The device of claim 1 wherein the sealing member comprises a
flexible disc having an aperture therein for mixing and
constraining the flow of components therethrough.
9. The device of claim 8 wherein the flexible disc is comprised of
a silastic polymer.
10. A laparoscopic spray device for mixing and applying a multiple
component agent to a target site, comprising: an elongated delivery
shaft having a proximal end, a distal end, and at least two fluid
delivery channels in fluid communication with the first and second
fluid reservoirs, the fluid delivery channels having distal ports;
a spray tip assembly detachably coupled to the distal end of the
elongated delivery shaft having a sealing member disposed at a
proximal end of the spray tip assembly that seals the distal ports
of the fluid delivery channels of the elongated delivery shaft when
the sealing member is in a relaxed state and which allows fluid
flow from the distal ports when pressure is applied to the sealing
member, and having a discharge aperture disposed at a distal end of
the spray tip assembly; an elongated mixing chamber having a
proximal end and a distal end, the elongated mixing chamber in
fluid communication with the fluid delivery channels when pressure
is applied to the first and second components in the fluid delivery
channels; at least one lateral port disposed proximally of a distal
end of the elongated mixing chamber and in fluid communication with
the elongate mixing chamber; and at least one spiral mixing channel
proximal to the discharge aperture of the spray tip assembly, the
at least one spiral mixing chamber in fluid communication with the
elongated mixing chamber via the at least one lateral port and in
fluid communication with the discharge aperture of the spray tip
assembly.
11. (canceled)
12. The device of claim 10 wherein the elongated mixing chamber of
the spray tip assembly comprises an elongated cylindrical cavity
that tapers distally to a transverse dimension that is less than a
transverse dimension of the proximal end of the elongate mixing
chamber.
13. The device of claim 10 wherein the sealing member comprises a
flexible disc having an aperture therein for mixing and
constraining the flow of components therethrough.
14. The device of claim 10 wherein the flexible disc is comprised
of a silastic polymer.
15. A method of mixing and spraying a multiple component agent,
comprising: providing a laparoscopic spray device having a first
fluid reservoir containing a first component and a second fluid
reservoir containing a second component, an elongated delivery
shaft having a proximal end, a distal end, and at least two fluid
delivery channels in fluid communication with the first and second
fluid reservoirs, a spray tip assembly detachably coupled to the
distal end of the elongated delivery shaft having a sealing member
disposed at a proximal end of the spray tip assembly that seals
distal ports of the fluid delivery channels of the elongated
delivery shaft when the sealing member is in a relaxed state and
which allows fluid flow from the distal ports when pressure is
applied to the sealing member and an elongated mixing chamber in
fluid communication with the fluid delivery channels when pressure
is applied to the first and second components in the fluid delivery
channels; advancing the components by pressure from the fluid
reservoirs through the fluid delivery channels to a distal end of
the elongated delivery shaft where the components then contact a
proximal surface of the sealing member; pushing a proximal surface
of the sealing member from distal ports of the fluid delivery
channels so as to break the seal between the distal end of the
fluid delivery channels and the sealing member; flowing the
components into a mixing chamber of the spray tip assembly where
the components are at least partially mixed; flowing the at least
partially mixed components laterally outward from the mixing
chamber and into a spiral mixing chamber; and discharging the mixed
components from a discharge aperture of the spray spiral mixing
chamber onto a target site.
16. The method of claim 15 wherein the mixed components are
discharged from the discharge aperture in atomized form.
17. The method of claim 15 wherein the sealing member comprises a
flexible disc having a central passage disposed in a center portion
thereof and the components flow radially inward from discharge
ports of the fluid delivery channels and converge and begin to mix
together as they pass through the central passage of the flexible
disc and thereafter, into the elongated mixing chamber.
Description
BACKGROUND
[0001] In recent years, minimally invasive surgical techniques have
emerged as an alternative to conventional surgical techniques to
perform a plurality of surgical procedures. Minimally invasive
procedures differ from conventional surgical procedures in that a
plurality of devices may be introduced into the body through a
small incision. As a result, trauma to the body is greatly reduced,
thereby decreasing the recovery time of the patient.
[0002] One example of a common minimally invasive surgery involves
laparoscopic surgical procedures. Laparoscopic procedures may be
used to treat hernias, colon dysfunctions, gastroesophageal reflux
disease, and gallbladder disorders. Typically, the patient
undergoing the procedures will return home hours after undergoing
surgery.
[0003] Generally, laparoscopic procedures require making at least
one small incision in the patient's abdomen near the area of
interest. A cannula or trocar may be inserted into to the incision
to limit blood loss and reduce the likelihood of infection.
Thereafter, various surgical instruments are introduced into the
patient's body through the incision. Generally, these instruments
enable the surgeon to visualize the inside of the patient's body
and access the internal organs of the patient. Current laparoscopic
surgical instruments include cameras, scissors, dissectors,
graspers and retractors. Generally, these instruments include a
handle attached to an elongated body having a distal tip used to
execute the particular procedure. The handle, which remains outside
the patient's body, is used by the surgeon to control the operation
of the instrument during the procedure.
[0004] One challenge presented when performing minimally invasive
surgical procedures relates to closing an incision made within the
patient's body by a cutting laparoscopic instrument. As opposed to
conventional surgical procedures, the surgeon's access to the site
of the incision is greatly reduced during minimally invasive
procedures. As a result, several knot pushing devices capable of
advancing suture knots formed outside the patient's body to an area
of interest in vivo have been developed. Typically, a suturing
laparoscopy device is inserted into the patient's body and advanced
to the incised area.
[0005] A needle is advanced through the various tissue portions
proximate the incision, thereby securing the suture material to the
tissue. Thereafter, the suturing device is removed from the
patient's abdomen leaving the suture material attached to the
tissue. A knot is formed in the suture material and advanced along
the suture material by the knot pusher to the incision, thereby
applying the suture knot. The extraneous suture material is trimmed
with laparoscopic scissors once the incision is adequately sutured.
Occasionally, the suture knot becomes entangled in the suture
material during the advancement process. The surgeon is then
required to remove the entangled suture material from the incision
area and reattach new suture material, thereby increasing the
likelihood of infection and the patient's exposure to
anesthesia.
[0006] Recently, the use of tissue sealants and other biological
adhesive materials has emerged as an alternate technique of closing
incisions. Preferred tissue sealants include fibrin, which is
comprised of thrombin and a fibrinogen material, although other
multiple component materials are available. Typically, the
individual components of the adhesive material are stored in
isolated reservoirs. When mixed, these components may coagulate
very quickly, yielding an adhesive gel within perhaps 10 or 20
seconds. When applied to the exterior of the body, or when
considerable access to the application site is possible, the rapid
coagulative properties of the tissue sealant are welcomed. Though
desirable for use during minimally invasive procedures, such
fast-acting properties of conventional tissue sealants and adhesive
have presented potential problems of fouling or clogging during the
application of tissue sealants through laparoscopic devices, which
typically results in the destruction of the device.
[0007] Thus, there is a need for a device capable of effectively
delivering a multiple component tissue sealant to a location in
vivo through from a remote location.
SUMMARY
[0008] Embodiments of the present invention enable a user to apply
a multiple component material to an incision site within the
patient's body from a remote location without the fouling or
clogging problems associated with prior art devices. In one aspect,
the present invention provides a laparoscopic spray device
comprising an interface member or manifold capable of detachably
coupling to a multiple component material applicator, an elongated
body or delivery shaft having at least two lumens formed therein in
fluid communication with the interface member, and a detachable
spray tip having a mixing chamber therein coupled to the elongated
body useful in generating a spray to apply the material in vivo.
The spray tip assembly may also include a flexible mixing member
adjacent the mixing chamber. The flexible mixing member may
generate a turbulent flow within the mixing chamber, thereby
resulting in impingement mixing of the components of the multiple
component material. In addition, the at least one flexible mixing
member may be used to prevent a back flow of material from the
mixing chamber to the at least two lumens within the elongated
body. Those skilled in the art will appreciate that a material
applicator may be coupled to the present invention in a plurality
of ways, including, without limitation, in slip-fit relation, in
Luer-lock relation, and in screw-like relation.
[0009] In another embodiment, the laparoscopic spray device
comprises an interface member capable of detachably coupling to a
material applicator, an elongated body having at least two lumens
therein in fluid communication with the at least two transport
lumens within the interface member, and a spray tip having a mixing
chamber containing at least one mixing member therein detachably
coupled to and in fluid communication with the elongated body. The
interface member further comprises at least two coupling members
having at least two receiving apertures formed therein. The
receiving apertures are capable of coupling to the material
applicator and are in fluid communication with at least two
transport lumen positioned within the interface member.
[0010] The elongated body comprises a stationary inner body member
positioned within a longitudinally slide-able outer body member.
The stationary inner body includes a spray tip receiver adapted to
receive a detachable spray tip. The slide-able outer body is
capable of being advanced and retracted to cover and expose,
respectively, the spray tip receiver. The at least one flexible
mixing member of the present invention is capable of generating
turbulent flow within the mixing chamber, thereby resulting in
impingement mixing of the components of the multiple component
material. In addition, the at least one flexible mixing member may
be used to prevent a back flow of material from the mixing chamber
to the at least two lumens within the elongated body.
[0011] Embodiments of the present invention also provide a method
of mixing a multiple component material with at least one flexible
mixing member. To practice the present invention the user positions
at least one flexible mixing member proximate to the entrance of a
material mixing chamber. The mixing chamber is attached to at least
two component lumens which are in fluid communication with a
multiple component source. The individual components are advanced
through the separate lumens towards the mixing chamber. Thereafter,
the at least one flexible mixing member engages the individual
components and forces the components together, thereby generating
turbulent flow within the mixing chamber. The generation of
turbulent flow within the mixing chamber results in impingement
mixing of the components which yields a mixed material. In addition
to enhancing the impingement mixing effects, the at least one
flexible mixing member prevents the back flow of material from the
mixing chamber to the at least two component lumens. Thereafter,
the mixed material is advanced through an aperture formed in the
mixing chamber and applied to a work surface.
[0012] Another embodiment includes a laparoscopic spray device for
mixing and applying a multiple component agent to a target site
having a first fluid reservoir containing a first component and a
second fluid reservoir containing a second component. An elongated
delivery shaft has a proximal end, a distal end, and at least two
fluid delivery channels in fluid communication with the first and
second fluid reservoirs. A spray tip assembly is detachably coupled
to the distal end of the elongated delivery shaft and has a sealing
member disposed at a proximal end of the spray tip assembly that
seals distal ports of the fluid delivery channels of the elongated
delivery shaft when the sealing member is in a relaxed state. The
sealing member is configured to allow fluid flow from the distal
ports when pressure is applied to the sealing member. An elongated
mixing chamber is in fluid communication with the fluid delivery
channels when pressure is applied to the first and second
components in the fluid delivery channels.
[0013] Other objects, features, and advantages of the present
invention will become apparent from a consideration of the
following detailed description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The apparatus of the present invention will be explained in
more detail by way of the accompanying drawings, wherein:
[0015] FIG. 1 shows a perspective view of the laparoscopic spray
device of the present invention;
[0016] FIG. 2 shows a perspective view of the interface member the
present invention;
[0017] FIG. 3 shows a cross-sectional view of the interface member
the present invention;
[0018] FIG. 4 shows a cross-sectional view of the interface member
attached to the elongated body the present invention;
[0019] FIG. 5 shows a cross-sectional view of a multiple syringe
material applicator useful in applying a multiple component
material to a work surface;
[0020] FIG. 6 shows a cross-sectional view of a multiple syringe
material applicator coupled to the interface member of the present
invention;
[0021] FIG. 7 shows a expanded cross-sectional view of an
embodiment of the interface member of the present invention
engaging a dispensing tip of a multiple syringe material
applicator;
[0022] FIG. 8 shows a perspective of another embodiment of the
interface member of the present invention engaging a dispensing tip
of a multiple syringe material applicator;
[0023] FIG. 9 shows a cross-sectional view of the embodiment of
FIG. 8 wherein the interface member of the present invention is
engaging a dispensing tip of a multiple syringe material
applicator;
[0024] FIG. 10 shows a perspective of yet another embodiment of the
interface member of the present invention engaging a dispensing tip
of a multiple syringe material applicator;
[0025] FIG. 11 shows a cross-sectional view of the embodiment of
FIG. 10 wherein the interface member of the present invention is
engaging a dispensing tip of a multiple syringe material
applicator;
[0026] FIG. 12 is a cross-section view of the elongated body of the
present invention wherein the slidable outer sleeve is positioned
over the spray tip receivers;
[0027] FIG. 13 is a cross-section view of the elongated body of the
present invention wherein the slidable outer sleeve is positioned
over the attachment channel;
[0028] FIG. 14 is a cross-section view of the at least two lumens
located within the elongated body of the present invention;
[0029] FIG. 15 is a cross-section view of an alternate embodiment
of the at least two lumens located within the elongated body of the
present invention;
[0030] FIG. 16 is a cross-section view of another embodiment of the
at least two lumens located within the elongated body of the
present invention;
[0031] FIG. 17 is a side view of the detachable spray tip of the
present invention; and
[0032] FIG. 18 is a cross-section view of the detachable spray tip
of the present invention;
[0033] FIG. 19 is a perspective view of another embodiment of a
laproscopic spray device;
[0034] FIG. 20 is an elevational view in partial section of a spray
tip assembly of the laproscopic spray device of FIG. 19;
[0035] FIG. 21 depicts the spray tip assembly of FIG. 20 in
use;
[0036] FIG. 22 is an enlarged view in section of a distal portion
of the spray tip assembly of FIG. 19.
DETAILED DESCRIPTION
[0037] Embodiments of a laparoscopic spray device having features
of the present invention are used in conjunction with a multiple
component applicator to dispense a multiple component fluid to a
work surface located within the body of a patient. Embodiments may
be used to dispense a multiple component tissue sealant, such as
Fibrin, which is capable of effecting hemostasis or achieving other
therapeutic results. Embodiments are designed to permit the remote
application of a multiple component fluid and may be adapted to
functionally couple to a plurality of applicators, including, for
example, multiple reservoir syringe-type applicators such as the
DUPLOJECT.TM. syringe-type applicator manufactured by the Baxter
Healthcare Corporation. Embodiments may also include a laparoscopic
spray device capable of functionally coupling with a plurality of
applicators in a plurality of sizes. Some of the exemplary
embodiments disclsosed herein may be similar to or the same as
embodiments disclosed in co-pending U.S. application Ser. No.
09/972,495, titled "Laproscopic Spray Device and Method of Use",
filed Oct. 5, 2001, by Spero et al., which is incorporated by
reference herein in its entirety.
[0038] FIG. 1 shows a perspective view of an embodiment of the
present invention. As shown, the laparoscopic spray device 10
comprises an interface member 12 in fluid communication with an
elongated body 14 having a spray head 15 attached thereto. Those
skilled in the art will appreciate that the present invention may
be manufactured from a plurality of materials, including, without
limitation, polyethylene, polypropylene, polystyrene, or a like
material. A plurality of materials having different physical
properties may be used to manufacture various portions of the
present invention. For example, the interface member 12 and
elongated body 14 may be made rigid, while the spray tip 15 is
resilient. In an alternate embodiment, the interface member 12 may
be manufactured from a rigid material while the elongated body 14
and spray tip 15 is resilient.
[0039] FIG. 2 shows a perspective view of the interface member 12
of the present invention. The interface member 12 comprises a
member body 16 in communication with at least two coupling members
18A, 18B. A first receiving aperture 20A is formed within the first
coupling member 18A. Similarly, a second receiving aperture 20B is
formed within the second coupling member 18B. The receiving
apertures 20A, 20B are sized to receive a material applicator (not
shown). Those skilled in the art will appreciate that the interface
member 12 may be manufactured in a plurality of sizes to receiving
a plurality of material applicators. The interface member 12
further includes an elongated body receiver 22 which is in
communication with an attachment device aperture 24 sized to
receive an attachment device 26 therein. The attachment device 26
removably couples the interface member 12 to the elongated body 14.
The exemplary attachment devices 26 may include, without
limitation, screws and buttons.
[0040] FIGS. 3-4 show several cross sectional views of the
interface member 12. The receiving apertures 20A, 20B located
within the coupling members 18A, 18B are in fluid -communication
with at least two transport lumens 28A, 28B located within the
member body 16. As shown, the transport lumens 28A, 28B have a
uniform diameter. In an alternate embodiment the transport lumens
28A, 28B may have different diameters. The transport lumens 28A,
28B terminate within the elongated body receiver 22. As shown in
FIGS. 3 and 4, the elongated body receiver 22 includes at least one
aligning member 30 therein. The aligning member 30 ensures that the
at least two lumens 32A, 32B formed in the elongated body 14 are
aligned with and are in fluid communication with the transport
lumens 28A, 28B within the interface member 12. In addition, the
aligning member 30 may apply a constrictive force to the elongated
body 14, thereby assisting in the retention thereof.
[0041] FIG. 5 shows a cross-sectional view of an exemplary material
applicator 34 capable of coupling to the present invention. As
shown, the material applicator 34 comprises at least a first
syringe device 36 and a second syringe device 38 coupled by a
syringe coupler 40. It should be understood that the material
applicator 34 of the present invention may comprise a plurality of
material reservoirs, and the present embodiment should not be
construed as limiting.
[0042] The first syringe device 36 comprises a first syringe
reservoir 42 storing a first component 44 and a first syringe
piston 46, positionable within the first syringe reservoir 42. The
first syringe device 36 has a first syringe dispensing tip 48
connected to the first syringe reservoir 42 extending beyond the
syringe coupler 40 and a first syringe pusher 50, which is attached
to the first piston rod 52.
[0043] Likewise, second syringe device 38 comprises a second
syringe reservoir 54 storing a second component 56 and a second
syringe piston 58, positionable within the second syringe reservoir
54. The second syringe device 38 has a second syringe dispensing
tip 60 connected to the second syringe reservoir 54 extending
beyond the syringe coupler 40, and a second syringe pusher 62,
which is attached to the second piston rod 64.
[0044] The coupling members 18A, 18B of the present invention may
couple to the material applicator 34 in a plurality of ways,
including, in screw-able relation or snap-fit relation. FIG. 6
shows one embodiment of the interface member 12 of the present
invention coupled to a material applicator 34. As shown, the
syringe dispensing tips 48, 60 are slidably positioned within the
coupling members 18A, 18B, in a luer-lock relation. In one
embodiment the coupling members 18A, 18B are manufactured from a
resilient material such as a biologically compatible elastomer,
thereby permitting the coupling members 18A, 18B to resiliently
receive the dispensing tips 48, 60. Those skilled in the art will
appreciate that the receiving apertures 20A, 20B formed in the
coupling members 18A, 18B may be tapered to ensure that a sealable
interface between the interface member 16 and the applicator 34 is
obtained. In an alternate embodiment, the receiving apertures 20A,
20B is not tapered.
[0045] An alternate embodiment of the coupling members 18A, 18B is
shown in FIG. 7. A coupling member 18A is shown, which comprises a
rotate-able threaded sleeve 65 and includes a lock member 66
positioned within the receiving aperture 20A. The lock member 66
engages a tip thread 68 located on the dispensing tip 48 in a
screw-like relation.
[0046] FIGS. 8 and 9 show an alternate embodiment of the coupling
members of the present invention. As shown, the coupling members
18A, 18B may comprise engaging channels 70A, 70B formed in the
member body 16. The receiving channels 70A, 70B include at least
one lock ridge 72A, 72B positioned within each receiving channel
70A, 70B. The lock ridge 72A, 72B slide-ably engages at least one
engaging channel 74A, 74B formed on the dispensing tips 48, 60 of
the material applicator 34.
[0047] FIGS. 10 and 11 show yet another embodiment of the coupling
members 18A and 18B. As shown, the coupling members 18A, 18B each
include a compressible collet 76A, 76B therein. Each collet 76A,
76B, which defines a receiving aperture 20A, 20B sized to be a
slightly larger diameter than the inside diameter of the threaded
outer sleeve 80A, 80B, includes a threaded base 78A, 78B. As shown,
each collet 76A, 76B is tapered and includes a plurality of
compression slits 82 positioned radially around the collet. During
use each dispensing tip 48, 60 is inserted into the receiving
aperture 20A, 20B defined by the individual collet 76A, 76B.
Thereafter, the threaded outer sleeve 80A, 80B is positioned to
engage the threaded base 78A, 78B and rotated. As a result, the
threaded outer sleeve 80A, 80B forcibly compresses the collet 76A,
76B thereby decreasing the diameter of the receiving aperture 20A,
20B and applying a retentive force to the dispensing tips 48, 60 of
the material applicator 34 positioned therein. Those skilled in the
art will appreciate the dispensing tips 48, 60 of the material
applicator 34 may, but need not, include a retaining channel (not
shown) thereon.
[0048] FIG. 12 shows a cross-sectional view of the elongate body
14. As shown, the elongated body 14 includes a longitudinally
slide-able outer sleeve 84 positioned around a stationary inner
body 86. At least two elongated body lumens 32A, 32B are positioned
within the inner body 86. The at least two elongated body lumens
32A, 32B are capable of engaging the transport lumens 28A, 28B
positioned within the interface member 12. An attachment channel 88
is formed on the elongated body 14 thereby enabling the elongated
body to engage attachment device 26 positioned on the interface
member 12. The distal portion of the elongated body 14 includes a
spray tip receiver 90 capable of receiving a detachable spray tip
(not shown) thereon. As shown in FIG. 13, the outer sleeve 84 may
be slidably retracted towards the attachment channel 88 thereby
exposing the spray tip receiver 90.
[0049] The elongated body lumens 32A, 32B positioned within the
elongated body 14 may be formed in a plurality of shapes,
including, without limitation, circular lumens and D-shaped lumens.
FIG. 14 shows one embodiment wherein the elongated body lumens 32A,
32B are D-shaped. Those skilled in the art will appreciate that the
D-shaped elongated body lumens 32A, 32B of the present embodiment
allow a larger cross sectional area for the lumen in a smaller
overall diameter shaft. As a result, less force is required to
advance the individual components through the device with a flow
rate sufficient to permit the sprayed application of the multiple
component material.
[0050] As shown in FIG. 14, the elongated body lumens 32A, 32B
positioned within the elongated body 14 may have uniform diameters.
Commonly, the individual components comprising the multiple
component materials may have different viscosities and flow rates,
or may require a disproportionate amount of one component in
relation to another component. As such, in an alternate embodiment
of the present invention the elongated lumens 32A, 32B may be
different diameters to accommodate the different viscosities and
flow rates of the component materials, or to account for the uneven
distribution of one component in relation to another component.
FIGS. 15 and 16 show cross-sectional views of alternate embodiments
of the present invention wherein the elongated lumens 32A, 32B have
different diameters to account for different viscosities and flow
rate of individual components, or to dispense a disproportionate
amount of one component in relation to another component.
Similarly, the transport lumens 28A, 28B may also have different
diameters or shapes as well. As shown in FIG. 15, the first
elongated body lumen 32A has a diameter considerably smaller then
the diameter of the second elongated body lumen 32B. Therefore, the
device 10 will transport a greater volume of component material
through the second elongated body lumen 32B with respect to the
first elongated body lumen 32A. Similarly, FIG. 16 shows another
embodiment of the present invention wherein the second elongated
body lumen 32B is capable of transporting a larger volume of
material therethrough with respect to the first elongated body
lumen 32A.
[0051] FIGS. 17 and 18 show various views of the detachable spray
tip 15. As shown in FIG. 17, the exterior of the spray tip 15
includes a tip body having a spray aperture 94 formed therein. The
spray tip 15 further includes at least one low-profile mounting
member 96 attached thereto, thereby enabling the spray tip 15 to
detachably mount to the elongated body 14. The spray tip may be
manufactured from a plurality of materials, including, for example,
biologically-compatible elastomers, plastics, and metals.
[0052] FIG. 18 shows a cross sectional view of the detachable spray
tip 15 coupled to the elongated body 14. As shown, the at least one
mounting member 96 is located between the outer body 84 and the
stationary inner body 86 of the elongated body 14, and is engaging
the spray tip receiver 90. The detachable spray tip 15 of the
present invention may detachably couple to the elongated body 14 in
a plurality of ways, including, in snap-fit relation. At least two
lumen receivers 98A, 98B receive the elongated body lumens 32A,
32B.
[0053] The spray tip 15 further includes a mixing chamber 100 which
is in communication with the at least two lumen receivers 98A, 98B.
At least one flexible mixing member 102 is positioned within the
mixing chamber 100, proximate to the at least two lumen receivers
98A, 98B. The at least one flexible mixing member 102 assists in
causing impingement mixing of the at least two material components
by forming a turbulent flow within the mixing chamber 100. During
use, the individual components are advanced through the elongated
body lumens 32A, 32B and individually engage the at least one
mixing member 102 positioned within the mixing chamber 100. The
force applied by the advancement of the individual components
forces the at least one flexible mixing member 102 to flex in
response thereto. The at least flexible mixing member 102 provides
sufficient resistance to the applied force so as to form a
narrowing element within the mixing chamber 100 and thereby force
the individual components together within the mixing chamber 100.
The resistance applied by the at least one flexible mixing member
102 in addition to the forward advancement of the material results
in generation of turbulent flow within the mixing chamber 100. In
addition to forming turbulent flow within the mixing chamber 100,
the resilient nature of the at least one flexible mixing member 102
prevents a backflow of material from the mixing chamber 100 into
the elongated body lumens 32A, 32B thereby acting as a directional
flow valve. As shown in FIG. 18, the at least one mixing member 102
is capable of engaging the elongated body support member 103,
thereby restricting access of the material to the elongated body
lumens 31A, 32B from the mixing chamber 100 and preventing a
backflow of material. The at least one flexible mixing member 102
may be manufactured in a plurality of shapes, including, for
example, washer-like shapes.
[0054] A spray regulator 104 is positioned within the mixing
chamber 100 proximate to the spray aperture 94. The spray regulator
104 further ensures that the material located within the mixing
chamber 100 are adequately mixed and provides an impedance within
the mixing chamber 100 to aid in forming a material spray. Those
skilled in the art will appreciate that the position and size of
the spray regulator, in cooperation with the size of the spray
aperture 94, effects the emitted spray volume.
[0055] In use, a multiple component fluid may be applied by the
laproscopic spray device 10 to a work surface located within the
body of a patient The illustrated embodiment shows a syringe-type
material applicator 34, although other applicators may be used.
[0056] Initially, the user attaches the spray tip 15 to the
elongated body 14 by sliding the outer sleeve 84 of the elongated
body 14 towards the interface member 12, thereby exposing the spray
tip receiver 90. Thereafter, the user attaches the spray tip 15 to
the elongated body 14, wherein the at least one mounting member 96
of the spray tip 15 engages the exposed spray tip receiver 90 on
the elongated body 14. The outer sleeve 84 is then slid towards the
spray tip 15, thereby locking the spray tip 15 in place. The user
may then insert the dispensing tips 48, 60 of the syringe-type
material applicator 34 into the receiving apertures 20A, 20B formed
on the coupling members 18A, 18B of the interface member 12.
Thereafter, the coupling members 18A, 18B are actuated to engage
and retain the dispensing tips 48, 60. Syringe-type material
applicators 34 may be single-use disposable devices constructed of
inexpensive plastics and polymers. The application of force to the
first piston rod 52 and second piston rod 64 of the syringe-type
material applicator 34 will result in the application of the fluid
components.
[0057] The spray tip 15 may then be inserted into the patient's
body and advanced to the area of interest. Once suitably positioned
the user applies force to the first piston rod 52 and second piston
rod 64 of the syringe-type material applicator 34. Material stored
within the syringe reservoirs 42, 54 is advanced through the
dispensing tips 48, 60 and into the transport lumens 28A, 28B. The
continued application of force advances the material into the
elongated body lumens 32A, 32B, which are in communication with the
spray tip 15. Thereafter, the material encounters the flexible
mixing member 102 positioned within the mixing chamber 100 of the
spray tip 15. The mixing member 102 forces the individual materials
together and forms a turbulent flow within the mixing chamber 100.
The continued application of force expels the mixed material as a
spray mixture through the spray aperture 94. The disclosed
configuration permits the user to easily detach and apply the spray
tip 15 to the elongated body 14, thereby permitting the user to
easily replace the spray tip 15 should the device foul or clog.
[0058] Another embodiment of a laproscopic spray device 110 is
depicted in FIGS. 19-22. In this embodiment, at least two adhesive
components 112 and 114 can be delivered simultaneously from a dual
syringe assembly 115 through an interface member in the form of a
manifold assembly 113 in a manner that is similar to or the same as
the delivery of components discussed above with regard to the
applicators 34 and interface member 12. The adhesive components may
include any suitable biological materials for delivery to a desired
target site. Two such suitable components include fibrinogen and
thrombin, which when appropriately combined, form a useful
biological adhesive. The manifold assembly is in fluid
communication with isolated fluid channels 116 and 118 extending
the length of an elongated delivery shaft 120. The manifold
assembly may have features that are similar to or the same as the
interface member 12 discussed above. A spray tip assembly 122 is
detachably snapped onto a distal end of the elongated delivery
shaft 120 by means of a locking ring 124 which is radially
constrained by a rigid outer sleeve 126 of the elongated delivery
shaft 120. The spray tip assembly 122 may have features, dimensions
and materials which are similar to or the same as those of the
spray tip 15 discussed above, and vice versa. A sealing member in
the form of a flexible disc 128 is disposed over distal ports 130
and 132 of the fluid channels 116 and 118, respectively. The
flexible disc 128 in a relaxed state covers and seals the distal
ports 130 and 132. This sealed configuration prevents backflow of
components 112 and 114 into the fluid channels 130 and 132 when
positive pressure urging the components in a distal flow is not
present.
[0059] The spray tip assembly 122 can have an outer diameter of
about 2 mm to about 10 mm, more specifically, about 4 mm to about 8
mm. The spray tip assembly can have an axial length of about 10 mm
to about 25 mm.
[0060] The spray tip assembly 122 also includes an elongated
chamber body 134 disposed within an internal cavity 136 of an outer
spray tip body member 138. The elongated chamber body 134 may be
made from a high strength resilient material, such as stainless
steel and the outer spray tip body member can be formed of an
injection molded polymer. The elongated chamber body 134 has an
outer surface 140 that mates with an inner surface 142 of the
internal cavity 136 of the spray tip body member 138. The flexible
disc 128 is disposed within a recess of the proximal end 144 of the
elongated chamber body 134, and has a central passage 146 to allow
a flow of components therethrough. The diameter or transverse
dimension of the central passage 146 can be about 0.01 inches to
about 0.04 inches.
[0061] The central passage 146 is in fluid communication with an
elongated mixing chamber 148 of the spray tip assembly 122. The
elongated mixing chamber 148 is in fluid communication with lateral
ports 150 and 152 which in turn communicate with longitudinal
channels 154 formed into the inside surface 142 of the outer spray
tip body member 138. The lateral ports 150 and 152 are disposed
proximally of a distal end 149 of the elongated mixing chamber. The
longitudinal channels 154 terminate distally in spiral mixing
channels 156 on an inside surface 158 of the distal face 160 of the
outer spray tip body member 138. The spiral mixing channels 156
converge axially inward to an aperture 162 which is configured to
spray an atomized mixture of the components delivered from the dual
syringe assembly 115 as depicted in FIG. 21. The mixing chamber 148
can have an axial length of about 5 mm to about 25 mm, more
specifically about 10 mm to about 20 mm. The mixing chamber 148 can
have an inner diameter or transverse dimension of about 1 mm to
about 3 mm. The inner diameter of the mixing chamber 148 may taper
distally to a smaller transverse dimension relative to a transverse
dimension of the proximal end of the mixing chamber.
[0062] During use, as shown in FIG. 21, the individual components
112 and 114 are advanced by pressure from the dual syringe assembly
115 through the fluid channels 116 and 118 to a distal end of the
elongated delivery shaft 120 where the components 112 and 114 then
contact a proximal surface 164 of the flexible disc 128. Force from
the pressurized component flow then pushes the proximal surface 164
of the flexible disc 128 from the distal ports 130 and 132 of the
fluid delivery channels 116 and 118 and breaks the seal between the
distal end of the fluid delivery channels and the flexible disc
128. The components 112 and 114 then flow radially inward and
converge and begin to mix together as they pass through the central
passage 146 of the flexible disc 128 and thereafter, into the
elongated mixing chamber 148 disposed within the elongated chamber
body 134.
[0063] Turbulent flow of the components through the elongated
mixing chamber 148 serves to mix the components 112 and 114
substantially before the components are then expelled radially
outwardly through the lateral ports 150 and 152 of the elongated
chamber 148. The components 112 and 114 then flow into a gap 166
between an outer surface 140 of the elongated chamber body 134 and
an inside surface 142 of the outer spray tip body member 138, and
then into the longitudinal channels 154 of the outer spray tip body
member 138. The flow of components 112 and 114 then continues into
the spiral mixing channels 156 on the inside surface 158 of the
distal face 160 of the outer spray tip body member 138. Thereafter,
the mixed components 112 and 114 are expelled from the apterture
162 in atomized form onto a target site.
[0064] Embodiments disclosed herein are illustrative of the
principles of the invention. Other modifications may be employed
which are within the scope of the invention; thus, by way of
example but not of limitation, alternative coupling devices,
alternative spray tips, and alternative material applicator
devices. Accordingly, the present invention is not limited to that
precisely as shown and described in the present invention.
* * * * *