U.S. patent application number 12/697332 was filed with the patent office on 2010-05-27 for surgical stapling instruments structured for delivery of medical agents.
Invention is credited to Jerome R. Morgan, Frederick E. Shelton, IV.
Application Number | 20100127041 12/697332 |
Document ID | / |
Family ID | 37726727 |
Filed Date | 2010-05-27 |
United States Patent
Application |
20100127041 |
Kind Code |
A1 |
Morgan; Jerome R. ; et
al. |
May 27, 2010 |
Surgical Stapling Instruments Structured for Delivery of Medical
Agents
Abstract
A medical agent dispensing system can be provided that may be
structured for use with a surgical severing/stapling instrument
that is designed for severing and stapling tissue. The dispensing
system may include at least one storage reservoir structured for
storing at least a component of a medical agent; a gear pump casing
in communication with the storage reservoir; a screw pump auger
positioned within the gear pump casing capable of rotational
manipulation to move the medical agent through the gear pump
casing; and, at least one agent tube in communication with the gear
pump casing. The agent tube may be structured for communication
with a least one agent port formed in a staple cartridge of the
surgical instrument for dispensing the medical agent
therethrough.
Inventors: |
Morgan; Jerome R.;
(Cincinnati, OH) ; Shelton, IV; Frederick E.;
(Hillsboro, OH) |
Correspondence
Address: |
Philip S. Johnson, Esq.;Johnson & Johnson
One Johnson & Johnson Plaza
New Brunswick
NJ
08933-7003
US
|
Family ID: |
37726727 |
Appl. No.: |
12/697332 |
Filed: |
February 1, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11267811 |
Nov 4, 2005 |
7673783 |
|
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12697332 |
|
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Current U.S.
Class: |
227/175.1 ;
606/213 |
Current CPC
Class: |
A61B 2017/07214
20130101; A61B 17/07207 20130101; A61B 2017/00495 20130101; A61B
2017/00893 20130101 |
Class at
Publication: |
227/175.1 ;
606/213 |
International
Class: |
A61B 17/068 20060101
A61B017/068 |
Claims
1. A medical agent dispensing system structured for use with a
surgical severing/stapling instrument structured for severing and
stapling tissue, the dispensing system comprising: at least one
storage reservoir structured for storing at least a component of a
medical agent; a gear pump casing in communication with the storage
reservoir; a screw pump auger positioned within the gear pump
casing, the screw pump auger being capable of rotational
manipulation to move the medical agent through the gear pump
casing; and, at least one agent tube in communication with the gear
pump casing, the agent tube being structured for communication with
at least one agent port formed in a staple cartridge of the
surgical instrument for dispensing the medical agent
therethrough.
2. The dispensing system of claim 1, wherein the medical agent
includes a hemostatic agent.
3. The dispensing system of claim 1, wherein the medical agent
includes an adhesive.
4. The dispensing system of claim 1, wherein the gear pump casing
is positioned to extend longitudinally through a spine of the
surgical instrument.
5. The dispensing system of claim 1, wherein the gear pump casing
is in communication with the agent tube through a lateral
manifold.
6. The dispensing system of claim 5, wherein the agent tube is in
communication with both the lateral manifold and a plurality of the
agent ports.
7. The dispensing system of claim 1, further comprising at least a
second agent tube in communication with the gear pump casing,
wherein the first agent tube communicates with a first plurality of
agent ports formed in the staple cartridge, and the second agent
tube communicates with a second plurality of agent ports formed in
the staple cartridge.
8. The dispensing system of claim 1, further comprising at least
one agent port being formed generally adjacent to at least one
staple hole of the staple cartridge.
9. The dispensing system of claim 1, further comprising at least a
second storage reservoir in communication with the gear pump
casing, the second storage reservoir being structured for storing
at least a component of the medical agent.
10. The dispensing system of claim 9, wherein the component stored
in the first storage reservoir and the component in the second
storage reservoir are designed to be combined to form the medical
agent.
11. The dispensing system of claim 9, further comprising a
Y-manifold in communication with both the first storage reservoir
and the second storage reservoir.
12. The dispensing system of claim 1, further comprising an
electric motor structured to drive rotation of the screw pump auger
within the gear pump casing.
13. The dispensing system of claim 1, further comprising a
mechanically driven rotary trigger configured to drive rotation of
the screw pump auger within the gear pump casing.
14. A surgical severing/stapling instrument including a medical
agent dispensing system, the instrument comprising: a handle
portion including at least one storage reservoir structured for
storing at least a component of a medical agent; a shaft portion
connected to the handle portion, the shaft portion including a gear
pump casing in communication with the storage reservoir, the gear
pump casing including a screw pump auger extending therethrough
capable of rotational manipulation to move the medical agent
through the gear pump casing; an end effector portion operatively
associated with the shaft portion, the end effector including a
channel having a staple cartridge positioned removably therein; at
least one agent tube in communication with the gear pump casing,
the agent tube extending from the shaft portion to communicate with
at least one agent port formed in the staple cartridge for
dispensing the medical agent therethrough.
15. The instrument of claim 14, wherein the medical agent includes
a hemostatic agent.
16. The instrument of claim 14, wherein the medical agent includes
an adhesive.
17. The instrument of claim 14, wherein the gear pump casing is in
communication with the agent tube through a lateral manifold.
18. The instrument of claim 14, further comprising at least a
second agent tube in communication with the gear pump casing,
wherein the first agent tube communicates with a first plurality of
agent ports formed in the staple cartridge, and the second agent
tube communicates with a second plurality of agent ports formed in
the staple cartridge.
19. The instrument of claim 14, further comprising the handle
portion including at least a second storage reservoir in
communication with the gear pump casing, the second storage
reservoir being structured for storing at least a component of the
medical agent.
20. The instrument of claim 19, wherein the component stored in the
first storage reservoir and the component in the second storage
reservoir are designed to be combined to form the medical agent.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of and claims priority to
U.S. Ser. No. 11/267,811 filed on Nov. 4, 2005.
FIELD OF THE INVENTION
[0002] The present invention generally relates to surgical
instruments. The invention more particularly relates to delivery
and application of medical agents in association with the use of
surgical instruments to promote closure and healing of severed and
stapled tissue.
BACKGROUND
[0003] Conventional surgical staplers that can be used to
simultaneously make longitudinal incisions in tissue and apply
lines of staples on opposing sides of the incisions are known in
the art. Such instruments commonly include a pair of cooperating
jaw members that, when employed in endoscopic or laparoscopic
applications, are capable of passing through a cannula passageway.
One of the jaw members typically receives a staple cartridge having
at least two laterally spaced rows of staples. The other jaw member
defines an anvil having staple-forming pockets correspondingly
aligned with the rows of staples in the cartridge. Such stapling
instruments may also include a plurality of reciprocating wedges
that pass through openings in the staple cartridge when driven and
engage drivers supporting the staples to effect the firing of the
staples toward the anvil and through tissue.
[0004] Examples of surgical staplers suitable for use with
endoscopic applications are described in U.S. Patent Application
No. US 2004/0232196 A1. In operation of the surgical stapler, a
clinician closes or clamps the jaw members of the stapler on tissue
to position the tissue prior to firing or activation of the
stapler. Once the clinician has determined that the jaw members are
clamping the tissue in a desired position, then the surgical
stapler can be fired by the clinician to create an incision in the
tissue and at the same time staple tissue surrounding the incision.
This simultaneous action of the stapler avoids complications that
often arise when the severing and stapling operations are performed
sequentially (or at different times) with different surgical tools
(i.e., one device is used to sever the tissue, and then another
device is used to staple the tissue).
[0005] In general, application of certain medical agents to tissue
incisions can promote healing, reduce the possibility of infection,
and/or promote proper sealing of the incisions. If assisted by the
action of such medical agents, many surgical staplers could achieve
better surgical results with respect to enhanced healing, improved
infection resistance, and improved sealing of tissue incisions.
However, the structure of many conventional surgical staplers, and
the procedures in which such staplers are employed, do not leverage
the benefits of medical agents or systems that dispense medical
agents.
[0006] In view of the foregoing, there is a need for improved
surgical instruments and medical agent dispensing systems than can
more effectively and efficiently promote closure, treatment, and
healing of tissue incisions severed and stapled during operations
involving surgical staplers.
SUMMARY
[0007] In accordance with the present invention, various
embodiments of a medical agent dispensing system can be provided.
The medical agent dispensing system may be structured for use with
a surgical severing/stapling instrument structured for severing and
stapling tissue. The dispensing system may include: at least one
storage reservoir structured for storing at least a component of a
medical agent; a gear pump casing in communication with the storage
reservoir; a screw pump auger positioned within the gear pump
casing capable of rotational manipulation to move the medical agent
through the gear pump casing; and, at least one agent tube in
communication with the gear pump casing. The agent tube may be
structured for communication with a least one agent port formed in
a staple cartridge of the surgical instrument for dispensing the
medical agent therethrough.
[0008] In accordance with the invention, various embodiments of a
surgical severing/stapling instrument including a medical agent
dispensing system can be provided. The surgical instrument may
include a handle portion including at least one storage reservoir
structured for storing at least a component of a medical agent, and
a shaft portion connected to the handle portion. The shaft portion
may include a gear pump casing in communication with the storage
reservoir, wherein the gear pump casing includes a screw pump auger
extending therethrough capable of rotational manipulation to move
the medical agent through the gear pump casing. The surgical
instrument may also include an end effector portion operatively
associated with the shaft portion that has a staple cartridge
positioned removably therein. At least one agent tube may be
provided in communication with the gear pump casing; and the agent
tube may extend from the shaft portion to communicate with a least
one agent port formed in the staple cartridge of the surgical
instrument. The agent port may be structured to permit the medical
agent to be dispensed therethrough.
BRIEF DESCRIPTION OF THE FIGURES
[0009] The accompanying drawings, which are incorporated into and
constitute a part of this specification, illustrate embodiments of
the invention. Together with the description of the embodiments
provided herein, the drawings serve to explain the principles of
the present invention for those skilled in the art.
[0010] FIG. 1 depicts an three-dimensional, partially cut-away,
partially schematic view of a surgical instrument that may be
provided in association with embodiments of a medical agent
dispensing system in accordance with the present invention;
[0011] FIG. 2 illustrates a disassembled, three-dimensional view of
the end effector and a shaft portion of the surgical instrument of
FIG. 1;
[0012] FIG. 3 includes schematic depictions of handle, shaft and
end effector portions of the surgical instrument of FIG. 1;
[0013] FIG. 4 includes an enlarged view of the shaft and end
effector portions of the surgical instrument of FIG. 3;
[0014] FIG. 5 includes a enlarged view of the shaft and handle
portions of the surgical instrument of FIG. 3;
[0015] FIG. 6 includes an enlarged, three-dimensional view of a
screw pump auger that may be employed in accordance with various
embodiments of the invention;
[0016] FIG. 7 includes an enlarged, partially cut-away,
three-dimensional view of a portion of the instrument of FIG.
1;
[0017] FIG. 8 includes an end view of the channel of the surgical
instrument of FIG. 2; and,
[0018] FIG. 9 includes a process flow diagram illustrating various
aspects of an example of a method for using embodiments of the
medical agent dispensing system of the present invention.
DESCRIPTION
[0019] As applied herein, the term "tissue" may include a variety
of human or animal tissues, membranes, or other organic substrates.
The term "tissue" may also include any substance, substrate, or
composition of matter capable of being severed and stapled by the
various embodiments of surgical stapling/severing instruments
described herein.
[0020] As applied herein, the term "medical agent" may include a
variety of chemicals, liquids, high viscosity fluids, powders or
other compositions of matter that may be applied to tissues.
Examples of "medical agents" include, without limitation,
hemostatic agents, healing agents, adhesives, sealants,
antibacterial agents, infection-resistant agents, analgesics, and
various other kinds of medicinal or beneficial substances.
[0021] With general reference to the figures, and in association
with various embodiments of the invention, a surgical
severing/stapling instrument 10 may be structured with a handle
portion 20 that is connected to an implement portion 22. The
implement portion 22 may include a shaft 24 which extends distally
from the handle portion 20 and terminates in an end effector 26.
The end effector 26 may include an actuator or E-beam firing
mechanism ("firing bar") 28 that controls spacing between an
elongated channel 30 and a pivotally translatable anvil 32 included
within the end effector 26. It can be seen that the spacing between
the channel 30 and the anvil 32 may be configured to promote
effective stapling and severing of tissue during use of the
surgical instrument 10 by a clinician, for example.
[0022] The handle portion 20 of the instrument 10 may include a
pistol grip 34 toward which a closure trigger 36 may be pivotally
drawn by the clinician, for example, to cause clamping or closing
of the anvil 32 toward the channel 30 of the end effector 26. In
operation, the tissue of a patient, for example, may be clamped by
the closing of the anvil 32 toward the channel 30. A firing trigger
38 positioned adjacent to the closure trigger 36 can be pivotally
drawn in the direction of the pistol grip 34 to substantially
simultaneously staple and sever tissue clamped in the end effector
26 of the instrument 10. In a surgical operation, the clinician
first activates the closure trigger 36 to clamp the tissue of a
patient, for example. Once the clinician is satisfied with the
positioning of the end effector 26, the closure trigger 36 may be
drawn back to a fully closed and locked position proximate to the
pistol grip 34. The firing trigger 38 of the instrument 10 may then
be actuated to sever and staple the clamped tissue. The firing
trigger 38 may springedly return to a normal, inactivated state
when the clinician removes pressure applied to the firing trigger
38. A release button 40 positioned on the proximal end of the
handle portion 20 may be pressed by the clinician to release the
locked closure trigger 36 to its normally open position (as shown
in FIG. 1).
[0023] In various embodiments, the distal end of the shaft 24 may
include a closure tube 52 structured to receive and contain
portions of the components of the end effector 26, such as the
anvil 32 and the channel 30. The closure tube 52 may also be
structured to receive a spine 54 extending therethrough that
supports a knife shaft 56 having a distally positioned severing
edge 58. The knife shaft 56 may operatively interact with the
firing bar 28 at the severing edge 58 of the knife shaft 56. A
knife spring 60 may be inserted within the spine 54 and structured
with a resilient downward bias that promotes proper and secure
positioning of the knife shaft 56 within the spine 54. In
operation, when the instrument 10 is fired, the knife shaft 56 and
its severing edge 58 are moved through the channel 30 by a knife
rod 61 to sever tissue clamped between the anvil 32 and the channel
30. The channel 30 may be structured to receive a removable staple
cartridge 62 therein. The staple cartridge 62 may have multiple
staple holes (such as illustratively representative staple holes
64, 66, 68) formed therein and through which multiple staples (not
shown) may be driven that staple severed tissue when the instrument
10 is fired. In certain embodiments, the staple cartridge 62 may be
an "ETS45" or "ETS60" six-row cartridge, for example, marketed by
Ethicon Endo-Surgery, Inc., of Cincinnati, Ohio.
[0024] Examples of the structure and operation of typical surgical
stapling instruments that may be provided in association with
embodiments of the present invention are disclosed in a United
States published patent application to Shelton et al. entitled,
"Surgical Stapling Instrument having Separate Distinct Closing and
Firing Systems" (U.S. Pub. No. 2004/0232196, Ser. No. 10/441,632,
filed on May 20, 2003), the entirety of which is hereby
incorporated by reference.
[0025] With regard to embodiments of a medical agent dispensing
system that may be provided in conjunction with the surgical
instrument 10, a gear pump casing 72 may be positioned to extend
longitudinally through the spine 54, and may extend from the handle
portion 20 of the instrument 10 to a lateral manifold 74. The gear
pump casing 72 may be structured to receive therethrough a screw
pump auger 76 that is capable of rotational manipulation when
positioned within the gear pump casing 72. FIG. 6 shows an example
of a screw pump auger 76 that may be used in accordance with
various embodiments of the invention. One or more agent tubes 78,
80 may be positioned to communicate both with the lateral manifold
74 and with a plurality of agent ports (such as illustratively
representative agent ports 82, 84, 86) formed in the staple
cartridge 62 generally adjacent to the staple holes 64, 66, 68 of
the cartridge 62. The agent tubes 78, 80 may be structured for
communication with the agent ports 82, 84, 86 in the staple
cartridge 62 as shown in the end view of the cartridge 62 of FIG.
8. While a row of agent ports 82, 84, 86 is shown positioned next
to both sides of a longitudinal center line of the channel 30, it
can be appreciated that more or less such agent ports 82, 84, 86
may be provided in the cartridge 62. For example, more agent ports
82, 84, 86 may be provided in place of one or more of the staple
holes 64, 66, 68 formed in the cartridge 62 as shown. With
particular reference to FIGS. 3 and 5, one or more structures such
as mounting blocks 79, 81 may be included within the channel 30 to
facilitate securement and stability of the agent tubes 78, 80
(respectively) within the instrument 10. Also, it can be seen that
the agent tubes 78, 80 (such as the left-hand side agent tube 78,
as shown in FIG. 4, for example) may be positioned generally
adjacent to the knife shaft 56 as the agent tubes 78, 80 extend
longitudinally through the shaft 24.
[0026] In various embodiments, the handle portion 20 may include
one or more medical agent storage reservoirs 92, 94 mounted on the
handle portion 20 and in communication with the casing 72. The
storage reservoirs 92, 94 may contain a variety of medical agents,
or components thereof, that can be beneficially applied to severed
and stapled tissue by action of the dispensing system in connection
with use of the surgical instrument 10. While multiple storage
reservoirs 92, 94 are depicted with the instrument 10 for
convenience of disclosure, certain embodiments of the invention may
employ only a single storage reservoir or more than two storage
reservoirs. It can be seen that employing multiple storage
reservoirs 92, 94 can facilitate real-time mixing of
multiple-component medical agents during operation of the medical
agent dispensing system. For example, one storage reservoir 92 may
contain a powder and the other storage reservoir 94 may contain a
liquid. The powder and the liquid in the storage reservoirs 92, 94
may be mixed during operation of the instrument 10, such as by
directing the substances through the Y-manifold 96 (as shown in
FIGS. 3 and 5, for example). It can be appreciated that storing and
deploying components of a medical agent separately may preserve the
shelf life and thus the effectiveness of the individual components.
In another example, the use of multiple storage reservoirs 92, 94
permits the use of two-part adhesives, for example, in connection
with operation of the dispensing system within the instrument
10.
[0027] Also, in various embodiments of the medical agent dispensing
system of the present invention, an electric motor 98 may be
included within the handle portion 20 with a mechanical linkage
structured to drive rotation of the screw pump auger 76 within the
gear pump casing 72 upon activation of the motor 98. Those skilled
in the art will appreciate that the electric motor 98 may be any
conventional battery-driven or AC-powered motor provided with
specifications (e.g., a motor rating) suitable for safe and
effective use of the motor 98 in association with operation of the
surgical instrument 10. In certain embodiments, the electric motor
98 may be activated through conventional electrical circuitry or
components 100 that can be operatively associated with the firing
trigger 38, the release button 40, and/or an independent manual
activation switch 102 of the instrument 10. The electrical
circuitry 100 may be configured to activate the motor 98
automatically in association with the firing operation of the
instrument 10, for example; and/or to activate the motor 98
manually through use of the switch 102 which may be pressed by the
clinician, for example, when using the instrument 10. In certain
embodiments, a mechanically driven rotary trigger, for example, may
be configured to interact with the mechanical linkage operatively
associated with the casing 72 to drive rotation of the screw pump
auger 76 within the casing 72.
[0028] With reference to FIG. 9, a process flow diagram illustrates
a method of applying the instrument 10 with the medical agent
dispensing system in a surgical procedure performed on tissue, in
accordance with various embodiments of the invention. At step 202,
the instrument 10 may be fired as described above to sever tissue
and to apply staples to areas on both sides of an incision made in
the tissue. At step 204, in connection with retraction of the knife
shaft 56 from the severed/stapled tissue, the electric motor 98 may
be activated to initiate rotation of the screw pump auger 76 within
the gear pump casing 72 at step 206. At step 208 (which may occur
substantially in parallel with step 206), the gear pump casing 72
receives a quantity of a medical agent, or components combined to
create a quantity of the medical agent, from the Y-manifold 96. At
step 210, the medical agent is delivered by rotational action of
the screw pump auger 76 to the lateral manifold 74. At step 212,
the medical agent may be driven through the agent tubes 78, 80 to
be dispensed at step 214 through the plurality of agent ports 82,
84, 86 in the staple cartridge 62. Once dispensed through the
plurality of agent ports 82, 84, 86, the medical agent may then
cover or deluge at least a portion of tissue areas severed and
stapled by action of the instrument 10 at step 202.
[0029] It will be appreciated that the terms "proximal" and
"distal" may be used herein as convenient terms of relative
orientation, such as with reference to a clinician gripping a
handle of an instrument. For example, the end effector 26 may be
considered "distal" with respect to the "proximal" handle portion
20 (see, e.g., FIG. 1). It will be further appreciated that, for
convenience and clarity of disclosure, spatial terms of relative
orientation such as "vertical" and "horizontal" or "downward" and
"upward" may be used herein with respect to the drawings. Those
skilled in the art will appreciate, however, that surgical
instruments may be used in many orientations and positions, and
such terms are not intended to be limiting and absolute.
[0030] Any patent, publication, or other disclosure material, in
whole or in part, that is said to be incorporated by reference
herein is done so only to the extent that the incorporated material
does not conflict with existing definitions, statements, or other
disclosure material set forth in the present disclosure. As such,
and to the extent necessary, the disclosure as explicitly set forth
herein supersedes any conflicting material incorporated herein by
reference. Any material, or portion thereof, that is said to be
incorporated by reference herein, but which conflicts with existing
definitions, statements, or other disclosure material set forth
herein will only be incorporated to the extent that no conflict
arises between that incorporated material and the existing
disclosure material.
[0031] The examples presented herein are intended to illustrate
potential and specific implementations of the present invention for
those skilled in the art. No particular aspect or aspects of the
examples included herein are necessarily intended to limit the
scope of the present invention.
[0032] It is to be understood that the figures and descriptions of
the present invention have been simplified to illustrate elements
that are relevant for a clear understanding of the present
invention, while eliminating, for purposes of clarity, other
elements. Those of ordinary skill in the art will recognize,
however, that these and other elements may be desirable in a
typical computer system or database system. However, because such
elements are well known in the art and because they do not
facilitate a better understanding of the present invention, a
discussion of such elements may not be provided herein.
[0033] Any element expressed herein as a means for performing a
specified function is intended to encompass any way of performing
that function including, for example, a combination of elements
that perform that function. Furthermore the invention, as defined
by such means-plus-function claims, resides in the fact that the
functionalities provided by the various recited means are combined
and brought together in a manner as defined by the appended claims.
Therefore, any means that can provide such functionalities may be
considered equivalents to the means shown herein.
[0034] In various embodiments of the present invention disclosed
herein, a single component may be replaced by multiple components,
and multiple components may be replaced by a single component, to
perform a given function or functions. Except where such
substitution would not be operative to practice embodiments of the
present invention, such substitution is within the scope of the
present invention.
[0035] While the present invention has been illustrated by
description of several embodiments and while the illustrative
embodiments have been described in considerable detail, it is not
the intention of the applicant to restrict or in any way limit the
scope of the appended claims to such detail. Additional advantages
and modifications may readily appear to those skilled in the art.
The present invention has been discussed in terms of endoscopic
procedures and apparatus. However, use herein of terms such as
"endoscopic" should not be construed to limit the present invention
to a surgical stapling and severing instrument for use only in
conjunction with an endoscopic tube (i.e., trocar). On the
contrary, it is believed that surgical instruments structured in
accordance with the present invention may find use in many surgical
procedures, including but not limited to laparoscopic procedures
and open procedures. Moreover, the unique and novel aspects of the
embodiments of the present invention may find utility when used in
connection with other forms of stapling apparatuses without
departing from the spirit and scope of the present invention.
* * * * *