U.S. patent application number 13/697387 was filed with the patent office on 2015-01-29 for delivery applicator for radioactive staples for brachytherapy medical treatment.
The applicant listed for this patent is Thomas A. DiPetrillo, Matthew Hollows, John J. Munro, Kevin Schehr, David E. Wazer, Krissie K. Zambrano. Invention is credited to Thomas A. DiPetrillo, Matthew Hollows, John J. Munro, Kevin Schehr, David E. Wazer, Krissie K. Zambrano.
Application Number | 20150031935 13/697387 |
Document ID | / |
Family ID | 47177263 |
Filed Date | 2015-01-29 |
United States Patent
Application |
20150031935 |
Kind Code |
A1 |
Wazer; David E. ; et
al. |
January 29, 2015 |
DELIVERY APPLICATOR FOR RADIOACTIVE STAPLES FOR BRACHYTHERAPY
MEDICAL TREATMENT
Abstract
An instrument used for brachytherapy delivery in the treatment
of cancer by radiation therapy including a handle having first and
second handle actuators; an end effector; and an instrument shaft
that connects the handle with the end effector. The end effector
has first and second adjacent disposed staple cartridges that each
retain a set of staples. The first mechanism is for holding
standard staples in a first array, and dispensing the standard
staples under control of the corresponding first handle actuator.
The second mechanism is for holding radioactive source staples in a
second array, and dispensing said radioactive source staples under
control of the corresponding second handle actuator. The actuating
device is removably attachable to an actuator arm on a proximal
end. A staple applicator cartridge holder is attached to the
actuator arm on a distal end. The staple applicator cartridge is
mountable in the holder and having a plurality of slots for
mounting of radioactive source staples therein. An anvil therein
crimps the staples.
Inventors: |
Wazer; David E.; (Ashland,
MA) ; DiPetrillo; Thomas A.; (Dover, MA) ;
Munro; John J.; (North Andover, MA) ; Hollows;
Matthew; (Westminster, MA) ; Schehr; Kevin;
(New Orleans, LA) ; Zambrano; Krissie K.; (New
Orleans, LA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Wazer; David E.
DiPetrillo; Thomas A.
Munro; John J.
Hollows; Matthew
Schehr; Kevin
Zambrano; Krissie K. |
Ashland
Dover
North Andover
Westminster
New Orleans
New Orleans |
MA
MA
MA
MA
LA
LA |
US
US
US
US
US
US |
|
|
Family ID: |
47177263 |
Appl. No.: |
13/697387 |
Filed: |
May 9, 2012 |
PCT Filed: |
May 9, 2012 |
PCT NO: |
PCT/US12/37015 |
371 Date: |
September 23, 2014 |
Current U.S.
Class: |
600/8 |
Current CPC
Class: |
A61B 2017/07235
20130101; A61N 5/1027 20130101; A61B 17/0644 20130101; A61N
2005/1024 20130101; A61B 17/068 20130101; A61B 17/0686 20130101;
A61B 2017/07271 20130101; A61N 2005/1025 20130101 |
Class at
Publication: |
600/8 |
International
Class: |
A61N 5/10 20060101
A61N005/10; A61B 17/064 20060101 A61B017/064 |
Foreign Application Data
Date |
Code |
Application Number |
May 16, 2011 |
US |
13108759 |
Jun 13, 2011 |
US |
13158549 |
Claims
1. An instrument used for brachytherapy delivery in the treatment
of cancer by radiation therapy, said instrument comprising: a
handle having first and second handle actuators; an end effector;
an instrument shaft that connects the handle with the end effector;
said end effector comprised of first and second adjacent disposed
cartridges that each retain a set of staples; said first cartridge
for holding standard staples in a first array, and dispensing said
standard staples under control of the corresponding first handle
actuator; said second cartridge for holding radioactive source
staples in a second array, and dispensing said radioactive source
staples under control of the corresponding second handle actuator;
said first and second cartridges being retained in a substantially
parallel array so that the standard staples close the incision at a
surgical margin while the source staples are secured adjacent
thereto.
2. The instrument of claim 1 wherein both of said arrays of staples
are disposed spaced both longitudinally and laterally.
3. The instrument of claim 1 wherein said staples are constructed
of any one of platinum, titanium, nickel-titanium alloys, gold,
stainless steel, palladium, silica and alumina.
4. The instrument of claim 1 wherein the staples of both arrays are
spaced apart about 1.0 mm both longitudinally and laterally.
5. The instrument of claim 1 wherein said standard staples are
positionable for piercing said tissue in performing a surgical
procedure at a surgical margin while substantially concurrently
said source staples secure said radioactive source in a fixed
position at said surgical margin.
6. The instrument of claim 5 wherein said array of source staple is
constructed and arranged to extend spaced longitudinally of the
surgical margin.
7. The instrument of claim 1 wherein the radioactive source is for
cancer treatment and the standard staples are applied followed by
applying the source staples.
8. The instrument of claim 7 wherein a complete line of standard
staples are applied followed by a complete line of source
staples.
9. An instrument used as a brachytherapy delivery means in the
treatment of cancer by radiation therapy, said apparatus
comprising: a control handle; an end effector; an instrument shaft
that connects the control handle with the end effector; said end
effector comprised of first and second adjacently disposed
cartridges that each retain a set of staples; said first cartridge
for holding standard staples in a first array, and dispensing said
standard staples under operation from said control handle; said
second cartridge for holding radioactive source staples in a second
array; said source staples each comprised of a base, tissue
piercing ends, a radioactive source, and means for mounting the
radioactive source to the base; said second cartridge for
dispensing said source staples under operation from said control
handle; said cartridges for retaining and selectively applying the
staples along a surgical margin so that the standard staples close
the incision at a surgical margin while the source staples are
secured adjacent thereto.
10. The instrument of claim 9 including a distal holder for
retaining the first and second cartridges in a substantially
parallel array.
11. The instrument of claim 10 wherein each cartridge control
handle also has respective first and second handle actuators for
controlling the application of staples.
12. The instrument of claim 9 wherein said source staples fix the
position of the radioactive source relative to the surgical martin
to provide a stable dose distribution thereat.
13. A staple delivery applicator for delivering radioactive source
staples during a medical treatment, said staple delivery applicator
comprising: an actuating means, said actuating means for
controlling crimping of the source staples located distally from
said actuating means; an actuator arm, said actuating means being
removably attachable to said actuator arm on a proximal end; and a
cartridge holder, said cartridge holder operatively attached to
said actuator arm on a distal end and adapted to removably mount
therein a source staple cartridge; wherein said actuating means is
adapted for closing the anvil of the cartridge holder and for
firing of the source staples in the cartridge therein to cause the
staples to crimp, and opening and closing of the anvil.
14. The staple delivery applicator for delivering radioactive
source staples as recited in claim 13, wherein said actuating means
comprises a device operated by hand, by mechanical means, or
electrical/mechanical means.
15. The staple delivery applicator as recited in claim 14, wherein
said mechanical means comprises a trigger device comprising: a hand
holding section, a lever mounted in said hand holding section; a
control section, said control section having one or more controls
therein thereon for crimping staples located distally from said
trigger device, said control section having a control for closing
the anvil of the cartridge holder and for firing of the source
staples in the cartridge therein to cause the staples to crimp, and
a control for opening the anvil and releasing the trigger device
from the actuator arm; and an actuator arm mounting section.
16. The staple delivery applicator as recited in claim 13, wherein
said actuator arm has a proximal end and a distal end, said
proximal end having a control cable extending therefrom which is
mountable in said actuator arm mounting section, said distal end
being adapted to mount to said cartridge holder.
17. The staple delivery applicator as recited in claim 13, wherein
said cartridge holder further includes said anvil and a firing
hammer, said firing hammer being translatable within said staple
cartridge, said firing hammer operatively pushing upwards upon one
or more staple holders mounted therein, said pushing crimping the
legs of staples against said anvil.
18. The staple delivery applicator as recited in claim 13, wherein
said staple cartridge may be removably attached to said cartridge
holder, said staple cartridge having a plurality of slots for
mounting of radioactive source staples therein, said anvil for
crimping the staples therein.
19. The staple delivery applicator as recited in claim 13, further
including a connector, said staple holder being adapted for
removably mounting in said connector, said connector being
removably mounted to a surgical staple holder.
20. The staple delivery applicator as recited in claim 19, wherein
said connector may be mounted to one side or the other side of said
surgical staple holder.
21. The staple delivery applicator as recited in claim 20, wherein
said connector further includes radiation shielding.
22. The staple delivery applicator as recited in claim 13, further
including a modular connector with two modular units, one modular
unit being adapted to removably hold said source staple cartridge
holder, the other modular unit being adapted to removably hold a
surgical staple cartridge holder, said units being removably
mounted together in said modular connector when in use.
23. The staple delivery applicator as recited in claim 21, wherein
said modular unit for said cartridge holder may be mounted to
either side of the modular unit for holding said surgical staple
holder.
24. The staple delivery applicator as recited in claim 23, wherein
said connector further includes radiation shielding.
25. The staple delivery applicator as recited in claim 13, said
anvil further includes radiation shielding.
26. A staple delivery applicator for delivering radioactive staples
during medical treatment, said staple delivery applicator
comprising: an actuating means, said actuating means for
controlling crimping of the source staples located distally from
said actuating means; an actuator arm, said actuating means being
removably attachable to said actuator arm on a proximal end; a
cartridge holder, said cartridge holder operatively attached to
said actuator arm on a distal end and adapted to removably mount
therein a source staple cartridge; a connector, said staple holder
being adapted to removably mount in said connector; wherein said
actuating means is adapted for closing the anvil of the cartridge
holder and for firing of the source staples in the cartridge
therein to cause the staples to crimp, and opening and closing of
the anvil.
27. The staple delivery applicator for delivering radioactive
source staples as recited in claim 26, wherein said actuating means
comprises a device operated by hand, by mechanical means, or
electrical/mechanical means.
28. The staple delivery applicator as recited in claim 27, wherein
said mechanical means comprises a trigger device comprising: a hand
holding section, a lever mounted in said hand holding section; a
control section, said control section having one or more controls
therein thereon for crimping staples located distally from said
trigger device, said control section having a control for closing
the anvil of the cartridge holder and for firing of the source
staples in the cartridge therein to cause the staples to crimp, and
a control for opening the anvil and releasing the trigger device
from the actuator arm; and an actuator arm mounting section.
29. The staple delivery applicator as recited in claim 26, wherein
said connector may be mounted to one side or the other side of said
surgical staple holder.
30. The staple delivery applicator as recited in claim 26, wherein
said connector further includes radiation shielding.
31. The staple delivery applicator as recited in claim 26, further
including a modular connector with two modular units, one modular
unit being adapted to removably hold said cartridge holder, the
other modular unit being adapted to removably hold a surgical
staple cartridge holder, said units being removably mounted
together in said modular connector when in use.
32. The staple delivery applicator as recited in claim 31, wherein
said modular unit for said cartridge holder may be mounted to
either side of the modular unit for holding said surgical staple
holder.
33. The staple delivery applicator as recited in claim 19, wherein
said modular connector further includes radiation shielding.
Description
TECHNICAL FIELD
[0001] The present invention relates to an improved method and
system for applying a radioactive source to a tissue site. More
particularly, the present invention pertains to an improved
delivery system based upon the incorporation of a radioactive seed
by fastening means, such as a surgical staple. More specifically,
the present invention pertains to an improved brachytherapy
delivery system for applying a radioactive source to a tissue site.
Even more particularly the present invention relates to a new
instrument construction wherein a single stapler instrument is used
for precisely applying both standard surgical staples, as well as
brachytherapy source staples relative to a surgical margin.
BACKGROUND AND OBJECTS OF THE INVENTION
[0002] The incidence of lung cancer has been rising over the last
half century, although the rate has decreased somewhat over the
last decade because of increased publicity about the health risks.
The American Cancer Society estimates the number of new cases in
2009 to exceed 219,000. Lung cancer is the leading cause of cancer
deaths in the United States among both men and women, expected to
reach 159,000 in 2009, claiming more lives than colon, prostate and
breast cancer combined..sup.i
[0003] Non-small cell lung cancer (NSCLC) is the most commonly
diagnosed form of the disease, affecting 4 out of 5 patients. In
United States, .about.23% of patients present with early-stage (T1,
T2) disease..sup.ii In most cases, early stage NSCLC can be treated
successfully with surgery if the cancer has not spread beyond the
chest. Surgical resection is the definitive treatment and lobectomy
is the procedure of choice..sup.iii,iv,v Lobectomy is the most
common type of lung cancer surgery, involving removal of an entire
lobe of one lung. For these early stage NSCLC patients, lobectomy
yields a 5-year survival rate of 65-77%. Locoregional recurrence
occurs in 28% of T1N0 tumors submitted to thoractomy, with the
highest initial failure rates detected in the ipsilateral
hemithorax..sup.vi,vii Unfortunately, some patients with this
disease are poor candidates for lobectomy due to poor pulmonary
health or other medical issues.
[0004] Stage I NSCLC patients with compromised cardiopulmonary
status may undergo limited surgical resections in an attempt at
lung preservation while achieving adequate resection
margins..sup.viii However, lesser resections have been associated
with an increased risk of local recurrence, even for small
peripheral tumors..sup.ix Nonetheless, limited resection is viewed
as an acceptable alternative for patients with poor physiologic
reserve or of advanced age..sup.x,xi
[0005] Though sublobar resection alone is associated with an
increased incidence of post-operative disease recurrence, it is
still advocated for high-risk patients in the absence of a good
alternative. External beam radiation therapy has been used
successfully to reduce the risk of local recurrence in these
compromised patients..sup.xii However, external beam radiation
therapy further reduces pulmonary function because it generally
requires the beam to pass through normal lung tissue to reach the
target lesion. Some studies suggest that adding brachytherapy to
the regimen can make a dramatic difference in outcomes.
[0006] Intraoperative brachytherapy has been shown to be an
effective therapeutic modality for patients unable to undergo a
surgical lobectomy; it is an alternative to external beam
irradiation for patients who cannot tolerate further loss of lung
function..sup.xiii,xiv
[0007] The use of brachytherapy has been shown in several studies
to have a clinical benefit for compromised lung cancer patients for
whom more traditional surgical procedures, such as a lobectomy, are
not an option. This is now the subject of a NIH-sponsored Phase III
Clinical trial..sup.xv
[0008] These candidate patients would undergo limited (sublobar)
surgical resection (wedge resection) in an attempt at lung
preservation while achieving adequate resection margins, followed
by brachytherapy; Currently, brachytherapy is performed using
.sup.125Iodine seeds delivered at the time of surgery. Seeds have
been deployed by a variety of techniques such as manually suturing
stranded seeds,.sup.xvi manually delivering loose seeds via a
Mick.RTM. applicator,.sup.xvii thoracoscopic placement of vicryl
mesh imbedded with .sup.125Iodine radioactive seeds,.sup.xviii and
seed placement in the wedge resection margin using the da Vinci
robotic system..sup.xix
[0009] The problem with all of these techniques is the difficulty
in precisely delivering the brachytherapy seeds intraoperatively to
achieve the proper dose distribution and minimizing the radiation
dose to the clinicians performing the procedure.
[0010] When removing non-small cell lung cancers, the most
prevalent form of lung cancer, conventional staples are typically
used for the procedure. Moreover, the use of radioactive sources
are placed near the cancer site to provide a mode of treatment. In
this regard, U.S. Pat. Nos. 7,604,586 and 7,972,260 disclose one
mode of treatment using staples containing a radioactive material
and the attachment of these staples near the surgical resection.
Reference may also be made to the aforementioned patents for
background discussions pertaining to brachytherapy procedures.
[0011] Accordingly, there is a need for a staple delivery
applicator having means for the accurate placement of radioactive
staples at surgical sites.
[0012] Another object of the present invention to provide an
apparatus or instrument for incorporating a radioactive source into
or with a surgical procedure means such as a surgical staple so
that the radioactive source can be positioned substantially
concurrently with the application of the surgical tissue securing
means.
[0013] Still another object of the present invention is to provide
a brachytherapy source-delivery system and instrument that
facilitates the precise placement of brachytherapy sources relative
to a surgical margin, assures the seeds remain fixed in their
precise position for the duration of the treatment, overcomes the
technical difficulties of manipulating the seeds through a narrow
surgical incision inherent in minimally invasive procedures, and at
the same time reduces the radiation dose to the clinicians.
[0014] A further object of the present invention is to provide a
means for irradiating cancer tissue with the use of staples in
lung, colorectal and gynecological cancers, for example.
[0015] It is another object of the present invention to provide an
effective therapeutic modality for patients unable to undergo a
surgical lobectomy; it is an alternative to external beam
irradiation for patients who cannot tolerate further loss of lung
function.
[0016] It is a further object of the present invention to provide a
means to precisely deliver the brachytherapy sources
intraoperatively to achieve the proper dose distribution and
minimizing the radiation dose to the clinicians performing the
procedure.
[0017] It is still a further object of the present invention to
provide a means for precise placement of brachytherapy sources
relative to the surgical margin, assuring the sources remain fixed
in their precise positions for the duration of the treatment,
overcoming the technical difficulties of manipulating the sources
through the narrow surgical incision, and reducing the radiation
dose to the clinicians.
[0018] It is yet a further object of the present invention to
provide a delivery device having better shielding than the existing
stapler cartridges, thereby providing greater safety to the
physician and other operating room personnel.
[0019] It is yet a further object of the present invention to
provide a device that reduces the possibility of mis-locating
sources by reducing and/or by limiting the number of potential
source positions to only dosimetrically useful positions, rather
than all staple positions, and further locating the sources nearer
to the center of the treatment volume rather than at its edge.
SUMMARY OF THE INVENTION
[0020] The present invention facilitates the precise placement of,
for example, .sup.125Iodine seeds relative to the surgical margin,
assures the seeds remain fixed in their precise position for the
duration of the treatment, overcomes the technical difficulties of
manipulating the seeds through the narrow surgical incision, and
reduces the radiation dose to the clinicians. The concepts of the
present invention incorporate the radioactive .sup.125Iodine seeds
into a fastening means, preferably surgical staples, used in the
surgical procedure. In this way, the seeds are concurrently secured
in position directly adjacent to the surgical resection and remain
immobile. They are precisely located relative to the resection,
placed by a very convenient method eliminating the difficulties of
working through the narrow surgical incision. The seed position is
rigidly fixed, assuring that the dose distribution does not
uncontrollably change over the duration of the treatment. This
method permits the dose distribution to be precisely planned prior
to the surgery to achieve the desired result. Insertion of the
seeds in conjunction with the application of the staples also
significantly reduces the dose to the clinician.
[0021] In accordance with the present invention the source delivery
system is used in conjunction with a standard surgical stapling
instrument, such as one that is presently used for video-assisted
thoracoscopic surgery (VATS). By integrating a permanent
brachytherapy source in a standard surgical stapling instrument,
there is provided a single instrument to cut and seal lung tissue
and simultaneously place a permanent radioactive seed implant. With
the instrument of the present invention: (1) The source/staple does
not compromise the pre-established parameters of standard surgical
staple delivery systems; (2) Uses preferably the same materials,
measurements, and spacing of existing surgical staples; (3) Is
deliverable using currently available surgical spacing instruments;
(4) Is easily assembled with the standard stapler cartridge and is
readily sterilized; and (5) Can be deliverable with minimal
radiation exposure to the physician and other operating-room
personnel.
[0022] A staple delivery applicator for delivering radioactive
staples during brachytherapy medical treatment has an actuating
device for attaching source staples located distally from the
actuating device. The actuating device is removably attachable to
an actuator arm on a proximal end. A staple applicator cartridge
holder is attached to the actuator arm on a distal end. The staple
applicator cartridge is mountable in the holder and having a
plurality of slots for mounting of radioactive source staples
therein. An anvil therein crimps the staples. The staple applicator
cartridge holder is removably mountable in a connector and the
connector is also removably mounted to a surgical staple holder. In
one embodiment a trigger device has a control for closing the anvil
of the cartridge holder and for firing of the source staples in the
cartridge therein to cause the staples to crimp, and a control for
opening the anvil and releasing the trigger device from the
actuator arm.
DESCRIPTION OF THE DRAWINGS
[0023] Numerous other objects, features and advantages of the
present invention are now realized by a reading of the following
detailed description taken in conjunction with the accompanying
drawings, in which:
[0024] FIG. 1 is an example of the staple pattern in a typical
surgical stapling system;
[0025] FIG. 2 is an illustration of a single staple that is
attached with a retaining sleeve that accommodates a radioactive
seed;
[0026] FIG. 3 is a further example, like that shown in FIG. 2, but
using a pair of staples interconnected with a single sleeve;
[0027] FIG. 4 illustrates a plan for a single resection, margin
with an axially symmetric seed;
[0028] FIG. 5 illustrates another staple configuration;
[0029] FIG. 6 illustrates still another staple configuration;
[0030] FIG. 7 is a cross-sectional view of the staple of FIG. 6
showing the staple closed to join tissue;
[0031] FIG. 8 illustrates dose distribution for the embodiment of
FIG. 6;
[0032] FIG. 9 schematically illustrates another embodiment of the
present invention;
[0033] FIG. 10 schematically illustrates one standard staple array
in parallel with a source array;
[0034] FIG. 11 is a perspective view depicting an instrument
constructed in accordance with the principles of the present
invention and illustrating side-by-side staple mechanisms; one for
applying standard staples and the other for applying source
staples;
[0035] FIG. 12 is an enlarged fragmentary perspective view at the
distal end of the instrument with the staple mechanisms retained by
a common holder,
[0036] FIG. 13 is an enlarged fragmentary perspective view at the
distal end of the instrument with the standard staple mechanism
actuated;
[0037] FIG. 14 is an enlarged fragmentary perspective view at the
distal end of the instrument with the source staple mechanism
actuated;
[0038] FIG. 15 is a perspective view of the staple mechanism holder
used at the distal end of the instrument;
[0039] FIG. 16 is an enlarged exploded perspective view at the
distal end of the instrument;
[0040] FIG. 17 schematically illustrates the use of the staple
mechanism of the present invention in actual use during a surgical
procedure such as a lung resection;
[0041] FIG. 18A is a left side perspective view of an applicator of
the present invention;
[0042] FIG. 18B is right side perspective view of the applicator of
FIG. 18A;
[0043] FIG. 18C is a right side perspective view of the applicator
of FIG. 18B showing an anvil of a cartridge in the open
position;
[0044] FIG. 19 is a right side view of a cartridge unit separated
from a trigger of FIG. 18A of the present invention;
[0045] FIG. 20A is a right side view of the applicator of FIG. 18A
having a right side housing removed from the trigger of the present
invention;
[0046] FIG. 20B is a left side view of the applicator having a left
side housing removed from the trigger of the present invention,
showing the back of the toggle knob on the right side of the
applicator of FIG. 18B;
[0047] FIGS. 20C to 20D show a reverse switch mechanism that
interacts with the toggle rods of the toggle knob for changing the
direction of cable movement; this being one possible mechanism;
[0048] FIG. 21A is a partial perspective view of the cartridge unit
of FIG. 19 along side of a surgical staple cartridge with a
connector located below in the present invention;
[0049] FIG. 21B is a partial perspective view as in FIG. 21A but
showing the connector installed on the cartridges;
[0050] FIG. 22A is a partial side view of the cartridge unit of
FIG. 19 with the anvil open showing by x-ray view an inside of the
cartridge unit of the present invention;
[0051] FIG. 22B shows the anvil closed as compared to FIG. 22A of
the present invention;
[0052] FIGS. 23A to 23D shows by perspective views one embodiment
of the connector of the present invention;
[0053] FIGS. 24A to 24B shows by perspective views the embodiment
of both modular units being installed together, and
[0054] FIGS. 25A and 25B illustrate several actuating devices in
addition to the trigger device as shown above for operating the
cable attached to the cartridge unit.
[0055] Like reference numerals refer to like parts throughout the
several views of the drawings.
DETAILED DESCRIPTION
[0056] An objective of the present invention is to develop an
improved delivery system based upon the incorporation of a
radioactive seed into fastening means, preferably into a surgical
staple. More particularly the disclosed system is an improved
brachytherapy delivery system for treatment of, inter alia, lung
cancer based upon the incorporation of radioactive seeds into
surgical staples used in lung resection. For patients with
compromised cardiopulmonary status, the inclusion of brachytherapy
with sublobular resection has shown a significant improvement in
therapeutic outcome over sublobular resection alone. This present
technique facilitates the delivery of this therapy. Furthermore,
the techniques described herein may also be used in other medical
procedures. Moreover, the techniques of the present invention may
be used in applying a variety of radioactive sources.
[0057] The technique of the present invention facilitates the
precise placement of, for example, .sup.125Iodine seeds relative to
the surgical margin, assures the seeds remain fixed in their
precise position for the duration of the treatment, overcomes the
technical difficulties of manipulating the seeds through the narrow
surgical incision, and reduces the radiation dose to the
clinicians. The examples describe the use of Iodine-125 as the
radiation source but this is understood to be illustrative and that
any radionuclide commonly used for brachytherapy, including
Palladium-103, Cesium-131 and Ytterbium-169 could be incorporated
into these staple/sources.
[0058] The present invention develops a brachytherapy system that
can be used for intraoperative placement of radioactive seeds
simultaneously with fastener means, preferably surgical staples,
used in lung wedge resection procedures. Such a instrument
precisely fixes the position of the seeds relative to the resection
margin and provide a well defined, stable dose distribution to the
target, while facilitating the means for delivering these seeds
with reduced dose to the physicians. In one embodiment this is
performed by having the radiation source integral with the fastener
or staple so that when the resection occurs, concurrently
therewith, the radiation source is properly positioned.
[0059] The instrument of the present invention permits delivery of
the seeds and surgical staples using currently-available surgical
stapling instruments modified in accordance with the principles of
the present invention. The seed/staple combination is easily
assembled with the staple cartridge. The combination is readily
sterilizable. The combination is deliverable with minimal radiation
exposure to the physician. The design of any additional structure
around the .sup.125Iodine seed should be sensitive to excessive
modulation of the dosimetric parameters of the seed. Refer to FIG.
1 that illustrates an example of the staple pattern in a surgical
stapling system.
[0060] One embodiment of a source staple is shown in FIG. 2 and
includes the attachment of a sleeve 11 to a single surgical staple
20 by means of laser welding at 15. The sleeve 10 may be of 0.9 mm
OD.times.0.8 mm ID and accommodates a standard radioactive
.sup.125Iodine seed 30, as illustrated in FIG. 2. A standard seed
is 4.5 mm long, which is longer than an individual staple. This
could be accommodated in the cartridge in such a way as to not
interfere with adjacent staples. The radioactive .sup.125Iodine
seed 30 is inserted and fixed within the sleeve 10. As noted in
FIG. 2, the radioactive source and sleeve are preferably
symmetrically located relative to the staple 20. FIG. 2 also shows
the staple in both a rest position and a released bent position. It
is noted that the legs of the staple are pointed as usual.
[0061] An alternative embodiment, as shown in FIG. 3, illustrates
the attachment of a sleeve 10 to two adjacent staples 20A and 20B,
thereby accommodating the length and providing an additional
measure of stability. As noted in FIG. 3, the sleeve is preferably
symmetrically located relative to the pair of staples 20. The
sleeve 10 bridges between the adjacently disposed staple pair,
secured by means of the laser weld. The sleeve preferably is in
contact with each staple over a like length so as to provide the
symmetry. FIG. 3 also shows the staples in both a rest position and
a released bent position. The system of the present invention
provides an integral fastener in which the radiation source is
integrally formed with the fastener, and usable in a surgical
procedure.
[0062] In most brachytherapy situations, this treatment plan could
be performed using a standard treatment planning system. FIG. 4
shows a typical plan for a single resection margin using a standard
treatment planning system with axially symmetric seed dosimetry.
However, the I-Plant TPS, as well as all other commercial treatment
planning software assume axially symmetric dose distributions in
their calculational algorithms. Consequently, standard treatment
planning software does not account for axial asymmetry and
therefore does not provide precise results.
[0063] The cartridges for the surgical staples may be molded in
plastic. This material does not provide any appreciable shielding,
even for such a low energy radionuclide as .sup.125Iodine. However,
high density plastics containing tungsten are available and are
regularly used for radiation shielding for .sup.125Iodine seeds. We
would plan to fabricate the special cartridge using this type of
plastic. The cartridge would be designed to provide adequate
shielding for the clinicians handling this instrument during the
surgical procedure.
[0064] Another embodiment in accordance with the present invention
is shown in FIG. 5 and includes an integrally formed staple
structure shown in both open and closed positions. This is
comprised of a radioactive center element 41 and an encapsulating
outer element 42. The ends 44 are shown blunt but in practice would
be pointed so as to function as a surgical staple. The base of the
staple is preferably about 3 inches and each leg, in the open
position is about 2 inches. These can be readily accommodated in a
conventional staple delivery cartridge.
[0065] Reference is now made to FIG. 6 for an illustration of still
another embodiment that incorporates the radioactive material
inside the staple itself by sealing it within a cavity created from
a titanium tube. In FIG. 6 the staple is shown in both open and
closed positions. Refer also to FIG. 7 for further details of this
staple structure. FIG. 7 also illustrates the staple 50 as engaging
a tissue 55 at incision 57. This staple 50 includes a cylindrical
tube 52 that is preferably a titanium tube, but may also be of
other metal materials. These materials include platinum, titanium,
nickel-titanium alloys, gold, stainless steel, palladium, silica
and alumina. The tube 52 defines a tubular cavity that is
capped/sealed by titanium wires 54 that are laser-welded to the
tube. The wires 54 serve as the legs of the staple.
[0066] In the embodiment shown in FIGS. 6 and 7 the radioactive
material 56 is located inside the titanium tube which may be of
.about.0.40 mm in diameter with a wall thickness of .about.0.07 mm,
resulting in a cavity of 0.26 mm diameter. The ends of the tube 52
are plugged with titanium wires 54 of 0.25 mm diameter which may be
laser-welded to the tubing. These wires 54 are typical of the
wire-size currently used in surgical staples. Such a tubular
capsule of 0.40 mm diameter readily fits within the cavity of
currently-used staple delivery systems.
[0067] FIG. 9 shows still another embodiment for practicing the
present invention. Instead of providing the radioactive source
within the fastener or staple, in this embodiment there is
schematically illustrated a series of staples 60 that may each be
of conventional design but that have associated therewith a
radioactive source shown at 62. The staples 60 are shown as
associated with a surgical margin or incision 64. The sources 62
are distributed or positioned by means of a the line 66. In an
alternate arrangement a loop may be used at 62 and the line 66 may
be a radioactive line supported by the loops 62 or the line 66 may
carry spaced radioactive sources. FIG. 10 schematically illustrates
one standard staple array in parallel with a source array;
[0068] The concepts of the present invention are described in
connection with a lung brachytherapy. In this connection reference
is made to the schematic diagram of FIG. 17 illustrating a set of
stapler instruments at 70 that are each respectively engaged
through a skin incision. This is illustrated in FIG. 17 as between
ribs. FIG. 17 also illustrates the conventional video thoracoscopy
at 72 introduced through another incision for viewing the operative
site. As indicated previously, this particular procedure is
described herein in connection with a lung wedge resection. In this
regard refer to our previously issued U.S. Pat. No. 7,604,586, the
complete contents of which are now hereby incorporated by reference
herein.
[0069] Before discussing the particular stapler construction of the
present invention, reference is now made to FIG. 10 for an
illustration of the staple patterns. This includes a first pattern
of three rows of standard staples at 74. This array of standard
staples at 74 is disposed along the cut tissue edge 78. The lung
tissue is internal as sat 76 in FIG. 10. The source staples are
also illustrated in FIG. 10 at 75 in a row of two parallel arranged
sets of staples. It is noted that the staple array 75 is
substantially in parallel to the staple array 74. To provide
optimum brachytherapy application, it is noted that the source
array 75 is closest to the lung tissue 76.
[0070] Reference is now made to a surgical stapling instrument 80
illustrated in FIG. 11 as in accordance with the present invention.
This source delivery system is used in conjunction with a standard
surgical stapling apparatus. By integrating a permanent
brachytherapy source in association with a standard surgical
stapling instrument, there is provided a single instrument that can
cut and seal lung tissue and simultaneously place a permanent
radioactive seed implant. In the description, even though reference
is made to a procedure relating to a lung resection, it is noted
that the principles of the present invention may be applied to any
one of a variety of different surgical procedures. The instrument
80 in FIG. 11 illustrates this dual purpose use in a single
instrument.
[0071] In FIG. 11 the instrument 80 is comprised of a handle body
82 with a fixed handle 85 and a pair of staple cartridge actuators
86 and 87. The body 82 is coupled by means of the instrument shaft
84 to the end effector 83. FIG. 1 also illustrates a holder 88 for
retaining the two separate staple cartridges described in further
detail in FIGS. 12-16. Basically, these devices operate on the
basis of having a proximal actuator, such as the actuators 86 and
87 in FIG. 11 herein, operate distal staple application mechanisms
which typically include a cartridge of staples. One of these
packages holds standard staples while the other cartridge holds
source staples adjacent thereto.
[0072] FIG. 12 is a perspective view at the very distal end of the
staple instrument with the end effector 83 being comprised of
separate but commonly held (holder 88) staple mechanisms 90 and 91.
Associated with the staple mechanism 90 is actuator arm 96 and
associated with the staple mechanism 91 is the actuation arm 97. In
further connection with FIG. 11, the actuation lever 86 operates
the actuation arm 96 and separately the actuation lever 87 operates
the actuation arm 97. Each of the staple mechanisms 90 and 91 may
be comprised of a body and a cartridge that holds multiple staples.
These staples are illustrated in, for example, FIGS. 12-14. The
standard staples are shown at 74 and the source staples at 75. In
this particular instrument, there are side-by-side arrays of two
sets of standard staples. Each set includes three rows of staples.
For the source staples, there are two parallel rows of staples. In
addition to the actuator arms 96 and 97, there are typically
provided associated anvils (not shown) for closing each of the
staples. Further details of these stapling mechanisms are found in
the aforementioned U.S. patents which are hereby incorporated by
reference herein. FIG. 12 illustrates the side-by-side arrangement
of the stapler mechanisms 90 and 91 held within the holder 88.
Refer also to the perspective view of FIG. 15 which shows the
holder 88 having a channel 94 for receiving the mechanism 90 and a
channel 95 for receiving the mechanism 91. In the perspective view
of FIG. 12, it is noted that the standard staple array is disposed
on the inner side of the source staple array. In another
arrangement, and depending upon the particular surgical procedure,
these arrays may be alternated in position so that the standard
staple array is outside of the source staple array. The relative
placement between these two arrays is a function of the desired
side that the source staples are being placed in relationship to
the standard surgical staples.
[0073] FIG. 13 illustrates the actuation arm 96 being actuated from
the actuation lever 86 for applying standard staples. Similarly, in
FIG. 14 the actuation arm 97 is shown actuated from the actuation
lever 87 for the application of source staples. This action
provides a pattern as previously identified in FIG. 10 herein.
[0074] Reference is now also made to FIG. 16 that is an exploded
perspective view illustrating the stapling mechanisms 90 and 91 as
well as the holder 88. In FIG. 16 it is noted that there may
actually be provided two separate instrument shafts 84A and 84B.
These shafts typically retain a cable operated from the handle end
of the instrument for controlling the respective actuator arms 96
and 97.
[0075] The stapling sequence, particularly between standard and
source staples, can be performed in a number of different ways.
Usually, the standard staples are first applied followed by the
application of the source staples. However, it is also possible to
provide concurrent lever actuation so that a source staple is
applied at the same time as the standard staple. In a preferred
technique, the instrument progresses along the surgical margin
closing the tissue. Once a set of staples has been fastened in the
pattern previously described, then the surgeon can basically
progress along the same path applying the therapeutic source
staples with the same basic instrument but actuating the source
staple part of the end effector. Thereafter, the stapling
instrument may be moved to a different location and this type of
dual action repeated.
[0076] The staple delivery applicator 110 is composed of a trigger
device 112 and a cartridge unit 114, FIG. 18A, with a source staple
cartridge 116 mounted in a cartridge holder 174. The cartridge
holder 174 is mounted to a distal end 120 of an actuator arm 122 by
a cartridge holder 174/actuator arm connector 207, FIG. 22A. The
cable 136/sled connector 218, FIGS. 22A and 22B, allows flexible
movement between the cable 136 and the sled 202 within the actuator
arm 122. The actuator arm 122 is removably mounted to the trigger
device 112 at a proximal end 124 by a release lever 134. The
trigger device 112 has multiple controls thereon to operate the
attachment of the staples, not shown. The trigger device 112 has a
lever 126, a handle 128, and a release knob 130 as shown in FIG.
18A, and a toggle knob 132, FIG. 18B.
[0077] FIG. 18B shows the right side of the applicator 110 and the
trigger 112 having the toggle knob 132 thereon. FIG. 18C shows the
applicator 110 having an anvil 161 in the open position. FIG. 19
shows the actuator arm 122 removed from the trigger 112 with a
cable 136 extending from a tube 140 at the proximal end 124. The
spring loaded, release lever 134 allows the actuator arm 122 to be
removed from the trigger 112 as needed.
[0078] Referring to FIG. 20A, a right side housing 138 is removed
from the trigger 112 to show partially the interior thereof. A gear
142 is mounted to a central shaft 144. The gear 142 translates/acts
upon the cable 136 that is supported within cable guides 148. The
back of the toggle knob 132, FIG. 20B, has a pair of toggle rods
200 that act upon a toggle switch 146, FIG. 20A. When the toggle
switch 146 is reversed by the turning of the toggle knob 132, the
release knob 130 can be then turned to translate the cable 136 out
of the trigger 112 to be released. FIG. 20D shows one embodiment of
a reverse switch mechanism 220. The reverse switch mechanism 220
allows the gear 142 to reverse direction such as in a wrench
ratchet As shown in FIG. 20D, a reverse switch mechanism 220 is
comprised of a ratchet 237, which is connected to the central shaft
144, and a pawl 233. A spring 235 biases a lever 231 to hold the
pawl 233 in place. The rotating member 238 is connected to the
toggle switch 146, FIG. 20C. The pair of toggle rods 200 are shown
in FIG. 20C with a travel line in dashes as the toggle knob 132 is
turned. In operation, if the right toggle rod 200 is turned
clockwise, it will push the bottom of the toggle switch 146
clockwise to the position as shown in FIG. 20C. As a result,
turning of the central shaft 144 in a counterclockwise direction is
prohibited since the teeth of the ratchet and pawl are engaged 234
and the pawl hits a wall 236, preventing movement; Clockwise
rotation is possible as this motion moves the ratchet 237
clockwise, pushing the pawl 233 into the lever 232 and compressing
the spring 235. When the right toggle rod 200 is rotated
counterclockwise, it pushes the bottom of the toggle switch 146
clockwise and the detent mechanism functions in the opposite
direction. Clearly other embodiments of such a reverse switch are
possible in light of the present invention and in light of the
incorporated patents.
[0079] The trigger device 112 as shown above is one embodiment of
an actuating means or device for operating the cable 136 in the
actuating arm 122. Referring to FIGS. 25A and 25B, FIG. 25A
illustrates a manual means for operating the cable 136 by attaching
a handle 230 to the cable 136. It should be understood that the
cable 136 has appropriate teeth thereon to engage the gear 142, but
this is not required in that other actuating means may be used to
move the cable 136. As shown, the handle 230 is attached to the
cable 136 that extends from the actuating arm 122. The cable 136 is
secured in the handle 230 by a locking means 232. The operator
would then grasp the handle 230 and the tube 140 of the actuating
arm and move the cable 136 as desired and in a manner consistent
with the movement noted above. Another embodiment of the actuating
means is shown in FIG. 25B that is an electric actuating means 240
that is connected onto the actuating arm 122 by a release lever 134
such as shown on the trigger device 112. A power source 244 such as
batteries or an external source provides power to a reversible
electric motor 242 that is geared to mesh with the cable 136. A
forward or reverse switch 246 is used to control the movement of
the cable 136 within the actuating arm 122.
[0080] To better understand the operation of the applicator 110,
FIGS. 18A, 20A, and 21A, the source cartridge 152 is loaded into
the source cartridge holder 174. With the cartridge 152 in place,
the actuator sled 202, FIGS. 22A and 22B, is pushed toward the
proximal end of the cartridge holder 174 and into the proximal end
of the anvil 161 and causes the source anvil 161 to open as shown
in FIG. 22A. The source anvil 161 is a part of the source staple
cartridge holder 174 and is pivoted at a pivot 204. An upper spring
206 forces as end 208 of the source anvil into a first detent 210
to open. As the attached cable 136 is slightly retracted, the end
208 rides up an inclined groove to a top 212 of the actuator sled
202 and closes the anvil 161, FIG. 22B. Further pulling of the
lever 126 in a clockwise direction to further retract the cable 136
causes a sled hammer 214 to push up on the bottom of inclined
pushers 209 that push up on the bottom of the source staples
therein crimping them. After the crimping is completed, the end 208
falls into a second detent 216 in the sled 202 and then opens the
anvil 161. The source cartridge 152 then can be removed. At that
point, the cable 136 is fully retracted. In order to reverse the
cable 136 movement in direction, at any time, the toggle knob 132
is rotated to cause the toggle rods 200, FIG. 20B, to change the
position of the reverse switch 146. Then, the release knob 130 is
rotated to push the cable 136 back and the actuator sled 202 back
into the cartridge holder 174. The toggle knob 132 must then be
reset to its initial setting so that the cable 136 can be
retracted. Manual operation of the applicator 110 may be obtained
by allowing the cable 136 to extend from a rear of the trigger 112
with the attachment of a handle thereon. The handle can be pulled
to retract the cable 136 and pushed in to return the cable 136. The
toggle knob 132 would have to be also appropriately turned in the
manual operation.
[0081] In one embodiment as best shown in FIGS. 21A and 21B, the
delivery applicator 110 may be attached in a parallel manner to an
existing surgical staple device 150 such as disclosed in U.S. Pat.
No. 7,494,039. The applicator 110 may also be positioned in a
parallel manner next to the surgical stapler cartridge as shown in
FIG. 21B. The applicator cartridge 152 contains radioactive
sources/staples, not shown (see U.S. Pat. No. 7,604,586 showing
radioactive staples which is incorporated by reference) in
predetermined positions 154: two rows with staggered slots 156,
FIG. 21A. Other configurations of the slots 56 are clearly
appropriate and would be designed based upon the medical need for
such. There may be a standard set of slots such as shown in FIG.
21A, but the source staples could be placed therein as desired.
After deployment of the conventional surgical staples, not shown
also, the applicator staples would be independently deployed by use
of the trigger 112 immediately adjacent to the surgical staples.
The fixed relationship by use of a connector 158 on the applicator
cartridge 152 to the surgical staple cartridge 150 assures an
accurate fixed position of the source/staples relative to the
surgical staples, and therefore the surgical resection margin
created by the surgical staple device having a cutting means
therein.
[0082] Currently, surgical staples are delivered by a wedge-shaped
driving element within the cartridge which presses a piston through
the cartridge cavity causing the staples to be pressed against an
anvil 160 causing the staple legs to be bent over within an anvil
bending device such as seen in a common stapler.
[0083] The applicator cartridge holder 174 is attached to either
the right-hand or left-hand side of the surgical stapler cartridge
150 so as to be useful on either leg/side of a typical wedge
resection. Source positioning will not be restricted to the typical
"1-centimeter" spacing that is currently used. The ability to have
closer source positioning, especially at the ends of the line of
sources, will afford the opportunity to differentially load the
cartridge (i.e. have greater activity at the ends) to compensate
for the dose "drop-off" typical of such an array of
sources/seeds.
[0084] One embodiment of the present invention has a one-piece
connector 158, FIGS. 23A to 23D and FIGS. 21A and 22B, for holding
both the conventional surgical staple cartridge 150 and the
applicator cartridge 152 in parallel alignment so that the
radioactive applicator staples can be applied directly along side
of the conventional staples. This provides accurate placement of
the radioactive applicator staples near possible cancerous tissues.
The other embodiment of the connector is a modular connector 162,
FIGS. 24A and 24B, for holding the applicator cartridge 152, which
is connected to the conventional staple cartridge 150 also being
held in the modular connector 162.
[0085] The staple delivery applicator 110 may use the connector
158, FIGS. 23A to 23D, being the one-piece connector 158 having two
parallel channels 164 and for holding the applicator cartridge 152
in channel 166 and the conventional staple cartridge 150 in the
channel 164 such as shown in FIG. 21B. Sets of tabs 168, FIGS. 23C
and 23D, in each channel align the cartridge holder 174 to detentes
thereon wherein the front ends 170, 172, FIG. 21A, of each of the
cartridges align. FIGS. 23A to 23D show the one-piece connector 158
in various views. This one-piece connector 158 may fit upon the
carrier portion 250 as mentioned and shown in patent '039 above in
FIG. 19. It should be noted that the surgical staple cartridge
channel 164 is wider than the source/staple cartridge channel 166
since there are 6 slot rows in the surgical staple cartridge 150 as
compared to 2 in the source cartridge 152. Further, the width of a
separating wall 176 may be varied based on medical requirements.
The connector 158 is typically made of plastic and further may
include radiation shielding material. The cartridges 150 and 152
are mounted in cartridge holders 174 and 151 that are then pushed
into the channels 164/166. The applicator holder 174 is connected
to the actuator arm 122 as to the present invention.
[0086] The modular applicator connector 178 is shown in FIGS. 24A
and 24B. FIG. 24A shows the modular applicator connector 180 being
inserted/connected/mounted to one side of a staple device connector
182. The applicator connector 180 may be attached to either side of
the staple device connector 182. FIG. 24A shows one portion of a
male attachment 184 having a row 186 of flexible triangles 188
mounted on the applicator connector 180 vertical side 190. The
other portion of a female attachment 192 being the complement of
the male attachment 184 is shown. Both sides 194, 196 of the staple
device connector 182 have the female attachments 192 so that the
applicator connector 180 may be mounted to either side as required
during surgery. The modular connector 178 in FIG. 24B shows the
applicator connector 180 fully inserted onto the device connector
182.
[0087] The staple delivery applicator 110 further includes
radiation shielding in either the staple cartridge 152 itself or on
the applicator connector 158, preferably in the applicator
cartridge 152 since the radioactive staples would be mounted there.
The shielding material may be a part of the composition of the
cartridge 152 or be a layer of shielding mounted thereabout. The
anvil 161 of the cartridge unit 114 may also be shielded to fully
prevent exposure from radiation to the operators of the staple
applicator 110. The shielding would minimize the radiation dose to
the physician deploying the device as well as to the other
personnel in the operating room. The shielding will permit safe
storage of this device in the Operating Room until it is time for
use. The device will also be designed for sterilization, and
resterilization, using steam, ethylene oxide and gamma radiation to
provide total flexibility to the hospital.
[0088] Since many modifications, variations, and changes in detail
can be made to the described embodiments of the invention, it is
intended that all matters in the foregoing description and shown in
the accompanying drawings be interpreted as illustrative and not in
a limiting sense. Thus, the scope of the invention should be
determined by the appended claims and their legal equivalents.
[0089] Having now described a limited number of embodiments of the
present invention, it should be apparent to those skilled in the
art that numerous embodiments and modifications thereof are
contemplated as falling within the scope of the present invention
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* * * * *
References