U.S. patent application number 14/577323 was filed with the patent office on 2015-05-21 for methods and devices to decrease tissue trauma during surgery.
The applicant listed for this patent is PHYSCIENT, INC.. Invention is credited to Hugh Charles Crenshaw, Charles Anthony Pell.
Application Number | 20150141906 14/577323 |
Document ID | / |
Family ID | 41316795 |
Filed Date | 2015-05-21 |
United States Patent
Application |
20150141906 |
Kind Code |
A1 |
Pell; Charles Anthony ; et
al. |
May 21, 2015 |
METHODS AND DEVICES TO DECREASE TISSUE TRAUMA DURING SURGERY
Abstract
Methods and devices are disclosed to reduce the tissue trauma
that occurs when a physician retracts or otherwise deforms a
patient's tissues for surgery or other medical procedures. In one
part, methods and devices are disclosed for cooling the tissue
around the incision. In another part, methods and devices are
disclosed that elute drugs into the tissues of the tissue margin.
In another part, methods and devices are disclosed to engage
tissues during retraction to cushion, to sense tissue state, and to
modulate tissue state.
Inventors: |
Pell; Charles Anthony;
(Durham, NC) ; Crenshaw; Hugh Charles; (Durham,
NC) |
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Applicant: |
Name |
City |
State |
Country |
Type |
PHYSCIENT, INC. |
Durham |
NC |
US |
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|
Family ID: |
41316795 |
Appl. No.: |
14/577323 |
Filed: |
December 19, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12465978 |
May 14, 2009 |
8915845 |
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14577323 |
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61127520 |
May 14, 2008 |
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61054866 |
May 21, 2008 |
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61127598 |
May 14, 2008 |
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61133669 |
Jul 1, 2008 |
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61134278 |
Jul 8, 2008 |
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Current U.S.
Class: |
604/24 ; 604/244;
604/246; 604/247; 604/257; 604/82 |
Current CPC
Class: |
A61M 2005/006 20130101;
A61M 5/1407 20130101; A61B 17/02 20130101; A61M 5/16813 20130101;
A61B 18/02 20130101; A61M 5/1452 20130101; A61B 17/3417
20130101 |
Class at
Publication: |
604/24 ; 604/257;
604/244; 604/246; 604/247; 604/82 |
International
Class: |
A61M 5/168 20060101
A61M005/168; A61M 5/145 20060101 A61M005/145; A61B 17/34 20060101
A61B017/34; A61M 5/14 20060101 A61M005/14 |
Claims
1. A device for delivering fluid to incised tissues surrounding a
trocar, comprising: a hollow body configured to engage both the
trocar and the incised tissues surrounding the trocar, the hollow
body further comprising: a fluid reservoir configured to contain at
least one fluid; a double-walled, hollow sleeve associated with the
fluid reservoir, the double-walled, hollow sleeve further
comprising: a first, inner wall adapted to engage the trocar, and a
second, outer, tissue-facing wall that is fluid-permeable and
configured to engage the incised tissues surrounding the trocar; a
means configured to introduce the at least one fluid into the fluid
reservoir; a means configured to generate flow of the fluid from
the second, outer, tissue-facing wall to the incised tissues
surrounding the trocar.
2. The device of claim 1, wherein the second, outer, tissue-facing
comprises at least one perforation.
3. The device of claim 1, wherein the means configured to introduce
the fluid into the fluid reservoir comprises a self-sealing rubber
membrane easily pierced by a hypodermic syringe.
4. The device of claim 1, wherein the at least one fluid includes a
first fluid and a second fluid, where the first fluid is a liquid
substantially occupying the majority of the fluid reservoir and
filling the double-walled, hollow sleeve, and where the second
fluid is a gas.
5. The device of claim 4, wherein the first fluid is physiological
saline mixed with a pharmacological agent, and where the second
fluid is air.
6. The device of claim 4, wherein pressurization of the gas drives
flow of the first liquid across the second, outer tissue-facing
wall and into the incised tissues surrounding the trocar.
7. The device of claim 6, wherein the gas is pressurized by a
finger-actuated piston communicating with the fluid reservoir,
wherein the pressure of the first fluid is controlled.
8. The device of claim 2, wherein the at least one perforation is
so small that transport from the fluid reservoir to the incised
tissues surrounding the trocar is by diffusion.
9. The device of claim 1, wherein the hollow body is substantially
annular.
10. The device of claim 1, wherein the device is formed as part of
the trocar.
11. The device of claim 1, wherein the device is configured to
slide on to the trocar.
12. The device of claim 1, wherein the second, outer tissue-facing
wall comprises a membrane.
13. The device of claim 1, wherein the second, outer tissue-facing
wall is perforated with a frit fill.
14. The device of claim 1, wherein the second, outer tissue-facing
wall is nano-perforated.
15. The device of claim 1, wherein the second, outer tissue-facing
wall is controllably permeable.
16. The device of claim 15, wherein the second, outer tissue-facing
wall has a permeability that is controlled via direct pressure of
the fluid.
17. The device of claim 15, wherein the second, outer tissue-facing
wall has a permeability that is controlled via pressure of a second
working fluid, which may be a gas.
18. The device of claim 15, wherein the device has a permeability
that is electronically controllable.
19. The device of claim 15, wherein the device has a permeability
that may be electronically addressable in either time or space, or
both time and space.
20. The device of claim 15, wherein the device has a permeability
that is differentially controllable.
21. The device of claim 1, wherein more than one type of fluid is
introduced into the reservoir.
Description
RELATED APPLICATIONS
[0001] The present application is a continuation of co-pending U.S.
patent application Ser. No. 12/465,978, entitled "METHODS AND
DEVICES TO DECREASE TISSUE TRAUMA DURING SURGERY," filed May 14,
2009, which claims priority to U.S. Provisional Patent Application
No. 61/127,520, entitled "COOLING PADS TO REDUCE PAIN AND
INFLAMMATION AT SURGICAL INCISIONS," filed on May 14, 2008; U.S.
Provisional Patent Application No. 61/054,866, entitled "COOLING
PADS TO REDUCE PAIN AND INFLAMMATION AT SURGICAL INCISIONS," filed
on May 21, 2008; U.S. Provisional Patent Application No.
61/127,598, entitled "DRUG ELUTING PADS TO REDUCE PAIN AND
INFLAMMATION AT SURGICAL INCISIONS," filed on May 14, 2008; U.S.
Provisional Patent Application No. 61/133,669, entitled "PADS FOR
PROTECTING TISSUES, SENSING TISSUE STATE, AND ACTIVE TISSUE
MODULATION DURING MEDICAL PROCEDURES," filed on Jul. 1, 2008; U.S.
Provisional Patent Application No. 61/134,278, entitled "DRUG
ELUTING PADS TO REDUCE PAIN AND INFLAMMATION AT SURGICAL
INCISIONS," filed on Jul. 8, 2008, each of which is incorporated
herein by reference in their entireties.
FIELD OF THE DISCLOSURE
[0002] The field of the disclosure relates to spreaders,
retractors, and retraction devices used to deform tissue during
surgery or other medical procedures.
BACKGROUND
[0003] Deformation of tissues is commonly performed during surgery
or other medical procedures either to achieve surgical access or to
specifically alter the dimensions of one part of the anatomy.
Examples of deformations of tissue for surgical access include
spreading ribs during a thoracotomy, spreading a bisected sternum
during sternotomy, and separating the vertebrae of the spine for
surgery on the intervertebral disk. Examples of deformation of
tissues to alter the dimensions of the tissue include distraction
to adjust the position of vertebrae. Such deformations will
collectively be referred to as "retraction" here.
[0004] Spreaders, retractors, distractors, and even trocars
(collectively called "retractors") can impose significant forces on
surrounding tissues during retraction. The resulting strain on
these tissues, and on associated tissues, such as the ligaments
attaching ribs to vertebrae for example, can be large, leading to
damage of these tissues, including the fracture of ribs and the
rupture or irreversible deformation of ligaments and other fibrous
tissues.
[0005] Retraction occurs in two different phases--deforming the
tissue in a first retraction phase and holding the tissue at that
deformation in a second retraction phase. Both are usually done
with the same instrument. For example, a rib spreader is used both
to force the ribs apart during a thoracotomy (first phase of
retraction) and to hold the ribs apart during the surgical
procedure (second phase of retraction). In the medical literature,
both phases are frequently referred to as retraction.
[0006] Both phases of retraction traumatize tissue. Trauma from the
first phase of retraction can include the rending and tearing of
tissues; bones bend and break; muscles stretch beyond normal
limits; ligaments and other connective tissues stretch and tear;
nerves are stretched. Trauma from the second phase of retraction
can include trauma arising from the force of the retraction device
holding the tissue open and can include ischemia of the tissue due
to elevated tissue pressure, blockage of nerves, and blockage of
blood vessels causing ischemia in tissues distant from
retraction.
[0007] Tissue trauma and ensuing complications resulting from both
phases of retraction can be greater than the trauma resulting from
the medical procedure that required the retraction. For example,
thoracotomies are extremely traumatic, and can result in
post-surgical pain and respiratory complications that exceed that
of the thoracic procedure, such as a lung segmentectomy.
[0008] There is, therefore, need for improved devices, systems, and
methods to perform one or both phases of retraction.
SUMMARY OF THE DETAILED DESCRIPTION
[0009] The above and other needs are met by several embodiments
disclosed herein. In one embodiment, tissue is cooled around an
incision. A pad with cooling means is placed onto the margin of an
incision and cools the tissues at and near the margin of the
incision during both the first and second phases of retraction.
[0010] In another embodiment, a retraction device adapted to
retract tissue comprises at least one retraction member, with the
at least one retraction member being able to operably engage the
tissue to be retracted. A pad with cooling means is integrated with
the retractor such that the tissues being retracted are cooled
throughout the first and second phases of retraction.
[0011] In another embodiment, a trocar is fitted with a cooling
device such that tissues cut and deformed on insertion of the
trocar are cooled throughout a medical procedure.
[0012] In another embodiment, a retraction device includes at least
one pad in contact with the margins of an incision. The pad is
adapted to elute pharmacologically active compounds into the
tissues at the margin of the incision to achieve beneficial
outcomes, such as hemostasis or reduced inflammation, as
examples.
[0013] In another embodiment, a thoracic retractor is fitted with
pads that underlie the retractor blades of the retractor. The pads
are adapted to both cool the tissue and to elute pharmacologically
active compounds into the tissues at the margin of the
incision.
[0014] In another embodiment, a retraction device is fitted with a
pad having a gradient of stiffness modulus with the least stiff
material apposed to the tissue to be retracted and the most stiff
material apposed to the retraction device.
[0015] In another embodiment, a retraction device is fitted with a
pad having fluid-filled columns embedded in an elastomeric
material, with the columns being adapted to conform to the shape of
a tissue when pressed against the tissue during the first and
second phases of retraction.
[0016] In another embodiment, a retraction device includes an array
of elastomeric bladders, each in communication with a hydraulic
actuator controlled by a controller. Actuation of the hydraulic
actuators permits inflation and deflation of the elastomeric
bladders.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIGS. 1A and 1B show an exemplary cooling pad that can be
placed over the site of a planned incision to cool tissues before
incision;
[0018] FIGS. 2A and 2B show exemplary cooling pads for convective
air cooling and for cooling with a thermoelectric device;
[0019] FIGS. 3A and 3B show exemplary cooling devices having
thermoelectric cooling devices, recirculating cooling fluids, and
temperature sensors;
[0020] FIG. 4 shows an exemplary cooling pad having internal
channels for circulation of a cooling fluid;
[0021] FIGS. 5A and 5B shows exemplary cooling pads that can be
placed into an incision to cool the tissues at and surrounding the
margin of the incision;
[0022] FIG. 6 shows a side view of an exemplary pad having a
stiffened rolled edge for placement at the margin of an incision, a
friction coating to prevent sliding along a patient's skin, and a
clip for anchoring the pad to a surgical drape;
[0023] FIG. 7 shows a side view of an exemplary pad having both a
metal foil and a friction coating on the surface apposed to the
patient's skin;
[0024] FIGS. 8A through 8D show top and cross-sectional views of
exemplary cooling pads having a malleable wire mesh inside the pad
to permit shaping of the pad or having a mesh of interspersed
fluid-filled channels and malleable wires also to permit shaping of
the pad;
[0025] FIGS. 9A through 9C show exemplary cooling pads made of
pliable and deformable materials;
[0026] FIGS. 10A through 10C show exemplary tubing in which the
tubing carries cooling fluid but also contains filamentous
components with separate functions, such as heating or sensing;
[0027] FIG. 11 shows an exemplary liquid-filled cooling pad in
which internal struts prevent pooling of the liquid;
[0028] FIG. 12 shows an exemplary cooling pad with an overlapping
margin that permits adjustment to incisions having different
circumferences;
[0029] FIGS. 13A and 13B show an exemplary cooling pad with fiber
windings that facilitate adjustment of the length and width of the
pad;
[0030] FIGS. 14A and 14B show an exemplary cooling pad that can be
adjusted to different depths of incision;
[0031] FIG. 15 shows an exemplary cooling pad having a
fluid-saturated sponge to prevent dehydration of tissues at the
wound margin;
[0032] FIG. 16 shows an exemplary cooling pad having a
thermoelectric cooling device and a surface adapted for warming a
surgeon's hands;
[0033] FIG. 17 shows an example of a Finochietto thoracic retractor
in the prior art;
[0034] FIG. 18 shows an example a ring retractor for abdominal
surgery in the prior art;
[0035] FIG. 19 shows an example of a Weitlander retractor in the
prior art for retracting skin;
[0036] FIG. 20 shows an exemplary cooling pad fitted to the
Weitlander retractor of FIG. 19;
[0037] FIG. 21 shows an exemplary pad having multiple segments for
variable placement around the margins of an incision;
[0038] FIG. 22 shows an exemplary cooling pad attached to the
Finochietto thoracic retractor of FIG. 17;
[0039] FIG. 23 shows an exemplary cooling pad having two halves for
use with the Finochietto thoracic retractor of FIG. 17;
[0040] FIG. 24 shows an example trocar in side view penetrating a
patient's body wall in the prior art;
[0041] FIG. 25 shows a trocar in side view fitted with an exemplary
cooling pad;
[0042] FIG. 26 shows a trocar in side view fitted with an exemplary
cooling pad adapted to cool the margins of the incision created by
the trocar;
[0043] FIG. 27 shows a trocar in side view with an exemplary
cooling pad that has an annulus to slide onto the trocar and to
cool the margins of the incision created by the trocar;
[0044] FIGS. 28A and 28B show exemplary drug-eluting pads that
completely wrap the margins of an incision;
[0045] FIG. 29 shows the side view of an exemplary pad having a
stiffened rolled edge for placement at the margin of an incision, a
drug-eluting surface apposed to the cut tissues at the margin of
the incision, a friction coating to prevent sliding along the
patient's skin, and a clip for anchoring the pad to a surgical
drape;
[0046] FIG. 30 shows the side view of an exemplary pad having a
drug eluting surface apposed to the cut tissues at the margin of
the incision, a frictional coating apposed to the skin surrounding
the incision, and a metal foil surface to facilitate shaping of the
pad;
[0047] FIGS. 31A through 31C show top and cross-sectional views of
exemplary drug-eluting pads having a malleable wire mesh inside the
pad to permit shaping of the pad or having a mesh of interspersed
fluid filled channels and malleable wires also to permit shaping of
the pad;
[0048] FIG. 32 shows an exemplary drug-eluting pad filled with both
a drug-eluting fluid and a malleable mesh that permits shaping of
the pad;
[0049] FIGS. 33A and 33B show exemplary drug-eluting pads formed of
pliable materials;
[0050] FIG. 34 shows an exemplary drug-eluting pad having internal
struts to permit collapse of the bag due to motion of internal
fluid to lower parts of the pad;
[0051] FIG. 35 shows an exemplary drug-eluting pad with an
overlapping margin that permits adjustment to incisions having
different circumferences;
[0052] FIGS. 36A and 36B show an exemplary drug-eluting pad with
fiber windings that permit adjustment of the length and width of
the pad;
[0053] FIGS. 37A and 37B show an exemplary drug-eluting pad that
can be adjusted to different depths of incision;
[0054] FIG. 38 shows an exemplary drug-eluting pad fitted to a
Weitlander retractor;
[0055] FIG. 39 shows an exemplary drug-eluting pad having multiple
segments for variable placement around the margins of an
incision;
[0056] FIG. 40 shows a thoracic retractor with an exemplary
drug-eluting pad attached;
[0057] FIG. 41 shows an exemplary drug-eluting pad having two
halves for use with a thoracic retractor;
[0058] FIG. 42 shows an exemplary drug-eluting pad made from a
hydrogel fitted into the retractor blades of a thoracic
retractor;
[0059] FIG. 43 shows an exemplary drug-eluting pad made from an
elastomeric membrane filled with a drug-bearing fluid, where the
pad is filled with a reticular material and is fitted into the
retractor blades of a thoracic retractor;
[0060] FIG. 44 shows an exemplary drug-eluting pad made from a
hydrogel and having internal tubes through which a cooling fluid
flows, where the pad is fitted into the retractor blades of a
thoracic retractor;
[0061] FIG. 45 shows exemplary drug-eluting pads fitted to the
retractor blades of a thoracic retractor, where the drug-eluting
pads have a rigid component to distribute force along the margin of
the incision and for pressing the drug-eluting pads against the cut
tissues at the margin of the incision;
[0062] FIG. 46 shows exemplary drug-eluting pads fitted to the
retractor blades of a thoracic retractor, where the drug-eluting
pads have a rigid component divided into a more rigid central
portion and a less rigid peripheral portion;
[0063] FIGS. 47A and 47B show exemplary drug-eluting pads fitted to
the retractor blades of a thoracic retractor, where the
drug-eluting pads have a rigid component, a hydrogel drug-eluting
portion apposed to the cut tissues, and a cooling portion covering
the skin overlaying the edge of the incision;
[0064] FIGS. 48A and 48B show an exemplary drug-eluting pad fitted
to a retractor blade of a thoracic retractor, where the
drug-eluting pad has a rigid component and blades adapted to
penetrate the soft tissues overlaying the rib and to push against
the rib;
[0065] FIGS. 49A and 49B show cross-sectional and top views of
exemplary drug-eluting pads fitted to the retractor blades of a
thoracic retractor for sternotomy, where the drug-eluting pads have
a rigid component to support the cut sternum and to press the
drug-eluting pads against the cut sternal tissues during
retraction;
[0066] FIGS. 50A and 50B show cross-sectional and oblique views of
an exemplary drug-eluting pad fitted to the retractor blades of a
thoracic retractor for sternotomy, where the drug-eluting pads have
a rigid component and the drug-eluting pad is a hydrogel;
[0067] FIGS. 51A and 51B shows a trocar in side view fitted with an
exemplary drug-eluting reservoir that pumps to a sleeve that
delivers drug-bearing fluid to the cut tissues at the margin of the
incision created with the trocar;
[0068] FIG. 52 shows a trocar in side view penetrating the body
wall of a patient, where the trocar is fitted with an exemplary
hydrogel coated sleeve for delivering drugs to the cut tissues at
the margin of the incision created with the trocar;
[0069] FIGS. 53A and 53B show a trocar in side view that has an
exemplary, integral drug-eluting reservoir that pumps to
perforations in the side wall of the trocar to deliver drug-bearing
fluid to the cut tissues at the margin of the incision created with
the trocar;
[0070] FIG. 54 shows an example a thoracic retractor used in a
thoracotomy in the prior art;
[0071] FIG. 55 shows another example a Finochietto thoracic
retractor in the prior art;
[0072] FIG. 56 shows the actions of the retractor blades of a
retractor in the prior art when inserted between ribs for a
thoracotomy;
[0073] FIG. 57 shows another example of the prior art in which
fenestrations in blades decrease contact area with the rib;
[0074] FIG. 58 shows an embodiment of an exemplary Tissue Engaging
Device, TED comprising a pad having a gradient of stiffness placed
between a retractor blade and a rib;
[0075] FIGS. 59A through 59H show different embodiments of
exemplary TEDs having a gradient of stiffness and means for
fabricating pads having a gradient of stiffness;
[0076] FIG. 60 shows an embodiment of an exemplary TED having a a
gradient of stiffness formed by layers of materials;
[0077] FIG. 61 shows another embodiment of an exemplary TED having
a gradient of stiffness comprising a three-dimensional (3D) lattice
with members of varying thickness;
[0078] FIGS. 62A through 62C show different embodiments of
exemplary TEDs having a gradient of stiffness;
[0079] FIGS. 63A through 63C show an exemplary TED having a
differential stiffness arising loading of the TED;
[0080] FIG. 64 shows another embodiment of an exemplary TED having
a gradient of stiffness comprising a plurality of higher modulus
rods interdigitated into a pad of lower modulus;
[0081] FIGS. 65A through 65C show how the exemplary TED depicted in
FIG. 64 responds when loaded;
[0082] FIG. 66 shows another embodiment of an exemplary TED
comprising blocks of higher modulus elastomer at the periphery of a
pad having lower modulus;
[0083] FIGS. 67A and 67B show another embodiment of an exemplary
TED comprising a low modulus pad having a higher modulus plate near
the tissue face of the TED;
[0084] FIGS. 68A and 68B show another embodiment of an exemplary
TED comprising steel rods mounted into an elastomeric pad;
[0085] FIG. 69 shows another embodiment of an exemplary TED
comprising a pad with multiple sensors embedded into the pad;
[0086] FIGS. 70A through 70D show another embodiment of an
exemplary TED comprising a pad filled with a foam that expands on
being placed into the incision;
[0087] FIGS. 71A through 71D show more embodiments of exemplary
TEDs comprising an elastomeric pad having fibers embedded
within;
[0088] FIG. 72 shows another embodiment of an exemplary TED
comprising an elastomeric pad having fibers with varying angles of
orientation embedded within;
[0089] FIGS. 73A and 73B show another embodiment of an exemplary
TED comprising a pad attached to the blade of a retractor and
includes a fluid-filled internal compartment in communication with
a pressure signal display;
[0090] FIGS. 74A and 74B show another embodiment of an exemplary
TED comprising a soft elastomer pad having a magnetic mass
suspended inside and an electromagnetic coil that drives the magnet
in an oscillating motion;
[0091] FIG. 75 shows another embodiment of an exemplary TED
comprising multiple fluid-filled elastomer bladders all in
communication with a common plenum;
[0092] FIG. 76 shows another embodiment of an exemplary TED
comprising multiple fluid-filled elastomer bladders attached to a
rigid retractor blade and individually in communication with
hydraulic cylinders that are controlled by external sensors and
controllers;
[0093] FIG. 77 shows another embodiment of an exemplary TED
comprising an elastomer pad having multiple fluid-filled
compartments attached to a rigid retractor blade and individually
in communication with hydraulic cylinders that are controlled by an
external controller;
[0094] FIGS. 78A and 78B show exemplary sequences of activation of
the bladders or compartments in a TED, such as shown in FIG.
77;
[0095] FIGS. 79A and 79B show a side and oblique view of an
exemplary TED comprising a pad with internal fluid-filled
columns;
[0096] FIGS. 80A through 80C show multiple views of the TED
depicted in FIGS. 79A and 79B when loaded;
[0097] FIG. 81 shows an embodiment of an exemplary fluid-filled
column, such as those shown in FIGS. 79A and 79B, comprising a
fluid-filled bellow with a fluid port for communicating with a
plenum;
[0098] FIG. 82 shows another embodiment of an exemplary
fluid-filled column including a fluid-filled bellow with a fluid
port for communicating with a plenum;
[0099] FIG. 83 shows another embodiment of an exemplary
fluid-filled column that is helically wrapped by fibers;
[0100] FIG. 84 shows another embodiment of an exemplary retractor
comprising multiple steel blades each fitted with a TED having a
modulus gradient;
[0101] FIGS. 85A through 85F show exemplary means by which a
retractor blade can be made to move sideways by controlled
activation of the elastomer bladders of the retractor blade shown
in FIG. 77;
[0102] FIGS. 86A through 86D show another exemplary means by which
a retractor blade can be made to move sideways in either of two
directions, or multiple points of traction can be generated, or two
opposing forces can be generated;
[0103] FIG. 87 shows a bottom view of an exemplary retractor
comprising pressure sensors to generate a map of the forces applied
to the margin of an incision;
[0104] FIG. 88 shows exemplary means for cyclically loading a
tissue with a TED using a periodic waveform or an aperiodic
waveform;
[0105] FIG. 89 shows another embodiment of a exemplary retractor
comprising two opposed retractor blades each fitted with a TED,
where the TED comprises a row of individually addressable fluid-
and foam-filled pads that can be individually actuated and possess
multiple sensors; and
[0106] FIG. 90 shows an exemplary TED comprising a row of pressure
bladders, each individually engaged with a motorized drive attached
to a retractor arm, and each individually fitted with a variety of
sensors.
DETAILED DESCRIPTION
A. Cooling Pads
[0107] Surgery typically proceeds through an incision in the body
wall that provides surgical access to the interior of the body
where the bulk of the surgical procedure is performed. For example,
for direct coronary artery bypass grafting, surgical access is
provided by a sternotomy--the skin is cut, the sternum is bisected,
and the two halves of the sternum are pried apart by a thoracic
retractor called a sternal spreader. For an appendectomy, the
abdominal skin and muscle layer is cut open and pulled back by a
retractor to provide access to the appendix.
[0108] There is frequently post-surgical pain at the site of
incision, known as "incisional pain". Incisional pain can be
severe, requiring the administration of analgesics after surgery.
Even for minimally invasive approaches (e.g., "keyhole" surgery and
laparoscopy), port site pain (where the trocars and other
instruments are inserted) is common. For some procedures,
incisional pain can last long after surgery, leading to the
definition of various pain syndromes, such as post-thoracotomy pain
syndrome and chronic regional pain syndrome. Subsequently,
post-surgical pain management places a large burden on health care
and detracts from post-surgical quality of life for many
patients.
[0109] The cause of incisional pain is not known. It is believed to
be caused by a complex series of physiological processes arising
from the trauma of incision and retraction. These include nerve
damage, tissue damage from lack of perfusion due to the pressure of
retraction (which is believed to lead to tissue anoxia, tissue
reperfusion damage, etc.), and localized inflammation. Most of the
proposed mechanisms of pain are initiated at the time of incision;
however, ameliorative procedures are usually not initiated until
hours after the incision. For example, during a thoracotomy, an
incision is made between the ribs and a rib spreader is then used
to pry apart the ribs. During retraction, considerable tissue
trauma occurs, including stretching and breaking of ligaments and
bending and sometimes breaking of ribs. Considerable force is
required to pry apart the ribs and to hold them apart. Thus, tissue
pressures in the tissues underlying the retractor blades are
sufficiently high to block tissue perfusion. Intrathoracic
procedures can last hours, and retraction is maintained throughout.
After the procedure, retraction is relieved, the ribs are
re-apposed and sewn back into position, and the muscles and skin
over the incision are sutured back together.
[0110] Analgesia typically only begins at the conclusion of
surgery, which is frequently hours after the incision is made.
There has been growing use of techniques such as nerve block with
anesthetics (e.g., epidural) immediately before surgery and of
catheter delivery of opioid analgesics commencing immediately after
surgery, but results have been mixed.
[0111] Embodiments disclosed herein include an improved means of
reducing incisional inflammation and pain. In one embodiment, a
cooling pad is optionally placed preoperatively over the site of an
incision to locally cool the tissues affected by the incision. This
pad is removed just before the incision is made. After the
incision, a second cooling pad is immediately placed over the edges
of the incision, or surrounding a trocar entry, and is kept on the
edges of the incision throughout surgery. Surface and subcutaneous
temperatures can be measured to regulate the cooling pad. The
temperature of the pad can be controlled to avoid cold damage of
tissues. At the surgeon's discretion, either or both cooling pads
can be used.
A.1 Pre-Surgical Cooling Pad
[0112] FIGS. 1A and 1B show top and side cross sections of an
example of a Pre-Incision Cooling Pad (pre-ICP) A2. Pre-ICP A2 is
capable of removing heat from the underlying skin A3 and subdermal
tissues. As such, pre-ICP A2 is designed for efficient thermal
transfer from skin A3 to pre-ICP A2, including conforming to the
surface of the body A1 to maximize the area of contact and being
constructed of materials having good thermal conductivity. Pre-ICP
A2 may also optionally include a conducting medium A4, such as a
fluid or gel (e.g., sterile saline, hydrogel, thermally conductive
gel, etc.), placed between the surface of the pre-ICP A2 and the
skin A3 to improve thermal conduction between the skin A3 and
pre-ICP A2. Pre-ICP A2 may also have an insulating layer A5 over
the top surface (i.e., the surface not in contact with the patient)
both to reduce thermal transfer with the surrounding air, thereby
improving thermal efficiency, and to prevent cooling of objects
coming into contact with pre-ICP A2, such as tubing, surgical
instruments, or the surgeon's hands.
[0113] As shown in FIG. 2A, pre-ICP A2 may also employ evaporative
cooling, potentially enhanced by greatly increasing the evaporative
surface area A6 (i.e., by sporting a convoluted or sculptured
surface), by continuously supplying evaporating fluid from a
reservoir, and by increasing convection of air over the surface of
the pre-ICP A2. Pre-ICP A2 may also be covered with a tough,
penetration resistant material A7 to prevent accidental puncture or
cutting of the pre-ICP A2 or of the patient's skin A3.
[0114] As shown in FIG. 2B, means of cooling the interior of
pre-ICP A2 include filling the interior of the pre-ICP A2 with a
cooling medium A8, such as cool water or ice or with gels or solids
having high thermal capacity (e.g., the polymer resin filling found
in PolarPaks offered by sale from Adagen Medical International,
Atlanta, Ga.) or with gels undergoing phase transitions at
appropriate, cool temperatures. Cooling can also be achieved by
endothermic chemical reactions of reactants comprising or contained
within cooling medium A8 and initiated by rupture of an internal
compartment A9 (such as the Nexcare Instant Cold Pack from 3M,
Inc.). Cooling can also be achieved by circulating chilled water
through pre-ICP A2 from an external recirculating cooling unit
connected to pre-ICP A2 by tubing. Cooling can also be achieved by
a Peltier thermoelectric unit A10 placed into pre-ICP A2, with heat
removed from the warm side of the thermoelectric unit A10 by a heat
sink A11 that is air-cooled or by a heat sink that is cooled by
circulating water from an external cooling unit connected to the
heat exchanger by tubing. Cooling can be to reduce the temperature
of the tissues to be retracted by any appropriate temperature, e.g.
5.degree. Celsius below normal body temperature. Larger or smaller
differences from body temperature can be established, such as
2.degree. Celsius below normal body temperature, 15.degree. Celsius
below normal body temperature, or others.
[0115] Also, as shown in FIGS. 3A and 3B, the temperature can also
be regulated actively, by means of a temperature measuring sensor
A12 connected by electrical connections A13 to a feedback circuit
as part of the temperature regulation system A14 connected by
electrical connections A13 and controlling the output of a cooling
source, such as a thermoelectric unit A10, as shown in FIG. 3A, or
of a recirculating cooling unit A15 connected by tubes A16, as
shown in FIG. 3B. There can, optionally, be one or more heating
elements A17 inside pre-ICP A2 and connected to temperature
regulation system A14 (connections not shown) such that heating
elements A17 are used to rapidly elevate the temperature inside
pre-ICP A2, or to heat one portion of pre-ICP A2 (and thus the
underlying tissue), or to counter a cooling unit (e.g.,
thermoelectric unit A10 or recirculating cooling unit A15) to
control temperature. The temperature of the contents of pre-ICP A2
is measured by temperature measuring sensor A12 (e.g., a
thermocouple, thermopile, microprocessor-based sensor, or other
suitable sensor) placed inside pre-ICP A2 or an array of
temperature measuring sensors A12 distributed over pre-ICP A2 for
local measurement and control of temperature. The temperature of
the skin can be measured by placing a temperature measuring sensor
A12 inside pre-ICP A2, between the skin A3 and pre-ICP A2,
including a temperature measuring sensor A12 placed on the surface
of pre-ICP A2, or in direct contact with the skin A3, or beneath
the surface of the skin A3, or within a conducting medium A4
between pre-ICP A2 and the skin A3.
[0116] Pre-ICP A2 can be constructed with a surface that contacts
the skin, or a material overlaying the skin (such as an adhesive
surgical drape, including Steri-Drape from 3M, Inc.), and is
designed not to slide on that surface, including adhesive,
frictional coatings, coatings or surfaces relying on van der Waal's
interactions or hydrophobic/hydrophilic interactions, suction cups,
Velcro, etc. Attachment devices, such as Velcro strips or suction
cups or clips that attach to the skin or to surgical drapes, can
also be placed around the periphery of pre-ICP A2.
[0117] FIG. 4 shows pre-ICP A2 containing a circulating cooling
fluid A30, and the pre-ICP A2 is molded with internal walls A32
creating a serpentine channel A34 (or other shapes), permitting
flow of the circulating cooling fluid A30 through the pre-ICP A2.
This flow may be uni-directional, bidirectional, radial, dendritic,
countercurrent, steady-state, cyclic, or any other pattern
permitting the control and distribution of heat along the surface
of pre-ICP A2, or through the volume of pre-ICP A2, the better to
manage the distribution of heat on the surfaces of the body A1 of
the patient (i.e., to act as a heat sink to remove heat, so as to
cool the patient's tissues). To provide cooled circulating fluid
A30, pre-ICP A2 is attached by a union A36 that permits attachment
of an inlet tube A38 carrying the cooled circulating cooling fluid
A30 into pre-ICP A2 and an outlet tube A39 carrying the warmed
circulating cooling fluid A30 away from pre-ICP A2 to an external
cooling unit A15 (not shown).
[0118] When thermoelectric units A10 are used to cool pre-ICP A2,
then the thermoelectric units A10 can be oriented with a "cool
side" directed to one surface of pre-ICP A2 and the "warm side"
directed to the opposite surface of pre-ICP A2. The surface of
pre-ICP A2 having the cool side is then placed against the
patient's tissues, and the surface of pre-ICP A2 having the warm
side can be configured to optimize heat transfer from the warm side
of the thermoelectric unit A10. As described above, the warm side
of pre-ICP A2 can be configured with components and structures to
remove heat from the warm side of the thermoelectric unit A10
(e.g., a heat sink A11 that is air cooled or a heat sink A11 that
is cooled by circulating fluid). Optionally, the warm side of
pre-ICP A2 can also include structures and components to provide
heat to other objects in the operating room, including fluids,
surgical instruments, and the surgeon's hands. These structures can
include pockets, bags, flaps, or projections for holding these
objects to be warmed.
[0119] The pre-ICP A2 is removed just before the incision is made.
Then the incision is made (or the trocar is inserted) and a second,
cooling post-incision pad (post-ICP) is then placed on the edges of
the incision to keep the edges of the incision, and the tissues
immediately surrounding the incision, cool.
A.2 Post-Incision Cooling Pad, Post-ICP
[0120] Once an incision is made, treatment of the tissues,
especially those at the margin of the incision, can slow or block
inflammation responses initiated by the incision, by retraction
that is performed after the incision, or by any other injurious
action of gaining surgical access. Whether or not a tissue is
cooled before incision, cooling and other treatments immediately
after incision and throughout the procedure will best slow or block
inflammation or other injurious responses by the tissue. Section
A.2 describes new devices and means for cooling tissues after
incision and throughout a procedure.
[0121] FIG. 5A shows a post-ICP A20 that is one piece that
completely wraps the margins of an incision A22. Alternatively, as
shown in FIG. 5B, a post-ICP A20 can be made of multiple pieces
A24, A26, A28 (three pieces are shown, but more or less can be
used), permitting positioning of the post-ICP A20 around the edges
of the incision and including positioning around surgical
instruments, such as a hand-held retractor A29.
[0122] All of the embodiments described for the pre-ICP A2 can be
incorporated into the post-ICP A20.
[0123] Additionally, the post-ICP A20 can include means to
facilitate placement of the post-ICP A20 on the edges of the
incision A22 and for maintaining the position of the post-ICP A20,
including means to prevent the post-ICP A20 from being knocked
into, slipping into, or otherwise moving into the incision A22.
These can include a combination of hooks or a stiffer, rolled edge
to engage the edge of the incision A22 surfaces composed such as
not to slide (including textured surfaces, adhesive coatings,
frictional coatings, coatings relying on van der Waal's
interactions or on hydrophobic/hydrophilic interactions), suction
cups, Velcro, weighted saddles, etc. These means can also include
attachment devices, such as Velcro strips, suction cups, or clips
that attach to the skin or to surgical drapes, that can also be
placed onto the post-ICP A20, for example around the periphery of
the post-ICP A20.
[0124] FIG. 6 shows one embodiment of a post-ICP A40 having a
stiffened, rolled edge A42 that engages the edge (i.e., margin) of
an incision A44, a frictional coating A46 or surface preparation
that engages a patient's skin A47 and/or the edge of the incision
A44, and an anchoring means, such as a clip A48, that engages a
surgical drape A50. Additionally, post-ICP A40 can be cooled by a
thermoelectric unit A10 with a "cool side" directed into the
post-ICP A40 (toward the skin A47) and the "warm side" directed to
the opposite surface of post-ICP A40 (e.g., toward the top of the
post-ICP A40). Thus the surface of post-ICP A40 nearest the cool
side of thermoelectric unit A10 is then placed against the
patient's tissues, and the surface of pre-ICP A2 having the warm
side can be configured to optimize heat transfer from the warm side
of the thermoelectric unit A10. As described above, the warm side
of thermoelectric unit A10 can be configured with components and
structures to remove heat from the warm side of the thermoelectric
unit A10 (e.g., a heat sink A11 that is air cooled or a heat sink
A11 that is cooled by circulating fluid). Optionally, the warm side
of thermoelectric unit A10 can also include structures A41 and
components to provide heat to other objects in the operating room,
including fluids, surgical instruments, and the surgeon's hands.
Structures A41 can include pockets, bags, flaps, or projections for
holding these objects to be warmed.
[0125] The post-ICP A40 can include malleable components to
facilitate conformation of the post-ICP A40 to the incision A22 and
to the skin A47, thereby facilitating both heat transfer to the
margins of the incision A44 and skin A47 and maintaining position
on the contours of the skin A47. The malleable components can be
metal, polymer, or any other material that holds a resting shape to
which it is forcefully deformed. The malleable components can be
formed into foils, wires, ribs, coils, or stays.
[0126] FIG. 7 shows one embodiment of a post-ICP A40 having a
malleable component, here shown as a malleable metal foil A52, on
the bottom surface of the post-ICP A40 (the surface contacting the
skin A47 and the edge of the incision A44). The metal foil A52 has
high thermal conductivity, facilitating heat transfer, and it
retains the shape of the post-ICP A40 when it is bent by the
surgeon. The metal foil A52 can be "pre-puckered," having small
folds, creases, indentions, or other such structures (spaced
periodically or aperiodically) to facilitate forming or conforming
to three-dimensional, compound curved surfaces.
[0127] FIG. 8A shows a top view of another embodiment of a post-ICP
A62 having a wire mesh A60 inside the post-ICP A62. The surgeon can
deform the wire mesh A60 to shape the post-ICP A62 to the incision
A22. The wire mesh A60 can be free inside a membrane A64 of the
post-ICP A62, or wire mesh A60 can adhere to one surface of the
post-ICP A62 (as shown in side view in FIG. 8B). Conversely, as
shown in top view in FIG. 8C, the post-ICP A62 can be an interwoven
set of malleable wires forming a wire mesh A66 and flexible,
fluid-filled tubes A68, with no membrane covering the wire mesh
A66. The malleable wires of the wire mesh A66 permit the post-ICP
A62 to be bent to shape to conform to the surface of the skin A47
and to the edges of the incision A22, and cooling fluid flows
through the interspersed net of flexible, fluid-filled tubes A68 to
remove heat from the area around the incision A22. The wire mesh
A66 may also serve as a universal surface for attaching sutures or
other means of attaining and sustaining retraction.
[0128] The shape of the wire mesh A60 or A66 can be substantially
two-dimensional, as shown in FIG. 8B. Alternatively, as shown in
side view in FIG. 8D, the shape of wire mesh (here numbered A69)
can be substantially three-dimensional (i.e., volume-filling),
having a membrane A64 filled with wire mesh A69, or alternatively a
metal felt (not shown) having a composition similar to a low
density steel or bronze wool, with the wire mesh A69 filling the
lumen of the post-ICP A62 such that it can be pressed to shape but
fluids can still circulate through the wire mesh A69. For high
pressures, the membrane A64 of the post-ICP A62 can be bonded to
the surface of the wire mesh A69, which then resists inflation of
the membrane A64 under pressure.
[0129] Another means of making a post-ICP A62 pliable to permit
shaping by a surgeon is shown in FIG. 9A. Post-ICP A62 can be
composed of a pliable material A70, such as putty, or to have the
post-ICP A62 be a membrane A71 filled with a pliable material A70
or with granules A72. Thus post-ICP A62 can be shaped by the
surgeon to the shape of the incision A22. Preferably pliable
material A70 or granules A72 have high thermal conductivity. Such
pliable material A70 or granules A72 can include tubing A74
coursing through pliable material A70 or granules A72 to carry
circulating fluid to and from a recirculating cooling unit A15. For
example, as shown in FIG. 9B, the post-ICP A62 can have a membrane
A71 filled with polymeric granules A72, like the polymer resin
filling found in PolarPaks offered by sale from Adagen Medical
International (Atlanta, Ga.), in which the polymeric granules A72
move past one another to permit easy deformation of the post-ICP
A62. Optionally, as shown in FIG. 9C, flexible tubing A74 coursing
through the polymeric granules A72 inside the post-ICP A62 can
carry cooling fluid A30 to (A78, outflow from the post-ICP A62) and
from (A76, inflow to the post-ICP A62) a recirculating cooling unit
A15 (such as in FIG. 3B).
[0130] A post-ICP A62 containing fluid-filled tubes, whether the
tubes are part of a mesh (as shown in FIG. 8C) or are distributed
through some medium filling a membrane A71 (such as in FIG. 9C),
can have components placed inside the tube to provide other
advantageous features. For example, as shown in FIGS. 10A and 10B,
a tube A80, such as an elastomer tube, can have various filamentous
components coursing inside a fluid-filled lumen A81 of the tube
A80. These filamentous components can include a malleable wire A82
to retain a bend in the tube A80, a heat management cable A84 (such
as a heating wire), and a sensing wire A86. Such tubes A80
containing multiple filamentous components can then be woven into
more complex arrays, such as a crossed array A88 as shown in FIG.
10C. Alternatively, these same filamentous components might be
helically woven around the tubes A80.
[0131] As shown in FIG. 11, when a post-ICP A62 is a membrane A71
filled with fluid A73 and placed on the patient's body wall A94
such that one part of post-ICP A62 is higher than the other, then
fluid A73 would tend to pool in one portion of the post-ICP A62,
causing another portion of the post-ICP A62 to empty. To resist
such pooling, the post-ICP A62 can include internal struts, fibers,
or other reinforcements that act as internal tension-resisting
elements A90 that resist swelling of the post-ICP A62 and also as
internal compression-resisting elements A92 that resist emptying of
the post-ICP A62. Further, one may arrange these internal tension
A90 and/or compression-resisting A92 elements to provide, permit,
or prevent specific shapes that the post-ICP A62 may take, for
example the internal tension-resisting elements A90 or internal
compression-resisting elements A92 can be serially and obliquely
arranged to encourage the curl of the post-ICP's A62 edge around
the margin of an incision A96.
[0132] A post-ICP A62 can be adjusted to match the circumference of
an incision A22 by overlapping itself, as shown in FIG. 12. Such a
post-ICP A62 has an overlapping region A100 such that post-ICP A62
can automatically adjust to the changing circumference of an
incision A22 as it is retracted to provide surgical access.
Alternately, as shown in FIGS. 13A and 13B, the post-ICP A62 can
have a helically wound fiber surface A102, or the post-ICP A62 can
possess a surface made of a bias-cut, warp and weft woven fabric,
permitting adjustment of length, whereby pulling the post-ICP A62
to elongate it on one axis A104 causes the post-ICP to shorten on
the perpendicular axis A106 (and vice versa, as shown in FIG. 13B).
More complex geometries are possible. Alternately, the post-ICP A62
can be like a piece of tube, flattened tube tape, or rope (not
shown) that is cut to length, with the cut end being closed by
mechanical means, such as a clip.
[0133] The portion of the post-ICP A62 that wraps the edge of the
incision A44 can be configured for surgeries requiring incisions to
different depths and penetrating through different tissues. As
shown in FIG. 14A, when the incision is through only skin A47 or
some other thin tissue, then the portion of the post-ICP A62 that
wraps the edge A44 of the incision A22 extends only a short
distance into the incision A22. When the incision A22 is through
skin and an underlying muscle layer or thick adipose layer or other
thick tissue, the portions of the post-ICP A62 wrapping the edge
A44 of the incision A22 can extend down far enough to cover the
deeper edge A44 of the incision A22 through both the skin and the
muscle, as shown in FIG. 14B.
[0134] FIG. 15 shows a post-ICP A62 that includes means to prevent
dehydration of tissues facing the edge A44 of the incision A22,
including having the post-ICP A62 constructed of vapor impermeable
materials. The post-ICP A62 can also have a felted or sponge-like
layer A110 to retain fluids, such as sterile saline, that acts both
as a hydrating fluid and as a thermally conducting fluid.
[0135] Cooling post-ICPs A62 can be transparent, or can have
transparent windows, and be filled with transparent fluids,
allowing the surgeon clear view of the tissues under the cooling
post-ICP A62.
[0136] A post-ICP A62, like the pre-ICP A2 (such as in FIG. 3A),
can be cooled by a thermoelectric unit A10. As shown in FIG. 16,
the thermoelectric unit is placed such that its cold side A110
faces the patient's tissues and its warm side A112 is attached, for
example, to a structure A41 that is to warm something in the
surgery. In this example, the structure A41 is shown as being a
warming plate, made of a thermally conductive material, that a
surgeon places his/her hands against to warm the hands throughout
an operation. Optionally, the warming plate shown as structure A41
can be a conformable foil or other conformable materials permitting
the pre-ICP A62 to better conform to the incision A22. Thus, the
thermoelectric unit A10 can serve the functions of both a cooler of
the patient's tissues and a hand warmer for the surgeon.
Configurations can include multiple thermoelectric units A10
arrayed for optimal cooling of the tissues. Optionally, an
insulating layer A114 can cover the top of the membrane A71,
separating the cold post-ICP A62 from the warm structure A41 and
the surgeon's hands when placed into the incision A22.
A.3 Post-Incision Cooling Pad Integral with Retractor
[0137] Retraction is used in surgery to move or otherwise deform
tissues to gain surgical access. For example, to gain access to the
heart or lungs, a sternotomy is commonly performed. Retraction is
then maintained throughout the procedure. Retraction is performed
with a device variably known as a retractor, spreader, distractor,
and other names. For all methods and instruments of retraction, it
is desirable to cool the tissue before and during retraction,
possibly including the entire duration of the procedure.
[0138] In this Section A.3, new devices and means of integrating
cooling pads with retractors to cool tissues before and during
retraction, optionally spanning the entire duration of the surgical
procedure are described.
[0139] Frequently, the edges of an incision must be pulled apart
with a surgical device called a retractor (also sometimes called a
spreader). Retractors can be of several shapes and configurations,
each having one or more tissue engaging elements. For example, as
shown in FIG. 17, a Finochietto rib spreader A120 for thoracotomies
has two opposing arms A124 each bearing a retractor blade A122 that
serve as the tissue engaging elements. As shown in FIG. 18, a ring
retractor A124 for abdominal surgeries has multiple retractor
blades A126 (three (3) shown here) that serve as the tissue
engaging elements and these retractor blades A126 are mounted to a
ring frame A127 to support them. The ring frame A127 is typically
attached to the operating bed by a mounting arm. As shown in FIG.
19, a Weitlander retractor A128 for retracting skin has two
opposing retractor forks A130 as the tissue engaging elements.
[0140] Cooling post-ICPs can be made to fit around the tissue
engaging elements (e.g., retractor blades or forks) of such
retractors. FIG. 20 shows a cooling post-ICP A140, cooled with
recirculating fluid supplied by a fluid inlet tube A142 and a fluid
outlet tube A144, which fits around the forks A130 of a Weitlander
retractor A128 by means of a cut-out A148 where the retractor forks
A130 engage the tissue. Such a post-ICP A140 can be placed after
retraction has advanced to the point that the post-ICP A140 can be
easily positioned.
[0141] FIG. 21 shows a multi-segment post-ICP A160 composed of
three (3) segments A162, A164, A166 (more or fewer segments can be
used) that permits adjustment to retractor blades A126 that can be
variably placed around the margin of an incision. The segments
A162, A164, A166 of the post-ICP A160 can, themselves, be
independently adjusted. Conversely, the segments A162, A164, A166
of the post-ICP A160 can be connected, for example, by tubing to
permit flow of cooling fluid between segments A162, A164, A166.
[0142] Cooling post-ICPs A140, A160 can be integral to the
retractor, permitting coordinated placement of the post-ICP A140,
A160 with the retractor. Additionally, the post-ICP A140, A160 can
cool parts of the retractor, such as the tissue engaging elements
(e.g., retractor blades or retractor hooks) such that these
components of the retractor also serve to cool the tissue
underlying the tissue engaging elements. FIG. 22 shows a thoracic
retractor A180 with a cooling post-ICP A150 having two halves A170,
A172, each attached to the Finochietto rib spreader A120 such that
the dense, metal retractor blade A182 also acts (as a heat sink) to
cool the tissues under the retractor blade A182. The two halves
A170, A172 of the post-ICP A150 are attached to each of the two
retractor blades A182. The halves A170, A172 are physically
attached to the sides A171 of the retractor blades A182, with both
halves A170, A172 cooling the blades A182 and allowing the post-ICP
A150 to be inserted into the incision A22, during a thoracotomy for
example. Retractor blades A182 and halves A170, 172 of post-ICP
A150 can be inserted before retraction starts, allowing the margins
A44 of the incision to be cooled immediately, before retraction,
and throughout the duration of the surgical procedure. Cooling of
the tissue engaging element for any retractor can be by one of
several means, such as by conduction from the post-ICP A150.
Alternatively, the tissue engaging element, such as retractor blade
A182, can have internal channels A173 connected to a cooling fluid
in the post-ICP A150 to permit the flow of cooling fluid from the
cooling post-ICP A150 into and out of the retractor blade A182.
Cooling fluid can also be run directly into the base of the arms of
the thermally conductive retractor, out a hollow arm, and through
the tissue engaging element, such as the retractor blade A182. The
cooling fluid might run inside the retractor arm alongside the
post-ICP A150, or into the retractor blade A182 and then out into
the post-ICP A150, or in some combination.
[0143] Cooling post-ICPs can also underlie the tissue engaging
element of a retractor. FIG. 23 shows a cooling post-ICP A175
having two halves A174, A176 placed into an incision A22 such that
the retractor blades A122 of a Finochietto rib spreader A120
overlay the halves A174, A176, thereby each half A174, A176 is
interposed between the tissue and the retractor blade A122. The
material or the internal structure of the halves A174, A176 would
need to be able to perform cooling while also withstanding the
retraction pressure under the retractor blades A122. Thus, the
halves A174, A176 can be composed of a stiff gel, or the halves
A174, A176 can be filled with a fluid and with a reticular material
(like a stiff sponge or a series of tubes) that is able to
withstand the retraction forces while still permitting fluid to
flow through.
[0144] Note that such a post-ICP as shown in FIG. 23 can also be
separate from the retractor, with the post-ICP placed after the
incision and the retractor placed next, overlaying the post-ICP.
Cooling post-ICPs A40, A162 can be placed under the tissue engaging
elements of any retractor, such as a single-bladed hand-held
retractor (e.g., FIG. 5B showing a hand-held retractor A30 without
a post-ICP under the blade), the retractor blades A126 of a ring
retractor A124 (e.g., FIG. 18), or the forks A130 of a Weitlander
retractor A128 (e.g., FIG. 19).
[0145] Integration of the post-ICP and the retractor permits
integration of other functions as well. For example, the large
metallic structure of the retractor can be used as a heat sink for
a thermoelectric cooling device. This would offer the advantage of
cooling the tissues at the incision while warming the retractor to
keep the surgeon's hands warm.
[0146] A post-incisional cooling post-ICP A150, A175 can work with
a sternal spreader in ways similar to those shown for the
Finochietto rib spreader A120 in FIGS. 22 and 23. This permits
cooling of the margins of the bisected sternum throughout lengthy
procedures, such as multiple coronary artery bypass grafting.
A.4 Post-ICPs Integral with Trocars and Other Inserted Devices
[0147] Trocars A200 are surgical devices that are used to make
openings through the body wall A94 for endoscopic procedures (e.g.,
laparoscopy) within the patient's body cavity A45 (see FIG. 24).
Once inserted, trocars A200 provide a hollow tube for the insertion
of other surgical implements, such as a borescope, forceps, or
scissors. Thus, like a retractor, a trocar A200 is used to deform
tissue (here, strained circumferentially, around the shaft) to
achieve surgical access. As with retractors described in Section
A.3, Section A.4 describes new devices and means for cooling
tissues commencing on insertion of the trocar A200 and, optionally,
spanning the duration of the surgical procedure.
[0148] As shown in FIG. 25, a post-ICP A202 shaped like a donut,
pierced lens, or other substantially toroidal form can be placed
around the shaft of a trocar A200, or the shaft of a trocar A200
can be inserted through a hole A204 in a cooling post-ICP A202 and
into the skin A47, such that the trocar A200 passes through the
post-ICP A202, and the post-ICP A202 covers and cools all tissue
A45 surrounding the trocar A200.
[0149] Alternatively, as depicted in FIG. 26, a post-ICP (here
numbered as A210) can be integral with the trocar A200 such that
the shaft of the trocar A200, or a section A212 of the shaft of the
trocar A200, is kept cool and acts as a cooling element, cooling
the tissues of the patient's body wall A94 apposed to the trocar
A200. The section A212 of the shaft of the trocar A200 can be made
of materials having high thermal conductivity to efficiently convey
heat from the margin of the incision to the cooling medium in the
post-ICP A210; additionally, section A212 can have other features
to facilitate transport of heat from the margins of the incision to
the cooling medium of the post-ICP A210, such as channels A214 in
the wall of the trocar A200 for circulating cooling fluids, or the
post-IPC A210 can be equipped with one or more Peltier
thermoelectric cooling devices A10 to cool the cooling medium in
the post-ICP A210. Alternatively, one or more Peltier
thermoelectric cooling devices A10 can be mounted to the wall of
the trocar A200, and the wall of trocar A200 designed such that
heat is conducted from the tissues A45 around trocar A200 to the
Peltier thermoelectric cooling devices A10.
[0150] Alternatively, as shown in FIG. 27, a cooling post-ICP (here
numbered A220) can possess a cylindrical inner annulus A222 to
permit trocar A200 to easily insert through the body wall (here,
the abdominal wall A94) with post-ICP A220 attached. Such a
post-ICP A220 with a cylindrical inner annulus A222 permits fitting
of all trocars A200 with a cooling post-ICP that also cools the
patient's tissue A45 along the depth of the trocar's A200 incision.
The cylindrical inner annulus A222 has a thin wall A232 that
closely fits the shaft of the trocar A200 and extends into the
incision made by the trocar A200. The cylindrical inner annulus
A222 should be made of material having high thermal conductivity to
conduct heat from the patient's tissue A45 to the cooling devices
of the post-ICP A220 (e.g., to a cooling fluid A224 if the post-ICP
A220 is cooled by chilled liquid). Similarly, the cylindrical inner
annulus A222 should be thermally coupled to the cooling devices of
the post-ICP A220. In the example shown in FIG. 27, the post-ICP
A220 is filled with a cooling liquid A224. A bladder A226 material
of the post-ICP A220 can be composed of an elastomer, such as
rubber, and could be bonded to the cylindrical inner annulus A222
with a metal/rubber bond such that the material of the cylindrical
inner annulus A222 is in direct contact with the cooling liquid
A224. The cylindrical inner annulus A222 can have cooling fins A228
that project into the cooling liquid A224 inside the cooling
post-ICP A220 such that heat passes readily from the cylindrical
inner annulus A222 to the cooling liquid A224 and can thus cool the
cylindrical inner annulus A222. The cylindrical inner annulus A222
could extend away from the cooling post-ICP A220 forming a margin
to contact the tissue A45 along the incision made by the trocar
A200, and the trocar A200 might insert into the cylindrical inner
annulus A222. The cylindrical inner annulus A222 can fit the trocar
A200 snugly and can have a low profile such that it easily enters
the incision made by the trocar A200. The cooling post-ICP A220 can
include a rim A230 attached to the cylindrical inner annulus A222
that permits the surgeon to push with her fingers to ensure the
cylindrical inner annulus A222 positions properly in the incision.
Thus, when the trocar A200 is inserted into the patient's abdominal
wall A94, the margin of the cylindrical inner annulus A222 conducts
heat from the tissue A45 along the depth of the incision into the
cooling liquid A224 inside the post-ICP A220, thereby cooling the
tissue A45 along the incision.
B. Drug Eluting Pads
[0151] There is frequently post-surgical pain at the site of
incision, known as "incisional pain." Incisional pain can be
severe, requiring the administration of analgesics after surgery.
Even for minimally invasive approaches (e.g., "keyhole" surgery),
port site pain (where the trocars and other instruments are
inserted) is common. For some procedures, incisional pain can last
long after surgery, leading to the definition of various pain
syndromes, such as post-thoracotomy pain syndrome and chronic
regional pain syndrome. Subsequently, post-surgical pain management
places a large burden on health care and detracts from
post-surgical quality of life for many patients.
[0152] The cause of incisional pain is not known. It is believed to
be caused by a complex series of physiological processes arising
from the trauma of incision and retraction. These include include
nerve damage, tissue damage from lack of perfusion due to the
pressure of retraction (e.g., tissue anoxia, tissue reperfusion
damage), and localized inflammation. Most of the proposed
mechanisms of pain are initiated at the time of incision; however,
ameliorative procedures are usually not initiated until hours after
the incision. For example, during a thoracotomy, an incision is
made between the ribs and a rib spreader is then used to pry apart
the ribs. During retraction, considerable tissue trauma occurs,
including stretching and breaking of ligaments and bending and
sometimes breaking of ribs. Considerable force is required to pry
apart the ribs and to hold them apart. Thus, tissue pressure in the
tissues underlying the retractor blades is sufficiently high to
block tissue perfusion. Intrathoracic procedures can last hours,
and retraction is maintained throughout. After the procedure,
retraction is relieved, the ribs are re-apposed and sewn back into
position, and the muscles and skin over the incision are sutured
back together. Tissue reperfusion occurs on relief of retraction
and, while its sequelae are not well-studied, reperfusion injury is
possible.
[0153] Typically, anesthesia is used during surgery, and analgesia
begins at the conclusion of surgery, which is frequently hours
after the incision is made. There has been growing use of delivery
of analgesics and of anesthetics via catheters that are placed into
the incision immediately before closing the incision, e.g., after
sternotomy (12, 30, 49).
[0154] One underlying cause of post-surgical pain is inflammation
of tissues after incision and retraction. Trauma to the tissues
from cutting, from the deformations (and rending) of retraction,
and from physiological response to absence of perfusion all
initiate pro-inflammatory and inflammatory signals leading to
inflammation responses at the site of the incision and
retraction.
[0155] It is also desirable to achieve other important goals at the
edge of an incision, either to improve surgical outcome or to
enhance healing. These include the following: [0156] 1. It is
desirable to minimize bleeding at the edges of the incision.
Electrocautery is commonly used to minimize bleeding of freshly cut
soft tissues. For bones, the most common approach is to apply a
material to the cut surface of the bone to stop bleeding. Commonly
used materials are bone wax (a mixture of bees wax, paraffin, and,
optionally, a wax softening agent) and thrombin. Less commonly used
materials are Ostene.TM. (from Ceremed, Inc. of Los Angeles,
Calif.) and Surgicel (from Pfizer, Inc. of New York City, N.Y.).
[0157] 2. It is desirable to block inflammation at the incision and
at tissues neighboring the incision that are damaged during
retraction. It is also desirable to accomplish this block of
inflammation as soon as possible after immunological challenge,
typically the surgical incision, before pro-inflammatory and
inflammatory signals are initiated. [0158] 3. It is desirable to
encourage wound healing. Failure of an incision to heal is itself
problematic and can lead to other significant post-surgical
complications. [0159] 4. It is desirable to eliminate post-surgical
infection.
[0160] In this Section B, new devices and means of reducing
incisional inflammation and post-surgical pain and of enhancing
healing of incisions by pharmacological treatment of the tissues
cut during the incision or deformed during surgical retraction are
described. In general, a pad is placed over the site of an incision
to locally release pharmacological agents to the tissues affected
by the incision. This pad is placed after the incision, over the
edges of the incision, or surrounding a trocar entry, and is kept
on the edges of the incision throughout surgery to block or
otherwise reduce post-surgical inflammation, bleeding, pain, or
other undesirable consequence of the incision or of surgical
retraction.
B.1 Drug-Eluting Pads (DEPs) at the Margins of an Incision
[0161] In this section B.1, new devices and means to release a drug
or other pharmacological agent directly to the edges of an incision
are described. After the surgeon makes the incision, such as with a
scalpel or other means, a device configured as a pad is placed such
that it overlaps the edges of the incision and releases drug
directly to the freshly cut tissues throughout the duration of the
surgery. In this Section B, a pad configured to release drug to the
tissues is referred to as a drug-eluting pad DEP.
[0162] The drug or other pharmacological agent can include (singly
or as combinations): [0163] Agents to prevent infection, such as
antibiotics and antimicrobials. [0164] Agents to reduce blood flow
during surgery, such as thrombin, gelatin (denatured collagen),
solubilized or microfibrillar collagen, cellulose powder, or
clotting factors. [0165] Agents to reduce inflammation, such as
opioid analgesics (7, 32), inhibitors of complement response (e.g.,
C5a receptor agonists, APT070, TP10 from AVANT Pharmaceutical) (6,
10), anti-inflammatory cytokines IL-10 (16), inhibitors of
inflammatory cytokines (e.g., infliximab, adalimumab, etanercept,
pentoxifylline), inhibitors of nuclear factor-kappa B activation
(e.g., curcumin). [0166] Agents to encourage healing of the
sternum, including agents to promote revascularization of the wound
(examples include fibroblast growth factor 1 FGF-1, vascular
endothelial growth factor VEGF, transforming growth factor beta
TGF-.beta., platelet derived growth factor PDGF) and agents that
promote osteogenesis (examples include the bone morphogenetic
proteins, BMP, transforming growth factor beta, TGF-.beta.).
[0167] Release of drug from the DEP to the tissues can be by any of
several means. The DEP can be made of a hydrogel or another
material into which the drug is dissolved, and release of drug from
the DEP to the tissues is by diffusion (aided by convection driven
by DEP and tissue deformations) out of the DEP and into the
tissues. Examples of non-hydrogel materials into which drug is
dissolved include hydrophobic gels composed of cross-linked
polymers (which can be used to carry hydrophobic drugs),
polydimethylsiloxane, PDMS, and fluoro-elastomers, such as
Fluorocur from Liquidia Technologies, Inc. (Durham, N.C.). The DEP
can be a fluid-filled membrane, with the membrane being permeable
to the drug thereby allowing diffusion of drug out of the DEP and
into the tissue. The DEP can be a fluid filled membrane, with the
membrane being porous such that fluid slowly flows out of the DEP
and into the tissues. The DEP can include means for flowing
physiological saline or other fluid (into which drug is dissolved)
onto the tissue, such means including (a) tubes for delivery either
from the ends or from the sides of the tubes; (b) orifices; or (c)
channels.
[0168] Flow-based drug delivery means require an elevated pressure
(e.g., to drive a fluid flow). The pressure can be supplied by an
external pressure source (e.g., a pump attached to the DEP, an
elastomeric pump or pressure chamber, or a pressure reservoir) or
by a pressure source integrated into the DEP (e.g., an elastomeric
pump or pressure chamber, a pressure reservoir, a gas-generating
reaction, osmotic pressure, or pressure generated by surgical
retraction).
[0169] Note that a DEP can also reduce tissue drying during surgery
both by acting as a barrier to evaporation or absorption (for
example, by surgical gauze) and as a fluid delivery system that
directly perfuses the tissues with an appropriate fluid, such as a
physiological saline.
[0170] A DEP can also prevent accidental injury of the tissue, for
example, by stabbing with a surgical implement, by cutting with a
scalpel, or by other means.
[0171] As shown in FIG. 28A, a drug-eluting pad (DEP) B2 can be in
one piece that completely wraps the incision A22, or it can be in a
plurality of pieces B4, B6, B8 (as shown in FIG. 28B), permitting
positioning of the DEP B2 around the edge of the incision A22 and
including positioning around other surgical instruments, such as
retractors (shown in FIG. 28B as a hand-held retractor A30) and
other pads.
[0172] A DEP B2 can include specialized regions of the DEP B2,
including multiple components that enhance or augment the functions
of the DEP B2. The DEP B2 (also including pieces B4, B6, B8) can
include means to facilitate placement of the DEP B2 on the edges
A44 of an incision A22 and for maintaining the position of the DEP
B2, including means to prevent the DEP B2 from being knockied into,
slipping into, or otherwise moving into the incision A22. These can
include a combination of hooks or a stiffer rolled edge to engage
the edge A44 of the incision A22; surfaces composed such as not to
slide (including textured surfaces, angled bristles to provide
biased traction, adhesive coatings, frictional coatings, surfaces
relying on van der Waal's interactions or on
hydrophobic/hydrophilic interactions), suction cups, Velcro,
weighted saddles, etc. These means can also include attachment
devices, such as Velcro strips, suction cups, or clips that attach
to the skin, to surgical drapes, or to other structures surrounding
the incision A22. FIG. 29 shows one embodiment having a DEP B2
formed from an elastomeric membrane B5, filled with a drug-bearing
fluid B7, a stiffened, rolled edge B8 that engages the edge A44 of
an incision A22, a drug-eluting surface B10 apposed to the edge A44
of the incision A22, a frictional coating B11 that engages the
patient's skin A47, and a clip B12, attached by a cord B14, that
engages a surgical drape B16.
[0173] As shown in FIG. 30, DEP B2 can include malleable components
B20 to facilitate conformation of the DEP B2 to the edge A44 of an
incision A22 and to the skin A47, thereby facilitating delivery of
drug to the exposed tissue and maintaining position on the skin.
The malleable components B20 can be metal, or polymer, or any other
material that holds a shape once it is deformed. The malleable
components B20 can be formed into shape-holding structural elements
permitting also complex curvature, such as wrinkled foils, wires,
ribs, or stays. The malleable component B20 in FIG. 30 is shown as
a folded metal foil (also numbered as B20) on the top surface of
the DEP B2 (the surface not contacting the skin A47 nor the
incision A22). The metal foil/malleable component B20 retains the
shape of the DEP B2 when it is bent by the surgeon. FIGS. 31A and
31B show another embodiment having a malleable mesh B22 (e.g., a
metal mesh) enclosed within a membrane B3. The membrane B3 contains
a drug-eluting fluid B5, and the malleable mesh B22 permits the
surgeon to deform the mesh B22 to shape the DEP B2 to the incision
A22. The shape of the mesh B22 can be substantially
two-dimensional, as shown in FIGS. 31A and 31B (FIG. 31A shows a
top view and FIG. 31B shows a side view). Alternatively, as shown
in FIG. 31C, the DEP B2 can be a woven mesh of tubes having porous
walls ("porous tubes" B24), with no membrane surrounding the mesh
of porous tubes B24, such that the drug-bearing fluid in the porous
tubes B24 passes directly from inside of the porous tubes B24,
across the wall of the porous tubes B24, to the tissues. This
configuration (for example, if implemented in tubes of small
radius) permits the use of high internal pressures in the fluid
which would otherwise cause an elastomeric membrane DEP B3 to
inflate like a balloon. DEP B2 can, optionally, include interwoven
malleable mesh B22 to permit shaping of the DEP B2.
[0174] Alternatively, the shape of the mesh B22 inside DEP B2 can
be substantially three-dimensional, or volume-spanning, as shown in
FIG. 32, having a membrane B3 filled throughout with a malleable
mesh B22 having a composition similar to a low density steel wool,
with the steel wool filling the lumen of the DEP B2 such that DEP
B2 can be pressed to shape but fluids can still circulate through
the wool. For high pressures, the membrane B3 of the DEP B2 can be
bonded to the surface of the mesh B22, which then resists inflation
of the membrane B3 under pressure. Alternatively, the membrane B3
can incorporate within it tensily stiff fibers (not shown), the
arrangement of which can create anisotropies in the membrane
permitting any number of arbitrary shapes that resist or permit
swelling in directions according to the distribution stresses and
strains in the membrane. For example, membrane B3 stresses aligned
with fibers in the membrane B3 would be resisted (no strain
permitted), while stresses aligned perpendicular to the fibers in
the membrane B3 permitted large strains. Such fiber-reinforced
membranes can also be configured that when filled they actively
deform three-dimensionally to conform to the contours of the
patient and/or the incision A22.
[0175] The DEP B2 can also be composed of a putty-like material B24
having sufficient pliability to permit manual shaping of the DEP
B2. A drug (or drugs) is dissolved into the putty-like material
B24, as shown in FIG. 33A. Alternatively, as shown in FIG. 33B, the
DEP B2 can be filled with a putty-like material B24 having drug
dissolved into the putty-like material B24, wrapped by an
elastomeric membrane B3, such that the DEP B2 can be shaped by the
surgeon. Such putty-like material B24 can include tubing B27
coursing through the putty to carry drug-bearing fluid from a fluid
recirculating unit B28.
[0176] As shown in FIG. 34, when a DEP B2 is a membrane B3 filled
with fluid B31 and placed such that one part is higher than the
other, then fluid B31 can pool in the lower portions of the DEP B2,
causing higher portions of the DEP B2 to empty. To resist such
pooling, the DEP B2 can include internal struts, tensile stays,
trebeculae or other reinforcements that act as internal
tension-resisting elements B32 that resist swelling of the DEP B2
and could also act as internal compression-resisting elements B30
that resist emptying of the DEP B2. The direction and number of
these internal spanning elements B30, B32 can be transverse,
longitudinal, radial, oblique, helical, or in any combination.
[0177] A DEP B2 can be adjusted to match the circumference (or
perimeter) of an incision A22 by overlapping itself to create an
overlapped region B34, as shown in FIG. 35. Alternately, as shown
in FIGS. 36A and 36B, the DEP B2 can have a helically wound fiber
surface B36, or alternatively the DEP B2 can possess a surface made
of a bias-cut, warp and weft woven fabric, permitting adjustment of
length, whereby pulling the DEP B2 to elongate it on one axis B40
causes the DEP B2 to shorten on the perpendicular axis B42. More
complex geometries are possible.
[0178] Alternately, if the DEP B2 delivers drug from a solid or
semi-solid (e.g., hydrogel) portion of the DEP B2, then the DEP B2
can be like a piece of tape or rope that is cut to length (not
shown). If the DEP B2 delivers drug from a fluid-filled component,
then, again, the DEP B2 can be like a piece of tape or rope that is
cut to length with the cut end being closed by mechanical means,
such as a clip or a fold.
[0179] The portion of the DEP B2 that wraps the edge A44 of the
incision A22 can be configured for surgeries requiring incisions to
different depths and penetrating through different tissues, as
shown in FIGS. 37A and 37B. When the incision is through only skin
A47 or other thin tissue, then the portion of the DEP B2 that wraps
the edge A44 of the incision A22 extends only a short distance into
the incision (FIG. 37A). When the incision is through the skin A47
and an underlying layer of tissue B46 (e.g., a muscle layer, fat
layer, or other tissue), the portions of the DEP B2 wrapping the
edge A44 of the incision A22 can extend down far enough to cover
both the incisional margin of the skin and of the underlying layer
of tissue B46 (FIG. 37B).
[0180] A DEP B2 can be transparent, or can have transparent
windows, allowing the surgeon clear view of the tissues under the
DEP B2.
[0181] A DEP B2 can include means for cooling the tissue to further
suppress inflammation. Cooling can be via a fluid that is cooled by
an external cooled recirculating fluid system, with the drug
dissolved in the cooled fluid, or the drug can be dissolved in a
second fluid separate from but cooled by the cooled fluid. Cooling
can be by a thermoelectric device, such as a Peltier device or by
ice that is held in a portion of the DEP B2. Similarly, all of the
embodiments presented in Section A on cooling pads can be
incorporated into a DEP B2.
B.2 Drug-Eluting Pad (DEP) Integral with a Retractor
[0182] Frequently, the edges A44 of an incision A22 are pulled
apart with a surgical device called a retractor (also sometimes
called a spreader). As discussed in Section A.3, retractors can be
of several shapes and configurations, each having one or more
tissue engaging elements. For example, as shown in FIG. 17, a
Finochietto rib spreader A120 for thoracotomies has two opposing
retractor blades A122 that serve as the tissue engaging elements.
As shown in FIG. 18, a ring retractor A124 for abdominal surgeries
has multiple retractor blades A126 (three (3) shown here) that
serve as the tissue-engaging elements and these retractor blades
A126 are mounted to a ring frame A127 to support them. As shown in
FIG. 19, a Weitlander retractor A128 for retracting skin A47 has
two opposing retractor forks A130 as the tissue engaging
elements.
[0183] For all methods and instruments of retraction, it is
desirable to treat the tissue before and during retraction,
possibly including the entire duration of the procedure. In this
Section B.2, new devices and means of integrating DEPs with
retractors to treat tissues before and during retraction,
optionally spanning the entire duration of the surgical procedure
are described.
[0184] DEPs B2 can be made to fit around the tissue engaging
elements (e.g., retractor blades or forks) of such retractors. FIG.
38 shows a DEP B2 that wraps around the edge A44 of an incision A22
and fits around the forks A130 of a Weitlander retractor A128 by
means of a cut-out B50 where the forks A130 engage the tissue. Such
a DEP B2 can be placed after the incision is made and before
retraction has commenced or, optionally, after retraction has
advanced to the point that the DEP B2 can be easily positioned. The
DEP B2 shown in FIG. 38 has a recirculating fluid (not shown)
carrying drug into the DEP B2. A fluid inlet tube B52 and a fluid
outlet tube B54 carry the fluid from a pump (not shown) to the DEP
B2. Such a delivery system can be used if the drug must be kept
chilled until the moment of use or if elution of drug by the DEP B2
depletes the fluid of drug.
[0185] FIG. 39 shows a multi-segment DEP B2 that permits adjustment
to retractor blades that can be variably placed around the edge A44
of an incision A22. The segments (three (3) are shown here, B60,
B62, B64, but more or less are possible) of the DEP B2 can,
themselves, be independent DEPs. Conversely, the segments B60, B62,
B64 of the DEP B2 can be connected, for example by tubing
(directly, or through passages the ring frame) to permit flow of
cooling fluid or of drug-bearing fluids between segments B60, B62,
B64.
[0186] DEPs can be integral to a retractor, permitting coordinated
placement of the DEP with the retractor. FIG. 40 shows a thoracic
retractor B71 with a DEP B2 attached to the retractor blades B74.
The DEP B2 has two halves B70, B72, one attached to each of the two
retractor blades B74. The halves B70, B72 are physically attached
to the sides of the retractor blades B74, allowing each half B70,
B72 to be inserted into the incision A22, during a thoracotomy for
example, before retraction starts, allowing the edge A44 of the
incision to be treated with drug immediately, before retraction,
and throughout the duration of the surgical procedure.
[0187] DEPs can also be placed between the tissue and the tissue
engaging element of a retractor. FIG. 41 shows a DEP B2 having two
halves B80, B82 integrated into a thoracic retractor B84 such that
the halves B80, B82 lie along the surface of the retractor blade
B86, thereby being interposed between the tissue and the retractor
blade B86. The material of the DEP B2 would need to be able to
perform drug delivery while also withstanding the retraction
pressure under the retractor blades B86 (alternatively, the
retraction pressure under the retractor blades A122 can be tapped
to drive drug delivery from inside the DEP B2). Thus, the halves
B80, B82 can be composed of a stiff gel, or the halves B80, B82 can
be fluid-filled and filled with a reticular material (like a stiff
sponge or a series of tubes) that is able to withstand the
retraction forces while still permitting fluid to flow through.
Note that such a DEP B2 can also be separate from the retractor 84,
with the DEP B2 placed after the incision is made and the retractor
placed next, overlaying the DEP B2.
[0188] A DEP B2 can work with a sternal spreader in ways similar to
those shown for the thoracic retractor B71, B84 in FIGS. 40 and 41.
This permits delivery of drug to the margins of the bisected
sternum throughout lengthy procedures, such as multiple coronary
artery bypass grafting.
[0189] Note that a DEP can also act as a pressure-distributing pad,
reducing point loading (and thus stress concentration) in retracted
tissues. As shown in FIG. 42, a hydrogel DEP (numbered here as
B100) deforms when loaded, but is stiff enough when contained
within a retraction element, depicted as retractor blade B101, to
withstand retraction pressures. DEP B100 can distribute loads along
the cut edges B104A of, for example, the bisected sternum during a
sternotomy. Retraction is shown as being performed by a Finochietto
rib spreader (B120 as shown in FIG. 41). As the retractor blades
B101 push against the two halves B102 of the bisected sternum, the
edges B104A of each half B102 of the bisected sternum push into DEP
B100, deforming DEP B100 such that DEP B100 conforms to the surface
of each half B102 of the bisected sternum. Drug dissolved into the
hydrogel of DEP B100 diffuses into the tissue of the incised
sternum. The DEP B100 can be reinforced with fibers to permit
resisting shear as a part of a DEP B100; the fibers themselves can
be hollow and form the drug storage portion of the DEP B100.
[0190] Similarly, as shown in FIG. 43, a DEP B100 is formed by a
fluid-filled porous membrane B106, optionally filled with a
reticular material B108 (such as a flexible mesh or a stiff,
open-cell foam), that cushions a tissue and also, by slow flow of
drug-bearing fluid across the porous membrane B106, deliver drug to
the tissue.
[0191] FIG. 44 shows one embodiment of a sternal retractor, such as
a Finochietto rib spreader, a DeBakey retractor, or an Ankeney
retractor, fitted with a DEP (here numbered as B110) that cushions
the freshly cut bone surfaces (for example, B104B), delivers drug
to the cut surface B104B and cools the cut surface B104B. The DEP
B110 is composed of a hydrogel B111 that covers the edge A44 of the
incision A22, including the surface of the bone beneath the
retractor blades B114 of the sternal retractor. The hydrogel DEP
B110 thus cushions the cut bone surface B104B of the halves B102 of
the bisected sternum from the retractor blades B114. Furthermore,
drugs diffuse from the hydrogel DEP B110 into the cut surface B104B
of the halves B102 of the bisected sternum. The drugs can include
agents that block inflammation, stop bleeding, have antibiotic or
anti-microbial action, encourage wound healing, or have other
beneficial effects. Furthermore, there can be tubes B112 embedded
in the hydrogel B111 that circulate cooling fluid from an external
recirculating chiller (B28, not shown here), thereby cooling the
hydrogel B111 and thus the cut surface B104 of the sternum. The
tube B112 can be impermeable to the drug(s), to prevent loss of
drug(s) in the cooling fluid, or the tubes B112 can be permeable to
the drug(s) and the fluid used to deliver drug(s) to the DEP
B110.
[0192] A DEP can include a mechanically rigid component, such as a
metal plate that lines the side of the DEP opposite the tissue.
This rigid component can then be engaged by a retractor such that
the mechanically rigid component acts like a retractor blade that
both distributes force along the edge of the incision and pushes
the DEP under the plate against the edge of the incision. FIG. 45
shows an example of such an embodiment. Here a thoracic retractor
B123 has modified retractor blades B125 that are formed by two
descender posts B120 that engage and push against a rigid component
B122, shown here as a flat plate apposing each edge A44 of the
incision A22. There are two rigid components B122 (only one is
visible in this perspective drawing) that line each edge A44 of the
incision A22. The DEP B121 has two halves B124 and B126. Each rigid
component B122 is integral with its respective half B124 or B126,
optionally being fused together or fitting into a mechanical clasp
or other fixture. The rigid component B122 can be highly rigid, or
it can be flexible, or have flexible or sprung hinged portions, to
allow differing distributions of retraction forces along edge A44
of the incision A22. For example, as shown in FIG. 46, the rigid
component B122 can be more rigid at its center B128 where it pushes
against the middle of the edge of the incision and more flexible at
its ends B130 where it pushes against the ends of the incision. The
rigid component B122 can also possess discreet regions of desired
flexibility, for example narrowed sections or locally differing
materials, or conversely, the rigid component can possess a
smoothly, continuously varying gradient of flexibility. The
gradient(s) above can be aligned to a straight axis, a curving
axis, and/or multiple axes. The axes can cross each other.
[0193] Such a DEP B121 with a rigid component B122 can include
features or components that assist in engaging the tissue along the
edge A44 of an incision A22. For example, if the rigid component
B122 is a rigid plate, for example made of metal, rigid polymer or
composite, that lines the side of the DEP B121 opposite the tissue,
the plate can wrap around the DEP B123 such that it also wraps
around the tissue at the edge A44 of the incision A22 (above and
below, or exteriorly and interiorly, or along the edge A44 of the
incision A22). Examples include wrapping around a rib at the edge
A44 of an incision A22 during a thoracotomy or wrapping around the
soft tissues of the abdominal wall during an abdominal surgery.
Such wrapping around the tissue at the edge A44 of the incision A22
can reinforce mechanical engagement with the tissue; for example,
the wrapping can help resist slipping of the DEP B121 against a cut
sternum, or it can help resist torsion of the sternum during
retraction. These portions of the rigid component B122 that wrap
around the DEP B121 and tissue can be configured to facilitate
bending, folding, or otherwise adaptive reconfiguring of the rigid
component; for example, these portions can be divided into
segments. The segments (i.e., the divisions forming them) may be
oriented such that the segments automatically conform to the shape
changes of the anatomy as retraction progresses. FIGS. 47A and 47B
show such an embodiment.
[0194] FIG. 47A shows a perspective view, and FIG. 47B shows a
cross-sectional view through one-half of the assembly. Similar to
the embodiment shown in FIG. 46, a thoracic retractor B123 has
modified retractor blades B125 comprising two descender posts B120.
A DEP B121 has two halves, here numbered B140 and B142. Each half
B140, B142 has a rigid component, here numbered B144, that has
edges B146 that wrap abound the edge A44 of the incision A22. The
drug-eluting portion is a hydrogel B148 apposed to rigid component
B144 and wrapped by the edges B146, as shown in FIB. B26B. This
example also shows cooling pads B150 (similar to the post-incision
cooling pads disclosed in Section A) attached to the rigid
component B144 such that cooling pads B150 cover and cool the
tissues adjacent to the incision A22. The cooling pads B150 can be
cooled by one of several means, such as a fluid circulating through
cooling pads B150 from a recirculating chiller remote from the
cooling pad B150 and attached by a set of tubes (not shown).
[0195] The rigid component of a DEP can include features to
facilitate engagement with the arms of a retractor, such as
fenestrations, flanges, holes, hinges, posts, pivots, hooks, pads,
shocks, springs and features that specially match complimentary
features on the retractor.
[0196] The rigid component of a DEP can also include features to
facilitate engagement with the tissue. Such features can include
blades, spikes, barbs, or roughened sections, including features
that project through the drug-eluting portion of the DEP, to
prevent slipping and to facilitate engagement with specific tissue
components. FIGS. 48A and 48B show a DEP B155 used for a
thoracotomy. Sharp-edged blades B160, oriented vertically with
respect to the patient's skin and attached perpendicularly to the
rigid component B122, are manufactured such that they project
through the drug-eluting portion B148 to then slice or push through
soft tissues B162 overlaying rib B164 (i.e., those tissues lying
between the rib B164 and the exposed edge A44 of the incision A22)
to directly engage the rigid edge of the rib B164 such that the
intercostal nerve B166 of rib B164 is not touched (FIG. 48B).
[0197] Note that the rigid component of a DEP can include multiple
features for engagement of the retractor or a portion thereof.
These can be used to permit multiple placements of a retractor or
repositioning of a retractor or a part of a retractor.
Alternatively, the features of engagement can be used to engage
each blade of a multi-bladed retractor, such as an Ankeney
retractor, to assist in the distribution of forces along the
sternum.
[0198] FIGS. 49A and 49B show a DEP B170 with a rigid component
B122, B128, B144 (numbered here as B144) that is used to support
the two halves B102 of the sternum during a medial sternotomy or
other procedure requiring full or partial incision of the sternum.
FIG. 49A shows a cross-sectional view of the sternum and DEP B170;
FIG. 49B shows a top view (surgeon's view) of the sternum with the
assembled DEP B170 and sternal retractor B190. (Note that this is
similar to the DEP B100 shown in FIGS. 42 and 43, however, now a
rigid component B144 is part of the assembly. Note also that the
orientations and the mechanical properties of the segments in FIGS.
49A and 49B can be configured to create desirable deformations,
such as an "A"-shaped aperture during a sternotomy with the cranial
end of the incision being at the apex of the "A".) Two DEPs B170
are used, one supporting each of the two halves B102 of the
bisected sternum. Each DEP B170 has a rigid component B144 that
supports the edge B104 of each half B102 of the sternum along the
entire incision and edges B146 that wrap the cut edge B104 of the
sternum half B102. A drug-eluting hydrogel B148 delivers drug(s) to
the cut edge B104 of the sternum half B102. Additionally, each
rigid component B144 has a retractor blade engagement feature B172
to facilitate engagement with the arms B192 or retractor blades
B194 of sternal retractor B190 so permitting a more caudal
placement of the sternal retractor B190. This placement of rigid
component B144 and retractor blade engagement feature B172 largely
removes the thoracic retractor B190 from the surgical field, and
provides maximum opening at the caudal end of the sternum (creating
an "A"-shaped exposure), while also supporting the bisected sternum
along the entire length of the cut face B104 of each half B102 of
the sternum. (Other combinations of rigid components B144 and
engagement features B172 can provide alternative placements of
thoracic retractor B190 and/or DEP B170.) The retractor blade
engagement feature B172 is a reinforced section of the rigid
component B144 possessing an angled face to provide a surface that
is parallel to the blades B194 of sternal retractor B190;
alternatively, this section could be a hole into which is placed a
cylindrical post from the retractor arm B194 or any other
combination of retractor component/DEP feature to provide a
mechanically secure engagement between sternal retractor B190 and
rigid component B144 of the DEP B170. This combination of a rigid
component B144 along the entire length of the cut sternum half B102
plus a retractor blade engagement feature B172 to engage the
sternal retractor B190 prevents slipping of the sternal retractor
B190 against the angled sternum surface B104, provides mechanical
support of each sternum half B102, and reduces point loads and
other uneven distributions of force leading to stresses inside each
sternum half B102 that could lead to the damage of tissues in the
sternum or to fracture of the sternum half B102 during retraction.
The drug-eluting hydrogel B148 cushions the cut face B104 of the
sternum half B102, preventing further trauma of this tissue. The
drug-eluting hydrogel B148 can release sterile physiological saline
to keep the tissue hydrated, thrombin to reduce bleeding, a
cocktail of antibiotics to reduce the chance of infection, and/or
an opioid analgesic to reduce the local inflammation response and
to prophylactically treat pain or any other pharmacologically
advantageous compound or chemical. The drug-eluting hydrogel B148
can, optionally, be sufficiently soft that it easily deforms into
the cut surface of the sternum and blocks off cut blood vessels,
thereby acting as a physical dam to bleeding, in a fashion similar
to bone wax, but without leaving a residue after surgery, like bone
wax.
[0199] FIGS. 50A and 50B show an embodiment of a DEP B180 similar
to that shown in FIGS. 49A and 49B, but in this embodiment, the
drug-eluting portion B182 also wraps the tissues at the edge of the
incision. The drug-eluting portion B182 is a hydrogel that cushions
the cut edge B104 of the sternum half B102, and completely
underlies the rigid component B144, including edges B146 that wrap
the cut edge B104 of the sternum half B102. This arrangement
provides a cushioned, but firm, engagement with the sternum half
B102 that permits completely cradling the sternum half B102. FIG.
50B shows multiple cross-sections in an oblique view depicting how
a DEP B180 can then be used to support the full edge B104 of the
sternum half B102.
B.3 Drug-Eluting Pads (DEPs) and Devices Integral with Trocars and
Other Inserted Devices
[0200] Trocars A200 are surgical devices that are used to make
openings through a body wall A94 for endoscopic procedures (e.g.,
laparoscopy) (see FIG. 24). Once inserted, trocars A200 provide a
channel for the insertion of other surgical implements, such as a
borescope, forceps, or scissors. As with retractors described above
in Section B.2, this Section B.3 describes new devices and means
for treating tissues commencing on insertion of the trocar A200
and, optionally, spanning the duration of the surgical
procedure.
[0201] One example of a drug-eluting device B200 configured to
treat the tissues cut by a trocar A200 is shown in FIG. 51A and
FIG. 51B (FIG. 51B shows a cross-section of the device).
Drug-eluting device B200 has a double-walled, hollow sleeve B202
whose inner wall B204 closely fits the shaft of the trocar A200.
The double-walled sleeve B202 extends into the incision made by the
trocar A200. A drug reservoir B206 is attached to the double-walled
sleeve B202 such that the drug reservoir B206 sits just outside the
patient's tissues A45, for example against the skin A47. The
double-walled sleeve B202 has a hollow core permitting the flow of
fluid from the drug reservoir B206 into the double-walled sleeve
B202. On the tissue-facing side of the double-walled sleeve B202, a
tissue-facing wall B208 of the double-walled sleeve B202 is
perforated (perforations numbered as B210) such that drug-bearing
fluids can directly flow (arrows marked B212) from the inside of
the double-walled sleeve B202 out to the tissue A45. The
perforations B210 can be any suitable means of permitting direct
flow of fluid from inside double-walled sleeve B202 to the
surrounding tissue A45, including holes that are open or that are
covered with a fit to reduce fluid flow rates, or the perforations
B210 can be covered with a permeable membrane to permit slow flow
of fluid through the perforations B210. Alternatively, the
perforations B210 can be so small as to prevent fluid flow but
permit diffusion of drug from inside of the double-walled sleeve
B202 out to the tissue A45. Drug-bearing fluid B214, such as a
physiological saline, is placed into the drug reservoir B206 with a
hypodermic syringe, through a fill port B216 that is closed by a
self-sealing rubber membrane B218.
[0202] A drug can be placed into the drug reservoir B206 before the
trocar A200 is inserted. After insertion, a gas-filled head B220
over the drug-bearing fluid B214 is pressurized by a small
finger-actuated piston B222, thereby initiating the flow of the
drug-bearing fluid B214 through the perforations B210 and onto the
tissue A45. The piston B222 can be of the momentary action type
(return spring from the internal gas pressure), a locking type
which stays in once pushed, or an accumulating (valved) type that
builds increasing internal pressure with multiple finger pushes.
The seal between the drug reservoir B206 and the finger-actuated
piston B222 can be formed by an o-ring B224 or other appropriate
mechanism. The entire drug-eluting device B200 can be a single unit
that slips onto the trocar A200 before use. Alternatively, the
drug-eluting device B200 can be manufactured integrally with a
trocar A200.
[0203] FIG. 52 shows another drug-eluting device B230 in which a
thin layer of hydrogel material B232, impregnated with drug, coats
a thin-walled cylinder (not shown) that fits onto a trocar A200 as
a sleeve. Delivery of drug is by diffusion from the hydrogel
material B232 to the tissue A45 surrounding the trocar A200
incision. Again, this drug-eluting device B230 can slip onto a
trocar A200 before use, or, trocars A200 might be manufactured with
the drug-eluting device B230 in place.
[0204] FIGS. 53A and 53B (FIG. 53B shows a cross-section of the
device) show a drug-eluting device B240 that integrates the
drug-eluting device B200 shown in FIGS. 51A and 51B with the trocar
A200. In effect, the trocar A200 becomes a drug-eluting device
B240. A wall B242 of the trocar A200 that apposes the patient's
tissue A45 throughout the procedure possesses an array of
perforations B244 that connects via a double-walled portion of the
drug-eluting device B240 to a drug reservoir B206 filled with
drug-bearing fluid B214. The wall B242 has perforations B244 such
that drug-bearing fluid B214 can directly flow (arrows marked B212)
from the inside of the wall B242 out to the tissue A45. The
perforations B244 can be any suitable means of permitting direct
flow of fluid from inside wall B242 to the surrounding tissue A45,
including holes that are open or that are covered with a fit to
reduce fluid flow rates, or the perforations B244 can be covered
with a permeable membrane to permit slow flow of fluid through the
perforations B244. Alternatively, the perforations B244 can be so
small as to prevent fluid flow but permit diffusion of drug from
inside of the wall B242 out to the tissue A45. A drug-bearing fluid
B214, such as a physiological saline, is placed into the drug
reservoir B206 with a hypodermic syringe, through a fill port B216
that is closed by a self-sealing rubber membrane B218. Drug can be
placed into the drug reservoir B206 before drug-eluting device B240
is inserted. After insertion, a gas-filled head B220 in the drug
reservoir B206 is pressurized by a small finger-actuated piston
B222, thereby initiating the flow (arrows numbered B212) of the
drug-bearing fluid B214 through the perforations B244 and onto the
tissue A45.
[0205] It will be apparent to persons skilled in the art that many
aspects, configurations, and functions of cooling pads and
drug-eluting pads are complementary and can be combined. Functions
such as drug-elution, cooling, cushioning, protection of the
incision edge, and others can readily be combined into a single
embodiment.
C. Pressure Pads
C.1 Damage to Tissues Caused by Current Retractors
[0206] Many medical procedures require a surgeon to deform a
patient's bodily tissues. For example, to gain therapeutic access
to a patient's heart or lungs (see FIG. 54 85, color photo of a
Finochietto retractor in vivo), often a surgeon slices open the
intercostal musculature between two ribs and inserts a thoracic
retractor (i.e., a rib spreader, see FIG. 55). The blades C9100 of
a retractor C9000 forcefully pry the rib cage apart. As shown in
FIG. 55, the retractor C9000 is a steel jack usually sporting a
rack-and-pinion drive C9210, a hand crank C9220, a fixed retraction
element C9300, and a moveable retraction element C9200. Referring
now to both FIG. 55, and to FIG. 56 (which shows a view of the
surgical field and the position of the retractor blades C9100
therein), after insertion into an incision C9400 between ribs
C9500, the surgeon turns the hand crank C9220 that operates the
rack-and-pinion drive C9210 along a rack C9230 to separate
retractor blades C9100 and thereby create an opening (or aperture)
for surgical access. The steel retractor blades C9100 press
directly onto, and into, the muscle, nerves and other soft tissue
C9700 covering ribs C9500 on either side, and, drive ribs C9540 and
C9560 that border the incision C9400 into a next, adjacent set of
ribs C9520 and C9580, crushing also the soft tissues C9700 situated
between those bordering ribs (C9540 and C9560) and the adjacent
ribs (C9520 and C9580). However, the force C9600 required to
displace the patient's ribs C9500 is more than sufficient to damage
the patient's intervening soft tissues and even large enough to
fracture ribs and associated anatomy (2, 5, 9, 17, 25-27, 40, 47).
In fact, referring now to FIG. 57, the design of some retractors
C9000 and retractor blades C9100 is such that stresses on the soft
tissues C9700 are concentrated into a tiny total contact area C9120
by virtue of large fenestrations C9110 in the retractor blade
C9100. Other geometries of the retractor-tissue interface, such as
the very sharp corners C9130 of the retractor blades C9100 create
enormous stress concentrations there.
[0207] Thoracotomies and sternotomies require significant rib cage
deformations (50-150 mm) that, with current retractor blade
designs, generate local stresses and strains causing tissue trauma
and so, subsequently, pain. Thoracotomies, especially, induce
severe tissue trauma and are widely regarded as one of the most
painful surgical procedures. Attempts to ameliorate this pain in
the week or so following surgery have largely focused on analgesia
for the thoracotomy patient population (.about.0.5 million people
each year worldwide). However, for some of these patients,
thoracotomy-associated pain and morbidity can be long-lasting
(months to years), and sometimes the pain is permanent (1, 3, 4, 8,
11, 13-15, 18-24, 28-31, 33-39, 41-46, 48). Many patients may never
recover full function. A primary cause of the pain is thought to be
mechanically induced tissue trauma arising from rib spreading or
sternal spreading with a retractor, warranting an improvement in
the design of retractors and/or retractor blades.
[0208] The above examples are from thoracic surgery; however,
post-surgical pain is common for other procedures, frequently being
referred to as "port site pain" for laparoscopic procedures (or
other procedures using trocars, such as video-assisted
thoracoscopic surgery) or where retraction of soft tissue is used
for surgical access, such as with full-access abdominal surgery.
The inventions described here can be used whenever a biological
tissue must be displaced during a surgical or other medical
procedure.
[0209] Current retractors (e.g., Finochietto rib spreaders C9000,
Ankeney sternal spreaders, single-blade hand-held retractors, ring
retractors such as Bookwalter retractors, Mayo-Adson laminectomy
retractors, Weitlander retractors, and others) apply hard, rigid
materials (typically constructed of stainless steel) directly to
the biological tissue to be retracted. The transition at the
retractor-tissue interface is one of a material with a very high
modulus of stiffness (e.g., steel with Young's modulus .about.200
GPa or more) apposed against a material with a much lower modulus
of stiffness (e.g., bone .about.10 to 20 GPa; skin and muscle
<0.5 MPa (for severed, relaxed muscle) to <500 MPa (for fully
attached, fully active muscle). The materials on each side of this
interface, therefore, can deform in very different fashion from
each other, producing large interfacial stresses in the softer
material, for example in the patient's tissues, easily exceeding
the failure or yield stress.
[0210] Being in direct, firm contact with the patient's freshly
exposed tissues, retractor blades are, therefore, ideally suited
for measuring many aspects of the state of those tissues. However,
the current state of the art is such that no commercially available
retractor blades exploit this fact. The latest, most up-to-date
retractors are made of drop-forged steel, with a ground, brushed,
or polished surface, occasionally with a plastic overlay, and do
not possess any capabilities for detecting tissue state beyond a
simple, sudden mechanical report or pop when the patient's tendons
or bones snap under load. Given that these tissue trauma events are
already plainly audible to bystanders, current retractor blades
provide no added sensing benefit. There exists a need for retractor
blades capable of providing clinicians or automated mechanisms with
obtainable data or information on the (constantly changing) state
of the patient's tissues, that might not be obtainable any other
way, that could quantify and possibly prevent tissue trauma, and
thereby greatly improve patient outcomes.
[0211] Retractor blades merely pry open the patient's tissue to
widen an access hole. Beyond this (and the tissue trauma caused by
retractors, covered above), today's retractor blades do not
modulate the patient's tissues. Given that there are phenomena
where the physiological properties (say, the modulus) of living
tissue change in response to some input, there clearly exists a
need to exploit tissue modulation to improve patient outcomes.
C.1 Tissue Engaging Devices (TED) to Reduce Damage, Sense Tissue
State and Modulate Tissue State
[0212] In the first section below, forms of various components of
the present embodiment, including shapes, materials and material
arrangements, and some capabilities conferred by those are
described. In the second section, some of the functional
arrangements permitting tissue protection, sensing the state of the
tissues, and tissue property modulation are described. In the third
and final section, some embodiments that combine different elements
of the present embodiment are described.
C.1.1 Forms of the Components
[0213] One might think that the simplest way to prevent an
instrument from damaging a patient's tissues would be to just cover
a steel retractor blade with an isotropic, homogeneous soft rubber
pad. One surprising problem with this approach, though, is that in
order for the rubber to remain attached to a rigid steel retractor
blade, the pad should not distort at all along the interface where
it meets the blade, because if it does, the stress concentrations
between the steel blade and the soft rubber will be large,
promoting dislodgement or delamination leading to failure of the
instrument. Even the best adhesives cannot prevent delamination in
the face of the large stress concentrations arising from large
rubber strains against unyielding steel. To avoid detachment of a
pad from a steel blade under load, the pad must be stiff, roughly
within an order of magnitude or so of that of the steel's
.about.200 GPa, so the elastomer should possess a modulus of, at
the very least, 10 GPa, the better to reduce any strain that might
promote delamination. This value is still orders of magnitude
greater than the modulus of a typical patient's soft tissues.
Applying an object with a modulus of 10 GPa to the patient's
tissues would impose nearly as much stress as the steel, and likely
induce as much tissue trauma. It becomes clear that this problem
warrants a novel approach.
[0214] Embodiments disclosed herein permit the delivery of adequate
force from a surgical instrument's working surface (e.g., steel
retractor blades) to the patient's tissues without inducing tissue
trauma. These embodiments include some basic forms of a TED for
surgical instruments. For commercially available rib retractors, a
TED could take the form of a retrofit retractor blade pad (see for
instance, FIG. 73A far below). The TED could alternatively be an
entire retractor arm system that detachably mounts to a retractor
base. Still another form can be a complete thoracic retractor,
either a rib spreader or a one-hand abdominal retractor (e.g., a
Balfour or a Deaver hand-held retractor) retrofitted with TEDs. The
retractors might be manufactured at least partially from steel,
titanium, fiber-reinforced composite, or other stiff material.
Retractors could be designed from scratch to incorporate some of
the embodiments herein.
[0215] FIG. 58 shows an embodiment of a Tissue Engaging Device
(TED), which can take the form of a gradient pad C1000 able to
successfully incorporate or bond to rigid element C2000. The
gradient pad C1000 possesses a tissue face C1103 for apposing a
patient's soft tissues C9700 and an instrument face C1105 adapted
to engage, mount, associate with, or bond to a rigid element C2000.
The rigid element C2000 can be constructed out of medical grade,
hardened 400 series stainless steel, titanium, fiber-reinforced
polymer composite, or any other convenient material of high modulus
or sufficient rigidity to be able to apply enough force to displace
a patient's tissues during retraction. The gradient pad C1000 is
comprised of a pad body C1100 which can be made out of a hydrogel
or it can be made out of an elastomer, i.e., an elastomeric polymer
or "rubber" which might be a latex, silicone, polyurethane, vinyl
or any flexible, resilient material safe for medical use. The
gradient pad C1000's pad body C1100 can include more than one
modulus (hardness, stiffness) of elastomer in its makeup, and may
include at least one portion made out of a soft elastomer C1122,
and at least another portion made of a hard elastomer C1132. The
soft elastomer C1122 can form (or otherwise be positioned near, or
associated with) the tissue face C1103, while the hard elastomer
C1132 can form (or otherwise be positioned near or associated with)
the instrument face C1105. The modulus of the gradient pad C1000
thus can vary from portion to portion, in this example, there is a
modulus gradient C1120 running from the softest material at the
tissue face C1103 to the hardest material at the instrument face
C1105. The soft elastomer C1122 and the hard elastomer C1132 may be
separated from each other within the pad body C1100 by any
distance, leaving intervening material between them. The
intervening material may possess intermediate moduli.
[0216] The gradient pad C1000 can possess a modulus or stiffness
gradient C1120 that smoothly and gradually changes from a very high
value (for example by using a hard elastomer C1132) on the
instrument face C1105 to a very low value (by using a soft
elastomer C1122) on the tissue face C1103. The following variations
could be made from medical grade polymers from a variety of
commercially available sources, for one example, such as those
available from Apple Rubber of Lancaster, N.Y.
[0217] There are a number of ways to construct a gradient pad C1000
with a modulus gradient C1120. As shown in FIG. 59A, one could
create a gradient C1120 in a gradient pad C1000 by producing of a
series of bonded layers C1121 of increasingly softer or harder
elastomer (from a very soft elastomer C1122 (e.g., modulus of 0.1
to 0.5 MPa), to a slightly less soft elastomer C1124, to a slightly
harder elastomer C1126, to harder C1128, to even harder C1130, to
the hardest elastomer C1132 (e.g., modulus of 10 to 100 GPa), as
shown in the sequence where six layers produced separately on the
left side of FIG. 59A are bonded into a single large pad shown on
the right side of FIG. 59A).
[0218] FIG. 59B discloses an alternate method C1200 of creating a
pad C1210 possessing a stiffness gradient C1120, here by
continuously casting a series, blend, or mix of increasingly soft
elastomers on-the-fly during injection molding from a dispenser
C1240 fitted with nozzled streams of two distinct elastomers C1222
(which can be soft) and C1232 (which can be hard) into a pad mold
C1250. The process can begin (in FIG. 59B, left-hand side) by
dispensing a highly disproportionate ratio of mostly hard elastomer
C1232 and very little of soft elastomer C1222; this first portion
of the cast pad C1210 would thus form a high modulus instrument
face. The mix of the two (C1222 and C1232) can change over time
(depicted with multiple views C1282, C1284, C1286, C1288, C1290
proceeding to the right-hand side of FIG. 59B), with less and less
of hard rubber C1232 and more and more of the soft C1222 until the
pad mold C1240 is topped off with a ratio of mostly soft elastomer
C1222, appropriate for a tissue face.
[0219] FIG. 59C shows a foam gradient pad C1300 formed by
subjecting an elastomeric foam C1310 to a centrifuge during curing
to enhance gravity in order to drive a bubble density gradient
C1320 in the finished product. Larger bubbles C1322 float to the
"top" of the uncured elastomer foam to create a softer (lower
modulus) region appropriate for engaging the patient's soft tissues
C9700, while at the "bottom" of the foam gradient pad C1300 the
smallest (perhaps almost no) bubbles C1332 create a higher modulus
region appropriate for the instrument face, for bonding with a
rigid element C2000, which could be a steel retractor blade.
[0220] FIG. 59D shows yet another way of producing a gradient pad
C1400 by curing an elastomer pad C1410 in the presence of a heat
source C1450. By positioning heat source C1450 very close to a
freshly curing elastomer pad C1410 in an otherwise cool room, this
sets up a steep heat gradient. The stiffness of an elastomer is a
function of the rate at which it cures (i.e., to produce an
isotropic, homogenous rubber pad, it should be cured isothermally).
An elastomer pad C1410 close to a heat source C1450 would result in
a pad that is not isotropic: accelerated curing immediately
adjacent to the heat source C1450 produces a harder region C1432,
while slower curing more distant from the heat source C1450
produces a softer region C1422, forming a modulus gradient C1120
aligned with an axis C1460 oriented to the heat source C1450.
[0221] By manufacturing pads as shaped composites of elastomers,
fibers, foams and controlling the distribution of same within, one
can vary pad properties to suit. FIG. 59E shows a pad C1500
possessing a stiffness gradient C1120 formed by manufacturing a pad
of a soft elastomer C1122 with a gradual spatial distribution of
very short, transverse fibers C1520. The fibers C1520 are widely
spaced C1542 near the low-modulus C1522 tissue face and densely
packed, overlapping C1544 forming a higher modulus C1532 region
near a rigid element C2000 and promoting bonding thereon.
[0222] Gamma radiation is commonly used to induce changes in the
modulus of polymers. FIG. 59F shows a method whereby subjecting a
cured, bulk elastomer pad C1910 to a steep gamma radiation
gradient, say, with a moving lead shutter C1982 controlling the
emissions of a gamma ray source C1999 from a container C1980 can
induce a stiffness gradient C1120 in the pad C1910. The pad C1910
can be moved in a controlled manner C1988 on a radiolucent conveyor
belt C1986 past the source C1999 through a shielded box C1984.
[0223] FIG. 59G discloses an embodiment whereby shaping the pad's
cross-section using voids, columns, walls, or other structural
features produces regions of greater or lesser stiffness. A
stiffness gradient C1120 can be set up in an otherwise monolithic
elastomer pad C1100 by a series C1109 of transverse holes or
channels beginning with those of larger diameter C1101 near one
face and progressing to some of smaller diameter C1102 at the other
face. The larger holes on the soft tissue face act such that the
soft tissue face collapses or gives way gradually, while the
stiffer face can better bond with an instrument.
[0224] FIG. 59H shows another way of producing a particle gradient
pad C1800, which is done by mixing small, hard particulate matter
of a density different than the soft elastomer C1122 making up the
particle gradient pad C1800, for example by introducing glass
microballoons into an uncured elastomer resin, which is then cast
into a mold; the buoyant microballoons rise during curing to form a
smooth gradient of reinforcement, i.e., dense clouds of lightweight
microballoons create stiffer regions of the elastomeric particle
gradient pad C1800 near the top. This same method could be used
with a dense filler C1860 as well, but in reverse, as the dense
filler C1860 sinks, so in this case the stiffer region C1864 is
near the bottom, where the particles collect, as opposed to the
softer top region C1862, where there are fewest particles. The
rigid element C2000 could be positioned so as to bond with the
dense region.
[0225] In FIG. 60, showing a gradient pad C1801, the stiffer region
C1132 or instrument face can be designed to mount against, bond
with, or otherwise couple with a steel retractor blade C2072;
alternatively the stiffer portion C1132 or instrument face of the
pad C1801 could bond with a rigid polymer plate C1172 itself
possessing a modulus or modulus gradient between the steel and the
stiffest rubber, and itself mounting to the steel, C2072. The
softer tissue face C1103 of the gradient pad C1801 could be made of
a soft elastomer C1122, possessing a modulus the same or
substantially similar to the raw, soft tissue margins of an
incision through the intercostal muscles, for example of a
thoracotomy patient (e.g., possessing a modulus at least within 50%
of the modulus of the incised intercostal muscle). Some versions of
the TED pads incorporate non-steel elements of a retractor, such as
arms, arm supports or base, a drive, and a handle, and these
elements might not require any steel to be able to develop
sufficient force for retraction. For example, a retractor (such as
that shown in FIG. 55) incorporating many of the improvements
herein might be constructed out of fiber-reinforced plastics, like
fiberglass-reinforced epoxy resin or a carbon-carbon composite,
including rigid polymer retractor blades to which the TEDs
attach.
C.2.2 Pad Morphologies and Materials
[0226] FIG. 61 shows another way to arrange the geometry and
distribution of the pad material (soft elastomer C1122) to achieve
a gradient of modulus C1120. The modulus of the pad C1610, as
mentioned above, is a problematic issue if one is to manage the
transition from steel to flesh in just one step with a single
material. However, the shape of the pad can be designed to
accomplish modulus transition. For example, the softer tissue face
C1103 can be an open mesh or network C1630 of fine sheets or
elongate members (vertical posts C1644 and horizontal bars C1640)
forming a highly flexible surface or region of the pad, applying
orders of magnitude less force to the patient's tissues than would
a solid mass of soft elastomer C1122. This open architecture then
grades downwards to a more closed architecture (for example, the
vertical posts at the bottom would be much thicker, C1646),
possibly even transitioning to a solid block, to create a much
stiffer region at the instrument face C1105.
[0227] While one pad might be sufficient for protecting a patient's
soft tissues, providing more pads allows further advantages. For
example, a line of pads arranged along the margin of a thoracotomy
patient's incision can provide for several useful features:
controllable application of pressure along the margins of a
thoracotomy incision; regional measurements along the margin to
detect regions of excessively high or low application of pressure;
corrective control of applied pressure to even out irregularities
via differential actuation; and active manipulation of patterns of
pressure application. (See sections on sensing pads and active
pads, below.) Furthermore, multiple rows (or even multiple layers)
of pads can be used to accomplish the intent of the present
invention.
[0228] When using a material having a single modulus, the simplest
way for a retractor blade pad to develop chosen behaviors is to
change the shape of the pad (for examples, see FIGS. 59G, 61, and
C9A to 63C). Blocks of incompressible materials deform according to
the interaction of their material properties, the three-dimensional
distributions of those materials, and the contours of their three
dimensional surfaces. By forming channels, holes, voids,
corrugations, projections, deep textures, gaps, and other
reticulate surface forms in otherwise solid pads, one may control
how far an elastomeric pad deforms, and in which directions (and at
which rates), when loaded. Consider for example FIG. 62A,
indentations C1651 of greater or lesser depth and more or less
numerous on the sides of a pad C1650 can control how firmly and
what areas the pad C1650 loads the tissue it encounters. Providing
transverse channels that pass entirely through from one side to
another, placed close to the tissue-engaging surface, permit
changes in the strength of the forces applied to the tissue (FIG.
59G).
[0229] FIG. 62B and FIG. 62C show a pad C1010 possessing a
stiffness gradient C1120. The pad C1010 is constructed of stacked
and bonded layers (for example C1013 through C1014, not unlike FIG.
59A), some of which are solid and some of which have voids C1011
cut out leaving projections C1012. The resulting shape of one layer
C1172 differs from that of another layer C1173, such that building
up many layers of the same material but different shapes permits
one to create arbitrary, three dimensional spatial distributions of
stiffness, as desired.
[0230] Alternatively, in FIGS. 63A through 63C, a monolithic pad
C1600 can be formed of a single modulus of material (e.g., soft
elastomer C1122) and includes one or more shaped voids C1601 in the
pad, as well as incorporating the rigid element C2000. The void
C1601 or voids can, for example, define internal projections C1662
(domes, cones, walls), linear trenches C1660, or other regions of
extreme changes in thickness/thinness that can provide controlled,
complex changes in either the force outputs or the shape and
motions of the wall or other portions of the pad from an unloaded
(C1602) to a loaded (C1604) state (see FIG. 63B); in other words,
the pad can reconfigure its shape according to the tissue impinging
upon that pad. The molded shape of the pad C1600 can be designed so
that in an unloaded state C1602, certain inside regions (e.g.,
C1680) might exhibit contact between the extremities of internal
projections, while other inside regions (C1682) might initially
possess or exhibit wide spacing between the extremities of internal
projections.
[0231] As shown in FIG. 63B, once loaded (C1604), the thick and
thin regions of the wall of the pad C1600 move and reorient C1692
with respect to each other, according to the distribution of the
thick and thin portions of the wall, where thick portions can act
more-or-less as "stiff" segments and thin portions can act as
hinges or relief joints, and where internal extremities once
touched (C1680 in the unloaded state C1602), they now separate
(C1680 in the loaded state C1604), becoming wide, while other
regions where once internal extremities were not touching (C1682 in
the unloaded state C1602) now collapse into contact (C1682 in the
loaded state C1604). If there are no leaks, then internal pressure
can be used to mediate the shape changes between the loaded (C1604)
and unloaded (C1602) states. As shown in FIG. 63C, the loading
imposed by impinging tissues can be used to drive the wall motions
C1692 and pad shape changes that protect the patient's tissue. An
alternative to the thin/thick portions of the pad shown in FIGS.
63A to 63C is to use fibers in the wall of the pad, with the fibers
having controlled material properties and/or orientations in the
wall of the pad to result in folding of the pad. These examples
show a small range of the possible shapes capable of providing a
stiff surface for bonding to steel or other stiff material and a
soft surface for engaging a patient's tissue.
C.2.3 Composite Pads: Pad Material Plus Other Inclusions
[0232] A number of variations on the theme of a solid (e.g., an
elastomer) pad enable features useful for a TED. One may create
composites using different types of elastomers, or similar
elastomers of differing modulus. For example, pre-cured elastomer
components (such as spheres, ellipsoids, rods, rings, etc.) mixed
and cast into a different, uncured, elastomer create properties
neither elastomer possessed before. As one example shown in FIG.
64, a sparsely spaced forest C1805 of small, short parallel rods of
a somewhat hard elastomer C1132 are cast against, projecting from,
or near the rigid element C2000 (or instrument face, C1105) of an
otherwise very soft pad C1804 of elastomer C1122, with the rod's
axes aligned perpendicular to the instrument face C1103. Such a pad
C1804 will at first react to an impinging object (e.g., tissue
C9700) similarly to a simple soft pad, as shown in FIGS. 65A to
65C, but as the impingement (or force) increases, the rods C1805
come into play, providing more support later in the process than
would a simple soft pad. As the impingement by the tissue C9700
proceeds further, as shown in FIG. 65C, at some point the rods
C1805 begin to spread apart or otherwise deform at their tops,
changing the response of the pad C1804. The response of such a TED
to deformation can be changed by changing the rods: their spacing,
their orientation across the array, their taper, distribution of
rods of differing modulus, etc.
[0233] Another way to produce a solid, composite elastomer pad is
shown in FIG. 66. Pad C1806 is formed by casting blocks of an
elastomer of higher modulus C1807 into the volume of a pad of
otherwise very low modulus material (e.g., soft elastomer C1122).
The arrangement of the blocks C1807 will control the development of
shape as the pad impinges on the soft tissue of the patient. As one
example, suspending large blocks C1807 near the periphery of the
pad C1806 while leaving the middle of the pad C1806 filled with the
low modulus material (soft elastomer C1122) ensures that the sides
remain proud (raised) as the soft tissue of the patient impinges on
the region C1808 in the center of the pad's C1806 tissue face
C1103. Any number of mutually compatible elastomers are applicable
to this embodiment. Hydrogels, too, are suitable as pad materials,
and offer other advantages (for example, hydrogels containing drugs
can deliver these compounds directly to the wound site when in
contact with the margin of the incision).
C.2.4 Other Inclusions
[0234] As mentioned above, the modulus of solid inclusions affects
the behavior of the pad. Further, the low-force response of a very
soft retractor blade pad and the shape the pad takes upon loading
the patient's tissue can be relatively decoupled. For example, as
shown in FIG. 67A, if a stiff inclusion like a flat sheet or a
plate C2200 is included parallel to and close to the tissue surface
C1103 of a very soft pad C1809 (and a rigid element C2000, perhaps
a retractor blade, is attached to the instrument face C1105) then
the pad C1809 will at first give way under load while the surface
C1103 remains flat. On the other hand, as shown in FIG. 67B, if the
steel insert sheet C2300 is carefully pre-contoured, then this
might be useful, for example, where the tissue face C1803 of a very
soft pad C1810 must first conformally mate with the surface of an
impinging rib while still avoiding any loading of the intercostal
neurovascular bundle.
[0235] FIGS. 68A and 68B depict another useful form of a pad C1800
with solid inclusions (FIG. 68A shows a side view, and FIG. 68B
shows a front view). Soft pad C1800 possessing a series C2010 of
rods C2020 (made of steel or composed of another stiff material),
"floating" within the pad, here parallel to a rigid element C2000.
These rods C2020 could be designed at their ends C2240 to couple
well with (and so distribute the loads to) the soft elastomer C1122
there, while the middles C2220 of their length remain uncoupled to
the elastomer pad, their ends C2240 separated by spaces C2266
permitting the rods C2020 some leeway for moving and shifting
within the pad C1800. The coupling means might be expanded rod ends
C2242, fenestrations C2244, or fibrous anchors projecting from a
fiber-reinforced rod. These rods C2020 might have their middles
C2220 exposed to the oncoming margin of the incision. When a
properly prepared margin of the incision impinges on these pads
C1800, the soft elastomer C1122 meets (and matches the modulus of)
the muscle while the middles C2220 of the steel rods C2020 meet the
edges of the ribs, and so avoiding crushing the soft tissues.
[0236] FIG. 69 shows a sensor pad C3000. The sensor pad C3000
contains active inclusions that may be mechanical and or
electrical; objects permitting other functions can be included (as
inclusions cast within the elastomer, say). For instance, sensors
and actuators may be suspended within the soft body of a sensor pad
C3000 to allow, for example, tissue property modulation. Electronic
sensors for pressure C3040, acceleration C3021 and C3022,
acoustic-positional C3030, force C3010, and light (e.g., IR) may
also be suspended so as to be able to detect tissue state
parameters. Actuators might also be cast within a soft pad. Note
that one can include the rigid element C2000 itself as an inclusion
or insert, with fenestrations C2099 therein being one means for
facilitating bonding the rigid element C2000 (e.g., a retractor
blade) inside the sensor pad C3000.
[0237] Fluids can be incorporated into a TED. Fluids can provide a
medium for sensing (e.g. pressure sensing), a structural material
for resisting compression, a hydraulic medium for distributing a
load or transmitting forces or pressures to remote locations,
and/or a means for cooling or warming the tissue under or near
retractor blades. For example, a fluid that circulates from a
water-filled pad to a chiller and back can be used to cool a tissue
next to the pad. Conversely, including gas within an elastomer
makes the pad lighter, cheaper, and can provide thermal insulation.
Similarly, the acoustic properties of pads can be designed by
controlling the proportions and types of gas and/or fluid filled
bubbles. Elastomers can be obtained as foam, which is one way of
achieving gas inclusions (admixing gases and elastomers), but one
may also arrange large bubbles, or single chambers (as with a
balloon), or a gradient of air inclusions (see for instance FIGS.
59C, 59G, and 63C). Gases are compressible, whereas liquids are
incompressible, each affecting pad construction differently.
[0238] Referring to FIGS. 70A through 70D, an expandable TED C5900
can be constructed by mounting a hollow bladder C5901 on a rigid
element C2000 and filling the inside with a mixture (not shown) of
gases or liquids or both appropriate for creating wet foams,
expanding foams, or emulsified foams. Prior to use (FIG. 70A), the
TEDs C5900 may be constructed as thin, low-profile, and easy to
insert into the incision. The components of an expanding foam can
first be separated inside the bladder C5901 by walling them off
from one another, by emulsifying one component, or by arranging the
internal structure of the bladder C9501 into separate compartments,
that connect to drive internal mixing when the bladder C5901 is
squeezed or sheared. The foam components can be reacted to expand
when desired, for example once the bladders C5901 are sheared or
distorted upon insertion (FIG. 70B) of the retractor blades into
the incision C9400. The advantage of an expanding TED is that it
allows the pads C5901 to start out thin and small (i.e., easy to
insert into the incision C9400) and then react the foam components
and grow (FIG. 70C, expand to fit the shape of the margins of the
incision) when the rigid element C2000, here represented as
retractor blades, are fully inserted, and to the extent needed
(FIG. 70D) to adapt to and cushion the patient's soft tissues C9700
and or hard tissues C9500.
[0239] The fluid component of a TED pad can also convey other
benefits, for instance the fluid can facilitate cooling (if the
fluid is pre-chilled, or if it contains an endothermic reaction, or
if it is pumped through the pads, or from pad to pad, and/or
through a chiller), or the fluid can serve as the carrier for (or
it could itself be) a therapeutic pharmaceutical agent or bathe a
tissue to prevent tissue dehydration, should provisions be made for
the fluid's emergence into or onto the tissues.
[0240] Note also that fluids can circulate within the boundaries of
a single pad; the pad may contain internal volumes (e.g., channels,
conduits, chambers, membranous walls, valves and other forms of
fluid-accommodating passages). These passages can possess sections
that are straight, sinuous, branching, converging, dendritic and
otherwise tortuous. The passages can be arranged in layers, arrays,
and complex three dimensional patterns. Such features can permit
useful loading-rate-sensitive pad behaviors: for instance (A) where
multiple thin-walled, soft, interconnecting fluid-filled chambers
forming the soft tissue face soften initial impact with a tissue
but then give way over time to conform to the irregular surface of
the tissue as fluid flows and redistributes in the pad; or (B) If
cyclic loading is applied through the pads via an outside actuator,
the fluid channels may be fitted with narrowed sections (perhaps
with vessel-like valves) so that the fluid flows slowly and the pad
gives way easily for slow, low-frequency motions, but becomes
stiffer to higher frequency flows owing to the resistance to rapid
flows in the narrowed channels, permitting faithful delivery of
high-frequency vibrations for modulating tissue properties
(effectively this is an hydraulic low band-pass filter, or a
high-band-pass filter, depending on whether you want accommodation
or vibration transmittance); or (C) If an elastomer retractor blade
pad is properly designed it can possess a first set of fluid-filled
chambers in the middle of the soft tissue face, held full by the
tension in a second, thicker-walled set of chambers around the
sides of the pad that communicate with the first set, so that when
the surgeon initially presses the pad into and against the
patient's tissues at the margin of an incision, the centers of the
pads apply sufficient pressure to force their way into place, but
then as the pads remain in place over time and retraction
increases, the fluid is driven out of the first set of pads,
inflating the second set, which wrap around the upper and lower
edges of the margin of the incision to secure the pads in place. As
retraction eases off at the end of the operation, the second set of
chambers finally overcome their loading and disengage the tissue,
refilling the first set of chambers, which push off to help with
the removal of the retractor blades.
[0241] Including fibers within an elastomeric TED effectively
creates a compliant, elastomeric composite that can enhance the
TED's function (e.g., by more effectively surrounding and
supporting a patient's tissues), as the mechanical properties of
included fibers modify and so control the behaviors of the TED, the
better to match the mechanical properties of the patient's tissues.
FIGS. 71A, 71B, 71C and 71D show embodiments of compliant
elastomeric TEDs. For example, as shown in FIG. 71A (and as
depicted in FIG. 59E), incorporating straight, high tensile
strength (stiff, elastic) fibers C4005 oriented transversely within
the structure of a pad C4000 backed by a rigid element C2000 will
prevent stretching in the direction(s) parallel to those fibers
provided the fibers are well-bonded to the matrix (which can be a
soft elastomer C1122). If fibers C4010 are instead kinked when in
place (FIG. 71B) the pad C4000 can stretch under load. An
elastomeric pad C4000 will stretch out under load in the strained
portion C4020 of the pad C4000 until those stiff fibers C4010
become more nearly straight, halting the soft elastomer's C1122
stretching. As loading progresses, the effective stiffness of the
pad C4000 rises as a function of the decreasing curvature of the
fibers C4010. Beginning with more sinuous (i.e., longer) fibers
C4010 permits greater elastomer pad strains before the fibers C4010
straighten fully and stop the pad's C4000 deforming. Provided that
the fibers C4010 bond well with the matrix (for example, soft
elastomer C1122), elastic recoil of the entire structure (pad
C4000) is assured. Adding lower tensile strength (extensible,
elastic) fibers C4010 permits larger strains; changing the angles
of these fibers C4010 changes the distribution of (and axes for)
the elastic deformation.
[0242] Referring now to FIGS. 71C and 71D, one may add fibers C4012
to the pad C4000 that absorb energy by deforming in some
way--either by themselves plastically deforming, or as illustrated
by non-reversibly dislocating within the matrix itself. FIG. 71C
depicts an elastomeric composite pad C4000, filled with tiny
sinuous fibers C4012 throughout its volume and mounted on a rigid
element C2000. Upon retraction, this pad slowly loads the patient's
tissues, deforms permanently to accommodate the greatest strains
therein, dissipates the energy of doing so and on-the-fly
customizes the shape of pad C4000 to that portion of that patient's
tissues. Referring now to the sequence of images in FIG. 71D, we
see in the first of three images relatively inextensible fibers
that are sinuous (C4012) or straight (C4014) suspended within a
soft elastomer C1122 (depicted as a cross-hatched, gridlike
region). The fibers C4012, and C4014 may possess a poor bond with
respect to the soft elastomer C1122, and so those fibers each
create around themselves a close-fitting cavity (for example,
cavity C4018 around the straight fiber C4014, and cavity C4016
around the sinuous fiber C4012) of the same shape as the fiber.
Since the inextensible fibers C4012 and C4014 resist length
changes, should the elastomeric composite pad C4000 be strained
sufficiently (as seen in the second image of FIG. 71D), the fiber
cavities stretch along with the matrix (observe the stretched
grid), but the fibers C4012, C4014 do not: the cavities C4016 and
C4018 become longer than the fibers C4012, C4014 that created them,
i.e., the fibers C4012, C4014 dislocate within their respective
cavities, especially the fibers retreat from the ends of the
cavities. Gaps appear between each end of the strained cavities
C4016 and C4018 and each end of the particular fiber (here, either
C4012 or C4014) that created that cavity. Straight fibers C4014
resist strains immediately, creating a steep rise in the forces
applied to the patient's tissues, and they begin to slip and
dislocate immediately, redirecting and dissipating some of that
energy. Conversely, upon loading the elastic pad C4000, sinuous
fibers C4012 will first straighten, then take up the load, then
slip (dissipating energy); these sinuous fibers C4012 create a
slower rise in the stiffness under increased loading than will the
straight fibers C4014. Given the friction between the surface of
the fibers C4012 and C4014 and the interior edge of the cavities
formed in the soft elastomer C1122, and given that fibers C4012,
C4014 in general possess almost zero stiffness in compression or
bending, the chances are vanishingly small that the fibers C4012,
C4014 would reinsert themselves back into the gaps formed in the
ends of the cavities C4016, C4018 when the load is removed from the
pad C4000. The third image of FIG. 71D shows that the fibers C4012,
C4014 instead collapse and buckle (remaining trapped in the middle
of the length of the cavity) as the soft elastomer C1122 recoils
with decreasing load on the pad C4000. This means that, for those
sections of the pad C4000 that both experienced strain and
contained the short fibers C4012, C4014, the pad C4000 does not
fully recoil there, so the pad C4000 as a whole retains a memory of
its strain (as depicted in the third image of FIG. 71D as a
distorted, unloaded grid of the soft elastomer C1122). Given this,
then, short fibers C4012, C4014 cast into elastomer pad C4000
permit pad C4000 to cushion the patient's tissues, adaptively
conform to the patient's tissues and the loads during retraction,
and to dissipate the energy and stresses of retraction, thereby
reducing tissue trauma. The length of included fibers C4012, C4014
will also affect the behavior of the pad C4000, and the fiber
trajectory will control the direction of force transmission within
the material of the TED pad C4000. As stated above, fluids may also
be present; a lubricating fluid that permits the short fibers
C4012, C4014 to slowly reinsert themselves within their respective
cavities would add to the previous embodiment the ability to permit
repeated adapting to changes in the tissue loading pattern arising
from substantial repositioning of the retractor. This would permit
using such pads C4000 on patients possessing wide variations in
size, shape, required procedures and tissue properties.
[0243] Of course, mixing multiple types of fibers within a pad is
possible. This is specifically disclosed by us as desirable, as the
patient's own tissues are composed this way. One embodiment would
be, for example, arranging in a pad: (A) some low modulus, highly
resilient, elastic fibers that are largely pre-aligned with
expected retractor blade pad strains, (B) some high tensile
strength fibers that are substantially kinked, bent, coiled,
folded, or otherwise arranged to be not initially aligned with the
expected retractor blade pad strains, and (C) a very low modulus
elastomer. The foregoing design could be expected to behave
statically, quasi-statically and potentially dynamically much like
the tissue of the patient, thereby reducing or eliminating stress
concentrations between the pad and the patient's tissue.
[0244] Referring now to FIG. 72, another pad C1570, this time with
a gradient C1120, can be created using a single, very low-modulus,
jellylike material (for example, soft elastomer C1122), and a
single type of stiff fiber C1525, all associated with a rigid
element C2000 of a surgical instrument. For example, consider the
spatial arrangement of such fibers C1525. The soft tissue face
C1550 of such a pad C1570 possesses mostly the jellylike soft
elastomer C1122 and beneath that a very sparse population of long
fibers C1590 oriented substantially perpendicular (90.degree.) to
tissue face C1550 (i.e., parallel to an axis of initial loading
when the tissue face C1550 of the pad C1570 is compressed between a
rigid element C2000 and the patient's tissues C9700). On the other
hand, the instrument face C1552 of such a pad C1570 possesses a
dense population of transverse fibers C1598 oriented substantially
parallel to that face (i.e., perpendicular to the axis C1580 of
initial loading); the transverse fibers C1598 at or near that
instrument face C1552 could be arranged in plan view like a sheet
of woven cloth, a felt, or a matt pressed against the surface of a
rigid element C2000. In the region in between the two faces C1550,
C1552, the fiber angle (and fiber density) of the fibers C1525 can
change rapidly from fibers C1598 at nearly 0.degree. (and very
densely fiber-packed) at the instrument face C1552 to fibers C1596
aligned at 5-10.degree. (and less well packed) a little farther in
(i.e., farther from the instrument face C1552), to fibers C1594
aligned at 10-30.degree. (with decreasing fiber density) still
farther in, to fibers C1592 aligned at .about.45.degree. (even
fewer fibers) more-or-less one-third through the thickness of the
pad, gradually to 50-80.degree. (fibers thinning out) from that
region to the soft tissue face where the fibers C1590 possess an
angle substantially near 90.degree.. (These fiber angles are
provided only for this example; other distributions and
orientations of fibers would produce different pad mechanics. The
fiber angles provided here are expected to produce a stiffness
gradient C1120 and so pad behavior generally useful for preventing
tissue trauma.) When a plain elastomer pad (an isotropic,
homogenous mass), being of constant volume, is loaded in
compression between two faces, the pad tends to get thinner (along
the axis of initial loading) and wider (perpendicular to the axis
of initial loading). The fibrous pad C1570 in FIG. 72, however,
behaves differently. The soft tissue face, being mostly low-modulus
elastomer, gives way easily, applies only gentle direct pressure to
the patient's tissues, and gets wider, as permitted by the lack of
any transverse fibers in that region (containing fibers C1590 to
C1592) of the pad C1570. The region near the instrument face C1552,
though, being highly reinforced by many stiff, more-or-less
transverse fibers C1596 and C1598, cannot get wider because the
transverse fibers C1596, C1598 prevent it. Thus that region
containing transverse fibers C1596, C1598 near the instrument face
C1550 is nearly as stiff in the transverse direction as the rigid
element C2000, and so reduces strain there, thus reducing stress
concentrations that otherwise would dislodge the pad C1570 from
rigid element C2000. The fiber angle changes, from very high angled
fibers C1590 near the tissue face C1550, to high-angled fibers
C1592, to moderately angled fibers C1594, to low-angled fibers
C1596, to very low angled (transverse) fibers C1598, as distributed
between the two pad faces C1550, C1552, provide a stiffness
gradient appropriate to both matching the properties of flesh on
one face (the tissue face C1550) and steel, for example, on the
other (the instrument face C1552) thus both protecting the
patient's tissues while delivering the force from the rigid element
C2000 in a stable manner.
[0245] One might also combine the device shown in FIG. 72 with more
than one elastomer or fiber type permitting fine tailoring of pad
properties, for example for matching distinct tissue types, for
accommodating different procedures, or for creating pads C1570 with
properties that vary across the tissue face C1550 to permit
engaging multiple tissue types presented simultaneously. Note also
that the fibers C1525 need not be straight; curved fibers can
provide fiber angle spatial distributions roughly equivalent to
those described above.
C.3 Pad Functions--Protection, Sensing, and Modulation
[0246] Outlined above are ways in which a TED in pad form might
protect the patient's tissues. Consider other functionality that
can be delivered using the TEDs described above, such as sensing,
actuating, and modulating the tissue's mechanical properties. The
TED can sense a number of clinically relevant parameters during the
course of a surgery. The TED can provide, for example, measurements
of the force applied by each pad to the tissue. If the pads are
fluid-filled, then pressure (force per unit area) is easily
obtained for each pad. If the pads are designed for heat conduction
through their surfaces, then temperature of the tissue can be
measured. Many measurements may be combined simultaneously.
[0247] The parameter of interest (for example, force) might be
sensed by a load cell constructed within the TED. In this case, the
load cell outputs a signal readable by electronics. Similarly, the
TED might contain a piezo-active polymer that sends an electrical
signal corresponding to the rate of deformation of the piezo-active
polymer (or acceleration, or the rate of change of acceleration, or
the rate of change of force).
[0248] One embodiment of a TED can be constructed comprising a
substantially elastomeric, liquid-filled pad equipped with a
display. Referring to FIG. 73A, in the case of measuring pressure
(for example the pressure generated when a retractor displaces a
patient's tissues during a thoracotomy), one might construct a
retrofit retractor blade pad C4100 that fits on a rigid element
C2000 (for example, a steel retractor blade) of existing retractors
C9000. The retrofit retractor blade pad C4100 can be constructed
out of a compliant, resilient material such as a soft elastomer
C1122, and can possess a blade-accepting cavity C4120 molded to fit
a rigid element C2000 (like a retractor blade) including a
retractor blade tip C2500, a blade-accepting opening C4122 that
allows the rigid element C2000 access to the blade-accepting cavity
C4120 so that the rigid element C2000 can be inserted (motion
arrows C4199) into the retrofit retractor blade pad C4100.
[0249] The retrofit retractor blade pad C4100 may also be provided
with a closed, sealed internal volume C4200 (distinct from, and not
communicating with, blade-accepting cavity C4120). The sealed
internal volume C4200 communicates hydraulically with an externally
visible (but still sealed) conduit, or transparent pressure signal
display window C4210. The pressure signal display window C4210 can
possess a dead end (trapping a gas bubble there), the internal
chamber passing from the interior volume of the pad to the surface
(or near the surface) of the pad, and running parallel to the
surface of the pad. The form of this pressure signal display window
C4210 may be a long, thin cylinder, a portion of which is forms the
exterior surface of the retrofit retractor blade pad C4100. The
retrofit retractor blade pad C4100 may also be equipped with a
graduated (vernier) pressure scale C4250 that is spatially
associated with the pressure signal display window C4210 (for
example, positioned alongside). The graduated markings (vernier) of
the pressure scale C4250 can be located on the outside of the
retrofit retractor blade pad C4100, or they can be positioned on
the inside of the pressure signal display window C4210, or in any
visually accessible location. The pressure scale C4250 can be
printed onto or molded into any convenient surface of the retrofit
retractor blade pad C4100. The sealed internal volume C4200 can
further be provided with a liquid C4230 (for example, colored water
or some other contrast agent) partially filling the sealed internal
volume C4200, a gas C4230 (for example, nitrogen) filling the
remainder of the sealed internal volume C4200, and a meniscus C4240
between the gas C4220 and the liquid C4230.
[0250] Candidates for the liquid C4230 are practically
incompressible near ambient pressure, while candidates for the gas
C4220 are easily compressed. The position of the meniscus C4240
along the pressure scale C4250 is therefore a function of the
pressure inside the sealed internal volume C4200 that is inside of
the retrofit retractor blade pad C4100, so the meniscus C4240
serves as the demarcation (indicium) of the internal pressure of
the sealed internal volume C4200 of retrofit retractor blade pad
C4100 to the operator (for example, a surgeon). As a the retrofit
retractor blade pad C4100 forcefully impinges upon the patient's
tissues during retraction, the position of the meniscus C4240 moves
along (for example, up) the pressure scale C4250 to provide the
operator a quantitative indication of the forces being applied to
the patient's tissues by the retractor. The pressure scale C4250
may be calibrated to indicate pressure (for example in Pascals),
but it may also be calibrated to indicate force (in units of
Newtons, kilogram-force, or dynes), or displacement (in
millimeters). The markings forming the pressure scale C4250 may be
letters, numbers, tick marks, shapes, colors or a combination of
these, and they may be equally spaced, logarithmically spaced, or
placed in some other convenient pattern alongside the pressure
signal display window C4210.
[0251] The retrofit retractor blade pad C4100 can also be designed
to avoid impingement on the retractor arm C2600, and may include a
provision for anchoring itself more securely to the rigid element
C2000 by the blade-accepting cavity C4120 being molded to fit a
hole pattern C2700 (for example, resembling the hole pattern on a
retractor blade) in the rigid element C2000. This embodiment
provides an inexpensive upgrade of immediate benefit to hospitals
worldwide that use conventional retractors. Measurement of pressure
can also be by one of many commercially available pressure sensors
that is placed in communication with the fluid C4230 in the
retrofit retractor blade pad C4100. Such commercially available
pressure sensors produce an electrical signal as a function of
applied pressure. The features above may be combined in a number of
convenient arrangements. For example, a plurality of such pads can
be arranged so that the clinician gains a sense of how the forces
are changing as the retraction proceeds, just by watching the
indicator tubes. The disclosed retrofit retractor blade pad C4100
thus permits surgeons to reduce tissue trauma by retrofitting
retractors currently in hospital inventories.
[0252] Some thoracic retractors employ removable retractor blades,
for example by providing locking pins on removable the retractor
blade and locking slots (holes) in the retractor's arms. In FIG.
73B shows an embodiment to take advantage of this opportunity, a
removable retractor blade with integral display pad C4900 designed
especially for those instruments. The removable retractor blade
with integral display pad C4900 can be molded from a compliant,
resilient, soft elastomer C1122, and can be provided with a
retractor blade insert C2800 (which can be made of steel,
fiber-reinforced polymer, or another convenient stiff material)
that is bonded with soft elastomer C1122. The removable retractor
blade with integral display pad C4900 is also provided with
retractor blade mounting pins C2810. The retractor blade mounting
pins C2810 can be designed to fit the locking slots in the arms of
commercially available thoracic retractors, thus enabling hospitals
to increase the functionality of their current instrument
inventories. As with the retrofit retractor blade pad C4100 (above,
FIG. 73A), the removable retractor blade with integral display pad
C4900 can also be provided with a sealed internal volume C4200 that
communicates with a pressure signal display window C4210, a
pressure scale C4250 associated with the pressure signal display
window C4210, a liquid C4230 and a gas C4220 to fill the sealed
internal volume C4200, a meniscus C4240 (forming the boundary
between the liquid C4230 and the gas C4220) visible within the
pressure signal display window C4210 and readable along the
pressure scale C4250, thus indicating to a surgeon retracting the
patients tissues the magnitude of the force being applied to those
tissues along the margin of the incision, thus enabling
amelioration of the retraction force, and so reducing tissue
trauma.
[0253] The signals noted above might be presented to the clinician
(e.g., a surgeon or an anesthesiologist) as visual or audio output
for consideration as part of the available information on the state
of the patient. The signals could also be routed to the input of a
control program directing the behaviors of actuators, for example
pressure actuated pads, that thus react to the signals in
advantageous fashion, for example to take corrective actions to
prevent application of too much force.
[0254] To reduce tissue trauma, patterns of activation of the TED
can provide useful effects. For example, the pads in a TED can
actively deform, as an actuator, for example to apply cyclic
loading to modulate tissue properties. Cyclically changing the
internal pressure of a fluid-filled pad can cause the pad to swell
repeatedly and thus push more strongly (or weakly) against the
tissue. Alternatively, as shown in FIG. 74A and C22B (FIG. 74A
shows an oblique view and FIG. 74B shows a cross-section view),
electromagnetic excitation (via power supplied via wires C3007 to
electric coils C3002 embedded near the instrument face C1105 of the
pad C1001) of magnetic mass C3001 suspended within a pad C1001 made
of a soft, highly resilient (i.e., low loss modulus) elastomer
C1172 can cyclically load the tissues C9500 and C9700 of the
patient for work softening to reduce the force required to displace
those tissues. To be free to move, the magnetic mass C3001 can be
suspended within the pad C1001, surrounded by the low loss modulus
elastomer C1172, leaving a gap C3009 between the magnetic mass
C3001 and the electric coils C3002. The elastomer C1172 can be
resilient (i.e., possess a low damping coefficient, say of 20% to
5% or less) so that the magnetic mass C3001 supported by the pad
C1001 can resonate, transferring some of the energy to the tissues
of the patient. The material of the retractor, retractor arm C2099,
or the rigid element C2000, can be a fiber-reinforced polymer
composite, thus also rendering the retractor nonmagnetic
(magnetically transparent). Cyclic loading by the pad can also be
performed by cycling the pressure within a fluid-filled pad.
[0255] In another example of active actuation of a TED, multiple,
active pressure pads enable controllable, addressable application
of pressure. This could be used, for example, to detect regions of
excessively high or low application of pressure and then to perform
corrective control of applied pressures to even out irregularities
through differential actuation; and active manipulation of pressure
actuation patterns. FIG. 75 shows a TED C5000 where hollow
compliant pads C5100 filled with fluid C5200 communicate between
each other for adjusting load via openings C2910 a plenum C2900
formed by a hollow steel element of the retractor or retractor
blade (rigid element C2000). If the TED is made of at least two of
these hollow compliant pads C5100 filled with an internal fluid
C5200, then communication between hollow compliant pads C5100
confers benefits. If in one example, the pads are fluid-filled and
communicate via this manifold system (including the plenum C2900
and openings C2910 permitting flow C5210 into the plenum from the
pads C5100 and flow C5220 from the plenum back into the pads
C5100), then an excessive loading on one pad C5100 during
retraction C5230 will automatically be transmitted hydraulically to
the other pads C5100, resulting in an even application of pressure
to the patient's tissues C9700 and C9500 by all of the pads C5100
in concert, thus reducing stress concentrations and so reducing
patient tissue trauma.
[0256] FIG. 76 shows another embodiment, a TED C5300 composed of
variable pressure pads C5100 (filled with fluid C5200) that do not
interconnect directly by pressure tubes, but are each connected by
an orifice C5210 in a rigid element C2000 to individually
addressable hydraulic actuators C5320 (that are themselves each
connected by wires C5332 to an actuator control C5330) and each pad
C5100 is further fitted with a pressure sensor C5310 electronically
connected by wires C5342 to a sensor input C5340; the actuator
control C5330 and sensor input C5340 are connected to each other by
a control circuit C5350. The control circuitry C5350 and associated
software can provide for the comparisons of pressures between
individual pads C5100, and so enables modulation of the applied
pressure per pad, for the whole array, and for creating whatever
spatial, temporal, or spatiotemporal patterns of applied pressure
are desired.
[0257] One activation pattern of a series of fluid-filled pads
(such as TED C5300 shown in FIG. 76) can be sequential (or
"metachronal") waves of applied pressure, where peaks of pressure
follow troughs of pressure across a linear array of variable
pressure pads C5100). This pattern, properly applied, can develop
traction against the margin of the incision and in the direction of
travel of the waves. This action can provide for active control of
the position of the array (and so retraction forces), including
corrective travel to restore the original position of the variable
pressure pads C5100 in the case of slippage. Combined with sensing
the pattern of pressure distribution across the array, this feature
allows for the continuous maintenance of the most clinically
appropriate application of forces throughout a surgery despite
changes in loading, posture, etc.
[0258] TED component arrays also provide the basis for maintaining
perfusion of the tissues retracted by, say, a rib spreader. When
current rib spreaders (e.g. C9000 in FIG. 54) retract ribs C9500,
the soft tissue C9700 between the ribs and the steel retractor
blades C9100 is compressed, so much so that perfusion (e.g., blood
flow supplying oxygen, nutrients, waste removal) is blocked. An
operation like a thoracotomy can last 2-8 hours, or more, so that
the cells in the retracted soft tissues die (either from lack of
perfusion, or from reperfusion injury, or the tissues are simply
crushed). Given the need for continuous surgical access, relieving
retraction to allow periodic perfusion is often not possible. Our
invention can avoid loss of perfusion, perhaps entirely, thereby
eliminating soft tissue trauma from this cause. For example, a TED
that takes the form of a hydraulically actuated array of individual
pads C5100 (as shown in FIG. 76) or as an array of elastically
linked pads C5110 (as shown in FIG. 77). Such an array C5110 can be
designed with more total contact area than that required to apply
sufficient force to hold the tissues during retraction. Given this,
one may use fewer than the full number of pads, or less than the
complete area of contact of large multi-compartment pad C5110 to
support retraction. Provided with this contact area surplus, proper
cycling of the volumes of fluid C5200 (and so the internal
pressures of compartments C5510) individual control of pad
actuation can provide a substantially continuous and sufficient
force for retraction while simultaneously relieving pressure on
selected areas of tissue, thus permitting regular perfusion of
tissues under the retraction elements. FIGS. 78A and 78B show two
of many possible pad C5100, C5110 actuation sequences that deliver
full retraction force while simultaneously frequent perfusion
providing (i.e., by relieving pressure) to those same retracted
tissues. The sequence C5334 shown in FIG. 78A alternately
pushes-and-relaxes on every other hydraulically actuated pad C5100
(numbered here 1, 2, 3, 4, 5 and 6) while delivering a constant
force to the patient's tissues. The individual hydraulic pad
actuation control pattern simply alternates from fully inflated to
fully deflated each pad C5100. This sequence pushes most of the
time with half the total area of the array of pads C5100. In the
first phase, shown in the top row, every odd-numbered pad C5100 is
inflating and so pushes against the tissue while every
even-numbered pad C5100 deflates, relieving pressure on the
retracted (or retracting) tissues underlying those even numbered
pads C5100. In the second row showing the second phase, we can
observe that all of the pads C5100 are in mid-travel, hydraulically
inflated to about the same (intermediate) dimensions, albeit at a
pressure less than that required to fully extend the pads C5100,
and more than that lower pressure permitting elastic recoil of the
pad C5100 to return them each to their original, deflated, smaller
size (as they would be before inserting the array of pads C5100
into the thoracotomy incision for retraction). The third row shows
the third phase, a similar situation to the first row, save that
the sequence has progressed further so that all of the odd-numbered
pads C5100 are now deflated while the even-numbered pads C5100 are
inflated. The fourth phase of the sequence visually matches the
second phase (shown in the second row), with all pads C5100
inflated to roughly the same extent, save that the direction of
inflation is reversed from the second phase. FIG. 78B shows an
alternate sequence C5336, briefly described as allowing every third
hydraulic pad C5100 to deflate whilst maintaining the hydraulically
inflated state of the two pads C5100 between, and cycling the
pattern ahead by one pad C5100 at a time. The individual hydraulic
pad C5100 actuation control pattern in this instance can be written
as "inflate for 2/3 of a cycle, then deflate for 1/3 of the cycle."
One difference here is that this sequence pushes with an area of
2/3 the total area of the array of pads C5100 at once, and so for
example permits the surgical instrument designer to reduce the
total number of pads C5100 (and so the total area of the array).
Note that one advantage of providing an array of individually
addressable hydraulic retraction pads C5100 is that any desired
arbitrary pattern of actuation can be created via software
modifications to suit any conceivable procedure in which the device
C5300 or other array of pads C5100 might be used. Every section of
soft tissue under the influence of the retractor can thus be
perfused often enough to maintain a healthy tissue.
C.4 Examples of TEDS for Specific Applications
[0259] Referring now to FIGS. 79A to 83, FIG. 79A shows a side view
and FIG. 79B shows an oblique view of a TED, here a
counter-conforming anisotropic pad C5400 that can be applied to the
margins of a thoracotomy incision. The counter-conforming
anisotropic pad C5400 is capable of displacing the ribs C9500 of a
patient while preserving the neurovascular bundle (part of the soft
tissues C9700) by using the compression of one part of the
counter-conforming anisotropic pad C5400 to drive expansion of
another part of counter-conforming anisotropic pad C5400. Disclosed
here is a counter-conforming anisotropic pad C5400 that can be in
the form of a single retractor blade pad that adaptively
reconfigures its shape to evenly distribute the required loads
applied to the hard and soft tissues at the margin of the incision.
Counter-conforming anisotropic pad 5400 can comprise a
multi-columnar (i.e., array of columns, C5405) structure making up
a portion of the interior of counter-conforming anisotropic pad
C5400 (which may be formed of a soft elastomer C1122) where each
column C5410 possesses access to a hydraulic plenum C2900, a fluid
volume C5200, a plenum communication component, such as an orifice
C5210, and a column cohesion means C5420. FIGS. 80A, 80B and 80C
show three instances of a counter-conforming anisotropic pad C5400
in action. FIG. 80A shows the counter-conforming anisotropic pad
C5400 just before tissue impinges upon the embodiment. FIG. 80B
shows what happens when tissue impinges on a portion of the
counter-conforming anisotropic pad C5400, showing that compressed
columns C5411 drive fluid into other columns C5412 which rise to
meet the tissue that has not yet impinged on the counter-conforming
anisotropic pad C5400, thus evening out the load before full force
develops, thus reducing stress concentrations in the patient's
tissue, thus reducing tissue trauma. FIG. 80C shows that this
process works across the whole of the counter-conforming
anisotropic pad C5400 to accommodate tissues impinging at angles,
again evening out the loads.
[0260] FIGS. 81 through 83 show alternate embodiments of single
components and elements that fit inside of larger monolithic
elastomeric bladders. These FIGS. 81 through 83 show the walls
C5415 of columns C5405, with walls C5415 of the column C5405 having
corrugated, bellows-like walls C5416 (FIG. 81), twisted ribs or
wrinkles C5418 (FIG. 82), or walls C5415 helically wrapped by
fibers C5416 (FIG. 83). Such wall constructions permit column
length changes in response to loads. The wall C5415 may be integral
to the bulk material (soft elastomer C1122) of the pad C5400, or
the wall C5415 might be a separate membrane from that of the
exterior wall C5499 of the larger monolithic elastomeric bladder,
alternatively, the wall C5415 may be comprised of distinct
materials (for example, it may be reinforced with fibers, such as
the helical fibers C5416 depicted as forming the wall C5415 of the
column in FIG. 83). The multiple columns C5410 within each single
pad C5400 are fluid-filled (as with a gas or a liquid C5200) and
communicate via ports C5210 to a single plenum C2900 to which other
columns also connect. As shown in FIG. 80A through 80C, for
example, when some of the columns C5411 in a single pad compress
under the load of retraction against tissues, those impacted
columns drive their internal fluid C5200 out of their individual
ports C5210 into the plenum C2900 and in through the ports C5210 of
other columns C5412 which are not compressed. This influx of fluid
pressurizes columns C5412, which then extend forwards (or upwards,
as appropriate for the drawing) to meet the oncoming tissue. To
extend like this, the walls C5415 of the columns C5410 might be
constructed as bellows C5416 (FIG. 81), or the walls C5415 could be
built to permit length changes C5422 (FIG. 82) by employing helical
creases or wrinkles C5418, so as to be able to wrinkle and
un-wrinkle by twisting C5424 one way as they rise C5428 (lengthen)
and twisting C5424 the other way as they fall C5426 (shorten) in
response to changes in internal volume (or pressure). So, if a
column's wrinkling and twisting counterclockwise was associated
with its getting shorter and a decrease in internal volume, then
increasing the internal pressure (or volume) drives un-wrinkling,
un-twisting, and so lengthening. If a wrinkled column was
compressed by tissue, then its internal volume would decrease under
the load, the twisting and wrinkling would increase, and the rise
in pressure (given the imposed decrease in volume) would drive the
fluid out of that column and into other, less loaded columns.
[0261] Alternatively, the columns C5410 embedded in the elastomer
matrix (soft elastomer C1122) could be helically fiberwound with
high tensile strength cordage or fibers C5416 in the walls C5415
(FIG. 83), which arrangement permits length changes in response to
changes in internal volume (or pressure). If the helical fiber
angle C5230 (pitch angle with respect to the long axis of the
column) was larger than 54.7 degrees (e.g., from 60 to 70 degrees)
when the column was unstrained, then increasing the internal
pressure or volume of such a column would drive the fiber angle
C5230 down to .about.54.7 degrees, which drives active
self-lengthening of the column (and the column diameter decreases).
If the fiber angle C5230 were instead smaller than 54.7 degrees
(e.g., 20 to 30 degrees), then increasing the internal pressure or
volume of the column drives the fiber angle C5230 up to .about.54.7
degrees and the column actively, forcefully shortens (and the
column diameter increases). Motions like these can be individually
tuned per column according to the needs of the region of the pad
C5400. Also, the columns C5410 can be omitted from the region where
the TED C5400 contacts the neurovascular bundle (or other softer
tissue) to reduce pressure applied to this sensitive tissue;
alternatively, this region of the TED C5400 can have columns C5410
that are modified such that they extend to a lesser degree when
responding to plenum C2900 pressure (by changing the shape of the
bellows C5416 there, by reducing the initial pitch angle C5230 of
the twisted wrinkling C5418, or by beginning with a lower pitch
helical fiber angle C5230). Other configurations of TEDs disclosed
above can be used in thoracotomy or in other procedures, such as in
a sternotomy in which stiffer portions of the TEDS C5400 push
against the harder compact bone on the outside of the sternum and
push only lightly, or not at all, on the fragile trabecular bone
exposed at the surface of the incision of the bisected sternum.
[0262] Given the above useful design space for the TED and given
the fact that the rigid steel blades C9100 of current retractors
C9000 crush the soft tissues against the ribs and block perfusion
during thoracotomy, there is a need for a retractor blade pad that
reduces or eliminates stress concentrations in soft tissue. This
can be accomplished as shown in FIG. 84 whereby multiple gradient
pads C1000 are attached to the rigid elements C2000 of a surgical
instrument, say, a new retractor or a retrofit set of retractor
blades C9100 for a prior art retractor C9000. This embodiment, if
rendered in a retractor blade TED C5500, could take the form of
smoothly varying elastomeric (rubber) gradient pads C1000 that
start with a very high modulus hard elastomer C1132 on one side
(the instrument face C1105) and transition to a very low modulus,
soft elastomer C1122 on another (soft tissue face C1103) (FIG.
84).
[0263] FIGS. 85A through 85F disclose another TED C7000 that is a
variation on the devices depicted in FIGS. 75 and 77. TED C7000 has
both pressure sensing and traction control. TED C7000 addresses
another shortcoming of currently available retractors C9000: in
order to prevent the retractor blades' C9100 slipping or sliding
along the raw, exposed margin of an incision C9400, some prior art
blades C9100 sport spikes that project into the flesh, as an
anchor, or prior art blades C9100 possess fenestrations C9110 to
(A) actually reduce the area of the steel pressed into the muscle,
increasing the stress there, and (B) increase the edge length, to
increase the bite of the blade C9100 (as shown in FIG. 57). These
fenestrations C9110 (and the outside perimeter of the blades C9100,
as well) are made with unrelieved, sharp edges that bite into the
tissue to help anchor the retractor blades C9100; thus the
designers expect tissue to bulge (i.e., herniate) through the
fenestrations C9110 to ensure that the retractor C9000 does not
slip when the surgeon bears down to pry open the patient's rib
cage. The "spikes" and "fenestrations" solution is an
unsatisfactory answer to the problems inherent in using steel
retractor blades C9100, given that the body wall damage is believed
by many clinicians to be the greatest source of patients' pain.
Given that some embodiments of our invention includes the use of
low modulus elastomers (e.g., soft elastomer C1122 in FIGS. 59A and
59B) and multiple actuators (e.g., C5110 in FIG. 77), one can
better secure the purchase of the retractor on tissues by cycling
the actuation of the several pads C5100, C5100', C5100'', C5100'''
to develop laterally stabilizing forces while simultaneously
protecting the raw margin of the incision. TED C7000, shown in
FIGS. 85A-85F, possesses a row of elastomeric pads C5100 each
connected to its own individually addressable hydraulic actuator
C5320 (not shown). The hydraulic actuators C5320 are controlled by
a central controller C5350 (not shown) that cycles the hydraulic
actuators C5320 in patterns (which may take the form of metachronal
waves) that creates a rolling motion C7010 of the combined surface
of the row of pads C5100. A single, continuous layer of fabric
C1104 is attached to the tissue surface C1103 of the pads C5100 to
convey lateral forces to the neighboring pads C5100 and to the
tissue C9700. As shown in the sequence in FIGS. 85A through 85F,
there is a sequential inflation of pads such that pads C5100 are
un-inflated, pad C5100' is inflating, pad C5100'' is maximally
inflated, and pad C5100''' is deflating. The point of greatest
projection into the tissue (marked "X") is formed by fully inflated
pad C5100'', with the pads on either side of pad C5100' inflating
on the forward traveling side (pad C5100') and deflating on the
rearward traveling side (pad C5100'''). The fabric C1104 makes
contact at point X, rolls rearward, and releases, under the
sequential inflation/deflation of pads C5100', C5100'', C5100'''
and so acts there like the limb of a rotating wheel, developing
traction in a direction parallel to the long axis of the row of
pads C5100 and opposite the direction of travel C7020, as depicted
in views at successive times presented in FIGS. 85A through 85F.
Thus, activation of the hydraulic actuators C5320 of pads C5100
generates traction along the surface of the tissue C9700 that can
be used to prevent slipping of the TED C7000 or even to move TED
C7000 along the surface of the tissue, for example to adjust the
position in a incision of TED C7000.
[0264] One may change the pressure actuation pattern of TED C7000
to generate forces in either direction (FIG. 86A and FIG. 86B), or
to create multiple points of traction (FIG. 86C), or to develop
forces in two directions at once (FIG. 86D). These patterns can be
generated by the appropriate control software. The software might
further parse the outputs of sensors to create traction and active
transport of the retractor blades across the landscape of an
incision to correct for slippage, swelling, movement, changes in
the conformation of the patient, or strategic redeployments of the
surgical instrumentation by the surgeons.
[0265] Given the design space for TEDs, and given the fact that
commercially available retractors are mute when it comes to sensing
tissue state, and given that clinicians welcome timely information
that improves their situational awareness and so improves patient
outcome, there is a need for a retractor that can rapidly and
simply provide the surgeon with a clear sense of the condition of
the tissues in the region of the incision throughout the surgery.
FIG. 87 discloses a parameter mapping device C8000 that provides
information about at least one relevant parameter of tissue
condition--for example, pressure inside the pads, indicating the
tissue pressure underlying the pads (i.e., the force applied by the
pads, divided by their area), is used as an example here, but other
parameters can be measured, such as tissue oxygenation. Parameter
mapping device C8000 possesses a TED comprised of at least two rows
of sensor pads C5100, at least one of which is associated with each
of two retractor blades C8004 attached to two retractor arms C8006,
where each of the sensor pads C5100 senses at least one parameter
of interest and produces at least one signal, for example a
magnitude C5102 (as indicated by the value on each pad). The
parameter mapping device C8000 further comprises a plurality of
signal pathways (not shown), at least one signal coordinator or
comparator (not shown), at least one pad controller (not shown),
hydraulic actuators (not shown), (all of which might be
accomplished by a laptop computer C8010), and, for each sensor pad
C5100, actuator control software, imaging software, and at least
one display C8010 (which may be the screen of the laptop computer
C8010). As shown in FIG. 87, the parameter mapping device C8000
(here depicted as a form of thoracic retractor) is operated by
inserting the retractor blades C8004 into the fresh incision C9400.
Upon widening the incision C9400 with the parameter mapping device
C8000, the TEDs measure at least one parameter of interest with
sensors inside the sensor pads C5100 and then transmit the
resulting signal(s) to the signal coordinator (which may be a
software program operating on the laptop computer C8010). The
signal coordinator then processes the signals for the imaging
software (the signal coordinator might also be a part of the
imaging software, which may be on the laptop computer C8010) and
sends information to at least one display C8020. The display shown
in FIG. 87 reports pressure both as a numeric value along the
margin of the incision (numbers C8112 on the display C8020
correspond to magnitudes C5102 reported by the sensor pads C5100)
and as a visual map of signal intensity, with regions of higher
pressure being indicated by color, brightness, or distortions in a
grid (as shown in FIG. 87). The display C8010 may be in the form of
an LCD screen, or it may take the form of color-coded LEDs directly
associated with each sensor pad C5100, or it may take the form of
an audio output, or at least one vernier scale. Alternatively, a
color-coded array can be used, with each retractor element
indicating the magnitude of say, the pressure (or stress in the
tissue) applied to that portion of the margin of the incision. In
this case, green might indicate that the stress is an "appropriate
applied stress," that is, sufficient or adequate to displace the
tissues without damage; yellow could caution that the applied
stress is going too high; and red could indicate that damage is
imminent or extremely likely. Any number of indicia could be
arranged that conveyed the state of the various regions of the
margin of the incision. Also, the determination of "appropriate
applied stress" can be made, for example, with reference to known
values for maximum sustainable stress for the tissue types normally
encountered along the margins of the incision, or, it might be
assessed directly, by sensing some relevant parameter about the
state of the tissue. Another way to determine appropriate applied
stress is by measuring the change in the magnitude of the applied
stress from the initial, "zero" position (or start time, or both)
of that retraction for that patient to the value(s) observed later
on for the same patient as retraction proceeds. Still another way
to determine the appropriate applied stress might be to compare the
magnitude of the pressure observed under one retractor element to
those for adjacent ones. One can, for instance, decide that a high
enough stress differential between two adjacent retractor elements
is problematic as that might indicate large stress gradients in the
tissue. The resolution of the display need not be high. The display
C8020 allows the surgeon to see at a glance a map of the tissue
conditions during retraction and so can modify actions
accordingly.
[0266] Given the design space for a TED, and given the fact that
current retractors cause damage due to forcefully breaking bones,
ligaments, tendons, and tearing muscle, surgical practice can be
improved by active modulation of the patient's tissues during the
course of retraction in order to reduce the force required for
retraction. We disclose an embodiment for a rib spreader that
cyclically loads the patient's tissues as retraction proceeds. The
cyclic loading may be applied to the tissue by oscillating internal
pressures within hollow, fluid-filled TEDs. The cyclic loading may
take many forms. The cyclic loading might be a large amplitude
motion (on the order of, or up to the value of, the width of the
surgical aperture, say, 100 millimeters), a small amplitude motion
(on the order of 1-5 mm), a low frequency motion (on the order of,
or equal to, that of the overall retraction action itself, say a
period of 2-6 minutes), and/or a higher frequency motion matching
physiological rates of deformation (0.1 Hz to 20 Hz), and/or a very
high frequency motion matching the resonant frequencies of
microstructures and microcomponents of the tissue (20 Hz to 20
KHz). The cycle, or oscillation, may possess a roughly periodic
waveform C10010, that is, a motion profile that is roughly the same
from cycle to cycle (FIG. 88), or, as may be useful for actuator
feedback control with very high update rates, or with waveforms
combining several frequencies, the oscillation may take a more
complex form C10020, with aperiodic behavior (FIG. 88). A very high
update rate servo system could serve the requests emerging out of a
signal processor that rapidly monitors, detects, characterizes, and
responds to, as one example, the second time derivative of the
measured force acting on at least one retractor blade pad.
[0267] Given the previous examples, it is reasonable to combine the
benefits of the earlier embodiments into one surgical instrument
(FIG. 89). A rib spreader C19000, similar to that in FIG. 55, is
fitted with a TED C8100 that is an array of individually
addressable fluid- and foam-filled retractor blade pads C8102
themselves comprised of fiber-reinforced, anisotropic, elastomer
bladders. Each blade pad C8102 within the array of pads can be of
the type shown in FIG. 83 in which fibers C5416 helically wrap
fluid filled columns C5410 connected by a plenum on the instrument
face of the pad C8102. The helically wrapped columns C5410 are then
encased in a block of low-stiffness gas-bubble filled elastomer
that possesses a density gradient C1320 as shown in FIG. 59C. This
pad C8102 is designed to provide a soft tissue face C1103 to the
tissue such that pad C8102 cups the tissue as the pad C8102 is
pressed against the tissue (e.g. a rib during a thoracotomy).
[0268] FIG. 90 shows a different TED C8500 illustrating how each
pad (C5100 in this example) forming a similar array of pads C1111
can also each be equipped with a pressure sensor C2222, a
temperature sensor C3333, and an IR-based oxygen sensor, comprised
of IR emitter C8560 and IR detector C8570 for measuring tissue
oxygen saturation (FIG. 90). Each pad is mounted onto a rigid
element C2000, with each rigid element C2000 operably attached by
blade mount C8530 to a motor C8540, mounted on retractor arm C8520,
that positions the rigid element C2000, and thus the pad C5100.
Thus, each pad C5100 can be independently positioned to increase or
decrease the pressure in the pad C5100 and thus the force that the
rigid element C2000 exerts on the edge of the incision. Optionally,
pads C5100 can include columns C5410 wrapped by helical fibers
C5416, and, further, each column C5410 can be modulated via its own
individually controllable hydraulic actuator (either one actuator
per helically wrapped cylinder or one actuator per pad in the array
of pads such that all cylinders in one pad have the same pressure).
The pad array C1111, supplied with a controller, becomes a
hydraulic servo array (with the pressure sensors as the feedback).
The controller can further contain sensor monitoring software that
receives the inputs from all the sensors in the array, compares all
their values, checks for impending tissue trauma events, and
actively, automatically modulates the behavior of the array to
prevent damage from occurring as the surgeon retracts the patient's
ribs to obtain surgical access. The controller might further
possess the capability to control the influx of a
temperature-modulating fluid from a temperature-controlled supply
into individual pads within the pad array, for example to cool the
tissue and thereby slow the metabolic rate of the tissue, or
optionally to cool just those regions that appear to be most at
risk. This device also allows the surgeon to heat the tissue for
other reasons, as desired, and the temperature-controlled fluid can
serve this purpose, too. If the pads are built with permeable
surfaces or volumes, then the circulating fluid might also be
titrated (for example, at the source, or at the
temperature-modulating unit) to release a desired amount of
pharmacological agent from the surface of the pads and into the
tissue. In these ways, the pressure, temperature, and
pharmacological state of the patient's tissues can all be
controlled before and throughout retraction, the better to
ameliorate or prevent any tissue trauma, and so improve patient
outcomes.
[0269] It will be apparent to those readers who are skilled in the
art that there are many other combinations and variations on the
themes above; all of those fall within the scope of the present
series of embodiments and are not relieved from protection
herein.
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