U.S. patent application number 11/122272 was filed with the patent office on 2005-12-01 for surgical retractor and stabilizing device and method for use.
Invention is credited to Bertolero, Arthur A., Bertolero, Raymond, Riebman, Jerome B..
Application Number | 20050267336 11/122272 |
Document ID | / |
Family ID | 21768568 |
Filed Date | 2005-12-01 |
United States Patent
Application |
20050267336 |
Kind Code |
A1 |
Bertolero, Arthur A. ; et
al. |
December 1, 2005 |
Surgical retractor and stabilizing device and method for use
Abstract
An adjustable surgical retractor and its use for improving a
surgeon's ability to perform closed-chest video-assisted
exploratory, diagnostic or surgical procedures on a patient. The
surgical retractor has opposable blades which can be inserted into
a surgical incision in a patient undergoing a surgical procedure
then spread apart to form an elongated access opening through which
a instrument may be inserted to perform exploratory, diagnostic or
surgical procedures. The blades used in the surgical retractor may
be flexible or rigid and are attachable to the retractor. The
blades are of a width, depth and thickness to provide an access to
an internal cavity or subcutaneous region to allow greater degrees
of freedom to the surgeon in inserting instruments into the access
opening. The use of the surgical retractor forms a substantially
ovoid channel, through which a medical instrument can be inserted
to perform surgical or other operations.
Inventors: |
Bertolero, Arthur A.;
(Danville, CA) ; Bertolero, Raymond; (Danville,
CA) ; Riebman, Jerome B.; (Sunnyvale, CA) |
Correspondence
Address: |
GREGORY SMITH & ASSOCIATES
3900 NEWPARK MALL ROAD, 3RD FLOOR
NEWARK
CA
94560
US
|
Family ID: |
21768568 |
Appl. No.: |
11/122272 |
Filed: |
May 3, 2005 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
11122272 |
May 3, 2005 |
|
|
|
10371756 |
Feb 21, 2003 |
|
|
|
10371756 |
Feb 21, 2003 |
|
|
|
09672110 |
Sep 27, 2000 |
|
|
|
09672110 |
Sep 27, 2000 |
|
|
|
09171206 |
Aug 10, 1999 |
|
|
|
09171206 |
Aug 10, 1999 |
|
|
|
PCT/US97/06112 |
Apr 10, 1997 |
|
|
|
60014922 |
Apr 10, 1996 |
|
|
|
Current U.S.
Class: |
600/219 |
Current CPC
Class: |
A61M 25/0026 20130101;
A61M 2210/127 20130101; A61M 25/1027 20130101; A61B 17/8085
20130101; A61B 2017/0046 20130101; A61B 46/10 20160201; A61B
2017/2904 20130101; A61M 2025/1086 20130101; A61M 1/3659 20140204;
A61B 17/320016 20130101; A61B 90/50 20160201; A61B 90/37 20160201;
A61B 17/0206 20130101; A61B 17/29 20130101; A61B 2017/2946
20130101; A61B 2017/00199 20130101; A61B 1/32 20130101; A61B 90/36
20160201; A61B 17/00234 20130101; A61B 17/2812 20130101; A61M
2025/1097 20130101; A61B 1/313 20130101; A61B 2017/00243 20130101;
A61M 2025/1052 20130101; A61B 1/05 20130101; A61B 2017/2905
20130101 |
Class at
Publication: |
600/219 |
International
Class: |
A61B 001/32 |
Claims
What is claimed is:
1. An adjustable surgical retractor that comprises (a) two handles
suitable for grasping positioned opposite each other and connected
so that the handles move reciprocatingly relative to each other,
(b) a head connected to each handle so that each head moves
reciprocatingly relative to the other, (c) a means for locking the
heads at a preset distance from each other, and (d) a blade
connected to each head, each blade having a width, depth and
thickness so that the width extends substantially parallel to the
length of the handle and the depth extends downward from the top of
the head wherein the blades taken together at the position of
closest proximity to each other are of a size suitable to be
inserted into a surgical incision in a patient undergoing a
surgical procedure then spread apart to form an elongated access
opening through which a medical instrument may be inserted to
perform exploratory or surgical procedures.
2. The surgical retractor of claim 1 wherein each blade has an
inside face and an outside face, said inside face of each blade
facing the inside face of the other blade and the outside face of
each blade designed to (i) minimize the trauma to the patient's
body at the incision when the head and blades are spread apart and
(ii) stabilize the blades in the incision.
3. The surgical retractor of claim 1 wherein the upper edge of each
blade when spread apart has a concavely smooth surface
corresponding to a concave surface of the inner face and is
designed to stabilize a surgical instrument when such instrument
contacts it.
4. The surgical retractor of claim 3 wherein each blade comprises a
flexible material with the outer face having a textured surface to
stabilize the blade in the incision.
5. The surgical retractor of claim 4 wherein when the inner faces
of the blades are in closest proximity, the width of each blade is
parallel to the other.
6. The surgical retractor of claim 3 wherein each blade is a
flexible material and the outer surface comprises a resilient
material.
7. The surgical retractor of claim 1 wherein each blade is rigid
and each inner face is concave relative to the other with an
outwardly protruding lip on the upper and lower edge of each blade
to assist in maintaining the blades in the incision when the head
and blades are spread apart after insertion into the patient's
surgical incision.
8. The surgical retractor of claim 1 wherein the blades are
disposable.
9. The surgical retractor of claim 1 wherein the width of each
blade is about one inch to about four inches, the depth is about
one inch to about three inches and the thickness is about
one-eighth inch to about three-quarters of an inch.
10. The surgical retractor of claim 1 wherein when the head and
blades are spread apart a surgical opening is formed having a
length of about one inch to about four inches and a width of about
one-quarter inch to about two inches.
11. The surgical retractor of claim 1 wherein each blade is
connected to each head by a post and a corresponding
receptacle.
12. The surgical retractor of claim 11, wherein each blade can
swivel on each post.
13. The surgical retractor of claim 11, wherein each post is formed
of a locking pin, thereby preventing the blade from swiveling on
the post.
14. The surgical retractor of claim 11 wherein said post is
frictionally held in said receptacle.
15. The surgical retractor of claim 11 wherein the blade is
removably connected to the head.
16. A method of providing surgical access to the internal thoracic
region of a patient, which method comprises making an intercostal,
surgical incision through the skin and soft tissue of the patient,
wherein the incision is sufficiently sized to allow for the
insertion of a surgical retractor in the incision; providing a
surgical retractor including: (a) two handles suitable for grasping
positioned opposite each other and connected so that the handles
move reciprocatingly relative to each other; (b) a head connected
to each handle so that each head moves reciprocatingly relative to
the other; (c) a means for locking each head at a preset distance
from the other; and (d) a blade connected to each head, each blade
having a width, depth and thickness so that the width extends
substantially parallel to the length of the handle and the depth
extends downward from the top of the head; inserting two blades of
said surgical retractor perpendicularly through the incision; and
spreading the blades of said retractor to provide a relatively
symmetrical, elongated channel for accessing the internal thoracic
region of the patient, said channel being defined by said blades
wherein the internal faces of the blades have a concave surface to
define a substantially ovoid channel, each blade having a smooth,
continuous upper surface.
17. The method of claim 16, wherein at least two surgical incisions
are made intercostally and sufficiently spaced apart to allow for
the insertion and spreading of the blades of two of said surgical
retractors, each pair of spread blades providing a relatively
symmetrical, elongated channel for accessing the internal thoracic
region of the patient.
18. The method of claim 16, wherein said two surgical incisions are
made laterally on said patient.
19. The method of claim 16, wherein said two surgical incisions are
made anteriorly on said patient.
20. The method of claim 16, wherein said two surgical retractors
are interconnected by a stabilizing bar to fix their positions
relative to the other.
21. The method of claim 16, wherein a third incision is made to
provide access to the patient's thoracic cavity sufficient to
insert an image transmission means to transmit an image of the
patient's internal thoracic region.
22. A method of performing minimally-invasive cardiac surgery on a
patient, which method comprises providing a surgical retractor
including: (a) two handles suitable for grasping positioned
opposite each other and connected so that the handles move
reciprocatingly relative to each other, (b) a head connected to
each handle so that each head means moves reciprocatingly relative
to the other, (c) a means for locking each head at a preset
distance from the other, and (d) a blade connected to each head,
each blade having a width, depth and thickness so that the width
extends substantially parallel to the length of the handle and the
depth extends downward from the top of the head; making an
intercostal surgical incision through the skin and soft tissue of
the patient, wherein the incision is sufficiently sized to allow
for the inserting and spreading of the blades of said surgical
retractor, inserting two blades of a surgical retractor,
perpendicularly through the incision, spreading the blades of said
retractor to provide a relatively symmetrical, elongated channel
for accessing the internal thoracic region of said patient, said
channel being defined by said blades wherein the internal faces of
the blades have a concave surface to define a substantially ovoid
channel, each blade having a smooth continuous upper surface,
inserting a surgical instrument through said substantially ovoid
channel, and performing a surgical procedure using the surgical
instrument so inserted.
23. The method of claim 22, wherein said surgery is cardiac surgery
and said patient is maintained on a cardiopulmonary by-pass
machine.
24. The method of claim 23, wherein at least two surgical incisions
are made intercostally and sufficiently spaced apart to allow for
the inserting and spreading of the blades of two of said surgical
retractors, each pair of spread blades providing a relatively
symmetrical, elongated channel for accessing the internal thoracic
region of the patient.
25. The method of claim 22, wherein said two surgical incisions are
made laterally on said patient.
26. The method of claim 22, wherein said two surgical incisions are
made anteriorly on said patient.
27. The method of claim 22, wherein said two surgical retractors
are interconnected by a stabilizing bar to fix their positions
relative to the other.
28. The method of claim 22, wherein a third incision is made to
provide access to the patient's thoracic cavity sufficient to
insert an image transmission means to transmit an image of the
patient's internal thoracic region.
29. The method of claim 28, wherein the surgery is performed by the
surgeon by manipulating the instruments viewing the image surgery
so transmitted by the transmission means.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This is a continuation of application Ser. No. 10/371,756
filed Feb. 21, 2003, which is a continuation of application Ser.
No. 09/672,110 filed Sep. 27, 2000, which is a continuation of
application Ser. No. 09/171,206 filed Aug. 10, 1999, which is a
National Stage application of international application number
PCT/US97/06112 filed Apr. 10, 1997, which claimed the benefit of
provisional patent application U.S. 60/014,922 filed Apr. 10, 1996
in the name of inventors Arthur Bertolero, Raymond Bertolero and
Jerome Riebman. This application is related to applications
PCT/US97/06533, PCT/US97/05910, PCT/US97/06070 and U.S. Utility
Ser. No. 08/838,774, which were concurrently or almost concurrently
filed with PCT/US97/06112, which is one of the application in the
priority chain listed above. Each of the above-identified patent
applications is incorporated by reference.
FIELD OF THE INVENTION
[0002] This invention relates to an adjustable surgical retractor
and its use for improving a surgeon's ability to perform
closed-chest, video-assisted exploratory, diagnostic or surgical
procedures on a patient. The invention also relates to unique
blades useful in combination with the retractor.
BACKGROUND OF THE INVENTION
[0003] Surgery on the heart is one of the most commonly performed
types of surgery that is done in hospitals across the U.S. Cardiac
surgery can involve the correction of defects in the valves of the
heart, defects to the veins or the arteries of the heart and
defects such as aneurysms and thromboses that relate to the
circulation of blood from the heart to the body. In the past, most
cardiac surgery was performed as open-chest surgery, in which a
primary median sternotomy was performed. That procedure involves
vertical midline skin incision from just below the super sternal
notch to a point one to three centimeters below the tip of the
xiphoid. This is followed by scoring the sternum with a cautery,
then dividing the sternum down the midline and spreading the
sternal edges to expose the area of the heart in the thoracic
cavity. This technique causes significant physical trauma to the
patient and can require one week of hospital recovery time and up
to eight weeks of convalescence. This can be very expensive in
terms of hospital costs and disability, to say nothing of the pain
to the patient.
[0004] Recently, attempts have been made to change such invasive
surgery to minimize the trauma to the patient, to allow the patient
to recover more rapidly and to minimize the cost involved in the
process. New surgical techniques have been developed which are less
invasive and traumatic than the standard open-chest surgery. This
is generally referred to as minimally-invasive surgery. One of the
key aspects of the minimally invasive techniques is the use of a
trocar as an entry port for the surgical instruments. In general,
minimally invasive surgery entails several steps: (1) at least one,
and preferably at least two, intercostal incisions are made to
provide an entry position for a trocar; (2) a trocar is inserted
through the incision to provide an access channel to the region in
which the surgery is to take place, e.g., the thoracic cavity; (3)
a videoscope is provided through another access port to image the
internal region (e.g., the heart) to be operated on; (4) an
instrument is inserted through the trocar channel, and (5) the
surgeon performs the indicated surgery using the instruments
inserted through the access channel. Prior to steps (1)-(5), the
patient may be prepared for surgery by placing him or her on a
cardiopulmonary bypass (CPB) system and the appropriate anesthesia,
then maintaining the CPB and anesthesia throughout the operation.
See U.S. Pat. No. 5,452,733 to Sterman et al. issued Sep. 26, 1995
for a discussion of this technique.
[0005] While this procedure has the advantage of being less
invasive or traumatic than performing a media, sternotomy, there
are numerous disadvantages to using trocars to establish the entry
ports for the instruments and viewscope. For example, the trocars
are basically "screwed" into position through the intercostal
incision. This traumatizes the local tissues and nerve cells
surrounding the trocar.
[0006] Once in place, the trocar provides a narrow cylindrical
channel having a relatively small circular cross-section. This
minimizes the movement of the instrument relative to the
longitudinal axis and requires specially-designed instruments for
the surgeon to perform the desired operation (See, e.g., the
Sterman patent U.S. Pat. No. 5,452,733). In addition, because of
the limited movement, the surgeon often has to force the instrument
into an angle that moves the trocar and further damages the
surrounding tissue and nerves. The need to force the instrument
causes the surgeon to lose sensitivity and tactile feedback, thus
making the surgery more difficult. The surgical retractor of this
invention is designed to reduce the initial trauma to the patient
in providing access to the internal region, to reduce the trauma to
the patient during surgery, to provide the surgeon with greater
sensitivity and tactile feedback during surgery, and to allow the
surgeon to use instruments of a more standard design in performing
the non-invasive surgery.
[0007] Other less invasive surgical techniques include access to
the region of the heart to be corrected by anterior mediastinotomy
or a thoracotomy. In a mediastinotomy, an incision is made that is
two to three inches in length of a parasternal nature on the left
or the right of the patient's sternum according to the cardiac
structure that needs the attention in the surgery. Either the third
or the fourth costal cartilage is excised depending on the size of
the heart. This provides a smaller area of surgical access to the
heart that is generally less traumatic to the patient. A
thoracotomy is generally begun with an incision in the fourth or
fifth intercostal space, i.e. the space between ribs 4 and 5 or
ribs 5 and 6. Once an incision is made, it is completed to lay open
underlying area by spreading the ribs. A retractor is used to
enlarge the space between the ribs.
[0008] At the present time, when either of these techniques are
used, a retractor is used to keep the ribs and soft tissues apart
and expose the area to be operated on to the surgeon who is then
able to work in the surgical field to perform the operation. The
types of retractors that are used may be seen, for example, in
volume 1 of Cardiac Surgery by John W. Kirkland and Brian G.
Barratt-Boyes, Second Edition, Chapter 2, at page 101.
Commercial-type retractors for minimally-invasive surgery that are
useful for a mediastinotomy or a thoracotomy are manufactured by
Snowden Pencer (the ENDOCABG rib spreader and retractor), U.S.
Surgical (the mini CABG system), and Cardiothoracic Systems (the
CTS MIDCAB. System). The ENDOCABG retractor is two opposing
retractor arms that are interconnected by a ratchet arm having a
thumbscrew which can adjust the distance between the retractor
arms. While this provides a useful retractor, it has certain
shortcomings in its ease of use. The mini CABG System is an
oval-based platform to which a number of retractors are then fitted
around the extremity of the universal ring base and adjusted by a
gear tooth connection. Each of the retractors have to be separately
adjusted and there are other devices that can be connected to the
universal base which can aid the surgeon in damping the heart
movement to better work on the artery or vessel to which the
surgeon is directing his attention. The CTS MIDCAB. System serves a
similar function to the ENDOCABG retractor, but is more complex.
The designation CABG refers to "coronary artery bypass graft."
[0009] Major disadvantages of these systems include their limited
positioning, complexity, and lack of reusability. It has now been
discovered that the shortcomings of the retractors that are known
in the prior art can be overcome with a new design as set forth in
the following description.
SUMMARY OF THE INVENTION
[0010] One aspect of this invention is an adjustable surgical
retractor that comprises
[0011] (a) two handles suitable for grasping positioned opposite
each other and connected so that the handles move reciprocatingly
relative to each other,
[0012] (b) a head connected to each handle so that each head moves
reciprocatingly relative to the other,
[0013] (c) a means for locking the heads at a preset distance from
each other, and
[0014] (d) a blade connected to each head, each blade having a
width, depth and thickness so that the width extends substantially
parallel to the length of the handle and the depth extends downward
from the top of the head wherein the blades taken together at the
position of closest proximity to each other are of a size suitable
to be inserted into a surgical incision in a patient undergoing a
surgical procedure then spread apart to form an elongated access
opening through which a medical instrument may be inserted to
perform exploratory or surgical procedures.
[0015] Another aspect of this invention is a blade suitable for use
as part of a surgical retractor, which blade comprises a
biocompatible material having dimensions defined by a width, depth
and thickness, the width and the depth defining an first and an
second face separated from each other by the thickness of the
blade, wherein the blade has a connector means for attaching to a
head means of the surgical retractor.
[0016] Another aspect of this invention is a method of providing
surgical access to a patient, which method comprises making a
surgical incision through the skin and soft tissue of the
patient,
[0017] inserting two blades of a surgical retractor perpendicularly
through the incision, and
[0018] spreading the blades of said retractor to provide a
relatively symmetrical, elongated channel for internally accessing
said patient, said channel being defined by said blades wherein the
internal faces of the blades have a concave surface to define a
substantially ovoid channel, each blade having a smooth, continuous
upper surface.
[0019] Another aspect of this invention is a method of performing
minimally invasive surgery on a patient, which method comprises
[0020] making a surgical incision through the skin and soft tissue
of the patient,
[0021] inserting two blades of a surgical retractor,
perpendicularly through the incision,
[0022] spreading the blades of said retractor to provide a
relatively symmetrical, elongated channel for internally accessing
said patient, said channel being defined by said blades wherein the
internal faces of the blades have a concave surface to define a
substantially ovoid channel, each blade having a smooth continuous
upper surface,
[0023] inserting a surgical instrument through said substantially
ovoid channel, and
[0024] performing a surgical procedure using the surgical
instrument so inserted.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] FIG. 1 is a top view of the surgical retractor of this
invention in the closed position with the proximal ends of the
retractor shown at the bottom of the page and the distal end at the
top.
[0026] FIG. 1A is the side view taken along line 1A-1A' shown in
FIG. 1.
[0027] FIG. 1B is an end view along line 1B-1B'.
[0028] FIG. 2 is a top view of the retractor of this invention with
the blades spread open.
[0029] FIG. 3 is a top view of a retractor of this invention having
finger holds on the proximal grasping end of the retractor, the
retractor being in the closed position.
[0030] FIG. 3A is a top view of the retractor of FIG. 3 shown in
the open position.
[0031] FIG. 4 is a side view along lines 4F-4F' of the retractor of
FIG. 3.
[0032] FIG. 5 is a top view of the surgical retractor of this
invention similar to FIG. 3 but with a shorter handle.
[0033] FIG. 6A is a top view of the retractor of this invention
shown without the blades positioned on the head region of the
handles and in the closed position.
[0034] FIG. 6B is a top view of the retractor of FIG. 6A in the
spread open position.
[0035] FIG. 6C shows the head region of the retractor in FIG. 6A
having removable blades attached to the head member on a post as
the connector means.
[0036] FIG. 6D is a side view of FIG. 6C.
[0037] FIG. 6E shows the head members of the surgical retractor
with swiveling blades on the head member in the closed
position.
[0038] FIG. 6F shows the head members in of FIG. 6E in the open
position.
[0039] FIG. 7A shows an alternative design for the retractor of
this invention where the handle has a roughened surface for
improved grasping.
[0040] FIG. 7B is a side view along line 7B-7B' and showing a
textured surface on the outside face of the blade.
[0041] FIG. 7C is a cross-sectional end view along line 7C-7C' of
the blades positioned together in the head member of the surgical
retractor.
[0042] FIG. 7D is an end view along line 7D-7D' showing the
conjunction of the blades of the surgical retractor.
[0043] FIG. 7E shows the surgical retractor of FIG. 7A with the
blades spread in the open position and the handles pulled
together.
[0044] FIG. 8A is a perspective view of a blade of this invention
having a slight curvature with a concave inner surface and a
resilient outer surface.
[0045] FIG. 8B shows the relative distance of the upper and lower
lip at the top and bottom of the blade.
[0046] FIG. 9A shows a pair of disposable retractor blades suitable
for use with the retractor of FIGS. 1 through 7.
[0047] FIG. 9B is an alternative design for a pair of disposable
retractor blades.
[0048] FIG. 9C is another design of the disposable retractor blade
useful in this invention.
[0049] FIG. 9D shows a pair of disposable retractor blades as shown
in 9A as they would look if they were flexed and attached to the
retractor head and spread in an open position pushing against a
patient's ribs.
[0050] FIG. 9E shows the blades of FIG. 9B as they would appear if
they would be spread apart and used to spread the ribs in
accordance with the process of this invention.
[0051] FIG. 9F is another design for the disposable retractor
blades for use in this invention.
[0052] FIGS. 9G-9I show the various positions blades that swivel on
the posts of FIG. 6C or 6D could take.
[0053] FIG. 9J shows tapered blades viewed along lines 9J-9J' in
FIG. 9C.
[0054] FIG. 10A shows a perspective view of a design of blades
having a lip at the top and bottom of the blade curling toward the
convex face.
[0055] FIG. 10B shows a profile view of the blades showing the
lip.
[0056] FIG. 11 shows the positioning of an incision in the
intercostal space as used in the process of this invention.
[0057] FIG. 12A shows two retractors in place and stabilized by
interconnecting bar shown in FIGS. 12B and 12C.
[0058] FIG. 12B shows an appropriate interconnecting bar.
[0059] FIG. 12C shows a notched interconnecting bar for
interconnecting two retractors and stabilizing them.
[0060] FIG. 13 shows entry incision ports suitable for use for with
the retractor of this invention in comparison to other trocars
which are generally used for minimally invasive surgery.
[0061] FIG. 14A shows the greater degree of freedom that a surgeon
would have in using the retractor of this invention as compared to
a trocar shown in FIG. 15.
[0062] FIG. 14B is a cross-section of the elongated access
opening.
[0063] FIG. 15A shows a trocar inserted into a patient between the
ribs.
[0064] FIG. 15B shows the small cross-section of 15A.
[0065] FIG. 16 shows a patient positioned for a lateral incision
using a retractor of this invention.
[0066] FIGS. 17A-17F show various preferred embodiments of the
surgical blades of this invention.
DETAILED DESCRIPTION AND PRESENTLY PREFERRED EMBODIMENTS
[0067] While the description of the surgical retractor of this
invention will be discussed primarily in relation to cardiac
surgery procedures, it should be understood that the surgical
retractor of this invention will find use in not only cardiac
surgery but also laparoscopic surgery in which a surgeon wishes to
gain access to an internal cavity by cutting the skin and going
through the body wall in order to keep the incision spread apart so
that surgical instruments can be inserted.
[0068] Thus the surgical retractor can find use in providing
surgical access generally where a limited incision is desired. It
is useful for subcutaneous access as well as for surgically
accessing various body cavities such as the abdominal region, the
thoracic region and the extremities.
[0069] It should also be understood that the surgical retractor of
this invention can be used for direct access to an internal organ
for surgical purposes with direct viewing of the work that's going
on but it is preferably used in conjunction with video assisted
cardiac surgery. In such a case, the surgical retractor of this
invention is used in combination with a video endoscope that is
positioned through a similar surgical retractor, a trocar or a
percutaneous access opening which allows the scope to be positioned
such that the internal work on the area to be operated on is
transmitted to a video screen and the surgeon then performs the
operation by viewing the screen and judging the use of the
instruments with the assistance of the video endoscope. The
surgical retractor has particular value in minimally invasive
surgical techniques used in cardiac surgery.
[0070] One aspect of this invention is an adjustable surgical
retractor. The retractor comprises
[0071] (a) two handles suitable for grasping positioned opposite
each other and connected so that the handles move reciprocatingly
relative to each other,
[0072] (b) a head connected to each handle so that each head moves
reciprocatingly relative to the other,
[0073] (c) a means for locking the heads at a preset distance from
each other, and
[0074] (d) a blade connected to each head, each blade having a
width, depth and thickness so that the width extends substantially
parallel to the length of the handle and the depth extends downward
from the top of the head wherein the blades taken together at the
position of closest proximity to each other are of a size suitable
to be inserted into a surgical incision in a patient undergoing a
surgical procedure then spread apart to form an elongated access
opening through which a medical instrument may be inserted to
perform exploratory or surgical procedures.
[0075] The blades, when taken together at the position of closest
proximity to each other are of a size suitable to be inserted into
a surgical incision in a patient undergoing a surgical procedure
then spread apart to form an elongated, ovoid access opening
through which a medical instrument may be inserted to perform
exploratory, diagnostic or surgical procedures.
[0076] Preferably, the surgical retractor is designed so that each
blade has an inside face and an outside face. The inside face of
each blade faces the inside face of the other blade and the outside
face of each blade is designed to (i) minimize the trauma to the
patient's body at the incision when the head means and blades are
spread apart, (ii) stabilize the blades in the incision and (iii)
allow customization for each patient's anatomy.
[0077] Referring now to FIG. 1, one sees the adjustable surgical
retractor of the invention generally designated as 2. The retractor
is characterized by having a elongated handle 4R and 4L for the
right and left side as shown in FIG. 1. The elongated handles have
a grasping end shown as 6L and 6R for the left and right sides of
the device which are proximal to the user. On the opposite end,
distal from the grasping handle are the ends 8L and 8R, again
indicating the left and the right side as shown in the figure.
Generally, the ends 8L and 8R when in the closed position shown in
FIG. 1 will be in contact and there will generally be a space
between opposing jaws of the device 9L and 9R. The handles which
are suitable for grasping and are positioned opposite to each other
are pivotally connected at pivot point which will have a male
member pivot pin 10 which will correspond to a female receiving
member 11 to allow the pivoting to take place. Thus the opposite
ends 8L and 8R that are distal to the grasping handles comprise
heads that are connected to each elongated handle so that each head
moves reciprocatingly relative to the other. When handles 6L and 6R
are drawn together as shown in FIG. 2, the distal ends or heads 8L
and 8R are spread apart. A key to the utility of this particular
design is the presence of a locking means to lock the heads at a
preset distance from each other. The means shown in this case is a
ratchet segment 14 having teeth 16 along the arcuate member 15
interconnecting handles 4L and 4R. Working in concert with the
ratchet segment 14 and its corresponding teeth 16 is a
corresponding pawl member 18 which is pivotally mounted at pivot
19, not shown, working in concert so that the teeth 20 on pawl 18
(as shown in FIG. 2) are complementary to the teeth 16 and provide
a means for locking the heads at a preset distance from each other.
Because of the numerous teeth 16 along ratchet member 14 the
distance between head members 8L and 8R can vary significantly and
in small incremental amounts. When pawl member 18 is disengaged
from the ratchet segment 14 by not having the teeth in contact,
tensioning means 12 tends to keep the handles 6L and 6R apart. Thus
if the teeth are not engaged, the handles will tend to be spread
apart by the tensioning means so that the heads 8L and 8R are
generally in contact and ready for insertion prior to a surgical
operation.
[0078] Each head means (which is shown as being unitary with the
handle) has a connector means suitable for connecting a connector
blade 22 to the corresponding heads 8L and 8R of elongated handles
4L and 4R. A blade 22 is connected to the head member of the
elongated handle 4 by a connector means not shown, with each blade
22 having a width, depth and thickness dimensions that define the
blade. The width, for purposes of this invention, is said to extend
substantially parallel to the length of the head or handle. The top
of the blade as seen as 23 in FIG. 1 such that while in use, the
blade would be inserted into the surgical incision and the top edge
23 would remain outside the patient's surgical opening. The depth
of the blade would extend downward from the top 23 of the blade
into the surgical incision. Thus by looking at the side view of
FIG. 1A, the bottom of the blade 22 would be shown as 24. The
thickness of the blade is shown in FIG. 1 by the approximate
extension dotted line at the head of the retractor device. The
bottom of blades 24, when taken together at the position of closest
proximity to each other as shown in FIG. 1, are of a size suitable
to be inserted into a surgical incision in a patient undergoing a
surgical procedure. Once inserted, the blades are then spread apart
as shown in FIG. 2 to form an elongated access opening through
which a medical instrument may be inserted to perform exploratory
or surgical procedures as discussed hereinafter. The view of FIG.
1A of the surgical retractor of this device is a side view along
lines 1A to 1A' in FIG. 1A while an end view along lines 1B to 1B'
is shown in FIG. 1B. The numbers in each of FIGS. 1, 1A, 1B and 2
all designate similar parts of the device.
[0079] Turning now to FIG. 3, one can see an alternative
configuration for the surgical retractor of this invention. In FIG.
3, the same numerals that are used in FIG. 1 are used as well. The
only difference here is that the grasping handle 6L and 6R has a
slightly modified design that allows the surgeon using the
retractor to insert a thumb and other digit to grasp the handle at
7L and 7R of the proximal end 6L and 6R. Otherwise the operation of
the retractor is the same as that shown in FIG. 1 and FIG. 2. FIG.
4 is a side view of the surgical retractor along lines 4F and 4F'
showing the inserted edge 24 of blade 22 of the retractor. FIG. 3A
shows the surgical retractor in the open position where the blades
are spread apart.
[0080] Referring again to FIGS. 1, 1A, 1B and 2, one can see
certain preferred aspects of the invention. Each blade for the
retractor has an inside face and an outside face. The outside face
can be seen in FIGS. 1A and 1B. The outside face of the blade is
designed to minimize the trauma to the patient's body at the
incision when the head means and the blade are spread apart and to
further stabilize the blade in the incision. To minimize the trauma
and stabilize the blade, it is preferred that the outside surface
of the blade be of a finish that is slightly irregular and
preferably is of a texture that is less traumatizing than a smooth,
hard texture. In general the blades are made of a material which is
strong enough to withstand the pressure of opening the retractor in
the manner in which it is to be used. For example, if an incision
is made in between the fourth and fifth ribs in the intercostal
area, the ribs will have to be spread apart and the blades will
have to be strong enough to withstand the pressure of gently
spreading apart the ribs. Thus material for the blades may be of
any material which is biocompatible with the patient's body and
using it in the incision. The materials that can be used are
stainless steel, plastic such as polyvinyl chloride (PVC),
polyethylene, polyesters of various sorts, polycarbonate, teflon
coated metal and the like. In addition to, or as an alternative to,
the irregular surface of the outside face of the blade, the outside
face may be padded or resilient to a certain extent to minimize the
trauma to the surrounding tissue as it is spread open. Thus the
blade may be of a laminated construction which has a stronger
material on the inner face with the outer face having a spongier or
padded characteristic.
[0081] Preferably, the surgical retractor blade will be designed so
that the upper edge 22 of each blade when spread apart has a
concavely smooth surface corresponding to a concave surface of the
interface which will be suitable for resting a surgical instrument
against. This allows for much better movement of the instruments,
e.g. in dissection of an internal mammary artery (IMA) and suturing
of vessels. This can be seen in FIGS. 1 and 2, particularly in FIG.
2 where the concave surface is shown as number 25 for each blade
connected to head 8L and 8R. Preferably there will be a lip at both
the top edge 23 and the bottom edge 24 as shown in FIG. 1B. A
slightly rolled edge is important for maintaining the blade in
place so that the heads are spread open as shown in FIG. 2. In some
instances it is preferred that the blade is of a flexible material
such as a plastic with the outer face having a slightly irregular
surface to stabilize the blade in the incision. In that case, the
blades, when inserted onto the heads of the retractor, can be
essentially parallel to each other but as the blades are spread
apart, the ends would tend to bend towards each other forming the
concavity shown in FIG. 2.
[0082] Alternatively, the blades may be preformed so that they have
a lip or ridge on both the top 23 and the bottom 24 and have a
preformed concavity that forms as the two interfaces rest against
each other. This can be seen at FIGS. 8A, 8B, 10A and 10B. In this
manner where each blade is rigid and the inner face of each is
concave relative to the other where the outwardly protruding lip or
ridge 23 on the upper and lower edge 24 of each blade, the blades
are maintained in the incision when the head and the blades are
spread apart after insertion into the patient's surgical incision.
Where a patient's abdominal region is being accessed the lower lip
will have to extend more than if the thoracic region is being
accessed through the rib cage. Generally the lip at the top edge 23
shown in FIG. 10B will extend out about 3/8" with the bottom lip 24
extending about 1/8" when entering intercostally. If abdominal
access is desired the lower lip 24 will have to extend out further.
The dimensions shown in FIG. 8B will vary with individual patients.
However, a particularly useful size for X is about 1.5 inches, for
Y is about 3/8 inch and for Z is about 1/8 inch. A preferable
aspect to the surgical retractor of this invention is that the
blades are removable. The surgeon can select a blade having the
desired width and depth to create exactly the size opening he or
she wants, depending on a patient's size, shape, age, anatomy,
etc., and the type of operation to be performed, e.g. lifting the
left IMA for dissection. This is a particularly attractive aspect
of the invention because the handles and the rest of the mechanism
can be made of a durable, sterilizable material such as stainless
steel. The blades can be made of a material that is
re-sterilizable, and may be reusable or disposable, thus making the
device easier and cheaper for the surgeon to use the device. For
example, at the present time the commercially available devices
through U.S. Surgical and CTS are very expensive and can be used
only once because they have numerous parts and they all cannot be
resterilized. By having removable blades 22 that can be disposed
of, the surgical retractor 2 can be used multiple times by simply
sterilizing then adding new disposable blades.
[0083] Preferably, the connector means on the head member of the
surgical retractor that is suitable for connecting the blade is
simply a male pivot pin as shown in FIGS. 6A-6F. Here the pivot
pin, which is at the distal end of the surgical retractor, is shown
as 26L and 26R. The surgical retractor blade which is removable has
a reciprocal female receiving port 27 into which the pivot pin will
slip. The pivot pin may be designed to lock the blade in place or
to allow the blade to rotate as shown in FIG. 6E-6F. When the
surgical retractor's handles are extended outwardly as shown in
FIG. 6A, the blades would be together as shown in FIG. 6E where the
male pivot pin seated in the female receiving port 27 as shown. As
the proximal ends 6L and 6R are pulled together through grasping
means 7L and 7R, the blades are pulled apart and can swivel
slightly to adjust to the tension in the process of spreading apart
the ribs.
[0084] The blades which are useful in the surgical retractor of
this device are of a width, depth and thickness which will allow
the surgeon access to the internal organs of the patient once an
incision is made. Generally, the width of each blade may vary
between about 1 inch to about 4 inches preferably 1 inch to about 3
inches. The depth will be of a sufficient depth to be adequately
retained within the surgical incision when the head of the
retractor are spread apart. Generally this depth will be about 1
inch to about 3 inches depending on the size and weight of the
patient. The thickness, of course, will be of sufficient thickness
to withstand the pressures of spreading apart the ribs of the
patient if that's how the retractor is to be used. The thickness
will depend on the strength and flexibility of the material used in
making the blade. Generally, the thickness will be about one-eighth
inch to about three-quarters of an inch.
[0085] When the blades are flexible, it is preferable that the male
pivot pin receiving means is designed to frictionally receive the
blade and retain it without pivoting. If, however, the material is
of a metallic nature such as stainless steel and is inflexible,
then it's preferable that the pivot pin would allow the inflexible
blade to pivot freely on the post. Thus if blades of the
approximate dimensions mentioned above are used it can be seen that
the surgical opening could have a length of about 1 inch to about 4
inches and a width of about one-quarter inch to about two
inches.
[0086] Turning now to FIG. 7A-7E one sees a variation on the design
of the retractor of this invention. Here, the same numbers
designate the same parts as in the previous FIGS. 1 through 6F. The
difference between the design in FIG. 1 and FIG. 7A is simply that
the handles 4L and 4R have notches designated at 5L and 5R to
provide a better grasp for the surgeon using the retractor.
[0087] These can be seen in both FIGS. 7A and 7B, 7B being the side
view along lines 7B and 7B'. In addition, the handles 6R and 6L may
have an additional notch designated as 28 for receiving a
stabilizing bar which the surgeon can use to connect two surgical
retractors of this invention. This is discussed hereinafter in
greater detail. The cross-sectional end view of the device along
lines 7C, 7C' shows a cross-section of the blade having the top
edge 23 slightly expanded and curved outwardly to form a lip at the
top edge. At the bottom edge 24 similarly the blade is curved
outwardly to form a smaller lip. By having these lips, the
retractor when used will tend to stay in place to a greater extent
than in the absence of the lips. By viewing FIG. 7D, which is an
end-on view, along lines 7D, 7D', one can see the end view showing
the outer side 21 of the blade 22 having a resilient material
attached thereto to minimize the trauma and to maximize the
friction to assist in maintaining the blade in place when in use.
FIG. 7A shows the retractor with the heads closed while FIG. 7E
shows the retractor with the head and the blades in an open
position spread apart. Of course, the locking mechanism for
maintaining the retractor in a spread, open position operates in
the same manner as explained for FIGS. 1 through 6.
[0088] Turning now to FIG. 8A, one can see a close-up of a blade
having the concave inner surface and convex outer surface along
with a top lip 23 which is more exaggerated than the bottom lip 24.
In general, the top lip might be anywhere from a quarter to a
three-quarters of an inch, generally about three-sixteenths of an
inch at the widest point with the bottom lip generally being
somewhat less than that amount, about an eighth of an inch, to
about a half an inch, generally about an eighth of an inch. These
dimensions are further shown in FIG. 8B.
[0089] Turning now to FIGS. 9A through 9F, one can see a
perspective view the designs of the pairs of blades that would be
used in the retractor of this invention. These blades are designed
to be disposable and may be made of any materials that would be
appropriate for the construction shown. In FIG. 9A, one sees a set
of blades that have a top edge 23 and a bottom edge 24 along with a
distal edge 29 and a proximal edge 30. Here, both the distal and
proximal edges are shown as being rounded. The inside face 25 of
the two blades is shown to be essentially straight, although it can
be designed to be slightly convex as shown in FIG. 9B, if desired.
A blade when attached to the connector means of the head member of
the surgical retractor and expanded against the ribs when the
retractor is in use will generally provide a convex outer surface
21 and a concave inner surface when the blade is of a flexible
material. This is thought to be due to the fact that the female
receiving port 27 in the blade 22 would receive the male pivot pin
which would be the strongest portion of the blade and which would
provide the outward stress to spread the ribs. Thus, the central
portion of the blade would tend to spread out further than the
distal and proximal edges, 29 and 30 respectively.
[0090] In FIG. 9B, one can see that there is a taper from the
central portion of blade 22 where the female receiving port 27 is
found to the distal edge 29 as well as to the proximal edge 30.
Here the blade is somewhat an elongate, ovoid in shape and would
take a shape similar to that shown in 9E when used with the
surgical retractor in the manner designed. Alternatively, the
design shown in 9C in essence shows a crescent shape for each of
the blades wherein the opposing faces of the internal sides 25 are
essentially parallel while the outside face 21 of each blade is
convex. When in use, this too would take the configuration
generally shown in FIG. 9E. Still another configuration is shown in
FIG. 9F. Here the inner faces 25 are essentially parallel to the
outer faces 21 and the edges of the proximal and distal edges 30
and 29, are somewhat blunter than those shown in either FIGS. 9A,
9B or 9C. This blade would take a configuration shown in FIG. 9D.
In each of the disposable blades shown in FIGS. 9A through 9F, when
viewed along line 9J-9J' as shown in FIG. 9C, the lower edge 24 is
slightly tapered to minimize the amount of space needed for the
initial insertion of the blades as attached to the surgical
device.
[0091] Particularly useful configurations of the disposable blades
of this invention are shown in FIG. 17A-17F. In the figures the
numbers used to designate the part are the same as in FIGS. 9A-9J.
Here in FIG. 17A one sees a blade which is thicker in the
midsection than at the ends somewhat similar to the configuration
in 9B and 9C. The view here is a direct top down view showing
distal end 29 and proximal end 30 along with the inside face 25 and
outside face 21. The top side is shown as 23 and the female
receiving means is shown as 27. When the blade is fitted on to the
corresponding male fastening means or post and the blades of the
surgical retractor are spread apart the blade to the left in FIG.
17A will take the configuration shown in FIG. 17B as compared to
configuration of FIG. 17A which shows the blade at rest. The
primary spreading force will be at the center of the blade 27 and
an elongated oval shaped opening will be formed as a result of the
spreading of the blades. Turning now to FIG. 17C one sees a
slightly different design wherein an internal channel 62 which aids
in the cushioning effect of the blade. Here when the blade is
attached to the head means through the male pivot pin which fits
into the female receptor 27 and the retractor is spread apart to
spread apart tissue and ribs as earlier discussed the blade will
flex as shown in FIG. 17D and the cutout channel will straighten as
shown. The channel 62 has a slightly curved part 63 that will
straighten somewhat to form the silhouette shown in FIG. 17D. Thus
the outer wall 21 prevents the blade from flexing too much when
expanded and the channel 62 provides a cushioning effect so that
the inner face 25 pushes against the outer wall 21 by compressing
channel 62 while making a greater opening between the convex
surfaces 25 of the blade. Alternatively in FIG. 17E one can see the
channel extending from the proximal edge of the blade 29 to the
distal edge of the blade 30. Here when the blade is attached to the
male connector means which is inserted into the female receptor and
the retractor and expanded then the design which has an essentially
flat face 35 changes to that silhouette shown in FIG. 17E. Here the
outer wall defined by 21 bears the force of the flexion of the
blade and prevents the limbs of the blade from flexing too much.
The air channel compresses to add some cushioning effect and
flexibility against the tissues to reduce the trauma to the
tissues.
[0092] In use, the surgical retractor of this invention can be
employed either in the anterior or lateral position on the chest
for thoracic retraction. Preferably, it is employed laterally and
in surgery the patient would be positioned to expose the lateral
side of the patient to the doctor. This position is shown in FIG.
16 where the arm 31 of the patient is raised to expose the lateral
side 32 of the patient to the doctor. The back 33 is positioned as
shown. In the semi-cutaway view of FIG. 11 one can see how the
retractor of this invention would work. Here the patient would be
positioned similar to that shown in FIG. 16 with the arm 31 raised
to expose the lateral side of the patient. The ribs shown as
numbers 34 through 44 are attached to the spine shown roughly as 45
with intercostal spaces between the ribs. Incisions 46 and 47 are
shown as being made between ribs 4 and 5 and 7 and 8. Once the
incision is made, the retractors are used in accordance with FIG.
12. Here, the retractors are shown inserted with the head spread
open to provide access for the surgeon to enter the thoracic
cavity. The retractors may be connected in accordance with the use
of connecting rods shown in FIGS. 12B or 12C and connected in
accordance with the use of a retractor having a notch in the handle
similar to that shown in FIG. 7B. The connecting rod may be of a
design shown in FIGS. 12B and 12C as configuration 48 or 50. Once
the retractors 2U and 2L are in place, creating the elongated
opening or windows, into the thoracic cavity, in intercostal spaces
between the fourth and fifth ribs shown as 46 in between the 7th
and 8th ribs shown as 47. The positioning for a bar such as that
shown in 48 and 50 in FIGS. 12B and 12C respectively, may be
accomplished by several ways. In one mechanism, a screw down
mechanism is used, shown as 48a and 48b in FIG. 12C. By using the
positioning bars with the retractors, the retractors are secured to
enable the retractors to be angled at the appropriate angle toward
the heart or other structure to enable a diagnostic or therapeutic
procedure is to be carried out. The angles of retractors to 2U and
2L is such that a 5 degree to 50 degree angle of the instruments
relative to a perpendicular line through the opening is achieved.
This provides the surgeon with an angle of access and a range of
movement that is similar to that of an open heart surgical
procedure. Locking screws 49A and 49B are shown where the solid bar
48 is rigid. While the bar is shown as straight it may optionally
be slightly curved to contour to the shape of the rib cage. In FIG.
12C, positioning bar 50 is made of interlocking metal pieces with
an interior wire that when tightened locks the position of the
shape of the bar into place and the securing screws shown as 51a
and 51b are shown protruding from one side of the interlocking
metal pieces.
[0093] FIG. 13 indicates the difference in the elongated opening or
window approach and the port method reported by Sterman, et al.
Elongated openings 46 and 47 show greater exposure and flexibility
compared with the trocar port in performing the work. Using the
trocars generally a port will be located at positions 52, 53, 54
and at 46. Alternatively, if a minimally invasive direct coronary
artery bypass MIDCAB incision such as a sternotomy incision is
used, it is done at 55. Whatever is used it is useful to provide a
percutaneous opening 56 for a view scope and one or more additional
instruments required for traction or manipulation of the thoracic
cavity. It should be understood that the invention retractor can
also be used for MIDCAB surgery where the entry is made anterially
as compared to laterally.
[0094] Turning now to FIG. 14, one can see the greater degree of
manipulation that a doctor would have using the surgical retractor
of applicant's invention as compared to the trocar. With the
surgical retractor one can see that one obtains a wider range of
motion for a surgical instrument shown as 58. The view here is of
the cross-section, end-on view that would be similar to that shown
in FIG. 7E along lines 7C-7C' shown in FIG. 7a. Here you can see
the top 23 of blade 22.
[0095] The bottom of the blade 24 sits inside the thoracic cavity.
Ribs 4 and 5 are shown as 37 and 38. The flexibility of the opening
46 in such a case should be compared with the lack of flexibility
in FIG. 15 where a trocar is used to enter the thoracic cavity.
This is visualized better by viewing a top-down view of FIG. 14A
that shows the cross-section of elongate opening 46 compared to the
cross-section of opening 60 of trocar 59 in FIG. 15A.
[0096] Having described the details of the surgical retractor of
this invention, one can now consider another aspect of the
invention, namely a method of providing surgical access to a
patient. The method comprises making a surgical incision through
the skin and soft tissue of the patient, inserting two blades of a
surgical retractor perpendicularly through the incision, and
spreading the blades of said retractor to provide a relatively
symmetrical, elongated channel for internally accessing said
patient. The channel is defined by the blades wherein the internal
faces of the blades have a concave surface to define a
substantially ovoid channel, each blade having a smooth, continuous
upper surface. The method of course, is best performed using the
surgical retractor described hereinbefore.
[0097] The method is particularly valuable in cardiac surgery where
the surgical incision is made intercostally for access to the
patient's thoracic region. Generally, at least two surgical
incisions are made intercostally and sufficiently spaced apart to
allow for the insertion and spreading of the blades of two of said
surgical retractors. Each pair of spread blades then provide a
relatively symmetrical, elongated channel for accessing the
internal thoracic region of the patient. Preferably, two surgical
incisions are made laterally on said patient, although the
incisions may also be made anteriorly on said patient. As shown in
FIG. 12A, the two surgical retractors may be interconnected by a
stabilizing bar to fix their positions relative to the other. To
provide viewing access to the patient's thoracic cavity a third
incision is made to insert an image transmission means to transmit
an image of the patient's internal thoracic region.
[0098] Another aspect of this invention is a method of performing
minimally-invasive invasive surgery on a patient. The method
comprises
[0099] making a surgical incision through the skin and soft tissue
of the patient,
[0100] inserting two blades of a surgical retractor,
perpendicularly through the incision, spreading the blades of said
retractor to provide a relatively symmetrical, elongated channel
for internally accessing said patient (the channel is defined by
the blades wherein the internal faces of the blades have a concave
surface to define a substantially ovoid channel, each blade having
a smooth continuous upper surface),
[0101] inserting a surgical instrument through said substantially
ovoid channel, and
[0102] performing a surgical procedure using the surgical
instrument so inserted. The method preferably employs the retractor
described herein. The size and shape of the retractor blades are
chosen for the exact size opening desired. The smooth continuous
upper surface allows the surgeon to carryout the surgical
procedures more easily. This method is particularly suited for
cardiac surgery when said patient is maintained on a
cardiopulmonary by-pass machine and the surgical incision is made
intercostally for access to the patient's thoracic region.
Preferably at least two surgical incisions (preferably lateral) are
made intercostally and sufficiently spaced apart to allow for the
inserting and spreading of the blades of two of said surgical
retractors, each pair of spread blades providing a relatively
symmetrical, elongated channel for accessing the internal thoracic
region of the patient.
* * * * *