U.S. patent application number 10/412187 was filed with the patent office on 2003-09-18 for devices and methods for performing vascular anastomosis.
Invention is credited to Bolduc, Lee R., Gannoe, James R., Johnson, Theodore C..
Application Number | 20030176878 10/412187 |
Document ID | / |
Family ID | 21817704 |
Filed Date | 2003-09-18 |
United States Patent
Application |
20030176878 |
Kind Code |
A1 |
Bolduc, Lee R. ; et
al. |
September 18, 2003 |
Devices and methods for performing vascular anastomosis
Abstract
Devices and methods for performing vascular anastomosis. A
needle passer is used to pass one or more needles through tissue to
thread one or more lengths of suture through the tissue. The needle
passer is operable using one hand and includes a handle supporting
a shaft assembly carrying first and second sets of needles
connected by lengths of suture. An actuator assembly uncovers the
first set of needles, moves them into a radially extended position,
and then passes them through tissue, for example, the wall of a
patient's aorta. The needle passer may be pistol-shaped with a
trigger that is moved in one direction to sequentially uncover,
radially extend, and move the first set of needles through the
aorta around an aortotomy. The needles may then be pulled away from
the patient to thread the suture through the tissue. A delivery
device is used to deliver a member adapted to be secure to body
tissue, such as a vascular conduit. The delivery device includes a
shaft and a collar mounted for relative movement. The shaft
supports a vascular conduit so that an end of the conduit is
disposed against the collar. A sealing element may be positioned on
the collar beneath the end of the conduit. The needles in the
second set are removed from the needle passer and are placed
through the conduit and sealing element and into the collar. The
shaft is then moved through the collar to move the vascular conduit
along the suture into contact with the aorta. The delivery device
is then removed and the respective ends of each suture length
secured to fix the end of the vascular conduit to the aorta.
Inventors: |
Bolduc, Lee R.; (Mountain
View, CA) ; Gannoe, James R.; (Redwood City, CA)
; Johnson, Theodore C.; (Atherton, CA) |
Correspondence
Address: |
AUDLEY A. CIAMPORCERO JR.
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
21817704 |
Appl. No.: |
10/412187 |
Filed: |
April 11, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10412187 |
Apr 11, 2003 |
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09840262 |
Apr 23, 2001 |
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09840262 |
Apr 23, 2001 |
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09023876 |
Feb 13, 1998 |
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6280460 |
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Current U.S.
Class: |
606/153 ;
606/144; 606/222 |
Current CPC
Class: |
A61B 2017/1107 20130101;
A61B 2017/00946 20130101; A61B 2017/0472 20130101; A61B 17/0483
20130101; A61B 17/062 20130101; A61B 17/11 20130101; A61B 2017/2927
20130101; A61B 2017/2924 20130101; A61B 2017/047 20130101; A61B
17/0469 20130101 |
Class at
Publication: |
606/153 ;
606/144; 606/222 |
International
Class: |
A61B 017/06 |
Claims
What is claimed is:
1. A device for passing at least one needle through tissue, the
device comprising: a handle; a shaft assembly including a shaft
movably coupled to the handle, at least one needle removably
supported by the shaft and movable between radially extended and
non-extended positions, and a protective cover overlying at least a
portion of the shaft and needle when the needle is in said radially
non-extended position, the cover being movable with respect to the
shaft to allow the needle to move to said radially extended
position; and an actuator assembly operable using one hand for
moving the cover to allow the needle to assume said radially
extended position and moving the shaft to pass the needle through
the tissue.
2. The device of claim 1, wherein the shaft assembly comprises a
ram slidably disposed over the shaft for moving the needle into
said radially extended position, and the protective cover is
slidably disposed over the ram.
3. The device of claim 2, wherein the actuator assembly comprises a
linkage coupled to a movable component, and movement of the movable
component drives the linkage and moves the protective cover to
allow the needle to assume said radially extended position, moves
the ram to force the needle into said radially extended position,
and moves the shaft to pass the needle through the tissue.
4. The device of claim 3, wherein the shaft comprises a solid rod,
the ram comprises a first sleeve coaxially disposed over the solid
rod, and the protective cover comprises a second sleeve coaxially
disposed over the first sleeve.
5. The device of claim 1, wherein the shaft has proximal and distal
ends, and the needle is supported at the distal end of the
shaft.
6. The device of claim 1, further comprising at least one length of
suture having two ends, one end being secured to the needle and the
other end being removably supported by the shaft assembly.
7. The device of claim 6, wherein a first plurality of needles are
removably supported adjacent the distal end of the shaft, and
wherein one end of each of a plurality of lengths of sutures is
secured to one of the needles, while the other end of each length
of suture is removably supported by the shaft assembly.
8. The device of claim 7, further comprising a suture supporting
member disposed on the shaft assembly, wherein the other end of
each length of suture is removably supported by the suture
supporting member.
9. The device of claim 8, wherein the suture supporting member
comprises an inner sleeve having channels each of which receives a
length of suture, and an outer tube disposed around the inner
sleeve to enclose each length of suture in one of said channels
10. The device of claim 8, wherein the suture supporting member is
fixed to the handle assembly and has a distal end provided with a
foot for contacting the tissue.
11. The device of claim 10, wherein the foot has a plurality of
slots receiving the lengths of suture and the needles after the
needles have passed through the tissue.
12. The device of claim 7, further comprising a second plurality of
needles each of which is secured to the other end of one of the
lengths of suture, wherein each of the second plurality of needles
is removably supported by the shaft assembly.
13. The device of claim 1, further comprising a needle guard
disposed around the needle when the needle is in said radially
extended and non-extended positions.
14. The device of claim 13, wherein the needle guard comprises a
cage disposed around the needle and movable between expanded and
collapsed orientations.
15. The device of claim 14, wherein the cage comprises a plurality
of flexible struts having one end secured to the shaft and another
end secured to a ram sidably disposed over the shaft, wherein
sliding the ram with respect to the shaft moves the needle into
said radially extended position and moves the cage into said
expanded orientation.
16. The device of claim 1, wherein the handle assembly is generally
pistol shaped and the actuator assembly comprises a trigger
slidably mounted on the handle assembly.
17. The device of claim 16, wherein the trigger is movable in one
direction to move the cover and the shaft, and the actuator
assembly is provided with a mechanism preventing movement of the
trigger in a different direction.
18. The device of claim 1, wherein the shaft assembly is
substantially straight over the length thereof.
19. The device of claim 1, wherein the shaft assembly comprises a
proximal portion adjacent the handle assembly and a distal portion,
and the distal portion is angled with respect to the proximal
portion.
20. A device for passing at least one needle and at least one
length of suture through tissue in a patient's body, the device
comprising: a handle; a shaft assembly supporting at least one
needle and at least one length of suture, the needle being movable
between radially extended and non-extended positions, wherein one
end of the length of suture is secured to the needles and the other
end of the length of suture is located away from the needle; a ram
movable from a first position to a second position in order to
force the needle to said radially extended position; an actuator
assembly operable using one hand to move the ram to said second
position to force the needle into said radially extended position
and to pass the needle through tissue.
21. A device for passing a plurality of needles and a plurality of
separate lengths of suture through tissue in a patient's body, the
device comprising: a handle; a shaft assembly supporting a
plurality of needles and a plurality of separate lengths of
sutures, the shaft assembly having a distal portion configured to
be positioned adjacent tissue of a patient's body through which the
needles are to be passed, wherein the needles are located adjacent
the distal portion of the shaft assembly and are movable between an
extended position and a non-extended position, and one end of each
length of suture is secured to one of the needles and the other end
of each length of suture is located away from the needles; and an
actuator assembly operable to pass the needles through tissue.
22. The device of claim 21, wherein the shaft assembly includes a
shaft to which the needles are mounted so as to be movable in a
radial direction between said extended and non-extended positions,
and the actuator is operable to move the shaft and pass the needles
through tissue.
23. The device of claim 22, wherein the shaft assembly comprises a
ram slidably disposed over the shaft for moving the needles into
said radially extended position, and a protective cover slidably
disposed over the ram
24. The device of claim 23, wherein actuation of the actuator
assembly moves the protective cover in a first direction, moves the
ram in a second direction to force the needles into said radially
extended position, and moves the shaft in said first direction to
pass the needles through the tissue.
25. The device of claim 24, wherein the ram comprises a solid rod
with individual portions each corresponding to one of the needles,
and the actuator assembly moves the individual portions of the ram
in unison to force the needles into said radially extended position
at the same time.
26. A method for passing needles through tissue adjacent an opening
in the tissue, the method comprising steps of: providing at least
first and second needles each of which is configured to pass
through tissue, the first needle having a first length of suture
secured thereto and the second needle having a second length of
suture secured thereto, the first and second lengths of suture
being unconnected; positioning the first and second needles through
an opening in the tissue with a portion of each of the first and
second lengths of suture extending through the opening in the
tissue; and passing the first and second needles through the tissue
adjacent the opening so that the first and second lengths of suture
each have a portion that extends through the opening and a portion
that extends through the tissue.
27. The method of claim 26, wherein the tissue is inside the
patient's body, and both ends of each length of suture are disposed
outside the patient's body after passing the needles through the
tissue and out the patient's body.
28. The method of claim 27, wherein the needles are passed through
the tissue on opposite sides of the opening therein.
29. The method of claim 28, wherein more than two needles are
passed through the tissue at locations spaced circumferentially
around the opening therein
30. The method of claim 28, wherein the opening is in a patient's
aorta, and the needles are passed through the wall of the aorta so
that the first and second lengths of suture each have a portion
that extends through the opening in the aorta and a portion that
extends through the wall of the aorta.
31. A method for placing a plurality of separate lengths of suture
through tissue in a patient's body adjacent an opening in the
tissue, the method comprising steps of: providing at least first
and second needles configured to pass through tissue, the first
needle having a first length of suture secured thereto and the
second needle having a second length of suture secured thereto,
each of the first and second lengths of suture having an end
disposed away from the needles to which the length of suture is
secured; positioning the first and second needles inside a
patient's body adjacent an opening in tissue within the patient's
body such that the ends of the first and second lengths of suture
are located outside an outer surface of the tissue; passing the
first and second needles into the tissue adjacent the opening while
maintaining the ends of the first and second lengths of suture
outside the outer surface of the tissue; and passing the first and
second needles through and out of the tissue to pull the first and
second lengths of suture through the tissue while maintaining the
ends of the first and second lengths of suture outside the outer
surface of the tissue.
32. A device for delivering a member adapted to be secured to a
patients' body tissue, the device comprising: a first component; a
second component mounted to the first component, the first and
second components being relatively movable; the first component
being configured to removably support a member adapted to be
secured to a patient's body tissue; the second component being
configured to hold at least one needle carrying suture for securing
the member to the body tissue; wherein the first component is
relatively movable with respect to the second component to move the
member along the suture into contact with the body tissue.
33. The device of claim 33, further comprising a sealing element
configured to be carried by the first component.
34. The device of claim 33, further comprising a vascular conduit
supported by the first component, the conduit having an end
overlying the sealing element.
35. A device for delivering a vascular conduit to body tissue
located at an anastomosis site within a patient's body, the device
comprising: a shaft having a proximal end and a distal end, a
portion of the shaft being configured to support a vascular conduit
adapted to be anastomosed to body tissue; a collar disposed on the
shaft, the shaft and collar being relatively movable, the collar
having an area configured to hold at least one needle adapted to be
passed through a vascular conduit supported by the shaft.
36. The device of claim 35, wherein the shaft comprises a tube with
a hollow interior configured to receive the vascular conduit.
37. The device of claim 36, wherein the tube has a cut-out section
for positioning the vascular conduit within the hollow interior of
the tube.
38. The device of claim 35, further comprising a sealing element
configured to engage an end of the vascular conduit.
39. The device of claim 38, wherein the sealing element comprises a
ring having a closed periphery.
40. The device of claim 38, wherein the sealing element has a
surface provided with at least one member for engaging an end of a
vascular conduit to hold the conduit on the sealing element.
41. The device of claim 40, wherein the sealing element has a
plurality of barbs for engaging an end of a vascular conduit.
42. The device of claim 35, wherein the distal end of the shaft has
at least one radially extending flange for supporting an end of a
vascular conduit.
43. The device of claim 42, wherein the distal end of the shaft has
a pair of radially extending flanges for supporting an end of a
vascular conduit.
44. The device of claim 35, wherein the collar has a proximal end,
a distal end, and a bore in which the shaft is slidably
mounted.
45. The device of claim 44, wherein the bore of the collar is
frictionally engaged with the shaft.
46. The device of claim 44, wherein the shaft has a guide element
along at least a portion of the exterior thereof, and the collar
has a slot slidably engaged with the guide.
47. The device of claim 44, wherein the area on the collar
configured to hold at least one needle comprises a sleeve
surrounding at least part of the shaft, and the sleeve is formed so
as to grip a needle placed therein.
48. The device of claim 47, wherein the sleeve is formed of a
resilient material.
49. A device for delivering a vascular conduit to body tissue
located at an anastomosis site within a patient's body, the device
comprising: an elongated shaft having a proximal end and a distal
end; the distal end of the shaft having a portion configured to
removably support a vascular conduit adapted to be secured to body
tissue located at an anastomosis site with a patient's body;
wherein said portion of the distal end of the shaft is configured
to deliver the conduit to the anastomosis site and thereafter
release the conduit.
50. A method for delivering a member adapted to be secured to body
tissue to a location adjacent the body tissue, the method
comprising steps of: placing suture through body tissue so that the
suture extends away from the body tissue, the suture having an end
which carries a needle; providing a delivery device comprising
first and second components mounted so as to be relatively movable;
positioning a member adapted to be secured to the body tissue on
the first component; placing the needle carried by the end of the
suture into the second component; and imparting relative movement
to the first and second components to move the first component and
the member along the suture to a location adjacent the body
tissue.
51. The method of claim 50, wherein the member is adapted to be
secured to the body tissue adjacent an opening in the body tissue,
and the suture passes through the body tissue adjacent the
opening.
52. The method of claim 50, wherein separate lengths of suture are
placed through the body tissue and extend through the opening and
through the tissue, each length of suture having an end which
carries a needle
53. The method of claim 52, wherein the member is adapted to be
secured over the opening in the body tissue, and the lengths of
suture extend through the opening and pass through the tissue at
locations spaced around the opening.
54. The method of claim 53, wherein the member is a vascular
conduit, and the opening in the body tissue is formed in a
patient's aorta, and the vascular conduit is moved along the suture
into contact with the aorta and then anastomosed thereto.
55. The method of claim 54, further comprising positioning a
sealing member between the first component and the vascular
conduit, and then securing the vascular conduit to the body tissue
with the sealing member therebetween.
56. The method of claim 55, further comprising the step of
measuring the size of the vascular conduit and selecting a
particular size sealing member.
57. The method of claim 50, wherein the opening in the tissue is
formed by a surgical cutting instrument comprising a plurality of
cutting surfaces configured to cut an opening in tissue having a
plurality of flaps.
58. The method of claim 56, wherein the cutting instrument
comprises four cutting surfaces and the opening has four flaps
59. An anastomosis system for securing a vascular conduit to a
hollow body structure, the system comprising: a needle passer
comprising a shaft assembly supporting at least one length of
suture secured to first and second needles, and an actuator for
moving at least one of the needles through tissue of a hollow body
structure to thread the length of suture through the tissue to
permit an end of a vascular conduit to be attached to the tissue in
fluid communication with the hollow body structure; and a sealing
element configured to be positioned against the end of the vascular
conduit, the sealing element being formed of a material that is
able to receive one of the first and second needles.
60. The system of claim 59, wherein the sealing element is
ring-shaped and is formed of a resilient material.
61. A device for use in anastomosing a vascular conduit to a hollow
body structure, the device comprising: a sealing element having an
opening configured to be aligned with a vascular conduit adapted to
be anastomosed to a hollow body structure, the sealing element
being formed of a biocompatible material which permits at least one
needle to be inserted and passed through the sealing element in
order to pass suture used to anastomose the vascular conduit to the
hollow body structure through the sealing element.
62. The device of claim 61, wherein the opening in the sealing
element is configured to surround an exterior surface of the
vascular conduit.
63. The device of claim 61, wherein the sealing element is
ring-shaped and is formed of a resilient material.
64. A method for anastomosing a vascular conduit to a hollow body
structure so that the vascular conduit is in fluid communication
with the interior of the hollow body structure, the method
comprising steps of: forming an opening in tissue of a hollow body
structure so that the opening passes into an interior of the body
structure; positioning an end of a vascular conduit against the
tissue; and attaching the vascular conduit to the tissue so that
the vascular conduit is in fluid communication with the interior of
the hollow body structure, wherein a sealing element is used to
enhance the attachment between the end of the vascular conduit and
the tissue.
65. The method of claim 64, wherein the end of the vascular conduit
is positioned against the tissue, and the sealing element is
positioned against the end of the vascular conduit to force the end
of the vascular conduit against the tissue.
66. The method of claim 65, wherein the sealing element is a ring
and the ring is positioned around the vascular conduit and forces
the end of the vascular conduit against the tissue.
67. A method of carrying out a surgical procedure on a hollow body
structure through which fluid is flowing, the method comprising
steps of: forming an opening passing through the hollow body
structure, the opening extending from an exterior surface of the
hollow body structure to an interior surface of the hollow body
structure; providing a tissue contacting member movable between
collapsed and expanded orientations, the tissue contacting member
being attached to an elongate support member; positioning the
tissue contacting member in said collapsed orientation through the
opening and adjacent the interior surface of the hollow body
structure; moving the tissue contacting member into said expanded
orientation and into contact with the interior surface of the
hollow body structure; and inserting an instrument through the
opening and into the hollow body structure to carry out a surgical
procedure on the hollow body structure, the tissue contacting
member substantially preventing fluid flowing through the hollow
body structure from escaping through the opening.
68. The method of claim 67, wherein the hollow body structure is a
patient's aorta, and the surgical procedure is carried out to
anastomose a vascular conduit to the aorta.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The invention relates primarily to devices and methods for
performing an anastomosis between a vascular conduit, such as a
vein, artery or artificial blood vessel, and a hollow body
structure, such as a patient's aorta. The invention, however, will
find use in various other applications, including, for example,
repairing atrial or ventricular septal defects, patent ductis
arteriosus, or closing vascular punctures, such as those created
during catheterization of a patient in order to perform
angioplasty, stenting or other endovascular procedures.
[0003] 2. Description of Related Art
[0004] Many devices and methods have been proposed for performing
an anastomosis (graft) between blood vessels. One of the most
common surgical procedures carried out today which requires
performing an anastomosis is coronary artery bypass grafting
(CABG), commonly referred to as bypass surgery. This procedure is
used to treat patients suffering from coronary disease in the form
of one or more coronary arteries that are partially or completely
blocked by stenoses. When blood flow through the coronary arteries
is restricted or occluded, the cardiac muscle tissue becomes
deprived of adequate blood flow, which eventually results in death
of the muscle tissue. Interventional procedures other than bypass
surgery, for example, angioplasty and atherectomy, are also used to
treat occluded coronary arteries. However, bypass surgery is
usually desirable or necessary to treat patients suffering from
severe or multiple coronary artery blockages, or when other
interventional procedures have been or would likely be
unsuccessful.
[0005] In order to bypass a blockage in a coronary artery, the
surgeon must anastomose a vascular conduit which is in
communication with a source of arterial blood to the coronary
artery at a location downstream of the blockage. The vascular
conduit may be a native artery carrying blood from the patient's
heart, for example, the right or left internal mammary artery
(IMA). In such case, the artery may be transected from the
patient's body to provide a free end which is prepared for distal
anastomosis to the coronary artery. Alternatively, the IMA may be
transected and removed from the body and one end prepared for
anastomosis to an arterial blood source and the other to a coronary
artery. Further, depending on the number of coronary arteries which
are blocked, in addition to using the right and/or left IMA, other
vascular conduits may be needed. One end of each conduit is
prepared for distal anastomosis to the coronary artery, while the
other end is prepared for proximal anastomosis to an arterial blood
source, for example, the aorta. The vascular conduits may be
harvested from the patient's body, suitable examples of which
include the left or right IMA, inferior epigastric artery, splenic
artery, subclavian artery, saphenous vein, etc. Also, animal or
synthetic vascular conduits may be used instead of or in addition
to those mentioned above.
[0006] The most common form of bypass surgery involves bypassing
blockages in multiple coronary arteries, e.g., quadruple, five or
six-way bypass procedures. As a result, most bypass procedures
require a number of vascular conduits to form the necessary
anastomoses. However, there is a limited number of native arterial
conduits available which may be used by simply attaching one end to
a blocked coronary artery. As such, it is usually necessary to use
free conduits or grafts, which requires forming an anastomosis at
both ends of each conduit, one end to an arterial blood source and
the other end to the blocked coronary artery. The patient's aorta
is a desirable arterial blood source to which the proximal end of
one or more conduits may be anastomosed. As is the case with all
other anastomoses, the surgeon must securely suture the proximal
end of each conduit to the patient's aorta in order to obtain a
strong, fluid tight connection, which is a highly technical and
time consuming procedure. Nevertheless, when performing bypass
surgery via conventional, open-chest procedures in which the
patient's sternum is split and retracted, the surgeon has
essentially unobstructed access to the heart and aorta, which
reduces the difficulty of forming the proximal anastomoses between
the vascular conduits and the patient's aorta.
[0007] During the last several years, however, there has been a
movement away from open-chest surgery toward minimally invasive
cardiac surgery. Some of the cardiac procedures presently being
performed in a minimally invasive manner include, for example,
coronary artery bypass, mitral or aortic valve repair or
replacement, and septal defect repair. These procedures are
typically carried out through incisions made between the ribs,
which requires surgeons to operate with considerably less access to
the heart and aorta as compared to open-chest procedures. This
reduced access to the heart has increased the difficulty and time
associated with forming the anastomoses between the vascular
conduits and the patient's arteries, and in particular, the
proximal anastomoses between the vascular conduits and the
patient's aorta. More specifically, the already highly technical
procedure of suturing the vascular conduits to the aorta or other
arterial blood source (as well as to the coronary arteries) is even
more difficult when the surgeon is operating through a small port,
e.g., an incision 3 or 4 inches in length. As a secure, fluid tight
anastomosis is highly desirable in order to provide long term
patency of the conduit bypassing the blockage, minimally invasive
cardiac surgery presents significant challenges for the
surgeon.
[0008] The devices and methods used in conventional open-chest
cardiac surgery, however, are not always usable or readily
adaptable to carry out minimally invasive cardiac surgery. In
addition, known devices that use staples to form an anastomosis
have had limited acceptance, perhaps due to the fact that suture is
the standard in cardiac surgery. Suture is biocompatible, flexible,
long-lasting, and well-accepted by cardiac surgeons. As a result,
there is a need in the art for improved devices and methods for
performing minimally invasive cardiac procedures, and in particular
forming anastomoses between vascular conduits and hollow body
structures by applying suture through ports or other openings
providing limited access to the body structure, and in which the
suture is applied in a relatively fast and automated manner to
produce a secure anastomosis which provides long term patency.
SUMMARY OF THE INVENTION
[0009] According to one aspect of the invention, a device is
provided for passing one or more needles through tissue. In one
preferred embodiment, the device includes a handle, a shaft
assembly supporting at least one needle, and an actuator assembly.
The needle is supported by the shaft assembly so as to be movable
between radially extended and non-extended positions. A protective
cover overlies the needle in the radially non-extended position and
is movable with respect to the shaft to permit the needle to assume
the radially non-extended position. An actuator assembly is
operable using one hand to move the cover to allow the needle to
assume the extended position and to pass the needle through
tissue.
[0010] In another preferred embodiment, the device includes a
handle and a shaft assembly supporting at least one needle so as to
be movable between radially extended and non-extended positions. An
actuator moves a ram from a first position to a second position to
move the needle to the radially extended position, and also passes
the needle through tissue.
[0011] In another preferred embodiment, the device includes a
handle and a shaft assembly supporting a plurality of needles and a
plurality of separate lengths of sutures, the needles being movable
between extended and non-extended positions. One end of each length
of suture is secured to one of the needles and the other end of
each length of suture is located away from the needles.
[0012] In more specific preferred embodiments, the handle assembly
of the device is preferably generally pistol shaped while the
actuator assembly comprises a trigger. This preferred construction
permits the device to be operated using one hand by grasping the
handle assembly in one hand and moving the trigger with one
finger.
[0013] In other specific preferred embodiments, the shaft assembly
removably supports first and second sets of needles secured to
separate lengths of sutures. Each length of suture has a needle
from the first set at one end and a needle from the second set at
an opposite end. A suture supporting tube is provided on the shaft
assembly to organize the lengths of suture and support the second
set of needles.
[0014] In other specific preferred embodiments, the device is
provided with a needle guard in the form of a shield surrounding
the needles and movable between expanded and collapsed
orientations. The shield expands as the needles assume their
radially extended orientation such that the shield is always
positioned exterior to the needle. This feature enables the device
to be used to pass the needles through tissue adjacent a medical
device that includes a portion capable of being punctured, with the
shield ensuring that the needles do not engage the portion or
component.
[0015] According to another aspect of the invention, a method is
provided for passing one or more needles through tissue adjacent an
opening in the tissue. In one preferred embodiment, the method
includes steps of providing at least first and second needles
secured to first and second lengths of suture, respectively. The
needles are positioned through an opening passing through a tissue
wall in a patient's body, and then are passed through the tissue
wall adjacent the opening so that each suture length has a portion
extending through the opening and a portion extending through the
tissue wall.
[0016] In another preferred embodiment, each of the first and
second lengths of suture have an end disposed away from the needles
to which the length of suture is secured. The first and second
needles are positioned inside a patient's body adjacent an opening
in tissue such that the ends of the first and second lengths of
suture are located outside an outer surface of the tissue. The ends
of the first and second lengths of suture are maintained outside
the outer surface of the tissue while the first and second needles
are passed into the tissue adjacent the opening, and then out of
the tissue to pull the first and second lengths of suture through
the tissue.
[0017] According to another aspect of the invention, a device is
provided for delivering a member adapted to be secured to a
patient's body tissue. The device includes a first component and a
second component mounted to the first component, the first and
second components being relatively movable. The first component is
configured to removably support a member adapted to be secured to a
patient's body tissue, while the second component is configured to
hold at least one needle carrying suture for securing the member to
the body tissue. The first component is relatively movable with
respect to the second component to move the member along the suture
into contact with the body tissue.
[0018] In one preferred embodiment, the first component is a shaft
and the second component is a collar movably mounted on the shaft.
A member adapted to be secured to body tissue is supported by the
shaft while the collar has an area configured to hold one or more
needles each carrying suture extending from the body tissue. After
the needles have been placed in the collar so as to pass through
the member supported on the shaft, a user imparts relative movement
to the shaft and collar to move the shaft and the member along the
suture into engagement with the body tissue.
[0019] In more specific preferred embodiments, the shaft is in the
form of a tube with a hollow interior configured to receive a
vascular conduit adapted to be anastomosed to the body tissue. The
vascular conduit is guided along the suture into contact with the
body tissue by imparting relative movement to the shaft and
collar.
[0020] According to yet another aspect of the invention, a method
is provided for delivering a member adapted to be secured to body
tissue. In one preferred embodiment, the method includes steps of
placing at least one length of suture through body tissue so that
the suture extends away from the body tissue, the suture having an
end which carries a needle, and providing a delivery device
including first and second components mounted so as to be
relatively movable. The member adapted to be secured to the body
tissue is positioned on the first component, and the needle carried
by the end of the suture is placed through the member into the
second component. Relative movement is imparted to the first and
second components to move the first component and the member along
the suture to a location adjacent the body tissue.
[0021] In more specific preferred embodiments, the member is
adapted to be secured to the body tissue adjacent an opening in the
body tissue, and separate lengths of suture are passed through the
body tissue adjacent the opening. The member may be adapted to be
secured over the opening in the body tissue, with the lengths of
suture passing through the tissue at locations spaced around the
opening. For example, the member may be a patch adapted to be
attached within a patient's heart to repair an atrial or
ventricular septal defect, or a valve adapted to be attached to a
patient's mitral or aortic valve annulus.
[0022] In other specific preferred embodiments, the member is a
vascular conduit adapted to be anastomosed to an arterial conduit
in the patient's body, for example, the aorta. Separate lengths of
suture are circumferentially disposed around an opening in the wall
of the aorta, with the two ends of each length of suture disposed
outside the patient's body and the portion connecting the ends
extending through the opening and then though the wall of the
aorta. One end of each of suture length is passed through the end
of the vascular conduit and the conduit is guided along the suture
until it contacts the wall of the aorta over the opening. The ends
of each suture length are knotted and the knots pushed against the
wall of the aorta to secure the end of the conduit thereto.
Alternatively, the sutures may be secured by clips or other
fasteners located adjacent the wall of the aorta.
[0023] In still another aspect of the invention, an anastomosis
system is provided for securing a vascular conduit to a hollow body
structure. In the preferred embodiment, the system includes a
needle passer comprising a shaft assembly supporting first and
second needles and at least one length of suture. An actuator moves
at least one of the needles and the length of suture through the
tissue of a hollow body. A sealing element configured to be
positioned against the end of the vascular conduit is also
provided, the sealing element being formed of a material that is
able to receive one of the first and second needles. In a specific
preferred embodiment, the sealing element is ring-shaped and is
formed of a resilient material.
[0024] In still another aspect of the invention, a device for use
in anastomosing a vascular conduit to a hollow body structure is
provided. In the preferred embodiment, the device comprises a
sealing element having an opening configured to be aligned with a
vascular conduit. The sealing element is formed of a biocompatible
material which permits at least one needle to be inserted and
passed through the sealing element, thereby permitting suture used
to anastomose the vascular conduit to the hollow body structure to
be passed through the sealing element.
[0025] In still another aspect of the invention, a method for
anastomosing a vascular conduit to a hollow body structure so that
the vascular conduit is in fluid communication with the interior of
the hollow body structure is provided. In the preferred embodiment,
the method comprises steps of forming an opening in the tissue of a
hollow body structure so that the opening passes into an interior
of the body structure, positioning an end of a vascular conduit
against the tissue, and attaching the vascular conduit to the
tissue so that the vascular conduit is in fluid communication with
the interior of the body structure. According to the invention, a
sealing element is used to enhance the attachment between the end
of the vascular conduit and the tissue.
[0026] According to yet another aspect of the invention, a cutting
instrument is provided for forming an access opening into a body
lumen or cavity, such as a blood vessel. The opening provides
access into the lumen or cavity while minimizing damage to the
lumen wall, which may occur, for example, during formation of the
opening or subsequent introduction of an instrument through the
opening. In one preferred embodiment, the cutting instrument
comprises a knife having a plurality of cutting surfaces arranged
to cut an opening in tissue having a plurality of flaps. The flaps
distribute the force exerted on the tissue over several locations
so that introducing an instrument through the opening is less
likely to propagate a tear along the cut lines.
[0027] According to yet another aspect of the invention, a
measuring device is provided for gauging the size of a hollow
member, such as a vascular conduit. The device includes a pair of
jaws provided with tips that contact the opposite inner surfaces of
the conduit. The jaws are relatively movable and are biased apart
to contact the inner surfaces of the conduit. A scale coupled to
the jaws provides a visual indication of the size of the internal
dimension of the conduit. In one preferred embodiment, a spring
biases first and second jaws apart, and an arm extends from the
second jaw and pivotally mounts a rotating scale provided with a
series of lumen sizes. The scale is coupled to the first jaw and
rotates about the pivot when the first jaw moves into contact with
the lumen of the conduit. A mark carried by the second arm
indicates the lumen size upon the tips of both jaws contacting the
inner lumen surfaces.
[0028] According to still another aspect of the invention, a device
and method for carrying out a surgical procedure on a hollow body
structure through which fluid is flowing is provided. In a
preferred embodiment, the method includes steps of forming an
opening passing through the hollow body structure which extendsfrom
an exterior surface to an interior surface of the hollow body
structure, providing a tissue contacting member movable between
collapsed and expanded orientations, the tissue contacting member
being attached to an elongate support member, and positioning the
tissue contacting member in the collapsed orientation through the
opening and adjacent the interior surface of the hollow body
structure. The tissue contacting member is moved into the expanded
orientation and into contact with the interior surface of the
hollow body structure, and an instrument is inserted through the
opening and into the hollow body structure to carry out a surgical
procedure on the hollow body structure, with the tissue contacting
member substantially preventing fluid flowing through the hollow
body structure from escaping through the opening. In a specific
preferred embodiment, the hollow body structure is a patient's
aorta, and the surgical procedure is carried out to anastomose a
vascular conduit to the aorta.
BRIEF DESCRIPTION OF THE DRAWING FIGURES
[0029] Other features, benefits and advantages of the invention
will be apparent from the detailed description of preferred
embodiments which follows, taken in conjunction with the
accompanying drawing Figures, wherein:
[0030] FIG. 1 is a perspective view of a needle passer constructed
according to one preferred embodiment of the invention;
[0031] FIGS. 2A-2D are enlarged perspective views of a portion of a
shaft assembly forming part of the needle passer shown in FIG. 1,
wherein the needle passer is shown, respectively, in an initial
position prior to actuation, a first stage of actuation, a second
stage of actuation, and a third stage of actuation;
[0032] FIG. 3 is a perspective view of the shaft assembly forming
part of the needle passer shown in FIG. 1;
[0033] FIG. 4 is an exploded perspective view of the shaft assembly
shown in FIG. 3;
[0034] FIG. 5 is an exploded perspective view of a handle and
actuator assembly forming part of the needle passer shown in FIG.
1;
[0035] FIG. 6A is an exploded perspective view of a portion of the
actuator assembly shown in FIG. 5;
[0036] FIG. 6B is a perspective view of the portion of the actuator
assembly shown in FIG. 6A with the components assembled;
[0037] FIG. 6C is an end elevation view of the portion of the
actuator assembly shown in FIG. 6B, looking at the rear of the
assembly; FIG. 6D is a perspective view of the portion of the
actuator assembly shown in FIG. 6B, including a trigger;
[0038] FIG. 6E is an end elevation view of the actuator assembly
shown in FIG. 6D, looking at the rear of the assembly;
[0039] FIG. 7 is a side elevation view of the needle passer shown
in FIG. 1, with part of the handle broken away and the device shown
in an initial position prior to actuation;
[0040] FIG. 8A is a side elevation view of the needle passer in the
position shown in FIG. 7, with the trigger shown in section and
part of the actuator assembly broken away;
[0041] FIG. 8B is a side elevation view isolating a portion of the
actuator assembly in the position shown in FIG. 8A;
[0042] FIG. 9A is a side elevation view of the needle passer shown
in FIG. 8A, with the device shown in a first stage of
actuation,
[0043] FIG. 9B is a side elevation view isolating a portion of the
actuator assembly in the position shown in FIG. 9A;
[0044] FIG. 10A is a side elevation view of the needle passer shown
in FIG. 9A, with the device shown in a second stage of
actuation;
[0045] FIG. 10B is a side elevation view isolating a portion of the
actuator assembly in the position shown in FIG. 10A;
[0046] FIG. 11 is a side elevation view of the needle passer shown
in FIG. 10A, with the device shown in a third stage of
actuation;
[0047] FIG. 12 is a perspective, schematic view of a patient's
chest with a port formed therein for carrying out a coronary artery
bypass procedure in a minimally invasive manner according to one
possible embodiment of the invention, with a portion of the chest
wall and a portion of the wall of the aorta broken away for
clarity;
[0048] FIG. 13 is a view corresponding to FIG. 12 showing an
incision formed in the patient's aorta according to the invention
and an aortic punch for forming the incision into an aortotomy;
[0049] FIG. 14 is an enlarged view of the incision shown in FIG. 13
and an instrument supporting the aortic punch adjacent the
incision:
[0050] FIGS. 15A and 15B are, respectively, front and end elevation
views of a tissue cutting instrument constructed according to a
preferred embodiment of the invention:
[0051] FIGS. 16A-16D are elevation views, partly in section,
illustrating forming an incision in the aorta and then forming the
incision into an aortotomy;
[0052] FIG. 17 is a view corresponding to FIG. 12, showing the
needle passer illustrated in FIG. 1 prior to its insertion into an
aortotomy for carrying out an anastomosis procedure according to
one embodiment of the invention;
[0053] FIG. 18 is an enlarged view of the needle passer shown in
FIG. 17 and an instrument supporting the needle passer adjacent the
aortotomy;
[0054] FIGS. 19A-19D are elevation views, partly in section,
showing the needle passer illustrated in FIG. 18 being used to pass
a first set of needles through the wall of the aorta according to
one embodiment of the invention;
[0055] FIGS. 20A and 20B are perspective and end views,
respectively, of a portion of the shaft assembly of a needle passer
constructed according to another embodiment of the invention which
includes a mechanism for shielding the needles;
[0056] FIGS. 21A-21C are side elevation views, partly in section,
showing the needle passer illustrated in FIG. 20A being used to
pass a first set of needles through the wall of the aorta according
to another embodiment of the invention;
[0057] FIG. 22A is an enlarged view of the needle passer shown in
FIG. 19D, illustrating a needle being removed from the needle
passer to thread a length of suture through the aortotomy and
tissue surrounding the aortotomy;
[0058] FIG. 22B is a sectional view of the needle passer shown in
FIG. 22A, taken along lines B-B in FIG. 22A;
[0059] FIG. 23 is a perspective view of the needle passer shown in
FIG. 22A, illustrating the length of suture carried by the removed
needle being secured to a suture organizer;
[0060] FIG. 24 is a perspective view of the needle passer shown in
FIG. 23 after all the needles have been removed and the lengths of
suture placed in the suture organizer;
[0061] FIG. 25 is a perspective view of the needle passer shown in
FIG. 24, illustrating withdrawing the needle passer through the
port in the patient's chest wall with the lengths of suture
extending from the needle passer, through the aortotomy, and
through the wall of the aorta back to the needle passer;
[0062] FIG. 26 is a perspective view of the needle passer shown in
FIG. 25, illustrating removing a needle from a second set of
needles carried by the needle passer, the second set of needles
being secured to the ends of the lengths of suture opposite the
ends held by the suture organizer;
[0063] FIG. 27 is a perspective view of the needle passer shown in
FIG. 26, illustrating placing the removed needle in a delivery
device for delivering a member adapted to be secured to body tissue
of a patient;
[0064] FIG. 28A is a perspective view of the delivery device shown
in FIG. 27;
[0065] FIG. 28B is a sectional view of the delivery device shown in
FIG. 28A, taken along lines B-B in FIG. 28A;
[0066] FIG. 29 is an exploded perspective view of the delivery
device shown in FIG. 28A;
[0067] FIG. 30A is a perspective view of a vascular conduit
positioned in the delivery device shown in FIG. 28A;
[0068] FIGS. 30B and 30C are perspective views showing,
respectively, placing needles from the second set through the end
of the vascular conduit and into the delivery device shown in FIG.
30A, and the configuration when all of the needles have been placed
through the end of the vascular conduit;
[0069] FIG. 30D is a perspective view illustrating the delivery
device shown in FIG. 30C being used to move the vascular conduit
along the lengths of suture;
[0070] FIG. 31 is a perspective view illustrating the delivery
device shown in FIG. 30D being used to move the vascular conduit
toward the aorta along the lengths of suture;
[0071] FIG. 32 is a perspective view of the delivery device shown
in FIG. 31, after the vascular conduit has been moved into contact
with the aorta;
[0072] FIG. 33 is a perspective view illustrating the delivery
device shown in FIG. 32 being withdrawn from the vascular conduit
with the suture lengths maintaining the conduit against the
aorta;
[0073] FIG. 34 is a perspective view corresponding to FIG. 33 after
the delivery device has been removed from the vascular conduit, and
after the lengths of suture and needles in the second set have been
removed from the delivery device and secured to the suture
organizer;
[0074] FIG. 35A is a perspective view corresponding to FIG. 34
after the opposite ends of each suture length have been secured to
form an anastomosis between the vascular conduit and the aorta;
[0075] FIG. 35B is a sectional view through the anastomosis shown
in FIG. 35A;
[0076] FIG. 36 is a perspective view of a needle passer constructed
according to another embodiment of the invention:
[0077] FIG. 37A is a side elevation view of the needle passer shown
in FIG. 36 with part of the device broken away, the device shown
prior to actuation;
[0078] FIG. 37B is a side elevation view of the needle passer shown
in FIG. 37A, with the device shown in a first stage of
actuation;
[0079] FIG. 37C is a side elevation view of the needle passer shown
in FIG. 37B, with the device shown in a second stage of
actuation;
[0080] FIG. 37D is a side elevation view of the needle passer shown
in FIG. 37C, with the device shown in a third stage of
actuation;
[0081] FIG. 38 is a perspective view of a needle passer constructed
according to another embodiment of the invention;
[0082] FIGS. 39A-39C are side elevation views, partly in section,
of a portion of the shaft assembly of a needle passer constructed
according to another embodiment of the invention, wherein the
needle passer is being used to pass a first set of needles through
the wall of an aorta;
[0083] FIGS. 40A-40C are side elevation views, partly in section,
of a portion of the shaft assembly of a needle passer constructed
according to still another embodiment of the invention, wherein the
needle passer is being used to pass a first set of needles through
the wall of an aorta;
[0084] FIG. 41 is a side elevation view of a device constructed to
one embodiment of the invention for measuring the inner diameter of
a tubular member, such as a vascular conduit;
[0085] FIG. 42 is a side elevation view of the device shown in FIG.
41, wherein the device is in a measuring position;
[0086] FIG. 43 is an end elevation view of the device shown in FIG.
41;
[0087] FIG. 44 is a side elevation view of a device constructed
according to another embodiment of the invention for measuring the
inner diameter of a tubular member, such as a vascular conduit;
[0088] FIG. 45 is a perspective view of a device constructed
according to the invention for occluding an opening in an aorta to
permit a surgical procedure to be carried out therein while blood
flows through the aorta; and
[0089] FIGS. 46A-46C are side elevation views, partly in section,
of the device shown in FIG. 45 being positioned through an opening
in an aorta.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0090] The present invention comprises various devices and
associated methods of using the devices to perform medical
procedures, and in particular minimally invasive surgical
procedures. One device is referred to as a needle passer and is
used to pass one or more needles through tissue. Another device is
referred to as a delivery device and is used to deliver a member
adapted to be secured to body tissue to a location adjacent the
tissue. Additional devices and methods are disclosed which may be
used with or without the needle passer or delivery device.
[0091] Referring to FIG. 1, a needle passer constructed according
to a first embodiment of the invention is designated generally by
the reference numeral 100 and comprises a handle 102 and a shaft
assembly 104 which is operated by an actuator assembly 106. The
needle passer 100 is preferably configured so that a user can grasp
and operate it using one hand. In the preferred embodiment, the
handle 102 is pistol-shaped and the actuator assembly 106 includes
a movable component that can be manipulated using one finger. The
preferred movable component comprises a trigger 108 which is
depressed in order to actuate the actuator assembly 106 and pass
one or more needles through tissue.
[0092] As shown best in FIGS. 2A-2D, the shaft assembly 104
supports one or more needles configured to be passed through
tissue. In the illustrated and preferred embodiment, the shaft
assembly 104 removably supports a first set of needles 110 each of
which is secured to a first end of a length of suture 112. A second
end of each suture length 112 is secured to one of a second set of
needles 114 which are removably supported by the shaft assembly
104. While the second ends of the suture lengths 112 are shown
secured to the second set of needles 114, they could alternatively
by secured to the shaft assembly 104, another portion of the needle
passer 100, a vascular conduit adapted to be secured to the tissue
or an element used to enhance the seal between the conduit and body
tissue.
[0093] As used herein, the term suture means any flexible or
substantially flexible filament or filament-like material suitable
for use in anastomosing tissue. The suture 112, in the preferred
embodiment, is 5-0 or 6-0 type suture, while the needles 110, 114
are preferably CC or CC-1 style straight cardiovascular needles.
The needles 110, 114, however, could instead have a bent, curved or
other nonlinear profile. In addition, while the illustrated
embodiment includes six needles in each set, any number of needles
may be used. The first and second sets of needles preferably
contain the same number of needles arranged in pairs disposed at
the opposite ends of each length of suture, although other
arrangements could be used. For example, a single needle could be
carried at one end of a suture length and passed through tissue and
grasped in order to traction the tissue. In this application, which
may be used to place one or more traction sutures in the
pericardium to allow its retraction to expose the heart, the
opposite end of each length of suture need not be secured to a
needle.
[0094] FIG. 2A shows the distal end of the shaft assembly 104 in an
orientation corresponding to an initial position of the needle
passer 100, wherein the needles 110 have not yet been oriented to
be passed through tissue. The needles 110 are supported on, a shaft
116 the distal end of which is provided with a collar 118 having
openings that receive and retain the needles 110. Each needle 110
extends through an opening in the collar 118 and is removably held
by an O-ring 120 located in an annular groove defined in the
collar. The O-ring 120 engages the exterior of each needle 110 to
frictionally retain it in the collar 118. The blunt end of each
needle 110 abuts the inner side of an atraumatically-shaped distal
end 122 of the collar, while the sharpened end of each needle is
disposed away from the distal end 122.
[0095] Each needle 110 is held in the collar 118 by the O-ring 120
so that it can be removed from the collar by pulling the needle
away from the distal end 122. Other structures, of course, may be
used to removably hold the needles 110. In the preferred
embodiment, the needles 110 are movable between radially extended
and non-extended positions. Thus, each of the openings in the
collar 118 extends radially a sufficient amount to permit the
needles 110 to move from the radially non-extended position shown
in FIG. 2A to a radially extended position shown in FIGS. 2C and
2D. The slots in the collar 118 preferably are configured to limit
or control the extent to which the needles 110 can move
radially.
[0096] The shaft assembly 104 is preferably provided with a
mechanism that protects the needles 110 when they are in their
radially non-extended position. In the illustrated and preferred
embodiment, the mechanism comprises a protective cover 124 in the
form of a sleeve slidably disposed over the shaft 116 so as to
overlie the needles 110; alternative structures, however, may be
used to protect the needles. As shown in FIGS. 1 and 2A, the cover
124 has a plurality of slots 126 through which the suture lengths
112 pass from the first set of needles 110 to the second set of
needles 114. In use, the trigger 108 of the actuator 106 is
depressed to move the cover 124 away from the distal end of the
shaft 116 and expose the needles 110, this position being shown in
FIG. 2B. Once exposed, the needles 110 are free to move into their
radially extended position for being passed through tissue. In the
preferred embodiment, the needles 110 are forced into their
radially extended position by a mechanism activated by the actuator
assembly 106. It will be recognized, however, that an alternative
manner of moving the needles 110 to their radially extended
position could be used. For example, the needles 110 could be
formed of a superelastic material and formed so that in an unbiased
state they are disposed away from the shaft 116, which results in
the needles moving radially away from the shaft 116 upon being
exposed by the cover 124. Alternatively, one or more spring members
(not shown) could be disposed on the shaft 116 to bias the needles
110 radially outward into a splayed configuration upon being
exposed by the cover 124.
[0097] In the preferred construction, the needles 110 are moved to
their radially extended position by a ram member slidably disposed
over the shaft 116. In the illustrated embodiment, the ram is in
the form of a sleeve 128 having a forward end 130 which contacts
and moves the needles 110 to their radially extended position. The
forward end 130 is preferably formed with a slight taper to
smoothly contact and move the needles 110. As explained above,
depressing the trigger 108 (from the position of FIG. 2A) causes
the actuator assembly 106 to retract the cover 124 which exposes
the needles 110, as shown in FIG. 2B. Further depressing the
trigger 108 (from the position of FIG. 2B) causes the actuator
assembly 106 to move the ram sleeve 128 toward the distal end of
the shaft 116 which moves the needles 110 to their radially
extended position, as shown in FIG. 2C. The actuator assembly 106
is preferably constructed so that the ram sleeve 128 does not move
forward into contact with the needles 110 until the cover 124 has
been fully retracted. If desired, the actuator assembly 106 may be
provided with a safety mechanism (not shown) to prevent inadvertent
actuation of the trigger 108.
[0098] Once in the position shown in FIG. 2C, with the cover 124
retracted and the ram sleeve 128 moved forward to force the needles
110 into their radially extended position, the needle passer 100 is
ready to pass the needles 110 through tissue. Further depressing
the trigger 108 (from the position of FIG. 2C) causes the actuator
to move the needles 110 in a proximal direction (toward the handle
102), as shown in FIG. 2D. The actuator 106 accomplishes this by
moving the shaft 116, the ram sleeve 128, and the cover 124
together in a proximal direction with respect to the handle 102,
and with respect to a suture tube 132 which forms the outermost
member of the shaft assembly 104 and is fixed to the handle 102.
The suture tube 132 is provided with a foot 134 at its distal end
which rests on tissue opposite the surface of the tissue through
which the needles 110 pass as they move to the position of FIG. 2D.
The foot 134 includes a plurality of radially extending fingers 136
separated by gaps that receive the needles 110 after they have
passed through the tissue. The gaps between the fingers 136 of the
foot 134 also receive the suture lengths 112 which extend to the
second set of needles 114.
[0099] In the preferred construction, the suture tube 132 secures
the shaft assembly 104 to the handle 102, and also supports the
second set of needles 114 and organizes the suture lengths 112
extending between the first and second sets of needles. The suture
tube 132 comprises a suture organizer portion 138 defining a
plurality of channels 140 each of which receives a suture length
112, the suture preferably being coiled in the channel. An outer
sleeve 142 is secured to the tube 132 so as to enclose the channels
140 along the length thereof to retain the suture lengths 112. An
alternative construction of the suture tube 132 could include
separate tubes respectively disposed in each channel 140, each tube
receiving a length of suture. In this embodiment the outer sleeve
142 could be used to secure the tubes in the channels 140, or it
could be omitted if the tubes are otherwise secured in the
channels.
[0100] The suture tube 132 preferably has an O-ring 144 which the
ends of needles 114 may be placed into (or under) so as to be
removably held by the tube 132. As shown in FIG. 2A, each suture
length 112 passes through a slot 126 in the cover 124 and around a
finger 136 of the foot 134, extends along the length of a channel
140 toward the handle 102, and then loops around and extends back
to where it is attached to one of the second set of needles 114.
Thus, when a needle 110 that has been passed through tissue is
pulled completely through the tissue and away from the collar 118,
the suture length 112 attached to the needle uncoils in the channel
140 and is threaded through the tissue.
[0101] FIGS. 3 and 4 show the shaft assembly 104 and illustrate the
relationship between the relatively movable components thereof. As
shown in FIG. 3, the shaft 116, ram sleeve 128 and cover 124 are
slidably nested one within the other. These three nested components
are slidably disposed within the suture tube 132. The suture tube
132 has a flange 146 adjacent its proximal end which is fixed
within a barrel portion 148 of the handle 102 (FIG. 1). As shown in
FIG. 5, the preferred handle 102 comprises first and second
portions 150, 152 secured in a side-by-side manner. The handle
portions 150, 152 have grooves 154 which cooperate to form an
annular groove in which the flange 146 of the suture tube 132 is
fixed by any suitable means.
[0102] The handle portions 150, 152 may be secured together in any
known manner, for example, the portions may be provided with mating
apertures 156 that receive threaded fasteners 158. The handle
portions 150, 152 are preferably formed of injection molded plastic
with the apertures 156 threaded to receive fasteners 158. Although
the illustrated handle 102 is formed by separate pieces secured
together, it could instead be formed of a single piece. The handle
portions 150, 152 are preferably shaped so that the needle passer
100 has a generally pistol-shaped configuration which may be
grasped in one hand, as shown in FIG. 1. However, while a
pistol-shaped handle is preferred and illustrated, it will be
recognized that other configurations may be used, such
configurations preferably permitting the needle passer to be
grasped and operated using one hand.
[0103] Each handle portion 150, 152 has a recess 160 configured to
receive part of the shaft assembly 104, as well as the actuator
assembly 106 which actuates the shaft assembly to the different
illustrated positions. FIGS. 5 and 6A-6D show a preferred
embodiment of the actuator assembly 106. It should be recognized,
however, that alternative assemblies or mechanisms for moving the
shaft assembly 104 between its various positions may be utilized
without departing from the basic concepts and principles behind the
invention.
[0104] The preferred actuator assembly 106 comprises a cover driver
162 which engages and moves the cover 124 to expose the needles
110. The preferred cover driver 162 comprises a body portion 164
and a bracket 166 which engages a flange 168 formed on the cover
124 (FIGS. 4 and 7). The bracket 166 includes first and second
spaced plates 170, 172 defining a gap 174 which receives the flange
168 of the cover 124 in a secure manner, for example, by a friction
fit, adhesive, etc. The plates 170, 172, respectively, have
cut-outs 176, 178 through which the tubular body of cover 124
passes (FIG.7).
[0105] Referring to FIGS. 5 and 6A-6E, the actuator assembly 106
also comprises a ram driver 180 which engages and moves the ram
sleeve 128 to move the needles into their radially extended
position. In the preferred embodiment, the ram driver 180 comprises
a body portion 182 and a bracket 184 which engages a flange 186
formed on the ram sleeve 128 (FIGS. 4 and 7). The bracket 184 is
similar to bracket 166 and includes first and second spaced plates
188, 190 defining a gap 192 which receives the flange 186 of the
cover 124 in a secure manner, preferably in the same manner that
the bracket 166 of cover driver 162 is secured to the flange 168 of
the cover 124. The plates 188, 190, respectively, have cut-outs
194, 196 through which the tubular body of ram sleeve 128 passes.
The cover 124 and the ram sleeve 128 are fixed, respectively, to
the cover driver 162 and the ram driver 180, and thus are moved
when the cover and ram drivers are moved by the actuator assembly
106 upon depressing the trigger 108.
[0106] The ram driver 180 has a ledge 198 which sits on an upper
edge 200 of the cover driver 162 so that the two components slide
with respect to one another during actuation of the needle passer
100 (FIG. 6A). In order to transmit motion from the trigger 108 to
the cover driver 162 and the ram driver 180, the actuator assembly
106 includes a transmission 202 which comprises a linkage housing
204 and a rotary linkage 206. In the illustrated embodiment, the
linkage housing 204 comprises a first housing member 208 and a
second housing member 210 secured together by any suitable means;
however, for manufacturing reasons it may be desirable to form the
housing 204 of a single piece. The rotary linkage 206 has a bore
212 which receives a pin 214 rotatably secured in a bore 216 in the
first housing member 208. The rotary linkage 206 and pin 214 rotate
with respect to the linkage housing 204. The rotary linkage 206 is
preferably formed as a portion of a cylinder having an outer
surface 218 which slides along a complementarily shaped surface 220
provided on the second housing member 210 of the linkage housing
204.
[0107] The rotary linkage 206 is coupled to the cover driver 162
and the ram driver 180 so that rotating the linkage 206 within the
linkage housing results in linear movement of the cover 124 (fixed
to the bracket 166 of cover driver 162) and the ram sleeve 128
(fixed to the bracket 184 of ram driver 180). In the preferred
embodiment, as shown in FIGS. 6A-6E, the rotary linkage 206 has a
first bore 222 containing a pin 224 engaged with a slot 226 in the
body portion 164 of the cover driver 162. Rotating the linkage 206
thus drives the pin 224 against the slot 226 to move the cover
driver 162. Similarly, the rotary linkage 206 has a second bore 228
containing a pin 230 engaged with a slot 232 in the body portion
182 of the ram driver 180. Thus, rotating the linkage 206 also
drives the pin 230 against the slot 232 to move the ram driver
180.
[0108] The rotary linkage 206 is rotated by depressing the trigger
108 which sequentially moves the shaft assembly 104 from the
position shown in FIG. 2A to the position shown in FIG. 2D. In
particular, with reference to FIGS. 5, 6D and 6E, the trigger 108
comprises opposite side walls 234, 236 which define a hollow
interior that receives the cover driver 162, the ram driver 180,
and the transmission 202 (i.e., the linkage housing 204 and the
rotary linkage 206). A pin 238 is mounted in a bore 240 formed in
one of the trigger side walls 234, 236 and passes through a slot
242 formed in the rotary linkage 206 (FIG. 6D). As such, depressing
the trigger 108 drives the pin 238 against the slot 242 to rotate
the rotary linkage 206 within the linkage housing 204.
[0109] The preferred actuator assembly 106 is constructed so that
depressing the trigger 108 rotates the rotary linkage 206 when
moving the shaft assembly 104 from the position shown in FIG. 2A to
the position shown in FIG. 2B and from the position shown in FIG.
2B to the position shown in FIG. 2C, but not from the position
shown in FIG. 2C to the position shown in FIG. 2D. That is, the
rotary linkage 206, rotates within the linkage housing 204 only
when the actuator assembly 106 moves the cover 124 to expose the
needles 110 and moves the ram sleeve 128 to force the needles 110
into their radially extended position. In order to move the needles
110 with respect to the handle 102 and suture tube 132, depressing
the trigger 108 does not rotate the linkage 206, but instead moves
the entire actuator assembly (cover driver 162, ram driver 180,
linkage housing 204 and rotary linkage 206) within the handle
102.
[0110] Moving the entire actuator assembly 106 within the handle
102 also moves the needles 110 because the shaft 116 which carries
the needles is secured to the linkage housing 204. In the preferred
embodiment, the proximal end of the shaft 116 is provided with
threads 244 (FIG. 4) which engage a threaded bore 246 provided in
the linkage housing 204 (FIG. 6A). The shaft 116, of course, may be
secured to the linkage housing 204 by other means, for example, the
end of the shaft 116 may be otherwise configured to be secured in a
bore in the linkage housing. One benefit of the threaded end 244 is
that it permits fine adjustment of the position of the shaft 116 in
the linkage housing 204 (and thus the relative position of the
needles 110 and foot 134) upon assembling the components of the
needle passer, thereby compensating for manufacturing tolerances of
the components.
[0111] Referring now to FIGS. 5 and 7-11, the actuator assembly 106
is provided with a mechanism for controlling whether depressing the
trigger 108 rotates the rotary linkage 206 within the linkage
housing 204 (to expose and then move the needles 110 into their
radially extended position), or moves the linkage housing 204 and
the shaft 116 with respect to the handle 102 (to pass the needles
110 through tissue). The preferred mechanism comprises a rail 248
having a bore 250 in which a lock pin 252 is positioned. The rail
248 is secured to the handle 102 (or, alternatively, formed
integrally with the handle) so as to be immovable with respect to
the handle. While the lock pin 252 can move vertically within the
bore 250 of rail 248, it is prevented from moving along the
direction indicated by arrow A. The lock pin 252 has an end 254
which extends into a notch 256 formed in the underside of the
linkage housing 204 (FIG. 8A). Thus, when the end 254 of lock pin
252 engages the linkage housing 204, as shown in FIG. 8A, the
linkage housing is prevented from moving with respect to the handle
102 along the direction of arrow A. The lock pin 252 has an
opposite end 258 which is biased into engagement with a bottom wall
260 of the trigger 108 by a spring 262, when the actuator assembly
106 is in the position of FIG. 8A.
[0112] FIGS. 8A and 8B illustrate the needle passer 100 (with
handle portion 150 omitted for clarity) in a position where the
cover 124 overlies the needles 110 and the ram 128 is retracted.
The cover driver 162 is positioned within the handle recess 160 so
that the cover 124 extends to the collar 118 and overlies the
needles 110. The ram driver 180 is positioned so that the ram
sleeve 128 is retracted out of engagement with the needles 110.
FIG. 8B is an isolation view showing the rotary linkage 206 in
engagement with the cover and ram drivers 162, 180, as they are
positioned in FIG. 8A. The rotary linkage 206 is in its initial
position, i.e., prior to being rotated along the direction
indicated by arrow B by depressing the trigger 108 in the direction
of arrow A. For purposes of explanation, movement of the trigger
108 and, the actuator assembly 106 is broken into three stages. In
operation though, the trigger 108 is depressed continuously so that
the actuator assembly 106 retracts the cover 124, moves the ram
sleeve 128 forward, and retracts the needles 110 in a smooth,
uninterrupted manner. However, if desired, the actuator assembly
106 may be provided with detents or other structure (not shown)
which provides an audible or tactile indication when the trigger
108 reaches one or more of the aforementioned stages.
[0113] FIGS. 9A and 9B illustrate the needle passer 100 in a first
stage of actuation wherein the cover 124 has been retracted by
depressing the trigger 108 a first extent in the direction of arrow
A. It should be noted that the actuator assembly 106 is preferably
provided with a mechanism for preventing movement of the shaft
assembly 104 in an opposite direction once actuation has started.
The preferred mechanism comprises a pawl 266 carried in a notch 268
formed in the trigger 108. The pawl 266 is biased by a spring 270
into engagement with a ratchet 272 secured to (or formed integrally
with) the handle 102. The pawl 266 and ratchet 272 prevent the
trigger 108 from moving opposite the direction of arrow A (FIG.
7).
[0114] To reach the position of FIG. 9A, the trigger 108 is
depressed from the position of FIG. 8A which forces the drive pin
238 against the slot 242 in the rotary linkage 206 to rotate the
linkage in the direction of arrow B (keeping in mind that the
linkage housing 204 is prevented from moving because it is fixed to
the rail 248 by the lock pin 252). Rotation of the rotary linkage
206 drives the pin 224 against the slot 236 in the cover driver
162, which moves the cover driver in the direction of arrow A. This
retracts the cover 124 from the position of FIG. 8A to the position
of FIG. 9A due to the flange 168 of the cover 124 being fixed to
the bracket 166 of the cover driver 162.
[0115] As the rotary linkage 206 rotates from the position of FIG.
8A to the position of FIG. 9A, the pin 224 moves the cover driver
162 (and cover 124) in the direction of arrow A. This is because
during such rotation the location of the pin 224 on the rotary
linkage 206 remains below the horizontal axis of the pivot pin 214
(as viewed in the Figures). In addition, the primary component of
the motion of pin 224 is horizontal due to the initial location of
the pin 224 on the rotary linkage 206 (approximately seven o'clock,
as seen best in FIG. 8B). As an example, in the preferred and
illustrated embodiment, the rotary linkage 206 rotates in a
counter-clockwise direction approximately 25.degree. in moving from
the position of FIG. 8B to the position of FIG. 9B (with the slot
242 moving from an initial position of approximately 35.degree.
below horizontal to approximately 60.degree. below horizontal).
[0116] Rotating the rotary linkage 206 from the position of FIG. 8A
to the position of FIG. 9A also moves the pin 230 in the slot 232
of the ram driver 180. The pin 230 moves in the direction of arrow
A because during such rotation it too remains below the horizontal
axis of the pivot pin 214, as seen best in FIG. 9B. This results in
the ram driver 180 (and ram sleeve 128) moving in the direction of
arrow A, as can be seen by comparing the positions of the ram
driver bracket 186 in FIGS. 8A and 9A. However, the distance that
the ram sleeve 128 is retracted is small due to the initial
location of the pin 230 on the rotary linkage 206 (approximately
four o'clock in FIG. 8B). The primary component of the motion of
pin 230 thus is vertical as the pin 230 travels within the slot 232
of the ram driver 182. Nonetheless, the ram sleeve 128 is moved
away from the needles 110 before it is moved toward the needles. At
the conclusion of this rotation of the rotary linkage 206, the pin
230 is located substantially at the horizontal axis of the pivot
pin 214 (FIG. 9B).
[0117] FIGS. 10A and 10B illustrate the needle passer 100 in a
second stage of actuation achieved by depressing the trigger 108 a
second extent in the direction of arrow A. Further rotation of the
rotary linkage 206 from the position of FIG. 9A to the position of
FIG. 10A drives the pin 224 against the slot 226 in the cover
driver 162, resulting in the cover driver continuing to move in the
direction of arrow A. Thus, the cover 124 continues to be retracted
as the rotary linkage 206 is moved from the position of FIG. 9A to
the position of FIG. 10A. This is due to the pin 224 remaining
below the horizontal axis of the pivot pin 214 during additional
rotation of the rotary linkage 206.
[0118] Further rotation of the rotary linkage 206 from the position
of FIG. 9A to the position of FIG. 10A also moves the pin 230 in
the slot 232 of the ram driver 180. However, because at the start
of this additional rotation the pin 230 is located substantially at
the horizontal axis of the pivot pin 214 (FIG. 9B), the pin 230 and
the ram driver 180 are moved in a direction opposite to that
indicated by arrow A. As a result, the ram sleeve 128 is moved
forward toward the needles 110. The first part of the movement of
the ram sleeve 128 makes up for the distance it was retracted when
the ram driver 180 was moved from the position of FIG. 8A to the
position of FIG. 9A. After making up this distance, the ram sleeve
128 starts to achieve a positive gain, i.e., the distance between
the needles 110 and the initial position (FIG. 8A) of the ram
sleeve begins to decrease. When the trigger 108 and ram driver 180
reach the position shown in FIG. 10A, the ram sleeve 128 is fully
engaged with the needles 110 to force them into their radially
extended position.
[0119] In moving from the position shown in FIG. 9A to the position
shown in FIG. 10A, the primary component of the motion of the ram
driver 180 and ram sleeve 128 is horizontal, as can be seen by
comparing the positions of the pin 230 in FIGS. 9B and 10B.
Consequently, in a relatively short period of time the ram sleeve
128 makes up the distance that it was previously retracted and
starts to achieve a positive gain. However, the cover 124 is being
retracted during the time the ram sleeve 128 is moving but not
achieving a positive gain, which further ensures that the needles
110 will not be forced into their radially extended position until
the cover has been sufficiently retracted. As an example, in the
preferred and illustrated embodiment, the rotary linkage 206
rotates in a counter-clockwise direction approximately 25.degree.
from the position shown in FIG. 9B before the ram sleeve 128 begins
achieving a positive gain toward the needles 110, and then
approximately an additional 50.degree. in moving to the position
shown in FIG. 10B (with the slot 242 moving from approximately
60.degree. below horizontal to a final position of approximately
135.degree. below horizontal).
[0120] While a rotary linkage is the mechanism used to transmit
motion from the trigger 108 to the components of the shaft assembly
106 in the illustrated and preferred embodiment, it should be
appreciated that other actuator mechanisms may be used, for
example, a bar linkage coupling the trigger and the ram and cover
drivers.
[0121] The actuator assembly 106 is next operated to pass the
needles 110 through tissue. At this point it is desirable to lock
the cover 124 in its retracted position and the ram sleeve 128 in
its forward position, thereby ensuring that the needles 110 remain
in their radially extended position as they are passed through
tissue. Thus, the needle passer 100 preferably includes a mechanism
for fixing the relative position of the cover 124, ram sleeve 128
and shaft 116. In the illustrated embodiment, the mechanism
comprises a bullet 274 disposed in a blind bore 276 formed in the
outer surface 218 of the rotary linkage 206 (FIGS. 8A-11A). The
bullet 274 is biased radially outward against the surface 220 of
the linkage housing member 210 by a spring disposed in the bore
276.
[0122] As the rotary linkage 206 moves from the position of FIG. 8A
to the position of FIG. 9A, the bullet 274 slides along the lower
portion of the surface 220 of the linkage housing member 210. When
the rotary linkage 206 moves into the position of FIG. 10A,
however, a portion of the bullet 274 moves into a notch 278 formed
in the surface 220 of linkage housing member 210. The notch 278 is
located so that it is aligned with the bullet 274 at the moment the
ram 128 fully moves the needles 110 to their radially extended
position. Once a portion of the bullet 274 enters the notch 278,
the rotary linkage 206 is locked against rotation with respect to
the linkage housing 204.
[0123] Locking the rotary linkage 206 to the linkage housing 204
also locks both the cover driver 162 (and cover 124) and the ram
driver 180 (and ram sleeve 128) to the linkage housing 204. The
shaft 116 carrying the needles 110 is fixed to the linkage housing
204 via the threads 244 received in the bore 246 in housing member
210. As a result, the relative position of the cover 124, ram
sleeve 128, shaft 116 and needles 110 is fixed as soon as the
bullet 274 engages the notch 278, i.e., when the needle passer 100
has reached its second stage of actuation (FIGS. 10A and 10B). It
will be appreciated by persons skilled in the art that mechanisms
other than that illustrated may be used to fix the relative
position of the cover 124, ram sleeve 128 and shaft 116 prior to
passing the needles 110 through tissue.
[0124] Once the needles 110 are ready to be passed through tissue,
as shown in FIG. 10A, the mechanism described above for controlling
whether depressing the trigger 108 rotates the rotary linkage 206
within the linkage housing 204, or moves the linkage housing 204
and the shaft 116 with respect to the handle 102, is actuated.
Depressing the trigger 108 to the extent shown in FIG. 10A seats
the bullet 274 in the notch 278 of the linkage housing 204, as
described above, and simultaneously moves the lock pin 252 out of
engagement with the notch 256 in the linkage housing. This occurs
because a slot 280 in the lower wall 260 of the trigger 108 becomes
aligned with the lock pin 252 carried by the rail 248. The lock pin
252 is now free to move vertically within the bore 250 of rail 248.
The spring 262 biasing the lock pin 252 toward the trigger 108 now
moves the end 258 of the lock pin into the trigger slot 280, which
moves the other end 254 of the lock pin out of the notch 256 in the
linkage housing 204. This frees the linkage housing 204 for
movement with respect to the rail 248 and the handle 102.
[0125] Thus, when the trigger 108 is depressed from the position
shown in FIG. 10A to the position shown in FIG. 11, the lock pin
252 moves freely within the trigger slot 280. As before, this
drives the pin 214 against the slot 242 in the rotary linkage 206,
which is now locked against rotation within the linkage housing 204
by the bullet 274 and the notch 278. However, as the linkage
housing 204 is no longer locked to the rail 248, depressing the
trigger 108 moves the rotary linkage 206 linearly, which in turn
moves the linkage housing 204 in the direction of arrow A. This
moves the shaft 116 and the needles 110 in the direction of arrow A
to pass the needles through tissue. When the needles 110 have
reached their fully retracted position shown in FIG. 11, the
trigger 108 cannot be further depressed due to the linkage housing
204 abutting the rear wall of the recess 160 in the handle 102. The
trigger 108 cannot be moved in the opposite direction due to the
pawl 266 engaging ratchet 272. Therefore, the needles 110 are
locked in their retracted position upon passing through the
tissue.
[0126] The various components of the needle passer 100 may be
formed of any suitable materials. For example, in a preferred
embodiment, the shaft 116 which carries the needles 110, and the
ram sleeve 128 are metal, e.g., machined or extruded stainless
steel, while the remaining components are plastic, e.g., injection
molded polycarbonate or ABS. It should be appreciated that
alternative materials may be used if desired. In addition, the
needle passer is preferably manufactured as a disposable
instrument, although it may comprise one or more reusable portions.
For example, the handle and actuator assembly could be reusable and
removably coupled to a disposable shaft assembly.
[0127] Further, the size and specific configuration of the needle
passer 100 may also be varied depending on the application and the
user's preferences. In the illustrated and preferred embodiment,
the needle passer 100 is designed for use in minimally invasive
procedures and is sized and configured to be grasped in one hand
and manipulated to pass at least the shaft assembly 104 into a
patient through a relatively small (e.g., 3 or 4 inches) port or
other access opening. As an example, the height, length and
thickness of the handle 102 may be, respectively, 4.195, 4.818 and
0.310 inches. The length and outside diameter of the shaft 116 may
be, respectively, 11 and 0.125 inches, while the length, outside
diameter and inside diameter of the ram 128 may be, respectively,
9.241, 0.148, and 0.135 inches. The length, outside diameter and
inside diameter of the cover 124 may be, respectively, 9.040, 0.168
and 0.156 inches, while the length and outside diameter of the
suture tube 132 may be, respectively, 10.25 and 0.396 inches.
[0128] In addition, the preferred actuator assembly 106 is
constructed so that depressing the trigger 108 from its initial
position (FIG. 8A) to its final position (FIG. 11A) results in the
shaft 116 moving approximately 0.620", the ram 128 moving
approximately 0.375" (i.e., net movement toward the distal end of
the needle passer), and the cover 124 moving approximately 0.510".
It should be recognized that the preferred size and configuration
of the various components are exemplary only and may be varied by
persons skilled in the art without departing from the principles of
the invention.
[0129] The needle passer of the present invention will now be
described in connection with one preferred application, namely,
carrying out an anastomosis procedure to secure a vascular conduit,
such as a blood vessel harvested from a patient's body, to a hollow
body structure, such as a patient's aorta. It will be appreciated
by persons skilled in the art, however, that this is only one of
many possible applications for the needle passer of the invention.
Accordingly, the description which follows should not be construed
as limiting the environment or procedures in which the needle
passer may be utilized.
[0130] Further, while in the exemplary, illustrated application the
needle passer is utilized with additional devices constructed
according to other aspects of the invention, it will be recognized
that the devices may be utilized separately to carry out various
medical procedures. Similarly, it will be appreciated that the
needle passer may be used with additional devices and methods, for
example, the devices and methods for performing anastomosis
disclosed in co-pending application Ser. No. 08/759,110, filed Dec.
2, 1996 and entitled SURGICAL STAPLING INSTRUMENT AND METHOD, the
subject matter of which is incorporated by reference.
[0131] Referring now to FIG. 12, a patient's chest is shown with a
port P formed in the chest wall, the port preferably passing
through an intercostal space defined between adjacent ribs (not
shown). The size and location of the port P, however, may be varied
from that shown in the Figures. A portion of the patient's chest
wall is broken away for clarity to expose the heart H and aorta A,
both of which may be accessed through the port P in order to carry
out a coronary artery bypass grafting procedure. The aorta A, a
portion of which is broken away for clarity, is occluded by an
aortic occlusion device comprising an expandable member in the form
of a balloon 10 supported by a catheter shaft 12. The aortic
occlusion device may be constructed as disclosed in co-pending
application Ser. No. 08/782,113, the subject matter of which is
hereby incorporated by reference. The aortic occlusion device is
used to block the flow of blood through the aorta in order to place
the patient on cardiopulmonary bypass (CPB), which may be
established, for example, as disclosed in the aforementioned
co-pending application, or as disclosed in U.S. Pat. No. 5,584,803,
the subject matter of which is hereby incorporated by
reference.
[0132] In order to provide easier access to the heart H and the
aorta A, a retractor (not shown) may be used to spread the opposite
sides of the incision forming the port P. A retractor may be used
which spreads the patient's ribs and the sides of the incision a
sufficient amount to permit the surgeon to visualize the heart and
aorta. For example, the retractor disclosed in co-pending, commonly
owned application Ser. No. 08/911,877, filed Aug. 15, 1997 and
entitled SURGICAL RETRACTOR, the subject matter of which is hereby
incorporated by reference, may be positioned in the port P to
spread the ribs and lift one side of the incision with respect to
the other side of the incision, thereby providing the surgeon ample
access to the aorta in order to perform the anastomosis.
Alternatively, the needle passer may be used without a retractor by
being positioned through the port.
[0133] A suture organizer is preferably provided for organizing the
suture used to anastomose a vascular conduit to the aorta A. The
illustrated organizer is in the form of a ring 20 with a plurality
of suture holding areas 22 configured to removably retain suture by
any suitable means, e.g., friction, clamps, adhesive, etc. A
plurality of tabs 24 extend from the ring 20 and are secured to the
patient's chest. The tabs 24 preferably are flexible strips of
fabric or other material and carry adhesive for removable
attachment to the patient's skin (or a surgical film or drape
disposed over the skin). The ring 20 defines a central opening that
overlies the port P such that instruments positioned through the
port P pass through the ring. This permits easy attachment of
suture extending from inside the patient's body and through the
port P to the holding areas 22 on the ring 20.
[0134] Referring to FIG. 13, an aortic punch 30 is positioned
through the port P and includes a handle 32 and an actuator 34. The
actuator 34 is depressed to move a punch head 36 with respect to an
anvil 38 to cut tissue surrounding the head 36. FIGS. 13 and 14
show the punch head 36 located adjacent an incision I in the wall
of the aorta A. The incision is preferably formed by a cutting
instrument 50 comprising a plurality of blades 52 supported by a
shaft 54, as shown in FIGS. 15A and 15B. The instrument 50 is
designed to cut an incision in tissue to provide an opening into a
lumen or cavity while minimizing damage to the lumen wall which may
be caused, for example, by forming the incision or inserting an
instrument through the formed incision.
[0135] The blades 52 of the instrument 50 each have a cutting
surface 56 which is tapered to a point for cutting through tissue
to form an incision I having flaps connected to the tissue at
several points. The incision I has increased surface area and
additional points of attachment between the flaps and surrounding
tissue, as compared to an incision made by a single blade, and thus
is less likely to tear along the incision lines. That is, the force
exerted on the tissue by inserting an instrument through the
incision is distributed over a wider area in an incision formed by
the instrument 50 than an incision formed by a single blade. In the
illustrated embodiment, the instrument 50 has four blades which
form a cut having four flaps; however, it will be appreciated that
an alternative number or configuration of blades may be used, for
example, three blades.
[0136] The cutting instrument 50 is used to form the incision I in
the wall of the aorta as shown in FIG. 16A, with the position of
the balloon 10 of the endoaortic clamp preferably being monitored
by any suitable technique, for example, fluoroscopy or
transesophageal echocardiogram (TEE), to ensure that the cutting
instrument 50 does not contact the balloon 10. An alternative way
to prevent such contact is to secure the position of the balloon in
the aorta A. This can be accomplished in various ways, for example,
by placing an instrument around the aorta A which engages and holds
the balloon 10 in place, or by using an instrument which constricts
the aorta between the balloon and the location of the anastomosis
to a size that does not permit the balloon to pass. In each case
the balloon 10 is prevented from migrating within the aorta A
toward the anastomosis area.
[0137] The instrument 50 is used to form the incision I in the wall
of the aorta and removed through the port P. The aortic punch 30 is
then inserted through the port P and the punch head 36 is
positioned next to the incision I. As shown in FIG. 14, the aortic
punch 30 may be supported by an instrument 40 resting on the outer
wall of the heart H. With reference to FIGS. 16B-16D, the punch
head 36 is placed through the incision into the interior of the
aorta A with the anvil 38 located just outside the wall of the
aorta. The actuator 34 is then depressed with respect to the handle
32 so that the punch head 36 moves into the anvil 38 and cuts
through the wall of the aorta. This results in the punch head 36
and anvil 38 cooperating to cut an opening in the wall of the
aorta, preferably in the form of a circular aortotomy O configured
to be anastomosed to an end of a vascular conduit (not shown in
FIGS. 16A-16D).
[0138] In the illustrated application, the needle passer 100 is
positioned as shown in FIGS. 17 and 18 so that the shaft assembly
104 extends through the port P to a location adjacent the aortotomy
O. The needle passer 100, and in particular the distal end of the
shaft assembly 104, may be supported by an instrument 40 resting on
the outer wall of the heart H. From this position the needle passer
100 is manipulated to place the distal end of the shaft assembly
104 into the aorta A through the aortotomy O, the foot 134 resting
on the outer surface of the aorta as shown in FIG. 19A. In order to
ensure that the needle passer 100 does not contact the balloon 10,
the position of the balloon within the aorta A is preferably
monitored or controlled as described above with respect to the
cutting instrument 50.
[0139] Next, the surgeon actuates the actuator assembly 106 by
depressing the trigger 108 which retracts the cover 124 to expose
the needles 110, as shown in FIG. 19B. At this point the needles
110 are in their radially non-extended position. As the surgeon
continues to depress the trigger 108, the actuator assembly 106
moves the ram sleeve 128 forward to force the needles 110 into
their radially extended position, as shown in FIG. 19C. As the
surgeon depresses the trigger 108 further, the actuator assembly
106 moves the shaft 116, needles 110 and ram sleeve 128 toward the
handle 102, which passes the radially extended needles 110 through
the wall of the aorta A, as shown in FIG. 19D. The needles 110 pass
through the aorta and between the fingers 136 of the foot 134, with
the lengths of suture 112 extending from the second set of needles
114 and through the aortotomy O to needles 110 held in the collar
118 by O-ring 120. The actuator assembly 106 is preferably
constructed so that the trigger 108 may be depressed in a
continuous, uninterrupted manner to move the shaft assembly from
the position shown in FIG. 19A to the position shown in FIG.
19D.
[0140] As mentioned above, in order to prevent contact between the
needle passer 100 (and in particular the needles 110) and the
balloon 10, the position of the balloon within the aorta A may be
monitored or controlled. Alternatively, the needle passer 100 may
be provided with a mechanism for shielding the needles 110 to
prevent contact with the balloon 10. A preferred embodiment of such
a mechanism is shown in FIGS. 20A-21C and is indicated by the
reference numeral 290.
[0141] Referring to FIG. 20A, in which the sutures 112 have been
omitted for clarity, the needle shielding mechanism 290 comprises a
plurality of flexible struts 292 positioned around the needles 110
in a spaced manner. Each strut 292 has one end 294 fixed to the
collar 118 and an opposite end 296 fixed to the ram sleeve 128. The
cover 124, shown retracted in FIG. 20A, is disposed over the struts
292. When the ram sleeve, 128 is in its retracted position, the
struts 292 are generally straight and, in the illustrated
embodiment, extend in a radial direction so as to be generally
coextensive with the needles. If desired, however, the mechanism
290 may be constructed so that the struts 292 extend beyond the
needles 110 when the needles are in their radially non-extended
position. As the ram sleeve 128 is moved forward to force the
needles 110 into their radially extended position, as shown in
FIGS. 20A and 20B, the ends 294, 296 of each strut 290 are brought
toward each other, which results in the struts 292 flexing outward
beyond the needles 110. The struts 292 are preferably formed of a
superelastic material, such as nitinol, however, other resilient
and flexible metals or polymers may be used. Similarly, while the
preferred embodiment includes six struts spaced evenly around the
needles 110, any number or configuration of struts may be used.
[0142] FIG. 21A shows the shaft assembly of the needle passer of
FIG. 20A located in a patient's aorta A adjacent the balloon 10 of
an occlusion catheter, with the cover 124 retracted and the needles
110 in their radially non-extended position. FIG. 21B shows the
shaft assembly after the ram sleeve 128 has been moved forward to
force the needles 110 into their radially extended position. Such
movement of the ram sleeve 128 causes the struts 292 to flex
outwardly so that they substantially surround the needles 110.
Thus, if the balloon 10 should move toward the needle passer (or
vice-versa), the balloon would contact the struts 292 of the
shielding mechanism 290, and not the needles 110. Further, as shown
in FIG. 21C, as the needles 110 are retracted and passed through
the wall of the aorta the struts 292 continue to flex so that the
balloon 10 cannot contact the needles 110. Accordingly, the balloon
10 is prevented from contacting the needles 110 from the time the
needles are moved to their radially extended position until the
tips of the needles have passed through the tissue.
[0143] The illustrated mechanism 290 for shielding the needles from
the balloon is only one possible means for preventing contact
between the balloon and needles. For example, rather than utilizing
the ram sleeve 128 to expand the struts 292, the struts could be
attached to the cover 124 so that they expand upon retracting the
cover. Alternatively, the struts 292 could be formed of a
superelastic material so that the struts expand around the needles
as soon as the cover 124 is retracted. Another possible
construction includes springs (not shown) that force the struts 292
into their expanded configuration as soon as the cover 124 is
retracted. It will be recognized by persons skilled in the art that
other needle shielding mechanisms could also be used.
[0144] Referring again to FIG. 19D, the needle passer 100 is shown
after the needles 110 have been passed through the wall of the
aorta. FIG. 22A illustrates the next step wherein one of the
needles, 110a, has been pulled completely through the aorta, for
example, by a needle driver D. The needle 110a is pulled through
the tissue and away from the aorta which threads one of the lengths
of suture, 112a, through the aorta at an area spaced from the
aortotomy. As the needle 110a is pulled away from the aorta, the
length of suture 112a uncoils within one of the suture retaining
channels, 140a, as can be seen from FIG. 22A. While each suture
length 112 is disposed in a single loop in a channel 140 (FIG.
22B), it will be recognized that the suture may be any size and
coiled in any desired manner.
[0145] FIG. 23 shows the configuration after the needle 110a has
been removed from the patient's body through port P and the length
of suture 112a carried by the needle has been secured to one of the
suture holding areas 22 of the suture organizer 20. The remaining
needles 110 are held by the shaft assembly 104 with their tips
projecting out of the tissue adjacent the aortotomy. In the
preferred embodiment, the needles 110 are circumferentially
disposed around the aortotomy; however, the needles could be
arranged in a different configuration. The steps of pulling each
needle 110 through the aorta A and removing it from the patient's
body through the port P, and then securing the length of suture 112
carried by the needle to a holding area 22 of suture organizer 20,
are repeated for each needle 110. Upon completion of these steps,
the suture lengths 112 are configured as shown in FIG. 24. Each
suture length 112 has one end secured to one of the needles 114 and
one end secured to a needle 110. The portion of each suture length
112 between the needles 110 and 114 passes between the fingers 136
of foot 134 and through the wall of the aorta, and then out of the
aorta through the aortotomy.
[0146] FIG. 25 shows the needle passer 100 being pulled away from
the aorta until it has passed through the port P and is located
outside the patient's body. As each suture length 112 has one end
held in the suture organizer 20 and the other end held by the shaft
assembly 104, moving the needle passer 100 away from the patient's
body causes each suture length 112 to uncoil within a channel 140
of the suture tube 132 (FIGS. 22A, 22B). In the resulting
configuration, the suture lengths 112 extend from the needle passer
100 down to the aorta A, and then from the aorta up to the suture
organizer 20, as shown in FIG. 25.
[0147] Upon reaching the position shown in FIG. 25, each needle 114
is removed from the needle passer 100, for example, by using a
needle driver D, as shown in FIG. 26. After the needles 114 have
been removed from the needle passer 100, both ends of each suture
length 112 are disposed outside the patient's body, which permits
easier manipulation of the suture in carrying out the anastomosis
of a vascular conduit to the aorta A.
[0148] A delivery device constructed according to the present
invention is preferably used at this point in the procedure to
deliver the vascular conduit to the aorta. The delivery device
comprises first and second components mounted to each other so as
to be relatively movable. One of the first and second components of
the device removably carries the vascular conduit, while the other
component holds the needles 114 so that each needle passes through
an end of the conduit. The first and second components are then
moved relative to each other to slide the conduit along the lengths
of suture.
[0149] FIG. 27 illustrates one of the needles 114 being placed into
one preferred embodiment of the delivery device of the invention,
indicated by reference numeral 300 in the Figures. As shown in
FIGS. 28A, 28B and 29, the delivery device 300 comprises a first
component in the form of an elongated shaft 302 for supporting a
vascular conduit, and a second component in the form of a collar
304 for holding the needles passing through the conduit. The collar
304 is mounted to the shaft 302 so that the components are
relatively slidable. The shaft 302 is formed of any suitable
material, e.g., stainless steel, and is configured to hold a
vascular conduit so that an end of the conduit is located against
the collar 304. The needles 114 are removed from the needle passer
100 and placed through the conduit and into the collar 304. The
shaft 302 is then moved relative to the collar to deliver the
conduit to the aorta.
[0150] According to the invention, a sealing element is provided
for use in enhancing the seal formed at the anastomosis between the
vascular conduit C and the aorta A. In the preferred embodiment, a
sealing element 306 is used with the delivery device 300. As shown
in FIGS. 28A and 29, the shaft 302 has a proximal end (which may be
in the form of a handle, not shown) and a distal end 308 adapted to
support the sealing element 306. The distal end 308 is provided
with a flange or similar structure which supports the sealing
element 306, for example, two arms 310 which extend from the distal
end 308 and have upstanding ends 312 to retain the sealing element
306 on the shaft 302. The illustrated delivery device 300 is
designed to deliver a vascular conduit to the aorta and, to that
end, the shaft 302 has a hollow interior for receiving the conduit.
The shaft 302 also has a cut-out portion 314 through which the
vascular conduit may be inserted into the shaft, and then moved
through an opening 316 passing through the sealing element
306..
[0151] The preferred collar 304 is a tubular member formed of any
suitable material, e.g., injection molded plastic, having an
internal bore that engages the outer surface of the shaft 302 in a
slight friction fit for controlled relative movement of the two
components. The collar 304 has a distal end 318 which defines two
portions 320 separated by a slot 322 configured to receive the arms
310 at the distal end 308 of the shaft 302. The portions 320 define
areas 324 for receiving needles that are passed through the end of
a vascular conduit and, in the preferred embodiment, the sealing
element 306 carried by the shaft 302. The collar 304 also has a
cut-out portion 326 which aligns with the cut-out portion 314 of
the shaft 302. The needle receiving areas 324, or alternatively the
entire distal end 318 or the entire collar 304, is preferably
formed of a material which can be penetrated by the ends of the
needles. For example, the two portions 320 may be formed of
urethane, silicone, cork, rubber or another elastomer capable of
releasably retaining the needles that carry suture for securing the
conduit to the aorta. Alternatively or in addition to using a
material that is penetrable by and capable of holding the needles,
positive locking structures for holding the needles may be used.
For example, the collar 304 may be provided with spring coils,
wedge-shaped openings, clamps, magnetic elements, etc.
[0152] The delivery device 300 preferably is provided with means
for preventing or limiting relative rotation of the shaft 302 and
collar 304. In the preferred embodiment, the shaft 302 has a guide
element 328 received in a slot 330 formed in the collar 304 (FIG.
28B). Other suitable means for preventing relative rotation of the
shaft 302 and collar 304 include forming the components with mating
noncircular cross-sections, a cooperating key and keyway, etc.
While in the preferred construction relative rotation of the shaft
302 and collar 304 is prevented, it will be appreciated that the
components could be formed to allow limited or complete relative
rotation.
[0153] FIGS. 30A-30D illustrate a preferred sequence of steps that
are performed in using the delivery device 300 to deliver a
vascular conduit C along the lengths of suture 112. As shown in
FIG. 30A, the vascular conduit C is positioned within the shaft 302
such that the end of the conduit projects out of the shaft distal
end 308 and out of the bore 316 of sealing element 306. As shown in
FIG. 30B, the needles 114 are placed one by one through the
interior of the conduit C and the sealing element 306 so as to
extend into the areas 324 of the collar 304. By placing the needles
114 first through the interior of the end of the conduit C, the end
of the conduit is everted against the sealing element 306, as shown
in FIG. 30C. In an alternative construction, the sealing element
306 has upstanding prongs or barbs (not shown) which penetrate the
end of the conduit to hold it in an everted position. After all of
the needles 114 have been inserted through the conduit and into the
collar 304, relative movement is imparted to the shaft 302 and
collar 304. As shown in FIG. 30D, the collar may be maintained
stationary while the shaft 302 is moved forward to slide the
conduit C and sealing element 306 along the suture lengths 112, the
needles 114 remaining in the collar 304 as shown.
[0154] FIG. 31 shows the conduit C being moved along the suture
lengths toward the aorta A, while FIG. 32 shows the delivery device
300 after the shaft 302 has been moved with respect to the collar
304 so as to place the everted end of the conduit C against the
aorta in communication with the aortotomy O. Each length of suture
112 has its end carried by a needle 110 secured to the suture
organizer 20, and its end carried by a needle 114 supported by the
collar 304 of the delivery device 300. From the position shown in
FIG. 32, the shaft is moved away from the aorta A such that the
conduit C remains against the outer wall of the aorta, as
illustrated in FIG. 33. While the suture lengths 112 preferably
engage the end of the conduit and the sealing element 306 with
sufficient friction so that upon retracting the shaft 302 the
conduit and sealing element are released from the arms 310, it may
be necessary to manipulate the shaft 302 to aid in releasing the
conduit and sealing element.
[0155] After the shaft 302 has been withdrawn through the port P,
the needles 114 are removed from the collar 304 and placed in the
suture organizer 20. In the configuration shown in FIG. 34, the two
ends of each suture length 112 are held in the same suture holding
area 22, which permits the opposite ends of each suture length 112
to be knotted quickly and easily outside the patient's body.
Alternatively, the lengths of suture may be knotted before the
shaft 302 is withdrawn away from the patient's body. The knots are
pushed down against the aorta or sealing element 306 and the free
ends of the suture severed to form the anastomosis, as shown in
FIGS. 35A and 35B. A suitable device for pushing the knots is
disclosed in U.S. Pat. No. 5,601,576. It will be recognized that in
lieu of knots, clips or other devices may be used to secure the
suture. The vascular conduit C is now anastomosed to the aorta and
is in fluid communication therewith.
[0156] As can be seen from FIG. 35B, the sealing element 306 is
sized such that it overlies the everted end of the vascular conduit
C. Of course, the size of the sealing element may be varied from
that shown and depending on the application. As shown in FIG. 35B,
each suture length 112 has a portion 112a which is threaded through
the wall of the aorta A, and a portion 112b which extends into the
aortotomy O and through the end of the conduit and the sealing
element 306. The portions 112a, 112b are secured, for example, by a
knot, which results in the sealing element 306 compressing the end
of the conduit against the wall of the aorta. The everted end of
the conduit acts somewhat like a gasket and provides a secure and
sealed anastomosis between the conduit C and the aorta A, due in
part to the fact that the force applied by the suture lengths 112
is distributed around the entire periphery of the end of the
conduit by the sealing element 306. This helps provide a fluid
tight (or substantially fluid tight) seal which increases long term
patency of the anastomosis.
[0157] The preferred sealing element 306 is formed of a
biocompatible material suitable for long-term implantation in the
body. Suitable materials include, for example, silicone, urethane,
pebax, polypropylene (PP), polymethylmethacrylate (PMMA), and
surgical felt comprising polyester or polytetrafluoroethylene
(PTFE). The material may be flexible or stiff, however, a
relatively resilient and compressible material is preferred. If the
sealing element is formed of a relatively stiff material, such as
PP or PMMA, then it may be necessary or desirable to reduce its
thickness in order to provide some flexibility, as compared to a
sealing element formed of a relatively soft material, such as
silicone or urethane. In addition, the sealing element may be
provided with radiopaque characteristics to function as a graft
marker by permitting its detection, for example, by forming the
element of silicone impregnated with 30% barium sulfate.
[0158] Further, the sealing element, rather than being formed of a
single sheet or layer, may comprise multiple layers of either the
same or different materials, e.g., a layer of bioabsorbable fabric
laminated to a layer of PTFE. Persons skilled in the art will
recognize that other materials may be used as well. In any case,
the material forming the sealing element is preferably penetrable
by a needle. Alternatively, or in addition to being formed of a
material penetrable by a needle, the sealing element may be
provided with openings which receive the needle(s) to allow the
sealing element to be slid over the suture.
[0159] Additionally, while the illustrated sealing element is in
the form of circular ring having a continuous periphery, it may
instead have a noncircular shape and comprise discrete segments,
for example, one segment per needle and length of suture. The
segments could be separated by cuts that extend completely or
partially through the material. Also, the material forming the
sealing element may be provided with markings indicating an optimal
location for placing the needles. It may be desirable to place the
needles closer to the outer edge of the sealing element than the
center in order to increase the pressure exerted against the edge
of the conduit and the tissue; however, placement of the needles
typically will vary depending on the application.
[0160] The size of the sealing element will vary depending on the
application. For the ring-shaped element depicted in the Figures,
the inside diameter (i.e., the diameter of the central opening) may
be 3.5 mm and the outside diameter 7.5 mm. Other configurations may
have an inside diameter of 4.5 mm and an outside diameter of 8.5
mm, or an inside diameter of 5.5 mm and an outside diameter of 9.5
mm. The thickness of the sealing element will also vary, but may be
within a range of from about 0.010 to about 0.060 inch, with a
preferred thickness of 0.030 inch.
[0161] Finally, while the sealing element is described and
illustrated in connection with forming an anastomosis between a
vascular conduit and a patient's aorta, it should be recognized
that it may be used in other applications. For example, the sealing
element may find use in securing a patch over an opening in tissue,
such as attaching a pericardial patch over an atrial or ventricular
septal defect, or repairing a patent ductus arteriosus. In this
case, the sealing element may comprise a solid disc as the patch is
used to close off the defect. Moreover, while the illustrated
sealing element is secured to tissue by separate lengths of suture
which form separate stitches, it could also be attached to tissue
by a running stitch formed by a continuous length of suture.
[0162] Referring to FIGS. 36 and 37A-37D, a needle passer
constructed according to an alternative embodiment of the invention
is indicated by reference numeral 400 and comprises a handle 402
and a shaft assembly 404 which is operated by an actuator assembly
406. The needle passer 400 is preferably constructed so that a user
can grasp and operate it using one hand. The handle 402 thus is
configured to be held in one hand and the actuator assembly 406
includes a movable component, preferably in the form of a slide
408, which can be manipulated by the user's thumb or finger in
order to actuate the shaft assembly 104 and pass one or more
needles through tissue. The handle 402 may comprise two pieces
secured together (as shown) or a single piece.
[0163] The shaft assembly 404 has essentially the same construction
as the shaft assembly 104 of the needle passer 100 described above.
The shaft assembly 404 supports one or more needles 410 configured
to be passed through tissue, each needle 410 being secured to a
first end of a length of suture 412. A second end of each suture
length 412 is secured to one of a second set of needles 414
removably supported by a suture tube 432. While the second ends of
the suture lengths 412 are preferably secured to the second set of
needles 414, they could alternatively by secured to shaft assembly
404 (or another portion of the needle passer 400).
[0164] The needles 410 are supported on a shaft 416 via a collar
418 and an O-ring located in an annular groove defined in the
collar. The O-ring engages the exterior of each needle 410 to
frictionally retain it in the collar 418 so that the needles 410
can be moved between the radially non-extended position shown in
FIGS. 37A and 37B to the radially extended position shown in FIGS.
37C and 37D. (The suture lengths 112 and the needles 114 are
omitted from FIGS. 37A-37D.) The collar 418 preferably has slots
which limit or control the extent to which the needles 410 can move
radially. The shaft assembly 404 preferably has a protective cover
424 in the form of a sleeve slidably disposed over the shaft 416
and needles 410. The cover 424 has a plurality of slots 426 through
which the suture lengths 412 pass from the first set of needles 410
to the second set of needles 414.
[0165] The actuator 406 is used to move the cover 424 and expose
the needles 410, this position of the cover being shown in FIG.
37B. Once exposed, the needles 410 are free to move into their
radially extended position. In the preferred embodiment, the
needles 410 are forced into their radially extended position by a
ram sleeve 428 activated by the actuator 406. It will be
recognized, however, that an alternative manner of moving the
needles 410 to their radially extended position could be used, for
example, any of the variations discussed above with respect to the
previous embodiment.
[0166] Referring to FIG. 37A, the cover 424, ram sleeve 428 and
shaft 416 are disposed in a suture tube 432 which has a flange 446
connected to the handle 402, the suture tube supporting the needles
414 and suture lengths 412. The actuator 406 is first used to
uncover the needles 410. The cover 424 is moved by a lever 448
which is free to travel in a slot 450 formed in the handle 402. The
lever 448 is secured to (or formed integrally with) the cover 424.
The lever 448 thus is retracted with respect to the handle 402 to
move the cover 424 from the position shown in FIG. 37A to the
position shown in FIG. 37B, thereby exposing the needles 410. The
cover 424 (or lever 448) is preferably frictionally engaged with
the handle 402 so that the cover remains in its retracted
position.
[0167] Next, the slide 408 of the actuator 406 is used to move the
needles 410 into their radially extended position. The slide 408
travels within a slot 452 in the handle 402 and is connected to a
ram driver 454 (FIG. 37C). The ram driver 454 has a groove 456 in
which is fixed a flange 458 formed on the proximal end of the ram
sleeve 428. A shaft driver 460 is fixed to the shaft 416 and is
disposed in a chamber 462 of the ram driver 454. The shaft driver
460 contains a spring-loaded detent in the form of a ball plunger
464 engaged with a recess 466 formed in the ram driver 454. The
shaft driver 460 engages a stop 468 which prevents movement of the
shaft driver (and thus shaft 416 and needles 410) toward the distal
end of the shaft assembly 104.
[0168] The slide 408 is moved forward from the position shown in
FIG. 37B which moves ram driver 454 and ram sleeve 424 forward. The
shaft driver 460, however, is prevented from moving forward by the
stop 462. Moving the slide 408 forces the shaft driver detent 464
out of recess 466 to permit the ram driver 454 to move forward. The
recess 466 is formed with tapered walls that permit the ball
plunger 464 to be forced out of the recess. As the slide 408
continues to be moved, the ram driver 454 moves along the shaft
driver 460 until the ball plunger 464 seats in a second recess 470
formed in the ram driver. At this point, shown in FIG. 37C, the ram
sleeve 428 has forced the needles 410 into their radially extended
position, and the relative position of the ram driver 454 and shaft
driver 460 is fixed by the ball plunger 464 and recess 470. The
recess 470 is preferably configured to prevent the ball plunger 464
from escaping once located therein.
[0169] Next, in order to pass the needles 410 through tissue, the
slide 408 is moved rearward with respect to the handle 402. This
moves the ram driver 454 and shaft driver 460 rearward to retract
the shaft 416, needles 410 and ram sleeve 428, thereby passing the
needles 410 through the tissue (not shown in FIGS. 37A-37D). The
needles 410 may then be removed from the needle passer to thread
the suture lengths 412 through the tissue, as described above with
respect to the previous embodiment.
[0170] While two specific embodiments of a needle passer have been
described in detail, many modifications and variations of this
aspect of the invention are possible. Although the shaft assemblies
of the preferred and illustrated needle passers are straight over
their length, they may instead be contoured. For example, as shown
in FIG. 38, a needle passer 100A is constructed so as to include a
shaft assembly 104A formed with a bend 105A so that the distal
portion supporting the needles 110A and suture lengths 112A is
offset from the proximal portion disposed adjacent the handle 102A.
This may be useful in passing needles through a tissue site that is
not aligned or directly accessible through the port or other
opening in the patient's body. The outermost component (the suture
tube in the illustrated embodiment) may be rigid and bent, while
the shaft (and ram sleeve and cover, if used) are formed of a
flexible material that permits axial movement of the shaft over the
bend. The shaft entire shaft may be flexible, or only the portion
that carries the needles may be flexible. Similarly, the entire ram
sleeve and cover may be flexible, or only the portions thereof that
move and cover the needles may be flexible.
[0171] In another alternative embodiment, the components of the
shaft assembly are formed of a malleable or ductile material,
thereby permitting the surgeon to shape the device into various
configurations by moving the distal portion with respect to the
proximal portion. Similarly, the shaft assembly could have an
articulated construction that would permit the surgeon to adjust
the position of the distal portion with respect to the proximal
portion. Each of these embodiments would be useful in passing the
needles through tissue located at areas that are not aligned with
the port or other access opening in the patient.
[0172] FIGS. 39A-39C show a shaft assembly 104B forming part of a
needle passer constructed according to another variation of the
invention. The distal end of the shaft assembly 104B is placed
within the aorta A through the aortotomy O, the foot 134B resting
on the outer surface of the aorta as shown in FIG. 39A. In order to
ensure that the needle passer does not contact the balloon 10, the
position of the balloon within the aorta A is preferably monitored
or controlled as described above with respect to the previous
embodiments. Next, the surgeon actuates the actuator assembly (not
shown) to move the ram sleeve 128B to move the needles 110B to
their radially extended position, shown in FIG. 39B. Although the
embodiment of FIGS. 39A-39C does not include a cover which overlies
the needles 110B, it should be recognized that a cover may be
included if desired.
[0173] Further actuation of the actuator assembly moves the shaft
116A, needles 110A and ram sleeve 128B toward the handle (not
shown) of the needle passer, which passes the radially extended
needles 110B through the wall of the aorta A, as shown in FIG. 39C.
The needles 110B pass through the aorta and between the fingers of
the foot 134B, with the lengths of suture extending from the second
set of needles and through the aortotomy O to needles 110A held in
the collar by O-ring 120B. (The second set of needles and lengths
of suture are omitted from FIGS. 39A-39C for explanatory purposes.)
As can be seen from FIGS. 39A-39C, the needles 110B, rather than
being straight over their length, are formed with a bend 111B which
results in the axis of each needle being generally perpendicular to
the aorta when in the radially extended position (FIG. 39B). This
feature allows the needles 110B to be passed through the tissue
with minimal force, as compared to passing the needles through the
tissue at an angle as in the above embodiments. It will be
understood that alternative needle configurations may be used if
desired.
[0174] FIGS. 40A-40C show a shaft assembly 104C forming part of a
needle passer constructed according to yet another variation of the
invention. As above, the distal end of the shaft assembly 104C is
placed within the aorta A through the aortotomy O with the foot
134C resting on the outer surface of the aorta, as shown in FIG.
40A. In order to ensure that the needle passer does not contact the
balloon 10, the position of the balloon within the aorta A is
preferably monitored or controlled as described above with respect
to the previous embodiments. The shaft assembly 104C comprises a
plurality of flexible struts 111C each of which is provided with a
member, such as a tubular piece 113C, which supports a needle 110C.
The struts 111C and thus the needles 110C are preferably positioned
around the axis of the shaft assembly 104C in a spaced manner.
[0175] Each strut 111C has one end fixed to the collar adjacent the
distal end 122C and an opposite end fixed to the ram sleeve 128C.
While the embodiment shown in FIGS. 40A-40C does not include a
cover which overlies the needles 110C, a cover may be included if
desired. When the ram sleeve 128C is in its retracted position, as
shown in FIG. 40A, the struts 111C are generally straight with the
needles 110C disposed along the shaft assembly 104C. As the ram
sleeve 128C is moved forward, the ends of each strut 111C are
brought toward each other, which results in the struts flexing
outward to the position shown in FIG. 40B. This moves the needles
110C to a radially extended position in which they are ready to be
passed through the tissue. The struts 111C may be formed of a
superelastic material, such as nitinol, although other resilient
and flexible metals or polymers may be used.
[0176] Further actuation of the actuator assembly (not shown in
FIGS. 40A-40C) moves the shaft, needles 110C and ram sleeve 128C
toward the handle of the needle passer, which passes the radially
extended needles 110C through the wall of the aorta A, as shown in
FIG. 40C. The needles 110C pass through the aorta and between the
fingers of the foot 134C, with the lengths of suture extending from
the second set of needles and through the aortotomy O to needles
110C held in the collar by O-ring 120C. (The second set of needles
and lengths of suture are omitted from FIGS. 40A-40C for
explanatory purposes.) As can be seen from FIGS. 40B and 40C, the
axis of each needle is generally perpendicular to the aorta when in
the radially extended position. As explained above with respect to
the embodiment of FIGS. 39A-39C, this allows the needles 110C to be
passed through the tissue with minimal force, as compared to
passing the needles through the tissue at angle.
[0177] In the illustrated and preferred embodiments the ram is
moved forward and simultaneously forces all of the needles into
their radially extended position. In some applications, it may be
desirable to move the needles individually into the radially
extended position. In order to accomplish this, the needle passer,
for example, could include a ram with individual segments or
portions corresponding to a respective needle. The actuator
assembly would permit the surgeon to actuate the ram to move a
specific needle into its radially extended position. Such a
construction could be used in applications where the suture must be
passed through a number of spaced tissue locations. The surgeon
could position the needle passer at one site and actuate the ram to
pass one needle through the tissue, and then move the needle passer
to a different site and actuate the ram again to pass a different
needle through the tissue. In this manner, the suture could be
passed through tissue in a larger tissue pattern than if the
needles are moved through the tissue simultaneously.
[0178] Additional modifications of the illustrated embodiments of
the needle passer include utilizing the needle passer to form the
opening in the hollow body structure, such as an aortotomy in the
patient's aorta. This could be accomplished by providing a cutting
element, such as trocar point, on the distal end of the needle
passer. For example, the collar which carries the needles could
include a trocar point or be formed with an aortic punch-like
cutting member which forms the opening in the aorta through which
the distal end of the needle passer is inserted. Further, a cutting
mechanism could be coupled to the needle passer for cutting through
the patient's chest wall and/or the aorta. It will be appreciated
that modifications such as these are within the spirit and scope of
the invention.
[0179] Another possible variation of the invention would be to
provide a tubular component capable of extending through the
patient's chest wall and functioning as a port or trocar sleeve by
permitting instruments to be inserted therethrough. For example,
the suture tube carried on the exterior of the needle passer could
be constructed to serve as such a port by being removed from the
shaft assembly of the needle passer after the needles and lengths
of suture have been passed through the aorta. Alternatively, a
separate tubular element could be carried by the shaft assembly
over the suture tube and removed therefrom and left in place in the
opening in the patient's chest wall to act as a port or trocar
sleeve.
[0180] Further still, it may be desirable to couple an endoscope
with the needle passer in order to enhance visualization of the
anastomosis site. The endoscope could comprise a camera and fiber
optic cables extending through the interior of the needle passer,
for example, by extending through a hollow shaft which carries the
needles, or by extending alongside the shaft or another component
of the shaft assembly. The endoscope could either be incorporated
into the needle passer or a separate device used with the needle
passer.
[0181] Persons skilled in the art will recognize that performing an
anastomosis is only one possible application of the devices and
methods of the invention. Many other uses for the various aspects
of the invention will be apparent to those skilled in the art. For
example, the needle passer of the invention may be used to close an
opening created in the wall of a blood vessel to carry out a
catheter procedure, or to close an opening in the wall of a body
cavity, such as a trocar opening in the abdominal wall. After
passing the needles through the tissue, the sutures could be tied
off or, alternatively, secured with clips or other fasteners in
order to close the opening.
[0182] For these applications it may be desirable to use needles
connected by a continuous length of suture the ends of which are
tensioned and tied off (or secured with a clip) to close the
opening. However, when using the needle passer in an anastomosis
procedure, it is more desirable to use needles carrying separate
lengths of suture so that the suture does not extend across the
opening, and thus is less likely to adversely affect flow through
the anastomosis site. It should nevertheless be appreciated that it
is possible to use needles connected by a continuous length of
suture to perform an anastomosis procedure, provided that the
needles are passed through the tissue at locations which do not
result in the suture extending significantly into or across the
anastomosis opening.
[0183] Further, while in the preferred embodiment of an anastomosis
procedure each suture length passes through the aortotomy and then
through the tissue, alternative configurations may be used. For
example, several pairs of needles may be provided, the needles in
each pair being connected by a length of suture. The needles in
each pair may be passed through the tissue at locations radially
spaced from the periphery of the opening in the tissue. The suture
lengths would then each pass under the tissue radially outward of
the opening and then through the tissue; as such, the suture would
not pass through the aortotomy. Similarly, the needles in a given
pair could be passed through the tissue at areas located on
opposite sides of the opening, the result being that the suture
length extends across the opening.
[0184] Another possible application for the invention is placing
sutures adjacent an opening in a vessel wall or body cavity wall
and delivering a patch or similar element along the suture to close
the opening. For example, the needle passer can be positioned
through an atrial or ventricular septal defect in a patient's heart
and used to pass needles and sutures through the tissue around the
defect. The sutures may then be passed through a patch and the
patch guided down to the tissue so as to overlie the defect, for
example by using the delivery device of the invention. The sutures
may then be tied off or secured with clips to secure the patch over
the defect. In this case, it may be desirable to use needles
carrying separate lengths of suture.
[0185] Alternatively, rather than using a patch, the sutures
extending from the tissue could simply be tied off or otherwise
secured to close the tissue around the defect. In the latter case,
as in the case of closing an opening in a vessel or the wall of a
body cavity, needles connected by a continuous length of suture may
be used if desired. Other procedures for closing atrial and
ventricular septal defects using patches and suture are disclosed
in co-pending application Ser. No. 08/425,179, filed Apr. 20, 1995
and entitled METHOD AND APPARATUS FOR THORACOSCOPIC INTRACARDIAC
PROCEDURES, the subject matter of which is incorporated by
reference.
[0186] Further, the invention can be used in valve surgery by
placing the needle passer in the annulus of a heart valve and
passing needles therethrough. The needles may then be picked up to
thread the suture through the annulus and carried to a suture
organizer disposed outside the patient's body. The needles located
at the other ends of the sutures can then be passed through a
replacement valve supported on the delivery device and the valve
moved along the sutures to the annulus and then secured thereto.
Other devices and procedures for securing a replacement heart valve
are disclosed in co-pending application Ser. No. 08/594,869, filed
Jan. 31, 1996 and entitled ENDOSCOPIC SUTURING DEVICES AND METHODS,
the subject matter of which is incorporated by reference.
[0187] According to another aspect of the invention, a device is
provided for measuring the internal size of a tubular member and
may be used, for example, to measure the inner diameter of a
vascular conduit prior to anastomosing the conduit to the patient's
aorta, as described above. Once the size of the conduit is
determined, an appropriately sized sealing element can be selected
to obtain the most secure and fluid tight anastomosis.
[0188] A preferred embodiment of such a device is indicated by
reference numeral 480 in FIGS. 41-43 and comprises a pair of jaws
482, 484 respectively provided with tips 486, 488 for contacting
the opposite inner surfaces of a tubular member, such as the
conduit C (shown in phantom). The jaws 482, 484 are relatively
movable and are biased apart so that upon insertion into the
conduit C, the tips 486, 488 move apart to contact the inner
surfaces of the conduit. In the preferred embodiment, the jaw 482
is fixed to a spring housing 490 by a pin 492, while the jaw 484 is
pivotally coupled to the spring housing 490 by a pivot pin 494. A
coil spring 496 is disposed in the housing 490 has legs that bias
the jaws 482, 484 in opposite directions.
[0189] A first arm 498 extends from the spring housing 490 and a
second arm 500 extends from the jaw 484. The spring housing 490 is
fixed to the jaw 482; thus, when the jaws 482, 484 move apart the
arms 498, 500 move apart. A scale 502 is pivotally coupled to the
first arm 498 by a pin 504, and is pivotally coupled to the second
arm 500 by a pin 506. The pin 506 is located in a slot in the
second arm 500 so that it is free to rotate and move laterally. As
the jaws 482, 484 move apart (or together) the pins 504, 506 rotate
the scale 502. The scale 502 has a series of markings 508 and the
spring housing 490 has an indicator 510 located adjacent the
markings. Each marking 508, when aligned with the indicator 510,
corresponds to a given distance measured between the tips 486, 488.
In use, the jaws 482, 484 are brought together and the tips 486,
488 are positioned inside the conduit C (FIG. 38). The jaws 482,
484 are then released and the tips 486, 488 move into contact with
the opposite sides of the interior of the lumen (FIG. 39). The
indicator 510 aligns with one of the markings 508 to provide a
measurement of the lumen size for the conduit, which measurement
may be used, for example, to select a particular size sealing
element in anastomosing the conduit C to the aorta or other
vessel.
[0190] Another embodiment of a device for measuring the internal
size of a tubular member is shown in FIG. 46 and is indicated by
reference numeral 580. The device 580 comprises a pair of arms 582,
584 respectively provided with tips 586, 588 for contacting the
opposite inner surfaces of a tubular member, such as a vascular
conduit (not shown). The arms 582, 584 are relatively movable so
that upon insertion into the conduit the tips 586, 588 may be moved
apart to contact the inner surface of the conduit. In the
illustrated embodiment, the arms 582, 584 are pivotally connected
at 590, although other attachments may be used. The arms 582, 584
are preferably biased apart by a spring (not shown) extending
between the arms. The arms 582, 584 are provided, respectively, at
their ends opposite the tips 586, 588 with grasping portions, such
as finger loops 592, 594. The loops 592, 594 are squeezed to close
the tips 586, 588 for insertion into a conduit; the loops are then
released to allow the tips to move away from each other and into
engagement with the inner surface of the conduit.
[0191] A scale 596 is carried by one of the arms 582, 584 and
comprises a slot 598 and a series of markings 600. In the
illustrated embodiment, the scale 596 is fixed to the arm 584 at
connection 602. A pin 604 is fixed to the arm 582 and is engaged
with the slot 598 so that upon the tips 586, 588 moving into
engagement with the conduit, the pin 604 moves within the slot 598.
The pin 604 becomes aligned with one of the markings 600 to
indicate the size of the internal diameter of the conduit (or width
if the conduit is not circular). If desired, the arms 582, 584 may
be provided with a mechanism for locking the tips 586, 588 in
position, e.g., mating ratchet members 606, 608.
[0192] According to still another aspect of the invention, a device
and method are provided for carrying out a procedure in a hollow
body structure while fluid is flowing through the structure. This
aspect of the invention may be used to substantially isolate a
portion of the body structure, e.g., a patient's aorta, from fluid
flowing therein. Referring to FIGS. 45 and 46A-46C, the device is
indicated by reference numeral 610 and comprises an elongate member
612 which may be in the form of a rod or guidewire, and a tissue
contacting member 614 which may be in the form of a sheet
configured to engage the tissue. The member 612, which may be
flexible or rigid, has a proximal end 616 and a distal end 618
secured to the member 614. The tissue contacting member 614 is
preferably flexible so as to be collapsible for insertion and
removal through an opening in the tissue. Although the illustrated
member 614 is generally circular, other configurations may be used.
The member 612 is preferably flexible; however, it may instead be
rigid. For example, the member 612 may take the form of a
conventional guidewire.
[0193] The tissue contacting member 614 is collapsed from the
position shown in FIG. 45 for insertion through an opening in the
tissue of the hollow body structure. In order to aid in inserting
the member 614 through the opening, which may be a slit or cut
formed in the wall of the tissue structure, an introducer is
preferably provided in the form of a hollow shaft 620. The tissue
contacting member 614 is collapsed and placed in the bore of the
shaft 620, as shown in FIG. 46A. The two components are then passed
through the opening which, in the illustrated embodiment, is a
passage P in the wall of an aorta A through which blood flows (as
indicated by the arrow). Once positioned in the passage P, the
member 612 is moved toward the aorta A until the tissue contacting
member 614 emerges from the end of the shaft 620. The member 612 is
then pulled away from the aorta A to expand the tissue contacting
member 614 into engagement with the interior of the wall of the
aorta, as shown in FIG. 46B. The member 614 prevents (or minimizes
the amount of) blood which may escape through the passage P. Next,
the introducer shaft 620 is removed from the member 612, leaving
the tissue contacting member 614 against the wall of the aorta and
the member 612 extending through the passage P, as shown in FIG.
46C.
[0194] With the device 610 positioned as shown in FIG. 46C, various
procedures may be performed without blood leaking through the
passage P. For example, the anastomosis procedure described above
with respect to the previous embodiments may be carried out by
slightly modifying the needle passer and delivery device. To
accomplish this, the aortic punch (not shown) may be formed with a
bore that allows the punch to be slid over the member 612 and
through the passage P, after which the punch is actuated to form an
aortotomy. The tissue contacting member 614 prevents blood from
leaking through the passage P or the aortotomy. Next, the shaft of
the needle passer (not shown) may be formed with a bore that allows
it to be slid along the member 612 and through the aortotomy, the
tissue contacting member 614 preventing blood leakage. The distal
end of the needle passer shaft assembly passes through the
aortotomy and into contact with the member 614; however, the foot
of the needle passer preferably contacts the exterior of the wall
of the aorta which, due to the foot being larger than the
aortotomy, serves to prevent blood leakage despite displacement of
the tissue contacting member 614. After the needles and suture have
been passed through the tissue, the needle passer is removed and
the tissue contacting member 614 is pulled into contact with the
wall of the aorta, thereby taking over the task of preventing
leakage through the aortotomy.
[0195] Next, the shaft of the delivery device, sealing element and
vascular conduit (not shown--but each of which is hollow) are slid
down the suture and over the member 612 into contact with the wall
of the aorta. The delivery device is then removed and the suture
secured to anastomose the vascular conduit to the aorta. The shaft
620 may then be inserted through the vascular conduit and the
member 612 pulled to collapse the tissue contacting member into the
shaft. The shaft 620 and members 612, 614 may then be removed from
the vascular conduit. Alternatively, the member 612 could simply be
moved to the side and the vascular conduit anastomosed to the
aorta. The shaft 620 could be used to collapse and withdraw the
member 614 just before securing the final suture(s), and after such
removal the anastomosis can be completed.
[0196] It will be appreciated that the device comprising member 612
and tissue contacting member 614 may be used to perform other
procedures on a hollow body structure through which fluid is
flowing. For example, the anastomosis could be performed by
hand-suturing rather than with a needle passer. In addition, it
will be recognized that other configurations may be used. For
example, the tissue contacting member could be umbrella-shaped to
that only the peripheral edge thereof contacts the tissue upon
being moved into the expanded orientation, the member forming a
working space between its interior and the interior surface of the
hollow body structure. The tissue contacting member 614 may be
formed of any suitable blood compatible, non-thrombogenic material,
while the support member 612 may be formed of any suitable material
such as those used for guidewires.
[0197] Many variations and modifications of the devices and methods
disclosed herein will be readily apparent to persons skilled in the
art. As such, it should be understood that the foregoing detailed
description of preferred embodiments is made for purposes of
setting forth a clear and complete disclosure, and is not intended
to limit the scope of the invention which is defined by the claims
which follow.
* * * * *