U.S. patent application number 10/897523 was filed with the patent office on 2005-02-03 for methods for performing anastomosis.
Invention is credited to Davis, John W., Willis, Geoffrey H..
Application Number | 20050027308 10/897523 |
Document ID | / |
Family ID | 25163299 |
Filed Date | 2005-02-03 |
United States Patent
Application |
20050027308 |
Kind Code |
A1 |
Davis, John W. ; et
al. |
February 3, 2005 |
Methods for performing anastomosis
Abstract
Methods of performing an anastomosis. A ring is installed at an
incision or other orifice in a vessel or other organ, for use in
performing an anastomosis. To install the ring, tines are advanced
against an anvil to cause them to grab tissue around the orifice
and curl radially. The anvil is then retracted to fold the tines so
their curled ends move radially outward. A sleeve may be advanced
to fold or bend the tines as their curled ends move further
radially outward. The folding, curling, and further bending of the
tines evert tissue near the orifice edges to expose the vessel's or
organs' intima.
Inventors: |
Davis, John W.; (Sunnyvale,
CA) ; Willis, Geoffrey H.; (Redwood City,
CA) |
Correspondence
Address: |
LAW OFFICE OF ALAN W. CANNON
834 SOUTH WOLFE ROAD
SUNNYVALE
CA
94086
US
|
Family ID: |
25163299 |
Appl. No.: |
10/897523 |
Filed: |
July 23, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10897523 |
Jul 23, 2004 |
|
|
|
09794670 |
Feb 27, 2001 |
|
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Current U.S.
Class: |
606/153 |
Current CPC
Class: |
A61B 2017/0641 20130101;
A61B 2017/1139 20130101; A61B 2017/1135 20130101; A61B 2017/1107
20130101; A61B 17/11 20130101; A61B 2017/00477 20130101; A61B
17/0644 20130101 |
Class at
Publication: |
606/153 |
International
Class: |
A61B 017/08 |
Claims
What is claimed is:
1. A ring for use in preparing a first organ having an orifice for
anastomosis with a second organ, said ring comprising: a ring
portion sized to extend around the orifice; and malleable tines
extending out from the ring portion, wherein the tines are movable
relative to the ring portion from an initial configuration into a
final configuration in which the tines can hold tissue of the first
organ around the orifice in an everted state, the tines are
configured to grab and evert the tissue as they move from the
initial configuration to the final configuration, each of the tines
has a free distal end and a weak portion between the ring portion
and the free distal end, and said each of the tines preferentially
folds at the weak portion in response to being subjected to bending
force.
2. The ring of claim 1, wherein said each of the tines has two
opposed major faces and a flat cross-section.
3. The ring of claim 2, wherein the weak portion is a section of
said each of the tines through which at least one hole extends from
one of the faces to another of said faces.
4. The ring of claim 2, wherein the weak portion is a section of
said each of the tines at which notches extend into said faces.
5. The ring of claim 1, wherein the ring portion is a tubular ring
portion having a top edge and a bottom edge, and said ring also
includes: at least one fastener element extending out from the ring
portion.
6. The ring of claim 5, wherein the fastener element is a malleable
tab that extends upward from the top edge of the tubular ring
portion.
7. The ring of claim 6, wherein the tab has a weak portion at the
top edge of the tubular ring portion.
8. The ring of claim 7, wherein the weak portion of the tab is a
notched section of the tab.
9. The ring of claim 7, wherein the weak portion of the tab is a
section of the tab through which at least one hole extends.
10. The ring of claim 5, wherein the fastener element is a slotted
tab having a proximal end extending out from the ring portion, and
a distal end defining a slot.
11. The ring of claim 5, wherein the fastener element is a spring
element which extends radially outward from one of the top edge and
the bottom edge of the ring portion.
12. The ring of claim 11, wherein the fastener element is a tab
having a body which extends radially outward from the top edge of
the ring portion and a flange which extends circumferentially
outward from the body.
13. The ring of claim 11, wherein the fastener element is a
generally U-shaped spring fastener comprising: a body which extends
out at an acute angle from the bottom edge of the ring portion; and
two tabs which extend out from the body at an obtuse angle.
14. The ring of claim 5, wherein the fastener element is a tab
element having: a generally flat body which extends generally
vertically from one of the top edge and the bottom edge of the ring
portion; and malleable wings which extend out from the body,
wherein the wings are preformed in a compact configuration in which
they extend generally parallel to each other and generally
perpendicular to the body, and wherein the wings are capable of
being bent away from each other relative to the body into a locking
configuration.
15. The ring of claim 5, wherein the fastener element is a.spring
fastener comprising: a spring portion which extends generally
vertically from one of the top edge and the bottom edge of the ring
portion; and a body having a generally flat central portion and
wings which extend out from the central portion, wherein said
central portion extends radially inward from the spring portion at
an acute angle relative to said spring portion, and the wings are
oriented generally parallel to each other in planes which are at
least substantially vertical.
16. The ring of claim 5, wherein the fastener element is a spring
element comprising: a spring portion which extends in an at least
substantially vertical plane from one of the top edge and the
bottom edge of the ring portion; and a body having a generally flat
central portion and two tabs which extend out from the central
portion, wherein said central portion extends radially inward from
the spring portion at an acute angle relative to said spring
portion, and the tabs are oriented generally parallel to each other
and at least substantially perpendicular to the spring portion.
17. The ring of claim 5, wherein the fastener element is a tab
which extends out from one of the top edge and the bottom edge of
the ring portion and has a free distal end portion which extends
radially outside of the ring portion.
18. The ring of claim 17, wherein the free distal end portion is
oriented in a substantially horizontal plane, the tab includes: a
proximal end portion which extends vertically outward from said one
of the top edge and the bottom edge of the ring portion; and a
curved middle portion between the proximal end portion and the free
distal end portion.
19. The ring of claim 5, wherein the fastener element is a tab
comprising: a proximal end which extends out from one of the top
edge and the bottom edge of the ring portion; a free distal end
portion which extends radially outside of the ring portion; a
central portion between the proximal end and the free distal
portion; and two wings extending vertically from the central
portion, each of the wings having a malleable end portion capable
of being bent relative to the central portion into a locking
configuration.
20. The ring of claim 5, wherein the fastener element is a
malleable tab having a proximal end which extends out from one of
the top edge and the bottom edge of the ring portion, and a free
distal end which extends vertically beyond the other of said top
edge and said bottom edge of the ring portion.
21. A ring for use in preparing a first organ having an orifice for
anastomosis with a second organ, said ring comprising: a ring
portion sized to extend around the orifice; and malleable tines
extending out from the ring portion, wherein the tines are movable
relative to the ring portion from an initial configuration into a
final configuration in which said tines can hold tissue of the
first organ around the orifice in an everted state, the tines are
configured to grab and evert the tissue as they move from the
initial configuration to the final configuration, each of the tines
in the final configuration has a proximal portion which extends
radially inward away from the ring portion, a distal portion shaped
for holding said tissue in said everted state, and a central
portion between the proximal portion and the distal portion, and
said each of the tines in the final configuration is bent radially
outward at said central portion toward the ring portion.
22. The ring of claim 21, wherein the ring portion is a tubular
ring portion having a top edge and a bottom edge.
23. The ring of claim 22, also including: at least one fastener
element extending out from the ring portion.
24. The ring of claim 23, wherein the fastener element is a spring
element which extends radially outward from one of the top edge and
the bottom edge of the ring portion.
25. The ring of claim 24, wherein the fastener element is a tab
having a body which extends radially outward from the top edge of
the ring portion and a flange which extends circumferentially
outward from body.
26. The ring of claim 24, wherein the fastener element is a
generally U-shaped spring fastener comprising: a body which extends
out at an acute angle from the bottom edge of the ring portion; and
two tabs which extend out from the body at an obtuse angle.
27. The ring of claim 23, wherein the fastener element is a
malleable tab element which extends generally vertically from one
of the top edge and the bottom edge of the ring portion.
28. The ring of claim 23, wherein the fastener element is a tab
element having: a flat body which extends generally vertically from
one of the top edge and the bottom edge of the ring portion; and
two malleable wings which extend out from the body, wherein the
wings are preforined in a compact configuration in which they
extend generally parallel to each other and generally perpendicular
to the body, and wherein the wings are capable of being bent away
from each other relative to the body into a locking
configuration.
29. The ring of claim 23, wherein the fastener element is a spring
fastener comprising: a spring portion which extends generally
vertically from one of the top edge and the bottom edge of the ring
portion; and a body having a generally flat central portion and two
wings which extend out from the central portion, wherein said
central portion extends radially inward from the spring portion at
an acute angle relative to said spring portion, and the wings are
oriented generally parallel to each other in at least substantially
vertical planes.
30. The ring of claim 23, wherein the fastener element is a spring
element comprising: a spring portion which extends in an at least
substantially vertical plane from one of the top edge and the
bottom edge of the ring portion; and a body having a generally flat
central portion and two tabs which extend out from the central
portion, wherein said central portion extends radially inward from
the spring portion at an acute angle relative to said spring
portion, and the tabs are oriented generally parallel to each other
and at least substantially perpendicular to the spring portion.
31. The ring of claim 23, wherein the fastener element is a tab
which extends out from one of the top edge and the bottom edge of
the ring portion and has a free distal end portion which extends
radially outside of the ring portion.
32. The ring of claim 23, wherein the fastener element is a tab
comprising: a proximal end which extends out from one of the top
edge and the bottom edge of the ring portion; a free distal end
portion which extends radially outside of the ring portion; a
central portion between the proximal end and the free distal
portion; and two wings extending vertically from the central
portion, each of the wings having a malleable end portion capable
of being bent relative to the central portion into a locking
configuration.
33. The ring of claim 21, wherein the distal portion of said each
of the tines in the final configuration is shaped for piercing said
tissue of the first organ.
34. A method for preparing a first organ having an orifice for
anastomosis with a second organ, using a ring having a ring portion
sized to extend around the orifice and malleable tines that extend
out from the ring portion, said method including the steps of: (a)
inserting an anvil into the first organ through the orifice, said
anvil having a tine-forming surface; advancing the ring toward the
tine-forming surface of the anvil to cause distal ends of the tines
to grab tissue of the first organ around the orifice and curl
against the tine-forming surface while gripping the tissue, thereby
forming a curled tine structure including curled tine ends and
portions of the tissue; and (c) after step (b), retracting the
anvil so that said anvil exerts force on the curled tine structure
to cause the curled tine ends of the curled tine structure to move
radially outward away from each other.
35. The method of claim 34, wherein the portions of the tissue in
the curled tine structure formed in step (b) have begun to evert in
response to force exerted thereon by the distal ends of the tines
during step (b), and movement of the tines in steps (b) and (c)
everts the tissue around the orifice sufficiently to expose an
inner surface of the first organ which can be joined with tissue of
the second organ.
36. The method of claim 34, wherein step (b) includes the steps of:
(i) advancing the ring to cause tips of the tines to pierce the
tissue of the first organ around the orifice; and (ii) after step
(i), continuing to advance the ring to cause the tips of the tines
to engage the tine-forming surface of the anvil and curl radially
inward while distal ends of the tines grip the tissue, thereby
forming the curled tine structure.
37. The method of claim 34, wherein step (b) includes the steps of:
(i) advancing the ring to cause tips of the tines to enter the
orifice and engage the tine-forming surface of the anvil before
grabbing the tissue, so that distal ends of the tines begin to curl
radially outward against said tine-forming surface before grabbing
the tissue; and (ii) after step (i), continuing to advance the ring
to cause the tips of the tines to grab the tissue of the first
organ around the orifice while the distal ends of the tines
continue to curl against said tine-forrning surface, thereby
forming the curled tine structure.
38. The method of claim 37, also including the step of: (d) after
step (c), advancing at least one sleeve into engagement with the
curled tine structure to fold said tines so their curled ends move
further radially outward, wherein movement of the tines in steps
(b), (c), and (d) everts the tissue around the orifice sufficiently
to expose an inner surface of the first organ which can be joined
with tissue of the second organ.
39. The method of claim 34, also including the step of: (d) after
step (c), advancing at least one sleeve into engagement with the
curled tine structure to fold said tines so their curled ends move
radially outward, wherein movement of the tines in steps (b), (c),
and (d) everts the tissue around the orifice sufficiently to expose
an inner surface of the first organ which can be joined with tissue
of the second organ.
40. The method of claim 39, wherein each of the tines has a free
distal end and a weak portion between the ring portion and the free
distal end, and said each of the tines preferentially folds at the
weak portion in response to the force exerted thereon by the anvil
during.step (c) and in response to force exerted by the at least
one sleeve during step (d).
41. The method of claim 34, wherein each of the tines has a free
distal end and a weak portion between the ring portion and the free
distal end, and said each of the tines preferentially folds at the
weak portion in response to the force exerted thereon by the anvil
during step (c).
42. A tool for installing an anastomosis ring at an orifice of a
first organ to prepare the first organ for anastomosis with a
second organ, wherein the anastomosis ring has a ring portion sized
to extend around the orifice and malleable tines extending out from
the ring portion, the tool comprising: an anvil having a
tine-forming surface, wherein the anvil is sized for insertion into
the first organ through the orifice; a set of independently movable
sleeves around the anvil, wherein the sleeves are concentric with
each other and with the anvil; and a control assembly coupled to
the anvil and the sleeves and configured to advance and retract
individual ones of the anvil and the sleeves relative to other ones
of the anvil and the sleeves to advance the ring toward the
tine-forming surface of the anvil to cause distal ends of the tines
to grab tissue of the organ around the orifice and curl against the
tine-forming surface while gripping the tissue, thereby forming a
curled tine structure including curled tine ends and portions of
the tissue, and to retract the anvil such that the anvil exerts
force on the curled tine structure to cause the curled tine ends of
the curled tine structure to move radially outward away from each
other.
43. The tool of claim 42, wherein the control assembly is also
configured to advance at least one of the sleeves, relative to at
least one other one of the sleeves and following retraction of the
anvil, into engagement with the curled tine structure to fold the
tines such that their curled ends move further radially outward to
evert the tissue around the orifice, thereby exposing an inner
surface of the first organ which can be joined with tissue of the
second organ.
44. The tool of claim 42, wherein at least one of the sleeves has a
distal end defining at least two slots, one of the slots sized to
receive a tubular ring portion of a first tined anastomosis ring,
and another of the slots sized to receive a tubular ring portion of
a second tined anastomosis ring, wherein the tubular ring portion
of the first tined anastomosis ring has smaller diameter than does
the tubular ring portion of the second tined anastomosis ring.
45. The tool of claim 42, wherein an outermost one of the sleeves
has a distal end portion that defines a tine-engaging surface, the
tine-engaging surface being shaped and sized to receive each of the
tines and constrain advancing motion of at least a portion of said
each of said tines as said tines advance into engagement with the
outermost one of the sleeves.
46. The tool of claim 45, wherein at least one of the sleeves other
than the outermost one of the sleeves is configured to advance
toward the tine-engaging surface of the outermost one of the
sleeves, to press the curled tine structure against said
tine-engaging surface following retraction of the anvil, thereby
forming the ring into a final configuration.
47. The tool of claim 42, also including a flat member releasably
mounted to an outermost one of the sleeves, wherein the flat member
defines a tine-engaging surface, the tine-engaging surface being
shaped and sized to receive each of the tines and constrain
advancing motion of at least a portion of said each of said tines
as said tines advance into engagement with the outermost one of the
sleeves.
48. The tool of claim 47, wherein at least one of the sleeves other
than the outermost one of the sleeves is configured to advance
toward the tine-engaging surface of the outermost one of the
sleeves, to press the curled tine structure against said
tine-engaging surface following retraction of the anvil, thereby
forming the ring into a final configuration.
49. The tool of claim 42, wherein the ring portion is a tubular
ring portion, and the set of independently movable sleeves
comprises: an outermost sleeve having a distal end portion which
defines a tine-engaging surface; a second sleeve concentric with
and radially within the outermost sleeve, said second sleeve having
a distal end defining at least one slot sized to receive the
tubular ring portion of the ring; a third sleeve concentric with
and radially within the second sleeve; and a fourth sleeve
concentric with and radially within the third sleeve.
50. The tool of claim 49, wherein the fourth sleeve has a distal
surface having a concave portion shaped to engage and exert folding
force on a convex portion of the curled tine structure when said
concave portion of the distal surface of the fourth sleeve is
advanced into engagement with the curled tine structure following
retraction of the anvil.
51. The tool of claim 49, wherein the third sleeve has a radially
inner surface having a recessed portion shaped to provide clearance
for the curled tine structure as said curled tine structure moves
radially outward in response to force exerted thereon by the
retracting anvil.
52. The tool of claim 49, also including an innermost sleeve
concentric with and radially within the fourth sleeve, wherein the
anvil is concentric with and radially within the innermost
sleeve.
53. The tool of claim 42, wherein the ring portion is a tubular
ring portion, and the set of independently movable sleeves
comprises: an outermost sleeve having a slot; a flat member
releasably mounted in the slot, said flat member having a
tine-engaging surface; a second sleeve concentric with and radially
within the outermost sleeve, said second sleeve having a distal end
defining at least one slot sized to receive the tubular ring
portion of the ring; a third sleeve concentric with and radially
within the second sleeve; and a fourth sleeve concentric with and
radially within the third sleeve.
54. The tool of claim 53, also including an innermost sleeve
concentric with and radially within the fourth sleeve, wherein the
anvil is concentric with and radially within the innennost
sleeve.
55. A method for installing an anastomosis ring at an orifice of a
first organ using a tool, to prepare the first organ for
anastomosis with a second organ, wherein the anastomosis ring has a
ring portion sized to extend around the orifice and malleable tines
extending out from the ring portion, the tool includes an anvil and
a set of independently movable sleeves around the anvil, the anvil
has a tine-forming surface, the sleeves are concentric with each
other and with the anvil, the sleeves include an outermost sleeve
and additional sleeves, and the outermost sleeve defines a
tine-engaging surface, said method including the steps of: (a)
releasably mounting the ring to the tool such that tips of the
tines extend away from the sleeves in a distal direction, the ring
portion is releasably engaged with at least one of the sleeves, and
the tine-engaging surface of the outermost sleeve exerts holding
force on at least one of the tines; (b) inserting the anvil into
the first organ through the orifice; (c) after steps (a) and (b),
advancing at least some of the sleeves in the distal direction,
thereby advancing the ring toward the tine-forming surface of the
anvil to cause the tips of the tines to grab tissue of the first
organ around the orifice, and curl against the tine-forming surface
while gripping the tissue, thereby forming a curled tine structure
including curled tine ends and portions of the tissue; (d) after
step (c), retracting the anvil away from at least one of the
sleeves such that said anvil exerts force on the curled tine
structure to cause the curled tine ends of the curled tine
structure to move radially outward away from each other; and (e)
after step (d), advancing at least one of the additional sleeves
relative to the outermost sleeve into engagement with the curled
tine structure to fold said tines so their curled ends move further
radially outward, wherein movement of the tines in steps (c), (d),
and (e) everts the tissue around the orifice sufficiently to expose
an inner surface of the first organ which can be joined with tissue
of the second organ.
56. The method of claim 55, wherein each of the tines has a free
distal end and a weak portion between the ring portion and the free
distal end, and said each of the tines preferentially folds at the
weak portion in response to the force exerted thereon by the anvil
during step (d).
57. The method of claim 55, wherein each of the tines has a free
distal end and a weak portion between the ring portion and the free
distal end, and said each of the tines preferentially folds at the
weak portion in response to the force exerted thereon by the anvil
during step (d) and in response to force exerted by the sleeves
during step (e).
58. The method of claim 55, wherein step (c) includes the steps of:
(i) advancing the ring to cause the tips of the tines to enter the
orifice and engage the tine-forming surface of the anvil before
grabbing the tissue, so that distal ends of the tines begin to curl
radially outward against said tine-forming surface before grabbing
the tissue; and (ii) after step (i), continuing to advance the ring
to cause the tips of the tines to grab the tissue of the first
organ around the orifice while the distal ends of the tines
continue to curl radially outward against said tine-forming
surface, thereby forming the curled tine structure.
59. The method of claim 55, wherein step (b) includes the steps of:
(i) advancing the ring to cause tips of the tines to pierce the
tissue of the first organ around the orifice; and (ii) after step
(i), continuing to advance the ring to cause the tips of the tines
to engage the tine-forming surface of the anvil and curl radially
inward while distal ends of the tines grip the tissue, thereby
forming the curled tine structure.
60. The method of claim 55, wherein the outermost sleeve includes a
first portion and a flat member releasably attached to the first
portion, and the tine-engaging surface is a first surface of the
flat member, said method also including the step of: (f) after step
(e), releasing the flat member from the first portion and removing
all of the tool other than the flat member from the first organ,
thereby leaving said flat member installed with the ring at the
orifice of the first organ.
61. The method of claim 55, wherein the additional sleeves include
a first sleeve concentric with and radially within the outermost
sleeve, a second sleeve concentric with and radially within the
first sleeve, a third sleeve concentric with and radially within
the second sleeve, and a fourth sleeve concentric with and radially
within the third sleeve, said method also including the step of:
(f) after step (c) but before step (d), retracting the third sleeve
and the fourth sleeve relative to the anvil and the outermost
sleeve, and wherein step (e) includes the step of advancing at
least the first sleeve and the second sleeve relative to the
outermost sleeve against the curled tine structure to fold said
tines.
62. The method of claim 55, wherein the additional sleeves include
a first sleeve concentric with and radially within the outermost
sleeve, a second sleeve concentric with and radially within the
first sleeve, a third sleeve concentric with and radially within
the second sleeve, and a fourth sleeve concentric with and radially
within the third sleeve, said method also including the step of:
(f) after step (c) but before step (d), retracting the third sleeve
and the fourth sleeve relative to the anvil and the outermost
sleeve, and wherein step (e) includes the steps of advancing the
first sleeve relative to the second sleeve and the outermost sleeve
to rotate the curled tine structure, then advancing the second
sleeve and the third sleeve relative to the outermost sleeve
against the curled tine structure to begin to fold said tines, and
then further advancing the second sleeve relative to the third
sleeve and the outermost sleeve against the curled tine structure
to further fold said tines.
63. The method of claim 55, wherein the additional sleeves include
a first sleeve concentric with and radially within the outermost
sleeve, a second sleeve concentric with and radially within the
first sleeve, and a third sleeve concentric with and radially
within the second sleeve, wherein the second sleeve has a radially
inner surface having a recessed portion shaped to provide clearance
for the curled tine structure as said curled tine structure moves
radially outward in response to force exerted thereon by the
retracting anvil, said method also including the step of: (f) after
step (c) but before step (d), retracting the third sleeve relative
to the anvil, the second sleeve, and the outermost sleeve, and
wherein step (e) includes the steps of: (g) retracting the second
sleeve relative to the first sleeve and the third sleeve; (h) after
step (g), advancing the third sleeve relative to the outermost
sleeve against the curled tine structure to begin to fold said
tines; and (i) after step (h), advancing the second sleeve relative
to the third sleeve and the outermost sleeve against the curled
tine structure to further fold said tines.
64. The method of claim 63, wherein step (e) also includes the
steps of: (1) after step (i), retracting the third sleeve relative
to the second sleeve and the outermost sleeve; and (k) after step
0), further advancing the second sleeve relative to the outermost
sleeve against the curled tine structure to further fold said
tines.
65. A method for installing a first anastomosis ring at an orifice
of a first organ, aligning the installed ring with a second
anastomosis ring that has been installed at an orifice of a second
organ, and fastening the aligned rings together, wherein the first
anastomosis ring has a ring portion sized to extend around the
orifice of the first orifice, and malleable tines and at least one
fastener element that extend out from the ring portion, said method
including the steps of: (a) inserting an anvil having a
tine-forming surface into the first organ through the orifice of
said first organ; (b) advancing the first anastomosis ring toward
the tine-forming surface of the anvil to cause distal ends of the
tines to grab tissue of the first organ around the orifice, and
curl against the tine-forming surface while gripping the tissue,
thereby forming a curled tine structure including curled tine ends
and portions of the tissue; (c) after step (b), retracting the
anvil relative to the first anastomosis ring such that the anvil
exerts force on the curled tine structure to cause the curled tine
ends of the curled tine structure to move radially outward away
from each other; (d) after step (c), aligning the installed first
anastomosis ring with the second anastomosis ring; and (e)
fastening together the aligned first and second anastomosis rings
by coupling each said fastener element of the first anastomosis
ring to the second anastomosis ring, thereby forming an anastomosis
joining the first organ in fluid communication with the second
organ.
66. The method of claim 65, wherein each of the tines of the first
anastomosis ring has a free distal end and a weak portion between
the ring portion and the free distal end, and said each of the
tines preferentially folds at the weak portion in response to
exertion of force on the curled tine structure by the anvil during
step (c).
67. The method of claim 65, wherein the ring portion is a tubular
ring portion having a top edge and a bottom edge, the fastener
element is a malleable tab that extends upward from the top edge of
the tubular ring portion, and step (e) includes the step of bending
the malleable tab relative to the second anastomosis ring to
constrain movement of the first anastomosis ring relative to said
second anastomosis ring.
68. The method of claim 65, wherein the ring portion is a tubular
ring portion having a top edge and a bottom edge, the fastener
element is a slotted tab having a proximal end extending out from
the tubular ring portion, and a distal end defining a slot, and
step (e) includes the step of inserting a feature of the second
anastomosis ring through the slot.
69. The method of claim 65, wherein the ring portion is a tubular
ring portion having a top edge and a bottom edge, the fastener
element is a spring element which extends radially outward from one
of the top edge and the bottom edge of the ring portion, and step
(e) includes the step of displacing the spring element relative to
a feature of the second anastomosis ring to cause said spring
element to lock against said feature.
70. The method of claim 65, wherein the ring portion is a tubular
ring portion having a top edge and a bottom edge, the fastener
element is a tab element having a generally flat body which extends
generally vertically from one of the top edge and the bottom edge
of the ring portion, and malleable wings which extend out from the
generally flat body, and step (e) includes the step of bending the
malleable wings relative to the second anastomosis ring to
constrain movement of the first anastomosis ring relative to said
second anastomosis ring.
71. The method of claim 65, wherein the ring portion is a tubular
ring portion having a top edge and a bottom edge, the fastener
element is a spring element comprising a spring portion which
extends in an at least substantially vertical plane from one of the
top edge and the bottom edge of the ring portion, and a body having
a central portion which extends radially inward from the spring
portion at an acute angle relative to said spring portion, and
wherein step (e) includes the step of displacing the spring portion
relative to the second anastomosis ring and allowing said spring
portion to spring back into a locking position in which the body
constrains movement of the first anastomosis ring relative to said
second anastomosis ring.
72. The method of claim 65, wherein the first organ is a blood
vessel having a sidewall and an intima, the orifice in the first
organ is an incision in the sidewall, and movement of the tines in
steps (b) and (c) everts the tissue around the incision
sufficiently to expose the intima of the blood vessel.
73. The method of claim 65, wherein the first organ is a blood
vessel having a sidewall and an intima, and the orifice in the
first organ is an incision in the sidewall, said method also
including the step of: (f) after step (c) but before step (d),
advancing at least one sleeve into engagement with the curled tine
structure to fold said tines so their curled ends move further
radially outward, wherein movement of the tines in steps (b), (c),
and (f) everts the tissue around the incision sufficiently to
expose the intima of the blood vessel.
Description
TECHNICAL FIELD OF THE INVENTION
[0001] The present invention relates to apparatus and methods for
performing anastomosis without hand-suturing.
BACKGROUND OF THE INVENTION
[0002] In the United States, many coronary artery bypass graft
(CABG) procedures are performed on patients annually. Each of these
procedures may include one or more graft vessels which are hand
sutured. Until recently, coronary artery bypass procedures have
been performed with the patient on cardiopulmonary bypass while the
heart is stopped with cardioplegia and the surgery is performed on
an exposed, stationary heart. Interest in developing a minimally
invasive CABG procedure is increasing.
[0003] A few pioneering surgeons are now performing minimally
invasive procedures in which a coronary artery bypass is performed
through a small incision in the chest wall, sometimes on a beating
heart, i.e., without heart-lung bypass and cardioplegia.
[0004] Until recently all bypass graft procedures have been
performed by hand suturing the tiny vessels together with extremely
fine sutures under magnification. There is a need (which is
addressed by the present invention) for methods and apparatus
useful for performing anastomosis during CABG surgery on a beating
heart, without hand-suturing.
[0005] The present invention can be used to perform end-to-end
anastomosis (in which the open end of a vessel or other organ is
attached to (and in fluid communication with) the open end of
another vessel or other organ without hand-suturing, end-to-side
anastomosis (in which the open end of one vessel or other organ is
attached to the side wall of a second organ in fluid communication
with an incision or other orifice in the second organ's side wall)
without hand-suturing, or side-to-side anastomosis (in which
incisions or other orifices in the side walls of two vessels or
other organs are aligned in fluid communication with each other and
the aligned tissue is attached together) without hand-suturing.
SUMMARY OF THE INVENTION
[0006] In a class of embodiments, the invention is a ring (for use
in anastomosis) that is integrally formed from metal, and includes
a central ring portion and tines (and typically also docking
features or fastener elements) that extend from the ring portion.
In some preferred embodiments, the tines are malleable tines which
are movable relative to the ring portion from an initial
configuration into a final configuration in which they can grab
tissue of an organ (around an incision or other orifice in the
organ) and hold such tissue in an everted state. In some preferred
embodiments, each tine has a weak section at which it
preferentially folds or buckles when subjected to bending force.
The ring portion can be rigid or malleable. In preferred
embodiments, the ring has a tubular central portion. In other
embodiments, the central ring portion is flat (rather than
tubular). In some embodiments, the ring is not integrally formed
from metal. For example, in some variations, it is assembled from
component parts which are connected together (e.g., by welding), or
is made of material (other than metal) which has the required
mechanical properties.
[0007] Another aspect of the invention is a method for installing
the ring at an incision or other orifice in a vessel (or other
organ) with the ring portion extending around the incision or other
orifice. In such method, the tines are advanced against an anvil so
that they grab the tissue around the orifice and curl radially
(inward or outward) against the anvil (in some embodiments the
tines pierce the tissue before they begin to curl; in other
embodiments the tines begin to curl before they grab the
tissue).
[0008] The term "grab" is used herein in a broad sense to denote
any operation of grabbing, gripping, grasping, or otherwise
capturing the relevant tissue (such that the captured tissue can be
moved by moving the thing which captures the tissue), and to denote
either "grab and pierce" or "grab without piercing."
[0009] The anvil is then retracted to fold (or buckle) the tines so
that their curled ends move radially outward. In an optional final
step (which is included in preferred embodiments), the tool is used
to further fold or bend the tines so that their curled ends move
further radially outward. The folding (or buckling), curling, and
optional bending of the tines everts the tissue near the orifice
edges to expose the inside surface of the organ (so that such
exposed inside surface can be joined to tissue of another vessel or
organ). In typical use, the ring is installed with the ring portion
extending around an incision in the side wall of a blood vessel,
and the action of curling the tines everts the incised edges of the
orifice to expose the inside lining (intima) of the blood
vessel.
[0010] In other embodiments, the invention is a tool for installing
an anastomosis ring in an incision (or other orifice) in a vessel
or other organ. The tool includes an anvil and a set of concentric,
independently movable sleeves around the anvil. Each sleeve, and
preferably also the anvil, can be advanced (in a distal direction)
and retracted (in a proximal direction) when desired relative to
the other elements of the tool. In some preferred embodiments the
tool has four independently movable sleeves; in other embodiments
it has five independently movable sleeves. It is contemplated that
the multiple movements of the various sleeves can be automated and
synchronized to some degree such that the installation process
requires a minimal number of operator manipulations of the
installation tool.
[0011] Preferably, the distal end of one of the sleeves has two or
more circular (or oblong) slots, each for receiving a tubular
central ring portion of an anastomosis ring. Thus, the tool can be
used to install a relatively small diameter ring (whose central
ring portion fits in an innermost slot) or a relatively large
diameter ring (whose central ring portion fits in an outermost
slot).
[0012] In some preferred embodiments, the outermost sleeve is
configured to receive a removable flat member (sometimes referred
to herein as a disk). The disk has an open center and is oblong or
annular, is preferably made of thin metal, and functions during
ring installation to provide a surface against which the ring (and
tissue engaged therewith) is pressed to deform (fold and/or bend)
the ring into its final configuration. When the ring is installed
in its final configuration, the disk is released from the
installation tool. The tool is then removed from the installed
ring, leaving the disk in engagement with the ring and held between
the ring and the adjacent tissue.
[0013] In other embodiments, the invention is a ring (for use in
anastomosis) including a central ring portion (preferably a tubular
central ring portion), and tines and fastener elements that extend
from the ring portion. Preferably, each tine has a weak section at
which it preferentially folds or buckles when subjected to bending
force. The ring portion can be rigid or malleable. The fastener
elements can be (or include) malleable elements, spring elements,
or both. The fastener elements are used to fasten together two
precisely aligned anastomosis rings, each installed in an incision
(or other orifice) of a different vessel or other organ, and
optionally also to align the two rings together. In preferred
embodiments, the fastener elements of one ring are spring elements
having a locking configuration in which they exert spring force on
fastener elements of another ring to clamp the two rings
together.
[0014] In other embodiments, the invention is a method for
performing an anastomosis, including the steps of installing an
anastomosis ring in an incision (or other orifice) in a vessel or
other organ, installing another anastomosis ring in an incision (or
other orifice) in another vessel or other organ, precisely aligning
the two installed anastomosis rings, and fastening the aligned
rings together.
BRIEF DESCRIPTION OF THE DRAWING FIGURES
[0015] FIG. 1 is a perspective view of an embodiment of the
inventive ring for use in performing anastomosis without hand
sutures.
[0016] FIG. 2 is a perspective view of another embodiment of the
inventive ring for use in performing anastomosis without hand
sutures.
[0017] FIG. 3 is a side elevational view of the ring of FIG. 2
[0018] FIG. 4 is a side cross-sectional view of a portion of the
ring of FIG. 1 and a portion of an apparatus for installing it, at
an early stage of installation of the ring around an incision in
the sidewall of a blood vessel.
[0019] FIG. 5 is a side cross-sectional view of a portion of the
ring of FIG. 1 and a portion of an apparatus for installing it, at
an intermediate stage of installation of the ring around an
incision in the sidewall of a blood vessel.
[0020] FIG. 6 is a side cross-sectional view of a portion of the
ring of FIG. 1 and a portion of an apparatus for installing it, at
a late stage of installation of the ring around an incision in the
sidewall of a blood vessel.
[0021] FIG. 7 is a side cross-sectional view of a portion of the
ring of FIG. 1 and a portion of an alternative apparatus for
installing it, at an early stage of installation of the ring around
an incision in the sidewall of a blood vessel.
[0022] FIG. 8 is a side cross-sectional view of a portion of the
ring of FIG. 1 and a portion of the FIG. 7 installation apparatus,
at an intermediate stage of installation of the ring around an
incision in the sidewall of a blood vessel.
[0023] FIG. 9 is a side cross-sectional view of a portion of the
ring of FIG. 1 and a portion of the FIG. 7 installation apparatus,
at a late stage of installation of the ring around an incision in
the sidewall of a blood vessel.
[0024] FIG. 10 is a perspective view of an embodiment of the
inventive anastomosis ring, with its tines (61) in their initial
configuration.
[0025] FIG. 11 is a side cross-sectional view of a portion of ring
60 of FIG. 10, and of a portion (shown in phantom view) of another
ring (identified by reference numeral 260) which is a variation on
ring 60.
[0026] FIG. 12 is a side cross-sectional view of portions of rings
60 and 260 of FIG. 11, after the tines thereof have been curled and
formed in accordance with the invention.
[0027] FIG. 13 is a perspective view of the ring of FIG. 10, with
each of its tines 61 in its final configuration.
[0028] FIG. 14 is a side cross-sectional view of a portion of ring
60 (with one tine 61 in the FIG. 13 configuration) installed in
tissue of a first vessel at the edge of an incision, and a second
vessel (shown in phantom view) aligned with the first vessel.
[0029] FIG. 15 is a perspective view of a portion of a variation on
ring 60 of FIG. 10, with one of its tines (61') in its initial
configuration.
[0030] FIG. 16 is a side cross-sectional view of a portion of an
embodiment (80) of the inventive ring and a portion of a tool (79)
for installing this ring, in the configuration in which they would
be at an early stage (to be referred to as a "first" stage) of
installing the ring around an opening of an organ.
[0031] FIG. 17 is a side cross-sectional view of ring 80 and tool
79 of FIG. 16, in the configuration in which they would be at a
second stage of installing the ring around an opening of an
organ.
[0032] FIG. 18 is a side cross-sectional view of ring 80 and tool
79 of FIG. 16, in the configuration in which they would be at a
third stage of installing the ring around an opening of an
organ.
[0033] FIG. 19 is a side cross-sectional view of ring 80 and tool
79 of FIG. 16, in the configuration in which they would be at a
fourth stage of installing the ring around an opening of an
organ.
[0034] FIG. 20 is a side cross-sectional view of ring 80 and tool
79 of FIG. 16, in the configuration in which they would be at a
fifth stage of installing the ring around an opening of an
organ.
[0035] FIG. 21 is a side cross-sectional view of ring 80 and tool
79 of FIG. 16, in the configuration in which they would be at a
sixth stage of installing the ring around an opening of an
organ.
[0036] FIG. 22 is a side cross-sectional view of ring 80 and tool
79 of FIG. 16, in the configuration in which they would be at a
seventh stage of installing the ring around an opening of an
organ.
[0037] FIG. 23 is a side cross-sectional view of ring 80 and tool
79 of FIG. 16, in the configuration in which they would be at an
eighth stage of installing the ring around an opening of an
organ.
[0038] FIG. 24 is a side cross-sectional view of ring 80 and tool
79 of FIG. 16, in the configuration in which they would be at a
ninth stage of installing the ring around an opening of an
organ.
[0039] FIG. 25 is a simplified perspective view of the distal end
of tool 79 (of FIG. 16), without sleeve 75, and with ring 80
mounted thereon.
[0040] FIG. 25A is a perspective view of ring 80 around a preferred
(fluted) implementation of anvil 70.
[0041] FIG. 26 is side cross-sectional view of a portion of ring 80
of (of FIGS. 16-25) and a portion of another embodiment of the
inventive tool (90) for installing this ring around an opening of
an organ.
[0042] FIG. 27 is a detail view of a portion of the apparatus shown
in FIG. 26.
[0043] FIG. 28 is a side cross-sectional view of a portion of ring
80 and a portion of tool 90, which have been installed (using tool
90) around an incision in a blood vessel.
[0044] FIG. 29 is a perspective view of portions of two aligned
anastomosis rings (rings 100 and 110) having tab fasteners for
fastening the rings together.
[0045] FIG. 30 is a perspective view of a portion of a variation on
anastomosis ring 100 (of FIG. 29) having a tab fastener which is a
variation on fastener 101 of FIG. 29.
[0046] FIG. 31 is a perspective view of portions of two aligned
anastomosis rings (rings 130 and 110) having tab fasteners, one of
which (tab 131) is a variation on fastener 101 of FIG. 29.
[0047] FIG. 32 is a perspective view of portions of two aligned
anastomosis rings (rings 140 and 150) having a different type of
tab fasteners for fastening the rings together, with the fasteners
in an open (unlocked) configuration.
[0048] FIG. 33 is a perspective view of the elements shown in FIG.
32, after these elements have been moved relative to each other
into a closed (locked) configuration to fasten the rings
together.
[0049] FIG. 34 is a side cross-sectional view of portions of two
aligned anastomosis rings (rings 160 and 180) having spring
fasteners for fastening the rings together.
[0050] FIG. 35 is a perspective view of portions of the aligned
anastomosis rings 160 and 180 shown in FIG. 34.
[0051] FIG. 36 is a perspective view of portions of two aligned
anastomosis rings (rings 160 and 170) having spring fasteners of
another type for fastening the rings together.
[0052] FIG. 37 is a perspective view of a portion of a variation on
ring 170 of FIG. 36.
[0053] FIG. 38 is a perspective view of portions of two aligned
anastomosis rings (rings 190 and 200) having spring fasteners of
another type for fastening the rings together.
[0054] FIG. 39 is a perspective view of portions of two aligned
anastomosis rings (rings 190 and 210) having tab fasteners for
fastening the rings together, with the fasteners in an unlocked
position.
[0055] FIG. 40 is a perspective view of portions of aligned rings
190 and 210 of FIG. 39, with the tab fasteners in a locked
position.
[0056] FIG. 41 is a side cross-sectional view of a portion of an
embodiment (220) of the inventive ring and a portion of a tool
(230) for installing this ring, in the configuration in which they
would be at an early stage (to be referred to as a "first" stage)
of installing the ring around an opening of an organ.
[0057] FIG. 42 is a side cross-sectional view of ring 220 and tool
230 of FIG. 41, in the configuration in which they would be at a
second stage of installing the ring around an opening of an
organ.
[0058] FIG. 43 is a side cross-sectional view of ring 220 and tool
230 of FIG. 41, in the configuration in which they would be at a
third stage of installing the ring around an opening of an
organ.
[0059] FIG. 44 is a side cross-sectional view of ring 220 and tool
230 of FIG. 41, in the configuration in which they would be at a
fourth stage of installing the ring around an opening of an
organ.
[0060] FIG. 45 is a side cross-sectional view of ring 220 and tool
230 of FIG. 41, in the configuration in which they would be at a
fifth stage of installing the ring around an opening of an
organ.
[0061] FIG. 46 is a side cross-sectional view of ring 220 and tool
230 of FIG. 41, in the configuration in which they would be at a
sixth stage of installing the ring around an opening of an
organ.
[0062] FIG. 47 is a side cross-sectional view of ring 220 and tool
230 of FIG. 41, in the configuration in which they would be at a
seventh stage of installing the ring around an opening of an
organ.
[0063] FIG. 48 is a side cross-sectional view of ring 220 and tool
230 of FIG. 41, in the configuration in which they would be at an
eighth stage of installing the ring around an opening of an
organ.
[0064] FIG. 49 is a side cross-sectional view of a portion of an
embodiment (320) of the inventive ring and a portion of a preferred
embodiment of the inventive tool (330) for installing the ring, in
the configuration in which they would be at an early stage (to be
referred to as a "first" stage) of installing the ring around an
opening of an organ.
[0065] FIG. 50 is a side cross-sectional view of ring 320 and tool
330 of FIG. 49, in the configuration in which they would be at a
second stage of installing the ring around an opening of an
organ.
[0066] FIG. 51 is a side cross-sectional view of ring 320 and tool
330 of FIG. 49, in the configuration in which they would be at a
third stage of installing the ring around an opening of an
organ.
[0067] FIG. 52 is a side cross-sectional view of ring 320 and tool
330 of FIG. 49, in the configuration in which they would be at a
fourth stage of installing the ring around an opening of an
organ.
[0068] FIG. 53 is a side cross-sectional view of ring 320 and tool
330 of FIG. 49, in the configuration in which they would be at a
fifth stage of installing the ring around an opening of an
organ.
[0069] FIG. 54 is a side cross-sectional view of ring 320 and tool
330 of FIG. 49, in the configuration in which they would be at a
sixth stage of installing the ring around an opening of an
organ.
[0070] FIG. 55 is a side cross-sectional view of ring 320 and tool
330 of FIG. 49, in the configuration in which they would be at a
seventh stage of installing the ring around an opening of an
organ.
[0071] FIG. 56 is a side cross-sectional view of ring 320 and tool
330 of FIG. 49, in the configuration in which they would be at an
eighth stage of installing the ring around an opening of an
organ.
[0072] FIG. 57 is a side cross-sectional view of ring 320 and tool
330 of FIG. 49, in the configuration in which they would be at an
ninth stage of installing the ring around an opening of an
organ.
[0073] FIG. 58 is a perspective view of two of the inventive
anastomosis rings (380 and 400), each installed in an incision in a
different blood vessel, and a pair of forceps 420 gripping one of
the blood vessels. Rings 380 and 400 are preferred embodiments of
the inventive anastomosis rings.
[0074] FIG. 59 is a cross-sectional view of the apparatus and
tissue of FIG. 58, after ring 400 has been lowered onto docking
tabs 383 of ring 380.
[0075] FIG. 60 is a cross-sectional view of the apparatus and
tissue of FIG. 59 after rings 380 and 400 have been aligned, while
docking tabs 383 are being folded into a locking configuration
[0076] FIG. 61 is a perspective view of ring 380 of FIG. 58, in its
pre-installation configuration.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0077] The expression "malleable" element is used herein to denote
an element that, when deformed from a first shape into a second
shape, will not relax back into the first shape from the second. A
flexible element can be elastic or malleable (the term "flexible"
is used in a broad sense encompassing both the narrower terms
"malleable" and "elastic").
[0078] FIG. 1 is a perspective view of an anastomosis ring 10,
which is an embodiment of the inventive ring for use in performing
anastomosis without hand sutures. Ring 10 is integrally formed from
metal, and includes a central ring portion 11, and tines 12 and
docking features 15 and 16 which extend out from ring portion 11.
Preferably, each of docking features 15 and 16 is implemented so as
to add stiffness to ring portion 11, and to define at least one
snap feature (or other fastener) for using in fastening together
ring 10 (after it has been installed in a vessel or other organ)
with another anastomosis ring. Tines 12 are malleable. Ring portion
11 can be implemented to be flexible but is preferably rigid. Ring
portion 11 is substantially flat in a plane perpendicular to the
central axis of ring 10.
[0079] Each tine 12 is manufactured to be generally flat, and is
then bent so as to define a bent edge 13 between ring portion 11
and a distal tine portion which terminates at a sharp distal end.
In the initial configuration, the distal tine portions are oriented
at least substantially perpendicularly to the plane of ring portion
11. Each tine 12 is preferably tapered, with its width decreasing
from its relatively wide proximal end (at portion 11) to its sharp
distal end. Each tine 12 also has a hinge or weak section
(sometimes referred to herein as a "weak portion") at a location
that is separated from (but typically near to) edge 13. Such weak
portions are not labeled in FIG. 1. The number of tines is variable
and depends on the size of the ring and the size of the tines. The
number should be sufficient to ensure that all of the tissue
surrounding the orifice is grasped and everted.
[0080] The method for installing ring 10 (and variations thereon)
in an opening (e.g., incision) in a vessel or other organ will be
described below in detail, but is generally as follows. An anvil is
inserted through the opening into the organ, and ring 10 is
positioned with the sharp tips of tines 12 contacting the tissue
surrounding the opening. An installation tool is then operated to
drive tines 12 against the anvil, causing tines 12 to penetrate
through the tissue into contact with the anvil and then begin to
curl (or to begin to curl against the anvil and then penetrate the
tissue as they continue to curl) so as to engage (and grab) the
tissue and optionally also to begin to evert the tissue that
surrounds the opening. Then, the anvil is retracted through ring
portion 11, thereby causing each tine 12 to fold or buckle about
its hinge (or weak portion) and thus move into a folded (or
buckled) and curled configuration. The tines grab the tissue
surrounding the opening and thus evert the incised tissue edges as
they fold or buckle in response to action of the anvil. In some
cases, additional shaping forces are exerted on the tines to move
them from their folded (or buckled) and curled configuration into a
final configuration. Retraction of the anvil does not significantly
deform ring portion 11 although it does deform tines 12 relative to
ring portion 11. When tines 12 have been deformed into their final
configuration and the anvil has retracted out of engagement with
ring 10, ring 10 is fully installed at the opening of the organ
with ring portion 11 surrounding the opening (so that fluid can
flow through the opening), ring 10 holding tissue around the
opening so as to expose its intima, and docking features 15 and 16
exposed so that features 15 and 16 can be aligned with and fastened
to docking features of another ring that has been installed at an
incision in (or opening of) another organ to produce an anastomosis
that joins the two organs.
[0081] FIG. 2 is a perspective view of an anastomosis ring 20,
which is another embodiment of the inventive ring for use in
performing anastomosis without hand sutures. Ring 20 is integrally
formed from metal, and includes a central ring portion 21, and
tines 22 and docking features 25 and 26 which extend out from ring
portion 21. Ring 20 differs from above-described ring 10 primarily
in that its central ring portion 21 is tubular (in the sense that
it surrounds a central axis, has substantially greater length
(parallel to the central axis) than width (perpendicular to the
central axis), and defines a circular or oblong cross-section in a
plane perpendicular to the central axis) rather than flat, and in
that tines 22 have slightly different shape than tines 12. Tines 22
are malleable. Ring portion 21 can be implemented to be flexible
but is preferably rigid.
[0082] Docking features 25 and 26 can be identical to
above-described docking features 15 and 16 of FIG. 1. As shown in
FIG. 3, features 25 and 26 are bent upward (at an obtuse angle)
relative to ring portion 21. Alternatively, the docking features
can be bent downward (at an acute angle) relative to ring portion
21, as are alternative docking features 25A and 26A shown in
phantom view in FIG. 3.
[0083] When two rings 20 (or 10) have been installed, each in an
opening of a different organ, an anastomosis to join the organs is
accomplished as follows: the two rings are aligned with each other
to cause one ring (and the tissue held thereby) to meet the other
ring (and the tissue held thereby) such that there is a plane
(denoted herein as a "sealing plane") between the two rings; and
the aligned rings are then fastened together.
[0084] With reference to FIG. 2, each tine 22 of ring 20 is
generally flat. Each tine 22 has a relatively wide proximal portion
between ring portion 11 and shoulder 24, and a narrower distal
portion beyond shoulder 24. Each tine is bent at an edge 23 to
define a distal portion (distally beyond edge 23) and a proximal
portion (between edge 23 and ring portion 11). Each proximal
portion defines a shoulder 24. The width of the distal portion
decreases in tapered fashion from edge 23 to a sharp distal end.
The distal portions of tines 22 (distal to bent edges 23) are
oriented at least substantially perpendicularly to the plane of
ring portion 21. During installation, each tine 22 curls tightly
from its tip to its edge 23 in response to being advanced against
an anvil of an installation tool. Later during installation, each
tine 22 tends to fold or buckle at shoulder 24 (rather than at
other locations along the tine) in response to retraction of the
anvil upward (when viewed as in FIG. 2) through ring portion 21, so
that shoulder 24 defines a hinge (or weak portion) of tine 22. In
some implementations, each tine 22 also has an additional hinge or
weak portion (not labeled) at a location which is separated from
(but typically near to) shoulder 24 and separated from edge 23.
[0085] More generally, in embodiments of the inventive ring in
which each tine (in its pre-installation configuration) has a
proximal portion that extends radially inward toward the ring's
central axis and a distal portion orientated at least substantially
parallel to the ring's central axis (e.g., the embodiments of FIGS.
1 and 2), the distal portion is preferably tapered to its sharp tip
to guarantee a tight curl when curling against the anvil of the
installation tool during installation. The proximal portion need
not be tapered (although the proximal portion of each tine of ring
10 is shown to be tapered in FIG. 1). In typical implementations,
the proximal portion of each tine is not tapered (as in FIG. 1) and
instead defines a shoulder (e.g., shoulder 24 of each tine of FIG.
2) or other hinge or weak portion (e.g., a hole), so that when the
anvil of the installation tool is retracted (so as to fold or
buckle the tines radially outward and thereby evert tissue being
grabbed by the tines), each tine will preferentially fold or buckle
at the shoulder (or other hinge or weak portion) of its proximal
portion in response to the force exerted by the retracting
anvil.
[0086] The method for installing ring 20 (and variations thereon)
in an opening (e.g., an incision) in a vessel or other organ will
be described below in detail, and is basically the same as the
method for installing ring 10. An anvil is inserted through the
opening into the organ, and ring 20 is positioned with the sharp
tips of tines 22 engaging the tissue surrounding the opening. An
installation tool is then operated to drive tines 22 against the
anvil, causing tines 22 to penetrate through the tissue into
contact with the anvil and then begin to curl (or to begin to curl
against the anvil and then penetrate the tissue as they continue to
curl) so as to engage (and grab) the tissue and optionally also to
begin to evert the tissue that surrounds the opening. Then, the
anvil is retracted through ring portion 21, thereby causing each
tine 22 to fold or buckle about one or more hinges (or weak
portions) thereof and move into a folded (or buckled) and curled
configuration. The tines grab the tissue surrounding the opening
and thus evert the incised tissue edges as they fold or buckle in
response to action of the anvil. In some cases, additional shaping
forces are exerted on the tines to move them from their folded (or
buckled) and curled configuration into a final configuration.
Retraction of the anvil does not significantly deform ring portion
21 although it does deform tines 22 relative to ring portion 21.
When tines 22 have been deformed into their final configuration and
the anvil has retracted out of engagement with ring 20, ring 20 is
fully installed at the opening of the organ with ring portion 21
surrounding the opening (so that fluid can flow through the
opening), ring 20 holding tissue around the opening so as to expose
its intima, and docking features 25 and 26 exposed.
[0087] The tines of each embodiment of the inventive ring
(including ring 10 or 20) are preferably wide and flat so that each
has a relatively wide surface oriented parallel to the edge of the
opening at which the ring is to be installed. This allows the tines
efficiently to exert everting force on the tissue around the
opening without tearing or otherwise causing trauma to the tissue,
while at the same time the tines can be easily formed in response
to exertion of moderate forces thereon (e.g., forces which fold or
buckle the tines about their hinges or weak portions).
[0088] Ring 10 can be installed using an installation tool
comprising anvil 30 and independently translatable sleeves 31 and
32 (as shown in FIGS. 4, 5, and 6) at the site of an incision in
the side wall of a blood vessel having exterior surface 40 and
interior surface (inside lining or "intima") 41. Only the right
half of the distal portion of each of elements 30, 31, and 32, and
the right edge of the incision (whose axis of symmetry extends
perpendicular to the plane of FIG. 4) are shown in FIGS. 4, 5, and
6. FIG. 4 shows ring 10 and the installation tool at an early stage
of the installation process, FIG. 5 shows them at a later stage,
and FIG. 6 shows them at a still later stage. When anvil 30 has
retracted (upward) into the position shown in FIG. 6, ring 10 has
been installed with ring portion 11 extending around the incision,
tines 12 grabbing the tissue around the incision, and tines 12
having been deformed so as to evert the incised edges of the tissue
to expose the intima 41 of the blood vessel as shown in FIG. 6.
[0089] More specifically, as shown in FIG. 4, anvil 30 is inserted
into the incision. Sleeves 31 and 32 are then advanced distally to
drive tines 12 of ring 10 into the tissue, so that the tines
penetrate the tissue and engage the tine-forming surface 30A of
anvil 30, and so that the tines begin to curl radially inward
(toward the central axis of anvil 30) as they advance against anvil
surface 30A. Then, as shown in FIG. 5, while sleeves 31 and 32
press ring 10's flat ring portion 11 in the distal direction
against the vessel's exterior surface 40, anvil 30 is retracted in
the proximal direction (toward the top of FIG. 5) to cause surface
30A to begin to bend the distal portion of each tine 12 toward the
top of FIG. 5 relative to the rest of ring 10. Since the tines 12
extend through the tissue, the tines grab the tissue as they bend,
and the bending of the tines causes the incised tissue edges to
begin to evert. Then, as shown in FIG. 6, sleeve 31 is retracted in
the proximal direction while anvil 30 continues to retract in the
proximal direction. In response to the force exerted on tines 12 by
retracting anvil 30 (when sleeve 31 has retracted proximally), each
tine 12 folds or buckles at its hinge (or weak portion) radially
outward (away from the central axis of anvil 30) as it continues to
grab the tissue, thereby completing the eversion of the incised
tissue edges as shown in FIG. 6. After such folding or buckling of
tines 12, sleeve 32 is withdrawn or retracted in the proximal
direction, leaving ring 10 installed at the incision with tines 12
holding the incised tissue edges in the desired everted state (for
joining to tissue of another vessel or other organ). Optionally, a
final step is performed in which an another element (not shown in
FIGS. 4-6) of the installation tool is advanced into engagement
with ring 10 (or the tissue that has been grabbed thereby), or in
which anvil 30 is again advanced into the incision and sleeves 31
and 32 are then advanced against anvil 30, to further bend the
tines 12 relative to the rest of ring 10 and thereby further evert
the incised tissue edges. The optional final step is included in
preferred embodiments of the invention.
[0090] Preferably (and as an alternative to the procedure described
with reference to FIGS. 4-6), ring 10 is installed using a slightly
different installation tool that comprises anvil 30 and
independently translatable sleeves 51 and 52 (as shown in FIGS. 7,
8, and 9) at the site of an incision in the side wall of a blood
vessel having exterior surface 40 and interior surface ("intima")
41. Only the right half of the distal portion of each of elements
30, 51, and 52, and the right edge of the incision (whose axis of
symmetry extends perpendicular to the plane of FIG. 7) are shown in
FIGS. 7, 8, and 9. FIG. 7 shows ring 10 and the installation tool
at an early stage of the installation process, FIG. 8 shows them at
a later stage, and FIG. 9 shows them at a still later stage. When
anvil 30 has retracted (upward) into the position shown in FIG. 9,
ring 10 has been installed with ring portion 11 extending around
the incision, tines 12 grabbing the tissue around the incision, and
tines 12 having been deformed so as to evert the incised edges of
the tissue to expose the intima 41 of the blood vessel as shown in
FIG. 9.
[0091] More specifically, as shown in FIG. 7, anvil 30 is inserted
into the incision. Then, sleeves 51 and 52 are advanced distally
(relative to anvil 30) to drive tines 12 of ring 10 between anvil
30 and the incised tissue edges until the tips of tines 12 engage
the tine-forming surface 30A of anvil 30, and begin to curl
radially outward (away from the central axis of anvil 30) as they
advance against anvil surface 30A. Sleeves 51 and 52 continue to
advance until they reach the position shown in FIG. 8, in which
they have pressed ring 10's flat ring portion 11 in the distal
direction against the vessel's exterior surface 40, and caused the
distal portion of each tine 12 to bend (against stationary surface
30A of anvil 30) relative to the rest of ring 10 until the tip of
each tine has penetrated (and grabbed) the tissue around the
incision. Then, as shown in FIG. 9, sleeve 51 and anvil 30 are
retracted (in the proximal direction) while sleeve 52 remains
extended in engagement with ring 10. In response to the force
exerted on tines 12 (and the incised tissue edges that have been
grabbed by tines 12) by retracting anvil 30, each tine 12 folds or
buckles at its hinge (or weak portion) radially outward (away from
the central axis of anvil 30) while continuing to grab the tissue,
thereby everting the incised tissue edges as shown in FIG. 9. After
such folding or buckling of tines 12, sleeve 52 is retracted in the
proximal direction or otherwise withdrawn, leaving ring 10
installed at the incision with tines 12 holding the incised tissue
edges in the desired everted state (so that the everted tissue can
be joined to tissue of another vessel or other organ). Optionally,
a final step is performed in which an another element (not shown in
FIGS. 7-9) of the installation tool is advanced into engagement
with ring 10 (or the tissue that has been grabbed thereby), or in
which anvil 30 is again advanced into the incision and sleeves 51
and 52 are then advanced against anvil 30, to further bend the
tines 12 relative to the rest of ring 10 and thereby further evert
the incised tissue edges.
[0092] FIGS. 10 and 13 are perspective views of anastomosis ring
60, which is an embodiment of the inventive anastomosis ring. Ring
60 includes ten malleable tines 61 which extend out from
cylindrical (tubular) ring portion 65. FIG. 10 shows tines 61 in
their initial configuration (the configuration in which they would
be when ring 60 is loaded onto an installation tool prior to
installation at an incision in an organ). FIG. 13 shows each of
tines 61 in its final configuration (the configuration in which it
would be following installation at an incision in an organ).
[0093] Each tine 61 of ring 60 has a flat cross-section, with two
opposed faces and relatively small (narrow) edge surfaces between
the faces. Each tine 61 has a relatively wide proximal end 64 (from
which it extends out from ring portion 65) and tapers to a sharp
distal end 62. Each tine 61 is preferably made from flat metal, and
has a weak portion 63 which is defined by a hole formed (e.g.,
stamped or etched) therethrough (from one of the opposed faces to
the other) at a location between ends 62 and 64. Prior to
installation, each tine 61 is pre-formed into an S-shape as shown
in FIG. 10, so that the tines' distal portions are oriented in a
distal direction (so that the tines' distal portions are generally
parallel to each other and to the axis of symmetry of ring 60).
During the installation process, a distal portion of each tine is
curled radially outward (away from ring 60's axis of symmetry) so
that it grasps tissue, and then the curled tines are folded (or
buckled) radially outward about their weak portions to evert the
tissue being grasped thereby, until each tine 61 reaches the final
configuration shown in FIG. 13. As shown in FIGS. 13 and 14, when
tines 61 are in their final configuration, the folded portion 67 of
each tine that is farthest from the ring's tubular portion 65 is at
(or very near to) the tine's weak portion 63. Assuming that the
central axis of tubular portion 65 is oriented vertically, the
folded portion 67 is preferably slightly raised in the sense that
it is slightly above the tine's lowest portion (66). When ring 60
has been installed around an incision in a vessel 68 (with tines 61
in the configuration shown in FIG. 14 so as to evert the incised
tissue edges), and vessel 68 is to be joined (at an anastomosis
site) to a second vessel 69 that has been prepared for anastomosis
by installation of an anastomosis ring (similar or identical to
ring 60) around an incision in the second vessel, the folded,
raised portions 67 of tines 61 (of ring 60) desirably shape the
everted, incised tissue edges of vessel 68. Specifically, the fact
that portions 67 are raised (relative to portions 66) causes ring
60 to present the intima of vessel 68 to the intima of vessel 69 in
an orientation that promotes healing together of, and formation of
a fluid tight seal between, the joined tissue of vessels 68 and
69.
[0094] A variation on ring 60 will be described with reference to
FIG. 15. This ring, identified by reference numeral 60', has a
tubular central ring portion 65' and ten malleable tines 61' which
extend out from the tubular ring portion. FIG. 15 shows one of
tines 61' in its initial configuration (the configuration in which
it would be when ring 60' is loaded onto an installation tool prior
to installation at an incision in an organ). The other tines 61' of
ring 60' are omitted from FIG. 15 for clarity. Each tine 61' has a
flat cross-section, with two opposed faces and relatively small
(narrow) edge surfaces between the faces. Each tine 61' has a pair
of notches 63' in the edge surfaces at a first distance from ring
portion 65'. These notches define a weak portion of tine 61' at
said first distance from ring portion 65'.
[0095] Ring 260 (shown in phantom view in FIGS. 11 and 12) differs
from ring 60 (of FIGS. 10, 11, and 12) in the following respects.
In ring 60's pre-installation configuration, each of its tines 61
(which extend out from ring 60's cylindrical portion 65) has a
distal portion 61A that is oriented vertically (when ring 60 is
viewed as in FIG. 11) and terminates at a sharp tip 62, a straight
proximal portion 61B oriented at a forty-five degree angle relative
to distal portion 61A, and a horizontally oriented straight portion
61C between portions 61A and 61B. Ring 260 (shown in phantom view
in FIGS. 11 and 12) has a central cylindrical portion which is
identical to cylindrical portion 65 of ring 60. However, each tine
261 of ring 260 in its pre-installation configuration extends out
from ring 260's cylindrical portion with a distal portion that is
oriented vertically (when ring 260 is viewed as in FIG. 11), a
curved proximal portion R, and a horizontally oriented third
portion between the distal portion and the curved proximal portion.
An important difference between the curved tines 261 of ring 260
and the piecewise linear tines 61 of ring 60 is that, in the ring
installation step to be described with reference to FIG. 22, tine
261 will bend and rotate farther than tine 61 due to the cam action
of surface 76 of sleeve 75 on the smoothly curved tine 261. This
additional bending and rotation of tines 261 (to move them from a
configuration corresponding to that shown in FIG. 21 to a
configuration corresponding to that shown in FIG. 22) allows
sleeves 72, 73, and 74 to more easily form the final bend in each
tine 261 as sleeves 72, 73, and 74 advance to press tines 261
against surface 76 (during the installation step to be described
with reference to FIG. 24).
[0096] Next, with reference to FIGS. 16-25, we describe a tool 79
for installing ring 80 (partially shown in each of FIGS. 16-25), in
tissue around an opening in an organ (e.g., an incision in a blood
vessel). With respect to all embodiments of tools for installing
the inventive rings disclosed herein, it is contemplated that the
multiple movements of the various sleeves can be automated and
synchronized to some degree such that the installation process
requires a minimal number of operator manipulations of the
installation tool. Ring 80 can be identical to ring 60 of FIG. 14.
In ring 80's pre-installation configuration, each of its tines 80A
(which extend out from ring 80's cylindrical portion 85) has a
distal portion 81 that is oriented vertically (when ring 80 is
viewed as in FIG. 17) and terminates at a sharp tip 82, a proximal
portion 83 oriented at a forty-five degree angle relative to distal
portion 81, and a horizontally oriented third portion 84 between
portions 81 and 83.
[0097] Each tine 80A of ring 80 will preferentially fold at the
junction between angled portion 83 and portion 84 (e.g., in
response to forces exerted on ring 80 by retracting anvil 70 during
the installation step shown in FIG. 20, and forces exerted on ring
80 by anvil 70 and sleeves 74 and 75 during the installation step
shown in FIG. 24). Each tine 80A preferably also has a weak portion
(e.g., a hinge) at a location near to (but spaced from) the
junction between portions 83 and 84, so that each tine 80A
preferentially bends at both this junction and the weak portion
during the steps described with reference to FIGS. 20 and 24. FIG.
25 is a simplified perspective view of the distal end of tool 79
with ring 80 (in its initial configuration) mounted thereon,
showing some of tines 80A of ring 80. Each tine 80A has a hole 86
extending through it (at a location along tine portion 84), each
hole 86 defining a weak portion of the tine.
[0098] FIG. 25A is a perspective view of ring 80 around a preferred
(fluted) implementation of anvil 70. Anvil 70 of FIG. 25A has
grooves along its sides, and concave, tine-forming portions 70B of
its surface 70A. Each concave portion 70B is dimensioned and
positioned to receive and form one of the tines of ring 80.
[0099] With reference to FIGS. 16-24 we next describe operation of
installation tool 79 which comprises anvil 70 and independently
translatable sleeves 71, 72, 73, 74, and 75, during installation of
an anastomosis ring 80 in an organ (the organ is not shown). Only
the right half of the distal portion of each of elements 71, 72,
73, 74, and 75, the distal portion of anvil 70, and the right half
of ring 80, are shown in FIGS. 16-24. Tool 79 also comprises
control assembly 79A (shown only in FIG. 16) which is coupled to
anvil 70 and sleeve elements 71-75 and configured to independently
advance and retract appropriate ones of elements 70-75 at
appropriate times. It is contemplated that some implementations of
assembly 79A are manually operated in the sense that a user must
manually manipulate at least one element of 79A to accomplish each
advancing or retracting movement of each desired one of elements
70-75, and that other implementations of assembly 79A are
automatically operated in the sense that they include a trigger,
and hardware for implementing a timed sequence of advancing and
retracting movements of elements 70-75 in response to a single
actuation of the trigger. Other embodiments of the inventive
installation tool (including those described with reference to
FIGS. 4-9 and 41-57) have control assemblies coupled to the tool's
anvil and sleeve elements and configured to advance and retract
appropriate ones of the anvil and sleeve elements at appropriate
times.
[0100] Initially, ring 80 is loaded onto tool 79 with tubular
portion 85 in circular slot 74A of sleeve 74 (shown in FIGS. 16 and
17), and tines 80A of ring 80 held between sleeves 71, 72, 73, 74,
and end portion 76 of sleeve 75 as shown in FIG. 16. Then, anvil 70
is inserted into the incision (or other opening) in the organ, and
sleeves 71, 72, 73, 74, and 75 are then advanced (distally)
together as a unit to drive tines 80A between anvil 70 and the
tissue edges until the tips of tines 80A engage the tine-forming
surface 70A of anvil 70, and begin to curl radially outward (away
from the central axis of anvil 70) as they advance against anvil
surface 70A. Sleeves 71, 72, 73, 74, and 75 continue to advance
until they reach the position shown in FIG. 17, in which they have
pressed portion 84 of each tine 80A against the organ's exterior
surface and caused distal portion 81 of each tine 80A to bend
(against stationary surface 70A of anvil 70) relative to the rest
of ring 80 until the tip 82 of each tine has penetrated (and
grabbed) the tissue around the opening. The distal end of sleeve 73
is angled to match the slope of each of tine portions 83 of ring 80
in its FIG. 16 configuration. FIG. 16 shows one tine 80A whose tip
has been advanced into engagement with surface 70A (but which has
not yet begun to curl), and FIG. 17 shows the same tine after it
has been advanced further (by sleeves 71, 72, 73, 74, and 75) and
begun to curl radially outward.
[0101] Then, while sleeves 71-75 remain stationary, anvil 70 is
retracted (toward the top of FIG. 18) to further curl the curled
distal portion 81 of each tine 80A relative to the rest of ring 80
into the configuration shown in FIG. 18, thereby causing portion 81
of each tine to further penetrate and more securely grab the tissue
around the opening.
[0102] Then, as shown in FIG. 19, sleeves 71 and 72 are retracted
in the proximal direction (toward the top of FIG. 19) while sleeves
73, 74, and 75 and anvil 70 remain stationary in engagement with
ring 80.
[0103] Then, as shown in FIG. 20, anvil 70 is retracted (in the
proximal direction) relative to sleeves 73, 74, and 75. In response
to the force exerted by anvil 70 on tines 80A (and the tissue edges
that have been grabbed by tines 80A), each tine 80A folds or
buckles at both its weak portion and at the junction (identified by
reference numeral 83A in FIGS. 17 and 25) between portions 83 and
84, so that its curled distal portion 81 moves radially outward
(away from the central axis of anvil 70) while it continues to grab
the tissue, thereby everting the tissue edges. As noted, each tine
80A preferably has a weak portion (e.g., a hinge) at a location
spaced from the junction (83A) between portions 83 and 84. In one
implementation, this weak portion is determined by a hole 86 (shown
in and described above with reference to FIG. 25) in each tine.
Each hole 86 is preferably located along the tine such that, when
tines 80A are in their final configuration (shown in FIG. 24), the
portion (87) of each tine that is farthest (radially) from the
ring's tubular portion 85 does not coincide with the junction 83A,
and such portion 87 coincides with (or is very near to) hole 86. In
this preferred implementation, hole 86 extends through portion 84
of each tine 80A at a location near to, but spaced from junction
83A between portions 83 and 84. Such separation between hole 86 and
junction 83A (and greater distance between portion 85 and hole 86
than between portion 85 and junction 83A) is preferred because it
reduces trauma to tissue in the following sense during installation
of ring 80 in the tissue. When ring 80 has been installed in the
tissue in its final configuration (shown in FIG. 24), the
installation procedure has not stretched the tissue along portion
83 of each tine (which is not shown in FIG. 24, but which would be
between portion 83 and sleeve portion 76). In contrast, the tissue
in immediate contact with tip 82 of each tine has undergone
significant stretching. The degree of stretching which the tissue
has undergone is roughly proportional to the tissue's distance
(along each tine from tip 82 to portion 87) from tip 82, with
tissue nearer to portion 87 (along the tine's axis) having
undergone less stretching than tissue farther from portion 87 along
the tine's axis. Thus, since the preferred location of the tine's
weak portion effectively moves portion 87 closer (along the tine's
axis) to tip 82 than it would be if the weak portion were not
present (or if the weak portion had coincided with junction 83A),
the weak portion effectively reduces the amount of stretching
undergone by the tissue during ring installation.
[0104] Each tine 80A preferentially bends at both junction 83A and
at the weak portion (the location of hole 86) during the steps
described with reference to FIGS. 20 and 24.
[0105] After the folding or buckling of tines 80A described with
reference to FIG. 20, sleeve 73 is retracted in the proximal
direction (as shown in FIG. 21), leaving ring 80 (and the tissue
gripped thereby) between anvil 70 and sleeves 71, 72, 74, and 75,
with sleeve 74 in a retracted position relative to sleeve 75.
[0106] Then, sleeve 74 is advanced distally relative to sleeve 75
(into the position shown in FIG. 22) to bend and rotate each tine
80A (relative to the rest of ring 80) from the configuration shown
in FIG. 21 to that shown in FIG. 22 as a result of force exertion
on ring 80 by stationary sleeve 75 and the distal end of advancing
sleeve 74. This bending and rotation further everts the tissue
edges around the organ opening, causes the tines 80A to penetrate
farther into the tissue, and allows sleeves 72, 73, and 74 to more
easily form a final bend in each tine 80A (in the step to be
described with reference to FIG. 24). When ring 80 has been formed
into the configuration shown in FIG. 22, portion 85 is at least
substantially perpendicular to portion 83 of each tine 80A, and
portions 83 and 85 are supported by sleeve 75.
[0107] After ring 80 has been placed in the configuration shown in
FIG. 22, sleeve 74 is retracted in the proximal direction relative
to portion 76 of sleeve 75, into the position shown in FIG. 23.
[0108] Then, sleeves 72, 73, and 74 are advanced distally relative
to portion 76 of sleeve 75 to press tines 80A and portion 85
against portion 76, thereby forming a final bend in each of tines
80A relative to portion 85 and moving the ring 80 into the final,
installed configuration shown in FIG. 24. Specifically, portions
81, 82, and 84 of each tine 80A are bent radially outward relative
to portion 83 and then pushed distally against portion 83 to put
ring 80 in the final configuration. In this final configuration,
ring 80 is installed at the opening in the organ with tines 80A
holding the tissue edges in the desired everted state (so that the
everted tissue can be joined to tissue of another vessel or other
organ).
[0109] After installation of ring 80, sleeve 75 is (e.g., portions
comprising the distal end of sleeve 75 are) spread or dilated
(radially outward away from anvil 70's central axis of symmetry) to
decouple tool 79 from the installed ring, and tool 79 is removed
from the installed ring.
[0110] In tool 79 (described with reference to FIGS. 16-24), flat
portion 84 of each tine 80A conforms with the flat upper surface of
portion 76 of sleeve 75 during the step described with reference to
FIG. 23, so that sleeves 72, 73, and 74 can efficiently form the
final bend in each tine 80A as sleeves 72, 73, and 74 advance to
press tines 80A against surface 76 (during the step described with
reference to FIG. 24). Variations on installation tool 79 (e.g.,
those used to install rings having curved tines, such as ring 60)
can include a sleeve that corresponds functionally to sleeve 75 but
has a tine-receiving surface (corresponding to the upper,
tine-receiving surface of portion 76) that is not flat, but is
instead curved to match the curvature of tines of rings to be
installed by such tool.
[0111] In variations on the described embodiments of the inventive
tined anastomosis ring, the weak point of each tine is determined
other than by a hole through the tine. For example, the weak point
can be determined by notches cut into the tine (to reduce the
tine's width), a tine portion having reduced thickness, or
perforations cut into the tine.
[0112] In variations on the described embodiments of the inventive
tined ring, the ring portion (from which the tines, and optionally
also docking features, protrude) is not malleable. For example, the
ring portion can be rigid or elastic. The ring portion is
preferably integrally formed from metal, but can alternatively have
another structure. For example, the ring portion can be assembled
from component parts (e.g., metal parts) which are connected
together (e.g., by welding), or can be made (entirely or partially)
of material other than metal but which has the required mechanical
properties (e.g., flexibility and/or moldability).
[0113] Next, with reference to FIGS. 26-28, we describe
installation tool 90 which is another embodiment of the inventive
tool for installing ring 80 (or variations on this embodiment of
the inventive tined ring) around an opening of an organ (e.g., an
incision in a blood vessel). Installation tool 90 includes anvil 70
and independently translatable sleeves 71, 72, 73, and 74 which are
identical to the corresponding, identically numbered, elements of
tool 79 described above with reference to FIGS. 16-25. Tool 90 also
includes sleeve 95 and annular disk 96 (which together replace
sleeve 75 of above-described tool 79), and hardware (not shown) for
advancing and retracting elements 70, 71, 72, 73, 74, and 95 at
desired times. The inner radius of annular disk 96 is equal to the
inner radius of portion 76 of sleeve 75 of tool 79, and the width
of disk 96 (from its inner to outer radius) is such that the
overall distance from the inner radius of disk 96 to the outer
radius of the distal portion of sleeve 95 is equal to the overall
distance from the inner radius of portion 76 of sleeve 75 to the
outer radius of sleeve 75's distal portion.
[0114] Tool 90 can be used to install ring 80 at the site of an
incision in the side wall of a blood vessel (shown in FIG. 28 but
not FIG. 26) having exterior surface 40 and interior surface
(inside lining or "intima") 41. FIG. 26 is a cross-sectional view
of the right half only of the distal portion of each of elements
71, 72, 73, 74, and 95, and the right half of ring 80 and disk 96.
Disk 96 is oblong (with an open center) or annular.
[0115] FIG. 26 shows ring 80 and tool 90 at an early stage of the
installation process. To load ring 80 and disk 96 at tool 90's
distal end, ring portion 85 is inserted into slot (or groove) 74A
of sleeve 74, and disk 96 is inserted in groove 95A in sleeve 95's
inner sidewall. Each of slot 74A and groove 95A is circular or
oblong (e.g., each is circular when the tubular central portion of
ring 80 is circular and disk 96 is annular). Sleeve 95 (or the
distal end of sleeve 95) can comprise multiple portions which can
be moved radially toward each other (to grip the disk 96) or
radially away from each other (to release the disk 96). The
portions comprising sleeve 95's distal end are spread or dilated
radially outward (away from each other and away from the central
axis of symmetry of anvil 70) to allow insertion of disk 96 in (or
removal of disk 96 from) groove 95A, or contracted radially inward
(toward the central axis of anvil 70) so that disk 96 is gripped
between sleeve 95 and tines 80A of ring 80. In alternative
embodiments of the invention, sleeve 95 includes an element which
releasably holds disk 96 in groove 95A. In other alternative
embodiments, disk 96 (or a variation thereon) is removably mounted
to a sleeve (sleeve 95 or a variation thereon) by a joining feature
other than a groove or notch in the sleeve.
[0116] When ring 80 and disk 96 have been loaded onto the distal
end of tool 90, tool 90 is operated to install ring 80 at an
incision or other opening in an organ. To accomplish this, tool 90
operates in essentially the same manner as above-described tool 79
would operate to install the same ring, with elements 95 and 96 of
tool 90 together corresponding functionally to sleeve 75 of tool
79, except in that disk 96 remains at the anastomosis site (with
the fully installed ring) after sleeve 95 and the other elements of
installation tool 90 are removed from the anastomosis site.
[0117] For the following reason, tool 90 can have a simpler design
than that of tool 79, and removal and release of tool 90 following
installation of a ring can be easier than removal and release of
tool 79 following ring installation. The radial distance over which
the distal end of sleeve 95 must move (distance "A" in FIG. 27) to
release disk 96 and to release portion 85 of ring 80 from between
sleeves 74 and 95 is much less than the radial distance over which
the distal end of sleeve 95 would need to move (distance "B" in
FIG. 27) to release portion 85 from elements 74, 95, and 96 if disk
96 were integrally formed with (or permanently attached to) sleeve
95, assuming that the overall distance from the inner radius of
disk 96 to the outer radius of sleeve 95 is equal to the overall
distance from the inner radius of portion 76 of sleeve 75 to the
outer radius of the distal end of sleeve 75.
[0118] Also, sleeve 95 of tool 90 (and sleeve 75 of tool 79) are
typically made of plastic, but it is practical to implement disk 96
as a metal disk. A metal implementation of disk 96 would typically
be stronger than a typical plastic implementation of portion 76 of
sleeve 75.
[0119] When tool 90 has completed the installation of ring 80 at an
incision in a blood vessel (as shown in FIG. 28), ring portion 85
extends around the incision, tines 80A have grabbed the tissue
around the incision and then been deformed so as to evert the
incised edges of the tissue to expose the intima 41 of the blood
vessel, and disk 96 is trapped between the vessel's exterior
surface 40 and tines 80A. Ring 80 can be implemented with docking
features (and optionally also fasteners) that extend out from ring
portion 85. Alternatively, disk 96 can be implemented with docking
features (and optionally also fasteners) that extend out from disk
96's outer periphery (for use in aligning ring 80 with, and
optionally also attaching ring 80 to, another anastomosis ring). In
the latter case, ring 80 is preferably implemented without docking
features or fasteners to simplify its design.
[0120] When only the inventive tined anastomosis ring (and not also
an additional element such as annular disk 96 of FIG. 28) is to be
installed, the ring is preferably implemented to have one or more
fasteners extending out from its central ring portion (the ring
portion from which its tines extend). Preferred implementations of
such fasteners will next be described with reference to FIGS.
29-40. Each fastener will be described as a feature of an
embodiment of a tined anastomosis ring having a tubular central
ring portion, although each fastener can be implemented as a
feature of an anastomosis ring having a flat central ring portion,
or as a feature of an annular ring (e.g., ring 96 of FIG. 28) to be
installed with any embodiment of the inventive tined anastomosis
ring.
[0121] FIG. 29 is a perspective view of portions of two of the
inventive anastomosis rings (ring 100 and ring 110) which have been
aligned together, and respectively include fasteners 101 and 111
which are tabs. Each of rings 100 and 110 has a tubular central
portion (having the same shape as portion 65 of ring 60 of FIG.
10), with tines (not shown) that extend out from such tubular
central portion. Ring 100 has tabs 101 that extend up from its
tubular central portion at locations evenly spaced around the
tubular central portion. Only one tab 101 is shown in FIG. 29. Each
tab 101 has notches 102 at the junction between tab 101 and ring
100's tubular central portion.
[0122] Ring 110 has one slotted tab 111 for each tab 101 of ring
100. Each tab 111 has a proximal portion 112 at the junction
between tab 111 and ring 110's tubular central portion, and a
distal end defining a slot 113. Each tab 111 is bent into the shape
shown in FIG. 29, so that tab 101 of ring 100 can be advanced
upward through slot 113 to align the rings 100 and 110 together.
When rings 100 and 110 have been aligned as shown, they are
fastened together by bending each tab 101 radially outward and
downward relative to table 111 so that tab 100 folds into an
orientation that locks ring 101 together with ring 100. The notches
102 in each tab 101 define a weak point at which tab 101
preferentially folds when it is bent as described.
[0123] Tab 121 (of anastomosis ring 120) of FIG. 30 is a variation
on tab 101 of FIG. 29. Anastomosis ring 120 has tabs 121 which
extend up from its tubular central portion at locations evenly
spaced around the tubular central portion, and tines (not shown)
that extend down from its tubular central portion. Only one tab 121
is shown in FIG. 30. Tab 121 differs from tab 101 only in that its
weak portion (at the junction between tab 121 and ring 120's
tubular central portion) is defined by a slot 122 extending through
tab 121, rather than by notches (e.g., notches 102 of FIG. 29) in
the tab's sides.
[0124] Tab 131 (of anastomosis ring 130) of FIG. 31 is another
variation on tab 101 of FIG. 29. Anastomosis ring 130 has tabs 131
which extend up from its tubular central portion at locations
evenly spaced around the tubular central portion, and tines (not
shown) that extend down from its tubular central portion. Only one
tab 131 is shown in FIG. 31. Tab 131 differs from tab 101 in that
its weak portion 131A (which can be a thin portion of tab 131) is
oriented vertically, and in that it has a notch 132 at the junction
between tab 131 and ring 130's tubular central portion. To fasten
ring 130 to ring 110, each tab 131 is bent or folded at its weak
portion 131A. In contrast, the weak portion of tab 101 is defined
by a set of notches (e.g., notches 102 of FIG. 29) in the tab's
sides.
[0125] FIGS. 32 and 33 are perspective views of portions of two
aligned anastomosis rings (rings 140 and 150) having a different
type of tab fasteners for fastening the rings together. Ring 140
has tabs 141 which extend out from around its tubular central
portion, and ring 150 has tabs 151 which extend out is from around
its tubular central portion. Only one tab 141 and one tab 151 are
shown in each of FIGS. 32 and 33. When rings 140 and 150 are
aligned, each tab 141 has a flange 142 that circumferentially
overlaps an edge 152 of one of tabs 151. Tabs 141 and preferably
also tabs 151 are made of spring metal (or are otherwise biased to
remain in their originally manufactured orientations relative to
the rest of the ring from which they protrude). To fasten ring 140
to ring 150, each tab 141 is bent below the adjacent tab 151
(assuming that the rings are oriented with tabs 141 initially above
tabs 151), with flange 142 bending relative to the rest of tab 141
to allow it to pass edge 152 of tab 151. After such relative
movement, tabs 141 and 151 have the relative positions shown in
FIG. 33, with spring force exerted by each tab 141 on tab 151
holding the rings together and tabs 151 preventing tabs 141 from
springing back into their original position (i.e., the original
position shown in FIG. 32).
[0126] Next, with reference to FIGS. 34 and 35, we describe another
type of fastener which can be included as part of the inventive
anastomosis ring. FIG. 34 is a side cross-sectional view of
portions of two aligned anastomosis rings (rings 160 and 180)
having spring fasteners for fastening the rings together. Each
spring fastener comprises elements 163 and 181. Fastener elements
163 are made of spring metal, are generally U-shaped, and each has
a body which extends out at an acute angle from an edge (the bottom
edge in FIG. 34) of ring 160's tubular central portion, with the
body of each element 163 being attached at a proximal end portion
162 to the tubular central portion of ring 160. Each element 163
has two tabs 161, which extend out at an obtuse angle with respect
to the body of element 163 (as shown in FIG. 34). When element 163
(in its FIG. 34 configuration) is rotated (counterclockwise in FIG.
34) about end portion 162 relative to ring 160's tubular central
portion, element 163 will spring back to the configuration shown in
FIG. 34. Each fastener element 181 is made from malleable material,
and has two wings 182. Each wing 182 is pre-formed to extend in a
plane oriented at a ninety-degree angle relative to the rest of the
element 181 of which it is a part. When ring 180 is oriented with a
vertical axis of symmetry, each element 181 extends vertically (or
substantially vertically) upward away from ring 180's tubular
central portion (as shown in FIG. 34).
[0127] To fasten ring 160 to ring 180, a surgeon (or a
surgeon-operated instrument) aligns ring 180 with ring 160 by
positioning the tubular central portion of ring 180 (which has a
slightly larger diameter than does the tubular central portion of
ring 160) around the tubular central portion of ring 160 so that
the rings have a common axis of symmetry (which we shall refer to
as being "vertical" to simplify the description) and so that an
element 181 of ring 180 extends between the tabs 161 of each
element 163 of ring 160 (in the relative orientation shown in FIG.
35). In some implementations of the rings, as the rings are
aligned, tabs 161 of one element 163 (on one side of ring 160's
tubular central portion) are temporarily displaced toward the tabs
161 of another element 163 (on another side, typically the opposite
side, of ring 160's tubular central portion), thus bending each of
the elements 163 about its end portion 162 toward the ring 160's
tubular central portion, and then the opposed tabs 161 spring back
(relax) away from each until each element 163 exerts spring force
radially outward against the tubular central portion of ring 180.
In other implementations of the rings, elements 163 are not
elastic. After the rings are aligned, wings 182 of each element 181
are spread apart by folding each wing 182 (outward in the
directions of arrows A in FIG. 35, about a vertical axis) over an
adjacent one of horizontally oriented tabs 161. When this has been
accomplished, the forces between fastener element 163 (including
tabs 161) and wings 182 fasten together the aligned rings 160 and
180. In the final configuration, the tabs 161 on both sides of
element 181 provide circumferential support to prevent rotation of
ring 160 relative to ring 180 about their common axis.
[0128] A variation on fastener element 181 of FIG. 35 will next be
described with reference to FIG. 36. The fastener elements of FIG.
36 implement an embodiment of the inventive tined anastomosis ring
fastener. In FIG. 36, ring 160 is identical to ring 160 of FIGS. 34
and 35, but ring 170 differs from ring 180 (of FIGS. 34 and 35) in
that it has fastener elements 171 which are shaped differently than
fastener elements 181 of FIG. 35. Each fastener element 171 has a
spring portion 173, and a body 172 which ends at free edge 174.
When ring 170 is oriented with a vertical axis of symmetry, the
spring portion 173 of each element 171 extends at least
substantially vertically upward away from the upper edge of ring
170's tubular central portion (as shown in FIG. 36). At least the
spring portion 173 of each element 171 is made of spring metal (or
portion 173 is otherwise biased so that element 171 tends to remain
in its originally manufactured orientation). To fasten ring 160 to
ring 170, a surgeon (or a surgeon-operated instrument) aligns ring
170 coaxially with ring 160 by positioning the tubular central
portion of ring 170 (which has diameter slightly larger than does
the tubular central portion of ring 160) around the tubular central
portion of ring 160 so that the rings have a common axis of
symmetry (which we shall refer to as being "vertical" to simplify
the description) and so that an element 171 of ring 170 extends
between the tabs 161 of each element 163 of ring 160 (in the
relative orientation shown in FIG. 36). Then, as ring 170 is moved
vertically upward into horizontal alignment with ring 160, the
central sloping portion of body 172 (between wings 176 of body 172)
slides over element 163 and/or the tubular central portion of ring
160, while spring portion 173 is displaced radially outward
relative to ring 170's tubular central portion to allow the
thickest portion of element 171 to pass over ring 160's tubular
central portion. In some implementations of the rings, when the
rings are aligned, tabs 161 of one element 163 (on one side of ring
160's tubular central portion) are temporarily displaced toward
tabs 161 of another element 163 (on another side, typically the
opposite side, of ring 160's tubular central portion), thus bending
each of the elements 163 about its end portion 162 toward the ring
160's tubular central portion, and then the opposed tabs 161 spring
back (relax) away from each other until each element 163 exerts
spring force radially outward against the tubular central portion
of ring 170. In other implementations of the rings, elements 163
are not elastic. When edge 174 has moved vertically above the upper
edge of ring 160's tubular central portion, spring portion 173
springs back (radially inward) into its at least substantially
vertical orientation (as shown in FIG. 36). When this has been
accomplished, the forces between edge 174 and ring 160's tubular
central portion and between fastener element 163 (including tabs
161) and ring 170 fasten together the aligned rings 160 and
170.
[0129] Variations on the FIG. 36 embodiment employ fastener
elements which are differently shaped than elements 163 and 173 of
FIG. 36. For example, FIG. 37 is a perspective view of a portion of
tined anastomosis rings 170' and 160', each embodying the
invention. Ring 170' has a tubular central portion and a number of
spring fastener elements 171'. Each element 171' is made of spring
metal (or is otherwise biased to remain in its originally
manufactured orientation relative to the rest of ring 170') and has
a shape which is a variation on that of above-described spring
fastener element 171. Preferably, elements 171' are integrally
formed with the rest of ring 170'. Each fastener element 171' has a
spring portion 173' (which corresponds functionally to spring
portion 173 of element 171), and a body having two tabs 174'. Ring
160' (of FIG. 37) is identical to ring 160 (of FIG. 36) except in
that its fastener elements 163' have straight circumferential
support tabs 161' that are oriented vertically; not bent
circumferential support tabs with vertical portions and
horizontally extending ends (e.g., bent circumferential support
tabs 161 of ring 160). When ring 170' has been aligned with ring
160', elements 163' and elements 171' spring into a locked
configuration in which they fasten together the aligned rings 160
and 170'. When rings 160' and 170' are aligned and fastened
together, tabs 174' of each element 171' are between the tabs 161'
of the corresponding one of elements 163', with the bottom surfaces
of tabs 174' exerting downward force on the upper edge of the
portion of element 163' between tabs 161' and on the upper edge of
the tubular central portion of ring 170'.
[0130] Another type of fastener that can be used to hold together a
pair of aligned anastomosis rings will be described with reference
to FIG. 38. FIG. 38 is a perspective view of portions of two
aligned anastomosis rings (rings 190 and 200). Each of rings 190
and 200 is a tined ring having a tubular central portion and
fastener elements for fastening the rings together. The fastener
elements of ring 190 are tabs 191 which extend out from ring 190's
tubular central portion. Each tab 191 has a proximal end portion
192 at ring 190's tubular central portion and a distal end portion
193 that extends radially outside of ring 190's tubular central
portion as shown in FIG. 38. The fastener elements of ring 200 are
tabs 201 which extend radially outward from ring 200's tubular
central portion. Each tab 201 has two parallel wings 202 which
extend vertically from tab 201's central portion (when tab 201's
central portion is oriented in a horizontal plane), and each wing
202 has a malleable end portion 203 as shown in FIG. 38.
[0131] To fasten ring 190 to ring 200, a surgeon (or a
surgeon-operated instrument) lowers ring 190 into alignment with
ring 200 by positioning the tubular central portion of ring 190
(which has a slightly smaller diameter than does the tubular
central portion of ring 200) within the tubular central portion of
ring 200 so that the rings have a common axis of symmetry and each
tab 191 fits between the wings 202 of a different one of tabs 201.
When the rings have been so aligned with each other, each fastener
is moved into its locking configuration (to fasten together the
aligned rings 190 and 200) by bending together the end portions 203
of wings 202 so that each tab 191 is held between a pair of
bent-together end portions 203 and the rest of tab 201.
[0132] Another type of fastener that can be used to hold together a
pair of aligned anastomosis rings will be described with reference
to FIGS. 39 and 40. The embodiments of FIGS. 39 and 40 are
variations on the snap fit fastener embodiment of FIG. 36. In each
of FIGS. 39 and 40, ring 210 is a tined anastomosis ring having a
tubular central portion and fastener elements for fastening ring
210 together with ring 190. Ring 190 (of FIGS. 39 and 40) is
identical to ring 190 of FIG. 38, except in that tabs 191 of FIGS.
39 and 40 have their distal portions 193 extending vertically
upward (rather than radially outward as in FIG. 38) prior to
locking of ring 190 to another ring (i.e., ring 210), and tabs 191
of FIGS. 39 and 40 are malleable while tabs 191 of FIG. 38 can but
need not be malleable. Note that the folded-over geometry of each
tab 191 (with a proximal end portion 192 extending in a first
vertical direction away from a first one of the top or bottom edge
of ring 190's tubular central portion to a folded portion, and
extending in the opposite vertical direction beyond the fold) is
needed where there is no room to add features to other one of the
top or bottom edge of the tubular central portion (such as where
the ring's tines extend out from said other one of the top or
bottom edge of the tubular central portion). The fastener elements
of ring 210 are slotted tabs 211 which extend generally vertically
upward from the upper edge of ring 210's tubular central portion as
shown in FIG. 39. Each tab 211 has a slot 212 extending
therethrough. One edge 213 of each slot 212 is formed so that it
extends radially inward (relative to the opposite edge of slot 212)
such that slot 212 is shaped to receive the distal end 193 of tab
191 when tab 191 is advanced vertically upward to bring ring 190
into alignment with ring 210 (as shown in FIG. 39). Tabs 191 and
211 (of the embodiment of FIGS. 39 and 40) are malleable. It is
desirable to design tabs 211 to have the minimum possible vertical
length, since if they are too long they may get in the way of one
of the blood vessels joined at the anastomosis site. It is
typically preferable to use fastener elements of the type to be
described with reference to FIGS. 58-61 (rather than those of FIG.
39) since the fasteners of FIG. 58-61 have lower vertical profile
(than do those of FIG. 39) after two aligned rings are fastened
together by folding the tabs 383, and since the FIG. 39 fasteners
may provide less circumferential positioning support (especially
where the rings' central portions are circular rather than oblong)
than do the fasteners of FIGS. 58-61.
[0133] To fasten ring 190 to ring 210, a surgeon (or a
surgeon-operated instrument) raises ring 190 into alignment with
ring 210 by positioning the tubular central portion of ring 190
(which has a slightly smaller diameter than does the tubular
central portion of ring 210) within the tubular central portion of
ring 210 so that the rings have a common axis of symmetry and each
tab 191 fits into slot 212 of a different one of tabs 211 as shown
in FIG. 39. When the rings have been so aligned with each other,
each fastener is moved into its locking configuration (to fasten
together the aligned rings 190 and 210) by bending each pair of
aligned tabs 211 and 191 radially outward (into the position shown
in FIG. 40).
[0134] Next, an alternative embodiment of a tool for installing the
anastomosis ring of the invention will be described with reference
to FIGS. 41-48. Installation tool 230 of FIGS. 41-48 comprises
anvil 70 (which is identical to anvil 70 of FIGS. 16-24) and
independently translatable sleeves 231, 232, 233, 234, and 235
(whose distal surfaces are shaped slightly differently than sleeves
71, 72, 73, 74, and 75 of FIGS. 16-24, as shown). FIGS. 41-48 show
the configuration of tool 230 during each of eight different steps
of installing tined anastomosis ring 220 in an organ (the organ is
not shown). Ring 220 is identical to ring 80 of FIGS. 16-24, except
in that its tines are longer relative to the height of its tubular
central portion 221 than are the tines of ring 80 relative to the
height of tubular central portion 85 of ring 80. Only the right
half of the distal portion of each of elements 231, 232, 233, 234,
and 235, and the right half of ring 220 are shown in FIGS.
41-48.
[0135] To install ring 220, the ring 220 is initially loaded onto
tool 230 with tubular portion 221 in slot 234A of sleeve 234 (as
shown in FIG. 41), and the tines of ring 220 held between sleeves
231, 232, and 234, and the end portion 236 of sleeve 235 (as shown
in FIG. 41). Then, anvil 70 is inserted into the incision (or other
opening) in the organ. Sleeve 234 of tool 230 differs from sleeve
74 of tool 79 in that sleeve 234 has two concentric slots 234A and
234B, each of which is circular or oblong, for receiving a tubular
central portion (of a tined anastomosis ring) having a different
diameter (largest radial dimension). Sleeve 74 has only one slot
74A. Thus, an anastomosis ring whose tubular central portion has a
larger diameter than that of ring 220 can be loaded onto and
installed by tool 230.
[0136] After ring 220 has been loaded and anvil 70 has been
inserted into the opening in the organ, sleeves 231, 232, 233, 234,
and 235 are advanced distally together as a unit to drive the tines
of ring 220 between anvil 70 and the tissue edges, until the tines'
tips engage the tine-forming surface 70A of anvil 70 and begin to
curl radially outward (away from the central axis of anvil 70) as
they advance against anvil surface 70A. Sleeves 231, 232, 233, 234,
and 235 continue to advance until they reach the position shown in
FIG. 42, in which they have pressed a horizontal portion of each
tine (assuming that ring 220 is oriented with a vertical axis of
symmetry as shown in FIG. 42) against the organ's exterior surface
and caused the distal portion of each tine to bend (against
stationary surface 70A of anvil 70) relative to the rest of ring
220 until the tip of each tine has penetrated (and grabbed) the
tissue around the opening. The distal end of sleeve 233 is angled
to match the slope of the angled proximal portion of each tine (of
ring 220 in its FIG. 41 configuration). FIG. 42 shows one tine in
the position it would have after its tip has penetrated the tissue
and its distal portion has curled radially outward to grab the
tissue.
[0137] Then, as shown in FIG. 43, sleeves 231 and 232 are retracted
in the proximal direction (toward the top of FIG. 43) while sleeves
233, 234, and 235 and anvil 70 remain stationary in engagement with
ring 220.
[0138] Then, as shown in FIG. 44, anvil 70 is retracted (in the
proximal direction) relative to sleeves 233, 234, and 235. In
response to the force exerted by anvil 70 on the tines of ring 220
(and the tissue edges that have been grabbed by the tines), each
tine folds or buckles at both its weak portion (at location 223
shown in FIG. 44) and at the junction (identified by reference
numeral 222 in FIGS. 43 and 44) between its horizontal and angled
portions, so that its curled distal portion 224 moves radially
outward (away from the central axis of anvil 70) while it continues
to grab the tissue, thereby everting the tissue edges. Each tine
preferably has a weak portion (e.g., a hinge) at a location spaced
from the junction (222) between the tine's horizontal and angled
portions. In one implementation, this weak portion is determined by
a hole in each tine. Each hole is preferably located along the tine
such that, when the tines are in their final configuration (shown
in FIG. 48), the portion of each tine that is farthest (radially)
from the ring's tubular portion 221 does not coincide with the
junction 222, and such portion coincides with (or is very near to)
the hole.
[0139] Each tine preferentially bends at both junction 222 and at
its weak portion during the steps described with reference to FIGS.
44, 47, and 48.
[0140] After the folding or buckling of the tines described with
reference to FIG. 44, sleeve 233 is retracted in the proximal
direction (as shown in FIG. 45), leaving ring 220 (and the tissue
gripped thereby) between anvil 70 and sleeves 234 and 235, with
sleeve 234 in a retracted position relative to sleeve 235.
[0141] Then, sleeve 234 is advanced distally relative to sleeve 235
(into the position shown in FIG. 46) to bend and rotate each tine
(relative the rest of ring 220) from the configuration shown in
FIG. 45 to that shown in FIG. 46 as a result of force exertion on
ring 220 by stationary sleeve 235 and the distal end of advancing
sleeve 234. This bending and rotation further everts the tissue
edges around the organ opening, causes the tines to penetrate
farther into the tissue, and allows sleeves 232 and 233 to more
easily form a final bend in each tine (in the step to be described
with reference to FIGS. 47 and 48).
[0142] After ring 220 has been placed in the configuration shown in
FIG. 46, sleeves 232 and 233 are advanced distally relative to
portion 236 of sleeve 235 (as shown in FIG. 47) to press the tines
against portion 236 (while sleeve 234 holds tubular portion 221
against portion 236), thereby further bending the tines relative to
tubular portion 221. Sleeve 233 then continues to advance until a
final bend has been formed in each tine relative to portion 221,
and the ring 220 has been bent into the final, installed
configuration shown in FIG. 48. Specifically, the curled distal
portion of each tine is bent radially outward relative to the
proximal portion of each tine (by sleeves 232 and 233, as shown in
FIG. 47) and then pushed (by sleeve 233, as shown in FIG. 48)
distally against the proximal portion to put ring 220 in the final
configuration. In this final configuration, ring 220 is installed
at the opening in the organ with its tines holding the tissue edges
in the desired everted state (so that the everted tissue can be
joined to tissue of another vessel or other organ).
[0143] After installation of ring 220, sleeve 235 is (e.g.,
portions comprising the distal end of sleeve 235 are) spread or
dilated (radially outward away from anvil 70's central axis of
symmetry) to decouple tool 230 from the installed ring, and tool
230 is removed from the installed ring.
[0144] Another alternative embodiment of a tool for installing one
of the inventive anastomosis rings will next be described with
reference to FIGS. 49-57. Installation tool 330 of FIGS. 49-57
comprises anvil 70 (which is identical to anvil 70 of FIGS. 16-24)
and four independently translatable sleeves 331, 332, 333, and 334
(which are shaped slightly differently than the five sleeves 231,
232, 233, 234, and 235 of FIGS. 41-48, as shown). FIGS. 49-57
illustrate the configuration of tool 330 during each of nine
different steps of installing tined anastomosis ring 320 in
incision 341 of blood vessel 340. Tool 330 of FIGS. 49-57 is a
preferred embodiment of the inventive anastomosis ring installation
tool, and it implements (during operation) a preferred embodiment
of the inventive method for installing an anastomosis ring in an
incision in a blood vessel (or another orifice of another type of
organ).
[0145] Ring 320 is similar to ring 80 of FIGS. 16-24, but its tines
(each comprising a distal portion 323 and a proximal portion 322)
are formed so that when ring 320 is loaded onto tool 330 with its
tubular central portion 321 oriented with a vertical axis of
symmetry, proximal portions 322 are horizontal and distal portions
323 are vertical. Only the right half of the distal portion of each
of elements 331, 332, 333, and 334, and the right half of ring 320
are shown in FIGS. 49-57.
[0146] To install ring 320, the ring 320 is first loaded onto tool
330 with tubular portion 321 in slot 333B of sleeve 333 (as shown
in FIG. 49), and the tines of ring 320 held between sleeves 332 and
333 and the end portion 335 of sleeve 334 (as shown in FIG. 49).
Then, anvil 70 is inserted into the incision 341. Sleeve 333 of
tool 330 differs from sleeve 74 of tool 79 in that sleeve 333 has
two concentric slots 333A and 333B, each of which is circular or
oblong, for receiving a tubular central portion (of a tined
anastomosis ring) having a different diameter. Thus, an
anastomosis-ring having a smaller diameter tubular central portion
(a tubular central portion having smaller diameter than that of
tubular portion 321) can be loaded onto tool 330 with its smaller
diameter tubular central portion in slot 333A.
[0147] After ring 320 has been loaded and anvil 70 has been
inserted into incision 341, sleeves 331, 332, 333, and 334 are
advanced distally together as a unit to drive the tines of ring 320
between anvil 70 and the incised tissue edges, until the tines'
tips engage the tine-forming surface 70A of anvil 70 and begin to
curl radially outward (away from the central axis of anvil 70) as
they advance against anvil surface 70A. Sleeves 331, 332, 333, and
334 continue to advance until they reach the position shown in FIG.
50, in which they have pressed part of the horizontal portion 322
of each tine against the exterior surface of vessel 340 and caused
the distal portion 323 of each tine to curl (against stationary
surface 70A of anvil 70) relative to the rest of ring 220 until the
tip of each tine has penetrated (and grabbed) the tissue around the
incision 341.
[0148] Then, as shown in FIG. 51, sleeve 331 is retracted in the
proximal direction (toward the top of FIG. 51) while sleeves 332,
333, and 334 and anvil 70 remain stationary in engagement with ring
320.
[0149] Then, anvil 70 is retracted (in the proximal direction)
relative to sleeves 332, 333, and 334 into the position shown in
FIG. 52. In response to the force exerted by anvil 70 on ring 320's
tines (and the edges of tissue 340 that have been grabbed by the
tines), each tine folds or buckles at both its weak portion (at
location 327 shown in FIG. 52) and at the location along its length
(identified by reference numeral 326 in FIG. 52) adjacent to the
radially inner edge of sleeve 332's distal end portion, so that the
curled distal portion 323 moves radially outward (away from anvil
70's central longitudinal axis) while it continues to grab the
tissue, thereby everting the tissue edges. The radially inner
surface of sleeve 332 has a recessed portion 332A to provide
clearance for distal portion 323 as distal portion 323 moves
radially outward. Each tine preferably has a weak portion (e.g., a
hinge) at a location spaced from location 326. In one
implementation, this weak portion is determined by a hole in each
tine. Each hole is preferably located along the tine such that,
when the tines are in their final configuration (shown in FIG. 57),
the portion of each tine that is farthest (radially) from the
ring's tubular portion 321 coincides with (or is very near to) the
hole; not with location 326.
[0150] Each tine preferentially bends at both location 326 and at
its weak portion 327 during the steps described with reference to
FIGS. 52 and 54-57.
[0151] After the folding or buckling of the tines described with
reference to FIG. 52, sleeve 332 is retracted in the proximal
direction (into the position shown in FIG. 53), leaving ring 320
held between sleeves 333 and 334.
[0152] Then, sleeve 331 and anvil 70 are advanced distally relative
to sleeve 332 until curved distal end surface 331A of sleeve 331
engages the tines of ring 320 (as shown in FIG. 54). Sleeve 331
then continues to advance so that the tines ride along surface 331A
so as to rotate the curled distal portion 323 of each tine radially
outward into the configuration shown in FIG. 54. This moves the
everted tissue adjacent to the tines radially outward, and further
everts the everted tissue.
[0153] Then, sleeve 332 is advanced distally relative to sleeves
331 and 333 (and anvil 70) until sleeve 332's distal end engages
the curled distal portion 323 of each tine. Sleeve 332 then
continues to advance so as to rotate each curled distal portion 323
further radially outward into the configuration shown in FIG. 55,
while surface 331A engages the intima of the everted tissue (to
prevent radially inward movement of the everted tissue). This
further everts the everted tissue and allows sleeve 332 to more
easily form a final bend in each tine (in the step to be described
with reference to FIG. 57).
[0154] Then, anvil 70 and sleeve 331 are retracted in the proximal
direction into the position shown in FIG. 56, without exerting
force on ring 320 or the everted tissue.
[0155] Then, sleeve 332 is advanced in the distal direction
(relative to sleeves 333 and 334) to bend and rotate each tine
(relative the rest of ring 320) from the configuration shown in
FIG. 56 to that shown in FIG. 57, by pressing curled distal portion
323 of each tine (and the tissue adjacent thereto) against portion
335 of sleeve 334. This final bending and rotation further everts
the tissue edges around incision 341. With ring 320 so installed in
the incision 341 in its final configuration, its tines hold the
incised tissue edges in the desired everted state (so that the
everted tissue can be joined to tissue of another vessel or other
organ).
[0156] After installation of ring 320, sleeve 334 is (e.g.,
portions comprising the distal end of sleeve 334 are) spread or
dilated (radially outward away from anvil 70's central axis of
symmetry) to decouple tool 330 from the installed ring, and tool
330 is removed from the installed ring.
[0157] Tool 330 is simpler than above-described tool 230 in that it
has only four advanceable and retractable sleeves (331, 332, 333,
and 334), whereas tool 230 has five such sleeves (sleeves 231, 232,
233, 234, and 235).
[0158] A preferred embodiment of the invention will be described
with reference to FIGS. 58, 59, 60, and 61. Anastomosis ring 380 of
FIGS. 58-61 is installed around an incision in the side wall of
blood vessel 378, with curled tines 381 of ring 380 holding the
incised tissue edges of vessel 380 with their intima 378A exposed
for anastomosis with vessel 379. Four docking tabs (or "fingers")
383 extend out from ring 380's tubular central portion (parallel to
the central longitudinal axis of ring 380, which is generally
vertical in FIG. 58). There is a hole 384 at the base of each tab
383, defining a weak portion at which tab 383 will preferentially
bend in response to exertion of radially outward bending force on
its distal end 383A.
[0159] FIG. 61 shows ring 380 in its pre-installation
configuration. Note that each tine 381 of ring 380 in the
pre-installation configuration has a proximal portion which extends
radially inward (perpendicular to ring 380's central axis of
symmetry) toward the center of ring 380's tubular portion, and a
distal (tip) portion extending perpendicular to such proximal
portion. The "flat" tine geometry of ring 380 of FIG. 61 (the term
"flat" denotes that the proximal portions of tines 381 are all
coplanar, in a plane perpendicular to the ring's central axis of
symmetry) is preferred over the "angled" tine geometry of ring 60
of FIG. 10 (in which the tines have proximal portions which extend
at a 45 degree angle relative to the ring's central axis of
symmetry, e.g., ring 60's central axis of symmetry).
[0160] Anastomosis ring 400 is installed around an incision in the
side wall of blood vessel 379, with curled tines 401 of ring 400
holding the incised tissue edges of vessel 379 with their intima
(not visible in FIG. 58) exposed for anastomosis with vessel 378.
In order to align the tubular central portion of ring 380 with the
tubular central portion of ring 400, vessel 379 is gripped by flat
end forceps (or "graspers") 420, and moved toward tabs 383 of ring
380 so that tabs 383 enter the space 403 between the everted tissue
of vessel 379 and the tubular central portion of ring 400.
[0161] FIG. 59 shows ring 400 being aligned with ring 380, with
tabs 383 of ring 380 extending upward through ring 400's tubular
central portion. Forceps 420 are lowering vessel 379 and ring 400
along tabs 383 toward the tubular central portion of ring 380,
which in turn rests on vessel 378 and the tissue 377 which
surrounds vessel 378. In FIG. 59, two arms of forceps 420 are
squeezing together opposite side walls of vessel 379. As apparent
from FIG. 59, the tubular central portion of ring 400 has greater
diameter than that of ring 380, so that the two rings can be
aligned together with their tubular central portions aligned
vertically (as shown in FIG. 60, in which the tubular central
portion of ring 380 is not visible since it is within that of ring
400)
[0162] After rings 380 and 400 have been aligned as shown in FIG.
60, forceps 420 release vessel 379. Two arms of forceps 420 (which
can be the same arms as were used to align the rings, but which
preferably are another pair of arms of an implementation of forceps
420 having two pairs of arms) are then moved into engagement with
the tabs 383 (e.g., slightly separated arms of forceps 420 are
moved into engagement with one pair of opposed tabs 383, and then
the other pair of opposed tabs 383). The tab-manipulating arms of
forceps 420 are moved downward (when viewed as in FIG. 60) to exert
bending force on tabs 383 to bend them radially outward into the
locking configuration shown in FIG. 60. In the locking
configuration, tabs 383 extend generally horizontally outward, away
from the common central axis of symmetry of rings 380 and 400, to
lock rings 380 and 400 firmly together against tissue 377 with the
exposed intima of vessel 378 sealed against the exposed intima of
vessel 379.
[0163] It is understood that while certain forms of the present
invention have been illustrated and described herein, the invention
is not to be limited to the specific forms or arrangements of parts
described and shown or the specific methods described.
* * * * *