U.S. patent application number 09/329504 was filed with the patent office on 2002-03-14 for thermal securing anastomosis systems.
Invention is credited to FLEISCHMAN, SIDNEY D., HOUSER, RUSSELL A., WHAYNE, JAMES G..
Application Number | 20020032462 09/329504 |
Document ID | / |
Family ID | 26778969 |
Filed Date | 2002-03-14 |
United States Patent
Application |
20020032462 |
Kind Code |
A1 |
HOUSER, RUSSELL A. ; et
al. |
March 14, 2002 |
THERMAL SECURING ANASTOMOSIS SYSTEMS
Abstract
A sutureless anastomosis systems for securing a bypass graft to
a host vessel or other tubular structure including a bypass graft
and fitting. A compression mechanism may be used with the system
for attachment of the bypass graft to the fitting. An electrode is
connected to the fitting and an energy source. The energy source
transmits energy to the electrode and causes the adjacent tissue to
rise in temperature and bond to a vessel or fitting.
Inventors: |
HOUSER, RUSSELL A.;
(LIVERMORE, CA) ; WHAYNE, JAMES G.; (SAN JOSE,
CA) ; FLEISCHMAN, SIDNEY D.; (MENLO PARK,
CA) |
Correspondence
Address: |
MORRISON & FOERSTER LLP
755 PAGE MILL ROAD
PALO ALTO
CA
94304-1018
US
|
Family ID: |
26778969 |
Appl. No.: |
09/329504 |
Filed: |
June 10, 1999 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60111948 |
Dec 11, 1998 |
|
|
|
60088705 |
Jun 10, 1998 |
|
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|
Current U.S.
Class: |
606/213 |
Current CPC
Class: |
A61B 17/32053 20130101;
A61B 17/11 20130101; A61B 2017/1135 20130101; A61B 2017/1107
20130101; A61F 2/064 20130101; A61B 2017/00867 20130101; A61B
2017/306 20130101; A61F 2/91 20130101 |
Class at
Publication: |
606/213 |
International
Class: |
A61F 002/06 |
Claims
1. A bypass graft system comprising: a fitting defining an inner
surface, an outer surface, at least two ends, and a compression
mechanism adapted to attach a bypass graft to the fitting; and at
least one electrode functionally connected to the fitting and an
energy source; wherein the energy source is adapted to transmit
energy to the electrode and cause functionally adjacent regions of
tissue to rise in temperature.
2. A bypass graft system comprising: a fitting defining an inner
surface, an outer surface, at least two ends, and a compression
mechanism adapted to attach the bypass graft to the fitting; a
sheath adapted for insertion through a puncture in a vessel wall
and including a lumen for passing the bypass graft and fitting into
the vessel interiors, the sheath adapted to split in two or more
pieces for removal from around the bypass graft; and at least one
electrode connected to the fitting and to an energy source; wherein
the energy source is adapted to transmit electrical current to the
electrode and cause thermal excitation of an adjacent region of
tissue.
3. A system for securing a graft comprising; a tubular structure
having at least two ends, an inner surface, and an outer surface; a
first fitting attached to one end of the tubular structure and
having a cross-section that substantially matches the cross-section
of the tubular structure; a second fitting attached to the other
end of the tubular structure and having a cross-section that
substantially matches the cross-section of the tubular structure; a
delivery mechanism adapted to access the lumen of the vessel and
adapted to hold the lumen in an expanded orientation, the delivery
mechanism adapted to functionally cooperate with the fittings and
tubular structure in order for the fittings and tubular structure
to be inserted through an opening established in the vessel; at
least one first electrode associated with the first fitting adapted
to thermally secure the first fitting to a vessel at the one
location; and at least one second electrode associated with the
second fitting adapted to thermally secure the second fitting to
the vessel at a second location.
4. The system of claim 3 wherein the fitting further includes more
than two ends and a first electrode is bonded to one end; and the
bypass graft attached to the fitting at one end; wherein the first
electrode and second electrode are adapted to thermally secure the
fitting to the vessel at one or more ends.
5. A bypass graft system comprising; a fitting attached to the
bypass graft, the fitting including a flared distal end and at
least one electrode associated with the flared distal end.
6. A bypass graft reinforcing structure comprising; a tubular
structure with an inner surface, outer surface, and two ends; a
first fitting attached to the tubular structure at one end; a first
compression mechanism adapted to secure a bypass graft to the first
fitting; a first electrode associated with the first fitting, the
first electrode adapted to thermally secure the bypass graft and
the tubular structure at one end; a second fitting attached to the
tubular structure at one end; a second compression mechanism
adapted to secure the bypass graft to the second fitting; and a
second electrode associated with the second fitting, the second
fitting adapted to thermally secure the bypass graft and the
tubular structure at the second end.
7. A bypass graft system comprising: at least one fitting defining
an outer surface, an inner surface and at least two ends; at least
one compression mechanism adapted to attach a graft to the at least
one fitting; at least one electrode associated with the at least
one fitting, the at least one electrode adapted to transmit thermal
energy to at least a region of tissue; at least one current
carrying member attached to the at least one electrode and adapted
to be separated from the at least one electrode; and a generator
connected to the at least one current carrying mechanism, the
generator adapted to transmit an electrical current to the at least
one electrode and cause a region of tissue adjacent the at least
one electrode to rise in temperature and become secured to one or
more members or body regions.
Description
[0001] This application is related to the following applications:
co-pending Provisional application Serial No. 60/111,948 filed Dec.
11, 1998; co-pending Provisional application Serial No. 60/088,705
filed Jun. 10, 1998; co-pending U.S. application Ser. No.
08/966,003 filed Nov. 7, 1997; co-pending Provisional application
Serial No. 60/030,733 filed Nov. 8, 1996; and co-pending U.S.
application Ser. No. 08/932,566 filed Sep. 19, 1997.
BACKGROUND OF THE INVENTION
[0002] The invention relates to devices for deploying and securing
the ends of bypass grafts and for providing a fluid flow passage
between at least two vessel regions or other tubular structure
regions. More particularly, the invention relates to bypass grafts
that are thermally secured at target vessel locations thereby
producing a fluid flow passage from the first vessel location
through the bypass graft to the second vessel location. The bypass
grafts and deployment systems of the invention do not require
stopping or re-routing blood flow to perform an anastomoses between
a bypass graft and a host vessel. Accordingly, this invention
describes sutureless anastomosis systems that do not require
cardiopulmonary bypass support when treating coronary artery
disease.
[0003] Stenosed blood vessels may cause ischemia and lead to tissue
infarction. Conventional techniques to treat partially or
completely occluded vessels include balloon angioplasty, stent
deployment, atherectomy, and bypass grafting. Coronary artery
bypass grafting (CABG) procedures to treat coronary artery disease
have traditionally been performed through a thoracotomy with the
patient placed on cardiopulmonary bypass support and using
cardioplegia to induce cardiac arrest. Cardiac protection is
required when performing bypass grafting procedures having
prolonged ischemia times. Current bypass grafting procedures
involve interrupting blood flow to suture or staple the bypass
graft to the host vessel wall and create the anastomoses. When
suturing or clipping the bypass graft to the host vessel wall, a
generally large incision is made through the vessel and the bypass
graft is sewn to the host vessel wall such that the endothelial
layers of the bypass graft and vessel face each other. Bypass graft
intima to host vessel intima apposition reduces the incidence of
thrombosis associated with biological reactions that result from
blood contacting the epithelial layer of a harvested bypass graft.
This is especially relevant when using harvested vessels that have
a small inner diameter (e.g. .ltoreq.2 mm).
[0004] Less invasive attempts for positioning bypass grafts at
target vessel locations have used small ports to access the
anatomy. These approaches use endoscopic visualization and modified
surgical instruments (e.g. clamps, scissors, scalpels, etc.) to
position and suture the ends of the bypass graft at the host vessel
locations. Attempts to eliminate the need for cardiopulmonary
bypass support while performing CABG procedures have benefited from
devices that stabilize the motion of the heart, retractors that
temporarily occlude blood flow through the host vessel, and shunts
that re-route the blood flow around the anastomosis site.
Stabilizers and retractors still require significant time and
complexity to expose the host vessel and suture the bypass graft to
the host vessel wall. Shunts not only add to the complexity and
length of the procedure, but they require a secondary procedure to
close the insertion sites proximal and distal to the anastomosis
site.
[0005] Attempts to automate formation of sutureless anastomoses
have culminated in mechanical stapling devices. Mechanical stapling
devices have been proposed for creating end-end anastomoses between
the open ends of transected vessels. Berggren, et al propose an
automatic stapling device for use in microsurgery (U.S. Pat. Nos.
4,607,637; 4,624,257; 4,917,090; and 4,917,091). This stapling
device has mating sections containing pins that are locked together
after the vessel ends are fed through lumens in the sections and
everted over the pins. This stapling device maintains intima to
intima apposition for the severed vessel ends but has a large
profile and requires impaling the everted vessel wall with the
pins. Sakura describes a mechanical end-end stapling device
designed to reattach severed vessels (U.S. Pat. No. 4,214,587).
This device has a wire wound into a zig-zag pattern to permit
radial motion and contains pins bonded to the wire that are used to
penetrate tissue. One vessel end is everted over and secured to the
pins of the end-end stapling device, and the other vessel end is
advanced over the end-end stapling device and attached with the
pins. Sauer, et al proposes another mechanical end-end device that
inserts mating pieces into each open end of a severed vessel (U.S.
Pat. No. 5,503,635). Once positioned, the mating pieces snap
together thereby bonding the vessel ends. These end-end devices are
amenable to reattaching severed vessels but are not suitable to
producing end-end anastomoses between a bypass graft and an intact
vessel, especially when exposure to the vessel is limited.
[0006] Mechanical stapling devices have also been proposed for
end-side anastomoses. These devices are designed to insert bypass
grafts, attached to the mechanical devices, into the host vessel
through a large incision and secure the bypass graft to the host
vessel. Kaster describes vascular stapling apparatus for producing
end-side anastomoses (U.S. Pat. Nos. 4,366,819; 4,368,736; and
5,234,447). Kaster's end-side apparatus is inserted through a large
incision in the host vessel wall. The apparatus has an inner flange
that is placed against the interior of the vessel wall, and a
locking ring that is affixed to the fitting and contains spikes
that penetrate into the vessel thereby securing the apparatus to
the vessel wall. The bypass graft is itself secured to the
apparatus in the everted or non-everted position through the use of
spikes incorporated in the apparatus design.
[0007] U.S. Surgical has developed automatic clip appliers that
replace suture stitches with clips (U.S. Pat. Nos. 5,868,761;
5,868,759; and 5,779,718). These clipping devices have been
demonstrated to reduce the time required when producing the
anastomosis but still involve making a large incision through the
host vessel wall. As a result, blood flow through the host vessel
must be interrupted while creating the anastomoses.
[0008] Gifford, et al provides end-side stapling devices (U.S. Pat.
No. 5,695,504) that secure harvested vessels to host vessel walls
maintaining intima to intima apposition. This stapling device is
also inserted through a large incision in the host vessel wall and
uses staples incorporated in the device to penetrate into tissue
and secure the bypass graft to the host vessel.
[0009] Walsh, et al propose a similar end-side stapling device
(U.S. Pat. Nos. 4,657,019; 4,787,386; 4,917,087). This end-side
device has a ring with tissue piercing pins. The bypass graft is
everted over the ring; then, the pins penetrate the bypass graft
thereby securing the bypass graft to the ring. The ring is inserted
through a large incision created in the host vessel wall and the
tissue piercing pins are used to puncture the host vessel wall. A
clip is then used to prevent dislodgment of the ring relative to
the host vessel.
[0010] The end-side stapling devices previously described require
insertion through a large incision, which dictates that blood flow
through the host vessel must be interrupted during the process.
Even though these and other clipping and stapling end-side
anastomotic devices have been designed to decrease the time
required to create the anastomosis, interruption of blood flow
through the host vessel increases the morbidity and mortality of
bypass grafting procedures, especially during beating heart CABG
procedures. A recent experimental study of the U.S. Surgical
One-Shot anastomotic clip applier observed abrupt ventricular
fibrillation during four of fourteen internal thoracic artery to
left anterior descending artery anastomoses in part due to coronary
occlusion times exceeding 90 seconds (Heijmen, et al. A novel
one-shot anastomotic stapler prototype for coronary bypass grafting
on the beating heart: feasibility in the pig. J Thorac Cardiovasc
Surg. 117:117-25; 1999).
[0011] All documents cited herein, including the foregoing, are
incorporated herein by reference in their entireties for all
purposes.
SUMMARY OR THE INVENTION
[0012] The present inventions provide sutureless anastomosis
systems that enable a physician to quickly and accurately secure a
bypass graft to a host vessel or other tubular body structure. In
addition, the invention enables the physician to ensure bypass
graft stability, and prevent leaking at the vessel attachment
points. The delivery systems of the invention do not require
stopping or re-routing blood flow while producing the anastomosis
as compared to some current techniques that require interrupting
blood flow to suture, clip, or staple a bypass graft to the vessel
wall.
[0013] A need for bypass grafts and delivery systems that are
capable of quickly producing an anastomosis between a bypass graft
and a host vessel wall without having to stop or re-route blood
flow. These anastomoses must withstand the pressure exerted by the
pumping heart and ensure that blood does not leak from the
anastomoses into the thoracic cavity, abdominal cavity, or other
region exterior to the vessel wall.
[0014] Current techniques for producing anastomoses during coronary
artery bypass grafting procedures involve placing the patient on
cardiopulmonary bypass support, arresting the heart, and
interrupting blood flow to suture or staple a bypass graft to the
coronary artery and aorta. Cardiopulmonary bypass support is
associated with substantial morbidity and mortality. The
embodiments of the invention are used to position and secure bypass
grafts at host vessel locations without stopping or rerouting blood
flow. Accordingly, the embodiments of the invention do not require
cardiopulmonary bypass support and arresting the heart while
producing anastomoses to the coronary arteries. In addition, the
invention generally mitigates risks associated with suturing or
clipping the bypass graft to the host vessel, namely bleeding at
the attachment site and collapse of the vessel around the incision
point.
[0015] The invention addresses vascular bypass graft treatment
regimens requiring end-to-end anastomoses and end-to-side
anastomoses to attach bypass grafts to host vessels. The scope of
the invention includes systems to position and thermally secure
bypass grafts used to treat vascular diseases such as
atherosclerosis, arteriosclerosis, fistulas, aneurysms, occlusions,
and thromboses. In addition, the systems may be used to bypass
stented vessel regions that have restenosed or thrombosed. The
bypass grafts and delivery systems of the invention are also used
to attach the ends of ligated vessels, replace vessels harvested
for bypass grafting procedures (e.g. radial artery), and
re-establish blood flow to branching vessels which would otherwise
be occluded during surgical grafting procedures (e.g. the renal
arteries during abdominal aortic aneurysm treatment). In addition,
the invention addresses other applications including arterial to
venous shunts for hemodialysis patients, bypassing lesions and scar
tissue located in the fallopian tubes causing infertility,
attaching the ureter to the kidneys during transplants, and
bypassing gastrointestinal defects (e.g. occlusions, ulcers).
[0016] One aspect of the invention provides fittings constructed
from a metal (e.g. titanium), alloy (e.g. stainless steel or nickel
titanium), thermoplastic, thermoset, composite of the
aforementioned materials, or other suitable material, and designed
to exert radial force at the vessel attachment points to maintain
bypass graft patency. The fittings are advanced through the
delivery system and are attached to the vessel wall at target
locations. The delivery system is a combination of tear-away
sheath, dilator, guidewire, and needle designed to be inserted into
the vessel at the desired locations. The tubing, hub and valve of
the tear-away sheath are configured to split so the entire sheath
may be separated and removed from around the bypass graft after
attaching the bypass graft to the host vessel. A plunger is used to
insert the bypass graft and fitting combination through the sheath
and into the vessel. The dilator and needle may incorporate
advanced features, such as steering, sensing, and imaging, used to
facilitate placing and locating the bypass graft and fitting
combination.
[0017] In accordance with the invention, the fittings incorporate
mechanisms to thermally secure a bypass graft to a host vessel. One
fitting configuration produces an anastomosis between a harvested
bypass graft and a host vessel such that only the endothelial layer
of the bypass graft is exposed to the interior of the host vessel.
The invention also describes fittings designed to permit retrograde
flow past the anastomosis site so as to maintain flow through the
lesion and to branching vessels located proximal to the anastomosis
site. A further aspect of the invention provides fittings having
branches to accommodate multiple bypass grafts using a single
proximal anastomosis.
[0018] Fittings and accompanying components constructed from a
conductive material may be used as electrodes to deliver
radiofrequency energy to tissue contacting the electrode.
Radiofrequency energy is applied to each fitting component
(unipolar to an indifferent electrode, or bipolar between fitting
components) to thermally secure the bypass graft to the vessel
wall. Radiofrequency energy produces ohmic heating of adjacent
tissue causing it to coagulate to the electrodes and locally
shrinking the vessel wall around the fitting to produce an
interference fit between the vessel wall and the bypass graft
fitting. This not only thermally secures the bypass graft to the
vessel wall but also prevents leaking around the bypass graft to
host vessel interface.
[0019] Still other objects and advantages of the present invention
and methods of construction of the same will become readily
apparent to those skilled in the art from the following detailed
description, wherein only the preferred embodiments are shown and
described, simply by way of illustration of the best mode
contemplated of carrying out the invention. As will be realized,
the invention is capable of other and different embodiments and
methods of construction, and its several details are capable of
modification in various obvious respects, all without departing
from the invention. Accordingly, the drawing and description are to
be regarded as illustrative in nature, and not as restrictive.
BRIEF DESCRIPTION OF DRAWINGS
[0020] FIG. 1 shows a heart containing multiple bypass grafts
positioned and secured to host vessels;
[0021] FIGS. 2a-b are side-sectional views of a bypass graft
support structure incorporating fittings;
[0022] FIG. 2c shows a support structure, with an attached bypass
graft, thermally secured to a host vessel at two locations;
[0023] FIGS. 3a-c show an end-to-end fitting that thermally secures
a bypass graft to a host vessel;
[0024] FIGS. 4a-i show retaining rings used to bond the bypass
graft to the fitting and/or the fitting to the vessel wall;
[0025] FIGS. 5a-e show retaining ring embodiments that act as
electrodes for thermally securing the fitting to the host vessel
wall;
[0026] FIGS. 6a-d show expandable retaining ring embodiments
capable of serving as electrodes for thermally securing the fitting
to the host vessel wall;
[0027] FIGS. 6e-f show an expandable retaining ring including
petals to make an end-to-end fitting able to produce an end-to-side
anastomosis;
[0028] FIGS. 7a-b show a bypass graft everted around and attached
to end-to-end fittings, and secured to the host vessel;
[0029] FIGS. 8a-d show a bypass graft secured to the host
vessel;
[0030] FIGS. 9a-c show a delivery system;
[0031] FIG. 10 shows a delivery system;
[0032] FIG. 11 shows a two-way plunger used to deliver the bypass
graft and fitting combination through the sheath and into the host
vessel;
[0033] FIGS. 12a-c show an alternative plunger embodiment;
[0034] FIG. 13 shows a bypass graft and fitting combination being
inserted through a sheath;
[0035] FIG. 14 shows a schematic of the system used to thermally
secure a bypass graft to a host vessel wall;
[0036] FIGS. 15a-e show an end-to-side fitting that may be
delivered past a vessel wall without the need for a sheath;
[0037] FIGS. 16a-g show alternative end-to-side fitting embodiments
that may be delivered past a host vessel wall without the need for
a sheath;
[0038] FIGS. 17a-b show an end-to-side fitting incorporating a
retaining ring with petals;
[0039] FIGS. 18a-g show an end-to-side fitting for host vessels
having small and medium diameters;
[0040] FIGS. 19a-f show a foldable end-to-side fitting;
[0041] FIGS. 20a-b show an end-to-side fitting incorporating an
electrode structure in the petals;
[0042] FIGS. 21a-d show an end-to-side fittings having an electrode
incorporated in the fitting;
[0043] FIGS. 22a-b show an end-to-side fitting containing an
electrode and able to fold into a low profile;
[0044] FIG. 23 shows a bypass graft and fitting combination
attached to a host vessel and designed to preserve flow proximal to
the anastomosis site;
[0045] FIGS. 24a-b are close-up views of the bypass graft and
fitting combination shown in FIG. 23;
[0046] FIGS. 24c-h show alternative bypass graft and fittings
designed to maintain retrograde blood flow;
[0047] FIG. 25 is a schematic of the system used to thermally
secure the ends of the bypass graft to the vessel wall;
[0048] FIGS. 26a-b show an end-to-end bypass graft having an
electrode incorporated in the bypass graft;
[0049] FIGS. 27a-b show an end-to-end bypass graft having an
expandable and compressible electrode secured to the bypass
graft;
[0050] FIGS. 28a-b show tear-away sheath embodiments;
[0051] FIGS. 29 shows a fitting system;
[0052] FIGS. 30a-d show other embodiments of a fitting system;
[0053] FIGS. 31a-d show other embodiments of a fitting system;
and
[0054] FIGS. 32a-b show other embodiments of a fitting system.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0055] The fittings and delivery systems are intended to produce
anastomoses between bypass grafts and host vessels to treat
vascular abnormalities such as stenoses, thromboses, other
occlusions, aneurysms, fistulas, or other indications requiring a
bypass graft. The systems are useful in bypassing stented vessels
that have restenosed. Some approaches to treating stenosed stents
have not been successful and reliable at removing the lesion and
opening the vessel lumen. The approach described by this invention,
produces a blood flow conduit around the stented lesion and
mitigates concerns associated with damaging the stent or forming
emboli when removing deposits attached to the stent. The fittings
are used for securing and supporting the ends of transected vessels
cut during organ transplantations. The embodiments also provide
mechanisms to secure branching vessels to a replacement graft
during surgical procedures in which the branching vessels would
otherwise be occluded from the blood flow (e.g. reattaching the
renal arteries, mesenteric artery, celiac artery, and intercostal
arteries during treatment of abdominal aortic aneurysms that are
pararenal, suprarenal, or thoracoabdominal in classification).
[0056] Referring more particularly to the drawings, FIG. 1
illustrates bypass grafts secured to host vessels during coronary
artery bypass grafting (CABG) procedures. Bypass graft 16 provides
a blood flow passage from the aorta to the right coronary artery.
An end-to-side fitting 18 is used to secure the proximal end of the
bypass graft 16 to the aorta and fitting 18 or end-to-end fitting
20 is used to secure the distal end of the bypass graft to the
right coronary artery. Bypass graft 16 provides a blood flow
passage along a small vessel such as a coronary artery by securing
the bypass graft to the host vessel with fittings 18, 20. Bypass
graft 16 is secured to the aorta with a fitting 18, 20 that
branches into distinct bypass grafts which are further secured to
the left anterior descending artery and circumflex artery using
fittings 18, 20. The bypass grafts and fittings in these examples
demonstrate representative applications and should not limit the
scope of use for the embodiments of the invention. It should be
noted that the combination of fittings used to secure a bypass 16
graft to a host vessel, along a host vessel, or between host
vessels depends on the application.
[0057] The bypass graft 16 may be a synthetic graft material
biological bypass graft, harvested vessel, or other tubular body
structure, depending on the indication. The harvested vessels may
be an internal mammary artery, radial artery, saphenous vein or
other body tubing. Harvested vessels may be dissected using newer
minimally invasive, catheter-based techniques or standard surgical
approaches. Fittings in accordance with the invention are designed
to attach bypass grafts to host vessels (or other tubular
structures). The fittings 18, 20 used to position and attach such
bypass grafts 16 are extensions of the collet and grommet
embodiments described in U.S. application Ser. No. 08/966,003 filed
Nov. 7, 1997. An advantage of biological bypass grafts over
available synthetic materials is the reduction in thrombosis,
especially when using small diameter (e.g. .ltoreq.2 mm) bypass
grafts. The fittings and delivery systems of the invention are
generally equally effective at positioning and securing all types
of bypass grafts, biological and synthetic.
[0058] Synthetic bypass grafts may be manufactured by extruding,
injection molding, weaving, braiding, or dipping polymers such as
PTFE, expanded PTFE, urethane, polyamide, nylon, silicone,
polyethylene, collagen, polyester or composites of these
representative materials. These materials may be fabricated into a
sheet or tubing using one or a combination of the stated
manufacturing processes. The sides of sheet materials may be bonded
using radiofrequency energy, laser welding, ultrasonic welding,
thermal bonding, sewing, adhesives, or a combination of these
processes to form tubing. The synthetic bypass graft may also be
coated, deposited, or impregnated with materials, such as paralyne,
heparin, hydrophilic solutions, or other substrates designed to
reduce thrombosis or mitigate other risks that potentially decrease
the patency of synthetic bypass grafts. The primary advantage of
synthetic bypass graft materials is the ability to bond the bypass
graft to the fittings prior to starting the procedure or
incorporate the fittings into the bypass graft design by injection
molding or other manufacturing process. Currently, synthetic bypass
grafts are indicated for blood vessels having medium and large
diameters (e.g. >3 mm), such as peripheral vessels, tubular
structures such as the fallopian tubes, or shunts for hemodialysis.
However, medical device manufacturers such as Possis Medical, Inc.
and Thoratec Laboratories, Inc. are clinically evaluating synthetic
bypass grafts for coronary indications.
[0059] Support members may be incorporated into a graft as
referenced in co-pending U.S. application Ser. No. 08/932,566 filed
Sep. 19, 1997 and in co-pending U.S. application Ser. No.
08/966,003 filed Nov. 7, 1997. When using synthetic bypass grafts,
the support members may be laminated between layers of graft
material. The synthetic bypass graft 16 may be fabricated by
extruding, injection molding, or dipping a primary layer of the
graft over a removable mandrel; positioning, winding or braiding
the support members on the primary layer; and extruding, injection
molding, or dipping a secondary layer over the material/support
member combination. The support members preferably have a shape
memory. Memory elastic alloys, such as nickel titanium, exhibiting
stress-induced martensite characteristics may be used to reinforce
the bypass graft and/or vessel wall and prevent permanent
deformation upon exposure to external forces.
[0060] Alternatively, synthetic bypass grafts 16 incorporating
support members may be fabricated using cellulosic materials such
as regenerated cellulose. Cellulosic materials may be extruded,
wrapped, injection molded, or dipped in layers to laminate the
support members between graft material layers. Cellulosics, and
other such materials, which have a high water adsorption rate, are
relatively stiff when dehydrated and flexible when hydrated. This
characteristic provides a means to maintain a self-expanding
material such as the support members in a collapsed state. The
cellulosic material in its dry, stiff state counteracts the radial
force of the self-expanding support members and prevents the graft
from expanding until it becomes hydrated, thus more flexible. When
the bypass graft 16 is inserted through the delivery system and
into the vessel, the cellulosic material contacts fluid, causing it
to become more flexible and the support members of the bypass graft
16 to expand towards its resting state and the graft into intimate
contact with the vessel wall.
[0061] Biological bypass grafts 16 may be reinforced with a support
structure 30 as shown in FIGS. 2a-c. This support structure 30 may
consist of a wire material wound into a helix or braided into a
mesh. Other reinforcing structures that limit expansion of the
bypass graft 16 may also be used. The support structure 30 is
bonded to fittings at each end by spot welding, crimping,
soldering, ultrasonic welding, thermal bonding, adhesively bonding,
or other bonding process, depending on the materials. The support
structure 30 defines a lumen into which the bypass graft 16 is
inserted. After advancing the bypass graft 16 through the support
structure 30, the bypass graft 16 is secured to the fittings at
each end of the support structure 30. The support structure 30
generally reduces the potential for kinking of the bypass graft 16,
limits the radial expansion of the bypass graft 16, prevents
aneurysm formation, and increases the burst strength of the bypass
graft 16. By mitigating the failure mechanisms of bypass grafts 16
such as the saphenous veins, such reinforcing structures may
improve the long-term durability and patency of the bypass graft
16.
[0062] The support structure 30 may alternatively be a synthetic
graft material formed into a tube, with or without support members.
The support structure 30 may be fabricated from a polymer that is
macroporous to permit blood leaking through the bypass graft to
flow outside the support structure. Biological bypass grafts
typically have branches that are sutured or stapled closed while
harvesting the vessel and may leak for a period of time immediately
after implantation. Blood leaking through a biological bypass graft
enclosed in a nonporous or microporous (e.g. pore size <8 .mu.m)
support structure may accumulate between the bypass graft and the
support structure 32 and occlude the bypass graft depending on the
pressure gradient between the inside of the bypass graft 16 and the
space between the graft and the support structure 30. For
applications where the biological bypass graft is completely
impervious to leaking or where the external surface of the
biological bypass graft can be bonded to the support structure
(e.g. using adhesives), nonporous or microporous support structures
may be used.
[0063] The support structure 30 is preferably affixed to the
fittings before attaching the bypass graft 16 to the fittings. This
ensures the support structure reinforces the entire length of the
bypass graft 16. Using a support structure that is not affixed to
the fittings may cause kinking of the bypass graft in the region
between the anastomosis site and the end of the support structure,
which defines a region where the bypass graft is not reinforced.
The support structure 30 incorporates fittings at each end for
attachment of a harvested vessel 16 and for securing the bypass
graft to the host vessel 38. As shown in FIGS. 2a-b, a grasping
tool 50 including a suture with a noose or a wire with a distal
gripping end such as forceps, is fed through the support structure
and is used to grab the harvested vessel 16. The harvested vessel
16 is pulled through the support structure 30 such that a length of
the harvested vessel extends beyond both ends of the support
structure fittings. FIG. 2c shows the ends of the harvested vessel
16 everted around the support structure fittings and secured at the
notched regions 40 of the fittings using retaining rings 42.
Electrodes 44 may be included in the support structure to thermally
secure the support structure 30 and the bypass graft to the host
vessel wall 39. The blood flowing through the bypass graft 16
contacts the endothelial layers of the harvested bypass graft and
host vessel thereby minimizing the potential for thrombosis or
biological reactions to foreign materials.
[0064] When microporous or nonporous support structures may be
used, the support structures may serve dual purposes. They may
function as synthetic bypass grafts designed to produce two end-end
anastomoses at opposite ends of the bypass grafts. The support
structure/bypass grafts may be configured with one or both ends
incorporating fittings that enable end-side anastomoses. They also
function as sutureless anastomosis devices to attach harvested
vessels and reinforce the biological bypass grafts. This combined
functionality minimizes the product portfolio required for bypass
grafting indications because a single device may reinforce and
facilitate attaching harvested vessels between anastomosis sites
and act as a synthetic bypass graft capable of producing sutureless
anastomoses.
[0065] The bypass graft fittings are constructed from a metal (e.g.
titanium), alloy (e.g. stainless steel or nickel titanium),
thermoplastic, thermoset plastic, silicone or combination of the
aforementioned materials into a composite structure; other
materials may also be used. The fittings may be coated with
materials such as paralyne or other hydrophilic substrates that are
biologically inert and reduce the surface friction. Alternatively,
the fittings may be coated with heparin or thrombolytic substances
designed to prevent thrombosis around the attachment point between
the bypass graft and the host vessel. The fittings consist of one
or more components designed to secure a bypass graft to the fitting
and the fitting to the host vessel wall for a fluid tight bond
between the bypass graft and the host vessel. The fittings may be
used at end-to-end anastomoses for applications where retrograde
blood flow is not essential (e.g. total occlusions) as shown in
FIGS. 2c and 8a; end-to-side anastomoses for medium and small
diameter vessels (e.g. peripheral vessels and coronary vessels)
where retrograde blood flow is essential as shown in FIG. 19c; and
end-to-side anastomoses for large diameter vessels (e.g. the aorta)
as shown in FIG. 18a. The end-side fittings may be configured to
orient the bypass graft at an angle, A, relative to the host vessel
ranging between approximately 30 and 90 degrees. This helps
optimize fluid flow through the bypass graft.
[0066] FIGS. 3a-cshow an end-end fitting 20 designed to secure
bypass grafts constructed from an internal mammary artery, radial
artery, saphenous vein, or other harvested vessel such that only
the endothelial layer of the bypass graft is exposed to blood flow.
In FIGS. 3a-c, the bypass graft 16 is fed through the interior of
the fitting and is wrapped around the distal end. A grasping tool
may be used to pull the bypass graft through the fitting,
especially when using long fittings. An everting tool may be used
to wrap the bypass graft around the fitting prior to securing the
bypass graft to the fitting. After the bypass graft is everted
around the fitting, a retaining ring 62 is positioned over the
everted bypass graft to compress it against the fitting. This
secures the bypass graft to the fitting. The retaining ring 62 is
connected to a signal wire 64 that is routed to a radiofrequency
generator to deliver radiofrequency energy to the retaining ring 62
for thermal securing of the fitting to the host vessel 38.
[0067] FIGS. 4a-i show embodiments of the retaining ring 62 used to
secure the bypass graft 16 to the fitting. The retaining rings may
be fabricated from a metal, alloy, thermoplastic material,
thermoset, composite of these materials, or other material.
However, the retaining rings must permit at least 30% enlargement
in diameter without becoming permanently deformed. Thus, after
placement, the retaining ring will compress around the bypass graft
and fitting interface to form a secure seal. In FIGS. 4a-f, the
retaining ring is a preshaped member having a rectangular,
circular, or elliptical cross-section and eyelets 63 that
facilitate positioning the retaining ring over the fitting and may
be used to suture the retaining ring closed for additional support.
The retaining ring shown in FIGS. 4a-b has a preshaped member wound
beyond a single turn. When the eyelets 63 are squeezed together,
the diameter of the retaining ring enlarges making it easier to
position over the bypass graft and fitting combination. In FIGS.
4c-d, the retaining ring 62 is a coiled wire extending to just less
than a single turn. When the eyelets 63 are spread apart, the
diameter of the retaining ring enlarges.
[0068] The retaining ring 62 shown in FIG. 4g is a preshaped member
wound beyond a single turn and having radiused edges and ends. One
representative fabrication process for the preshaped retaining ring
involves forming the raw material into a desired geometry and
exposing the material to sufficient heat to anneal the material
into this predetermined shape. This process applies to metals (e.g.
nickel titanium) and polymers. The preshaped retaining ring
configuration is expanded by inserting the expansion tool into the
middle of the retaining ring and opening the expansion tool thereby
enlarging the diameter of the retaining ring. Once the retaining
ring is positioned, the force causing the retaining ring to enlarge
is removed causing the retaining ring to return towards its
pre-formed shape thereby compressing the bypass graft over the
fitting. This retaining ring may also be used to secure a fitting
to a host vessel since this retaining ring may be expanded to
expose an opening between opposite ends adapted for placement over
the host vessel. Once positioned over the host vessel to fitting
interface, the retaining ring is allowed to return towards its
preformed shape thereby compressing the host vessel against the
fitting.
[0069] The retaining rings may incorporate elastic memory
characteristics. For example, a retaining ring shown in FIG. 4g,
may be manufactured from a deformable material and crimped over the
bypass graft to fitting interface or host vessel wall to fitting
interface for securing purposes. FIG. 4h shows another retaining
ring that does not incorporate elastic memory characteristics. This
retaining ring is opened for positioning around the bypass graft to
fitting interface or the host vessel to fitting interface and is
closed thereby causing the teeth to engage and lock the retaining
ring in the closed position. Further closing the retaining ring
causes the diameter to decrease and increase compression. FIG. 4i
shows another retaining ring 62 configuration having a preshaped
member wound beyond a single turn. This embodiment also permits
expansion of the retaining ring to facilitate positioning, but is
configured to form a complete ring in its resting shape.
[0070] FIGS. 5a-e and FIGS. 6a-f show retaining rings 62 which are
particularly useful when utilizing the thermal securing process in
attaching a bypass graft and fitting to a host vessel. The
retaining rings 62 may be embedded in the bypass graft when using
synthetic materials or advanced over the bypass graft and fitting
interface to produce an interference fit at the bond joint. The
retaining rings 62 shown in FIGS. 6a-d may be enlarged while being
deployed around the bypass graft and fitting combination and
allowed to return to its preformed shape, once positioned, thereby
securing the bypass graft to the fitting and providing a fluid
tight seal. The retaining rings 62 have numerous edges 65 including
straight notches as shown in FIG. 5b, slanted notches as shown in
FIG. 5d, holes through the retaining ring, spaces defined by mesh
material, or other geometry forming edges. The edges 65 produce
high current densities when radiofrequency energy is transmitted
through the retaining rings. The retaining ring electrodes have
several spaces into which the vessel can shrink and coagulum can
infiltrate thereby providing adherence between the host vessel and
the retaining ring 62. The retaining rings 62, shown in FIGS. 6e-f,
incorporate petals 67 so that an end-to-end fitting may be used for
an end-to-side anastomosis.
[0071] The bypass graft may be bonded to the fittings prior to
securing the fittings to the host vessel. This step may be
performed outside the patient to allow the physician to ensure a
strong and leak resistant bond. Another advantage of the fittings
is that they only expose the endothelial layer of a biological
bypass graft to blood flow which generally prevents thrombosis and
other interactions between foreign materials and blood.
[0072] Conventional anastomosis techniques require a relatively
large incision through the vessel wall and use of sutures,
commercially available clips, or stapling devices to bond the end
of the bypass graft to the exposed edges of the vessel wall. In
certain cases, the structural integrity of the vessel wall may be
weakened causing the vessel to collapse at the anastomosis site,
especially when the bypass graft is not appropriately aligned to
the host vessel incision. Therefore, the delivery system
embodiments are designed to access the vessel through a small
puncture in the vessel wall. The delivery systems are designed to
prevent excess blood loss when accessing the host vessel and
deploying the bypass graft and fitting combination thereby
eliminating the need to stop or re-route blood flowing through the
host vessel. This approach also generally improves the leak
resistance around the fitting due to elastic compression of the
vessel wall around the fitting and aligns the bypass graft to the
host vessel wall at the anastomosis site.
[0073] The particular delivery system embodiment used depends on
the application. For catheter-based bypass grafting applications,
further referenced in U.S. application Ser. No. 08/966,003 filed
Nov. 7, 1997, a catheter (e.g. guiding member) is intralumenally
advanced to the proximal anastomosis site. A puncture device (e.g.
needle) is used to perforate the vessel wall and enable advancing a
guiding member exterior to the vessel. A dilating member expands
the opening to atraumatically advance the guiding member through
the vessel wall. A balloon may be attached to the guiding member
and inflated to restrain the guiding member outside the host vessel
and to prevent leaking at the puncture site. The balloon is
deflated while the guiding member is advanced through the vessel
wall. The catheter is then manipulated to the distal anastomosis
site. The puncture device is used to perforate the vessel wall and
access the interior of the vessel at the distal anastomosis site. A
guidewire may be advanced through the puncture device or the
puncture device may function as a guidewire to provide a passage to
advance the guiding member into the interior of the host vessel at
the distal anastomosis site. Once the guiding member is advanced
through the puncture and into the interior of the host vessel, the
bypass graft is advanced inside or outside the guiding member to
the distal anastomosis site. A stylet may be used to advance the
bypass graft along the guiding member or maintain the position of
the bypass graft as the guiding member is retracted. The balloon
attached to the guiding member may again be inflated to keep the
guiding catheter within the vessel at the distal anastomosis site
and prevent leaking. The bypass graft is secured to the host vessel
at the distal anastomosis site. The guiding member may be retracted
so the bypass graft is able to contact the host vessel wall at the
proximal anastomosis site. If a balloon was inflated to maintain
the position of the guiding member within the vessel, it must be
deflated prior to retracting the guiding member through the vessel
wall. The bypass graft is then secured to the host vessel wall at
the proximal anastomosis site and the guiding member is removed
leaving the bypass graft as a conduit for blood to flow from the
proximal anastomosis to the distal anastomosis. The fittings used
to secure the bypass graft to the host vessel wall at the proximal
and distal anastomosis sites depend on the application and whether
retrograde blood flow through the anastomosis site is desired. Some
fittings used for end-to-end anastomoses may not permit retrograde
blood flow.
[0074] FIGS. 7a-b show fittings 60 attached in-line along a vessel
38. The fittings 60 are designed to support the bypass graft at the
vessel wall insertion site 90 and prevent the host vessel 38 from
constricting the diameter of the bypass graft 16. The bypass graft
16 is advanced through the fitting 60 and is everted around the
distal end of the fitting 60. A retaining ring 42 is used to secure
the bypass graft 16 to the fitting 60 and is positioned within the
notched region 40.
[0075] The bypass graft may be secured to the vessel by
transmitting radiofrequency energy to electrodes 44 attached to the
bypass graft 16. The electrodes 44 may be conductive fittings or
retaining rings bonded to the bypass graft as previously described.
The electrodes 44 may be fabricated from stainless steel, nickel
titanium, platinum, platinum iridium, gold, titanium, tungsten,
tantalum, or other material and may provide structural support to
the bypass graft. Electrodes 44 may be incorporated into the
fittings to thermally secure the fitting and the bypass graft to
the vessel wall at each anastomosis. The retaining rings may serve
to bond the bypass graft to the fitting and act as the electrodes
for thermal securing. Alternatively, the electrodes may be added to
the fitting as separate components aside from the retaining rings.
When fittings are laminated within layers of synthetic bypass graft
material eliminating the need for retaining rings, the electrodes
will be bonded to the fittings or bypass graft during
manufacturing. These end-to-end fittings are particularly useful
when performing in-line anastomoses along a vessel and around a
vascular abnormality. They are also useful to treat total
occlusions when retrograde blood flow is not beneficial.
[0076] For surgical applications, physicians may access the
anastomosis sites from the exterior surface of the host vessel.
Unlike the catheter-based approach where the bypass graft is
advanced past the distal end of the delivery catheter during
deployment, the delivery system of the surgical approach must
permit removal after both ends of the bypass graft have been
secured and the delivery system resides around the attached bypass
graft.
[0077] FIGS. 8a-d show that the bypass graft 16 does not need to be
everted. For example, synthetic bypass grafts may be attached to
the exterior of the fitting 65. The fitting 65 may be laminated
between layers of the bypass graft 16.
[0078] FIGS. 9a-c show steps to position a bypass graft and fitting
combination through a vessel wall 39. A needle 100 is inserted
through a dilator 102 and a sheath 104. The needle, dilator, and
sheath combination is positioned at the target vessel location.
Especially for minimal access procedures involving endoscopic
visualization and manipulation through small incisions, sensors may
be incorporated in the needle, dilator, and/or sheath to position
the delivery system at the target location. The sensors can include
ultrasonic transducers, such as those fabricated from piezoelectric
material, doppler crystals, infrared transducers, or fiberoptics.
Alternatively a lumen may permit the injection of radiopaque
contrast material within the vessel to verify the position using
fluoroscopy.
[0079] FIG. 9a illustrates needle 100 being used to puncture the
vessel wall 39 and advancing into the interior of the vessel 38.
The needle 100 may be designed with a tapered or stepped distal end
to restrict movement of the needle beyond the end of the dilator
102 and prevent perforating the opposite side of the vessel or
unwanted anatomy. A guidewire (not shown) may be advanced through
the needle to provide a path over which the dilator and sheath may
be advanced. When using a guidewire, the needle may be retracted to
prevent unwanted perforations or abrasions to the vessel or
adjacent anatomy. The dilator 102 is then advanced over the needle
100 or guidewire into the host vessel. Subsequently, the needle 100
(if not already retracted to insert the guidewire) may be removed
from the vessel or retracted inside the dilator 102. The dilator
102 is tapered to provide a smooth transition when advancing
through the vessel wall 39. The vessel wall 39 forms a seal around
the dilator 102 to preventing excess blood leakage from the vessel.
A sheath 104 having a radius or tapered distal end forms a smooth
transition around the dilator 102. Once the dilator 102 is
positioned within the vessel 38, the sheath 104 may be advanced
over the dilator 102 and into the vessel 38 as shown in FIG. 9b. At
this point, the dilator 102 may be removed. Insertion of a sheath
104 into a vessel 38 over a dilator 102 and needle 100 is commonly
used by physicians when performing the Seldinger technique during
catheterization procedures or inserting I.V. catheters into veins
for withdrawal of blood or introduction of medicines. The sheath
104 and dilator 102 may be constructed from polyethylene, or other
polymer and be extruded or molded into a tube. The sheath 104 and
dilator 102 may incorporate a braided layer laminated between two
polymers to resist kinking and improve the column strength and
torque response. A taper and radius may be formed in the distal end
of the dilator and sheath by thermally forming the raw tubing into
the desired shape.
[0080] The hub 106, 108 on the sheath 104 and dilator 102,
respectively may be fabricated from polycarbonate, polyethylene,
PEEK, urethane or other material and be injection molded,
adhesively bonded, or thermally bonded to the tube. The hub 106
contains at least one and preferably two grooves, slits, or series
of perforations along the hub to enable the operator to split the
hub when removing the sheath from around the bypass graft. The hub
106 houses a hemostatic valve 110 constructed of silicone or other
material having a large percent elongation characteristic. The
hemostatic valve 110 prevents excess blood loss through the sheath
when positioned into the vessel. The valve 110 also incorporates at
least one groove, slit, or series of perforations to permit
separation when tearing the sheath from around the bypass graft. A
side port may be included to aspirate and flush the sheath. The hub
may alternatively be a separate piece from the tear-away sheath and
be independently removed from around the bypass graft. This hub may
include a luer fitting to enable screwing onto a mating piece of
the tear-away sheath, or other mechanism to permit removable
attachment of the hub to the tear-away sheath. This hub may
incorporate at least one groove, slit, or series of perforations to
enable splitting the hub to form an opening to remove the hub from
around the bypass graft. Alternatively, the hub may include a slot
which may be closed to prevent fluid leaking and may be aligned to
form an opening for removal from around the bypass graft.
[0081] The needle 100 and dilator 102 may incorporate a number of
additional features to facilitate positioning at the host vessel.
For example, a number of sensors may be placed within the tapered
region of the dilator such that they face axially or laterally with
respect to the axis of the dilator lumen. As a result, imaging
modalities may be directed forward or around the periphery of the
dilator. For both configurations, the sensors may be oriented
around the dilator 102 at known angular increments. Sensors used to
position the delivery system include ultrasonic transducers, such
as those fabricated from piezoelectric material, infrared
transducers, or fiberoptics. For example, four ultrasonic
transducers may be placed around the dilator 102 separated by 90
degrees to provide a 3-dimensional interpretation of anatomic
structures in front of the dilator to better detect the host
vessel. Conventional phased array imaging modalities may be used to
derive images extending distal to the dilator 102 or around the
circumference of the dilator 102. Sensors may be placed at the
distal end of the needle 100 to facilitate positioning the needle
at vessel location. The sensors may be used with the dilator
sensors to provide better imaging resolution and determine the
location of the needle tip relative to the end of the dilator
102.
[0082] Another feature which may be used in the dilator 102 and
needle 100 is the inclusion of unidirectional or bidirectional
steering. A steering mechanism may be positioned within the sheath,
dilator, and/or needle. Typically, the steering mechanism may
include a pull-wire terminating at a flat spring or collar in the
sheath, dilator, or needle. The steering system has a more flexible
distal section compared to the proximal tube body. When tension is
placed on the pullwire, the sheath, dilator, or needle is deflected
into a curve which helps direct the delivery system to the target
vessel location. The pullwire may be wound, crimped, spot welded or
soldered to the flat spring or collar placed in the sheath or
dilator. This provides a stable point within the sheath or dilators
for the pullwire to exert tensile force thus steer the sheath or
dilator. To incorporate steering in the needle, the pullwire may be
spot welded or soldered to one side of the needle hypotubing. The
proximal tube body of the sheath or dilator may be reinforced by
incorporating a helically wound wire within the tube extrusion to
provide column support from which to better deflect the distal
section.
[0083] FIG. 10 shows sheath 118 with at least one groove 120, slit,
or series of perforations formed along the tube and hub 122 to
provide a tear-away mechanism along at least one side for use after
securing the bypass graft to the vessel wall. Alternatively, the
sheath 118 may include a section of tubing material pre-split into
at least two sections such that the tubing tends to continue to
split into two pieces as the sections are pulled apart. This
feature is essential for removal of the sheath 118 from around a
bypass graft 16 when the sheath 118 is unable to slide past the
opposite end of the bypass graft 16. Support material incorporated
into a tear-away sheath to improve column strength should split
along the grooves formed in the sheath. The support material may be
fabricated into two braided sections oriented on opposite sides of
the sheath such that the grooves reside along the spaces between
the braided sections. Alternatively, the supporting material may be
strands of wire (e.g. stainless steel, nylon, etc.) laminated
between layers of sheath material and oriented axially along the
longitudinal axis of the sheath. The tear-away sheath 118 may
further incorporate features to maintain blood flow through the
host vessel while positioned inside the lumen of the host vessel as
further referenced in FIGS. 28a-b.
[0084] The plunger 124 is designed to insert the bypass graft 16
and fitting 130 as an attached unit and includes a lumen to pass
the bypass graft 16 through while inserting the fitting 130 into
the host vessel. A plunger 124 is essential when inserting
biological bypass grafts or synthetic bypass grafts that do not
have adequate column strength to be pushed through the hemostatic
valve of the sheath. In addition, the plunger 124 protects the
bypass graft during insertion through the hemostatic valve of the
sheath. After one side of the bypass graft is placed at a first
vessel location, the plunger 124 must be removed. The plunger 124
may be retracted beyond the opposite end of the bypass graft, if
possible, or the plunger 124 may be split along at least one groove
120, 126 incorporated along the side of the plunger. The plunger
124 is used to insert the opposite end of the bypass graft,
attached to a fitting, through a second sheath inserted at a second
vessel location. After attaching the second end of the bypass graft
to the vessel, the plunger 124 is contained between the ends of the
attached bypass graft and must be removed by tearing the plunger
along at least one and preferably two grooves 120, 126. The
tear-away groove 120, 126 must permit splitting the plunger wall
and hub 128 along at least one side to remove the plunger 124 from
around the bypass graft. To facilitate removal from around the
bypass graft, the plunger 124 and tear-away sheath 118 discussed
above preferably incorporate grooves, slits, or perforations 126 on
two sides to enable separation into two components.
[0085] FIG. 11 shows a bypass graft assembly containing fittings 60
already attached at the bypass graft 16 ends and plunger 140
preloaded onto the bypass graft 16. This plunger 140 is designed
with the hub 142 located at the middle region to facilitate
insertion of both ends of the bypass graft and attached fittings
without removal and repositioning of the plunger prior to insertion
of the second end of the bypass graft. The plunger 140 has grooves,
slits, or perforations 126 along at least one side of the plunger
tube 144 and hub 142 to permit removal after positioning and
attachment of the bypass graft at both ends.
[0086] FIGS. 12a-c illustrate another plunger embodiment. Plunger
150 includes an axial slot through its entire length. The slot
enables pulling of the plunger 150 from the side of the bypass
graft when removing the plunger and permits pressing of the plunger
150 over the side of the bypass graft when placing the plunger over
the bypass graft. One end 152 has a short length stepped down to
form a smaller outer diameter that fits inside the inner diameter
of the fitting and provides a stable anchor to insert and
manipulate during delivery of the bypass graft and fitting
combination into the vessel. The other end 154 has the inner
diameter reamed out and notched for a short length to fit over the
outer diameter of the bypass graft and fitting combination during
manipulations. The plunger 150 maintains its integrity upon removal
from the bypass graft and may be used to deploy multiple bypass
graft and fitting combinations through sheaths.
[0087] FIG. 13 is an enlarged view of sheath 172 inserted into host
vessel 39 with dilator removed, and with bypass graft 16 everted
about fitting 170 and retained by ring 174.
[0088] For situations where blood flow is occluded and an incision
has been made through the vessel wall, a modified hockey stick
introducer may be used to insert the bypass graft and fitting
combination into the host vessel. The hockey stick introducer has a
tapered distal end and a partially enclosed body. This introducer
is advanced through the incision and is used to expand the vessel
wall so the bypass graft and fitting combination may be advanced
through the lumen of the introducer and into the host vessel
without catching the top part of the fitting on the vessel wall.
This is especially important when the bypass graft and fitting
combination has an outer diameter larger than the inner diameter of
the vessel where the host vessel must be expanded to insert the
bypass graft and fitting combination. The introducer may
incorporate an extension perpendicular to the longitudinal axis
that provides a handle to manipulate the introducer.
[0089] FIG. 14 shows electrodes 181 including conductive material
bonded to the bypass graft or fitting 180. The electrodes 181 are
used to transmit energy to the vessel wall and may be deposited
(e.g. ion beam assisted deposition, sputter coating, pad printing,
silk screening, soldering, or painting conductive epoxy) on the
fittings 180, bypass graft 16 or retaining ring 182. The electrodes
181 may be flexible and follow the contours of the fittings and/or
bypass graft. The electrodes may be formed in a helix, mesh, or
braid and bonded to the exterior surface of the fitting and/or
bypass graft. Signal wires 183 and 184 are connected to the
electrodes through spot welding, mechanical fit, or soldering, and
are routed to the leads of a radiofrequency generator 186. A large
surface area indifferent ground pad may be placed on the patient's
back, thigh, or other location so radiofrequency energy may be
delivered in a unipolar configuration. Alternatively, energy may be
delivered between electrode pairs in bipolar configuration.
[0090] By delivering radiofrequency energy to the electrodes,
tissue contacting the electrodes heats and coagulates the vessel
wall to the electrode and provides a secure, leak resistant bond. A
dramatic increase in impedance results from the formation of
coagulum on the electrode. This measurement of the bond strength
can be used to determine the quality of the bond generated between
the electrode 44 and the vessel wall 39. Different impedance
thresholds may specify different degrees of thermal bonding.
Initial thermal bonding has been demonstrated during experimental
studies when impedance increased above 300.OMEGA. using a signal
frequency of 500 kHz, which represented a threshold approximately
50% above baseline. The baseline impedance differs depending on the
frequency of the signal and the surface area of the electrode;
these characteristics must be taken into account when determining
the thresholds. Commercial electrosurgical generators operating at
a frequency of approximately 500 kHz commonly measure impedances up
to and exceeding lkQ when producing complete hemostasis using
tissue coagulating probes.
[0091] FIGS. 15a-e show a system for producing an end-to-side
anastomosis that compresses the vessel wall between two fitting
components. In this embodiment, the fitting 196 incorporates a
flared distal region 190 having a slot 192 that defines two edges.
The slotted distal end of the fitting is inserted through a
puncture 194 of the vessel wall 39 by positioning the edge of the
slotted fitting at the puncture site 194, angling the distal flared
region 190 so the edge may be further advanced through the vessel
wall, and rotating the fitting 196. Upon further rotation of the
fitting 196, the entire flared region of the fitting is advanced
into the interior of the vessel 38, as shown in FIG. 15d. Then a
compression ring 198 is positioned over the fitting 196 and past
the tabs 200 to compress the vessel wall 39 between the flared
distal end 190 and the compression ring 198.
[0092] FIGS. 16a-c show fitting 210 including edge 212 at a flared
end, and a slotted region to ensure a fluid tight fit after
deployment and securement of the fitting 210 to a vessel with a
compression ring (not shown). As shown in FIG. 16c, the lower edge
is advanced through the puncture site 214, and the fitting 210 is
rotated to advance the distal, flared end of the fitting into the
vessel. Once in the vessel, a compression ring is advanced over the
fitting 210 and is locked in place with the tabs 200 thereby
securing the vessel wall between the distal, flared end of the
fitting and the compression ring. The fitting 210 includes multiple
rows of tabs 200 to accommodate various sized vessel walls. This
feature is important when treating vascular diseases associated
with thickening of the vessel wall.
[0093] FIGS. 16d-e show fitting 220. In this configuration, a
guidewire is inserted through the vessel wall and into the interior
of the host vessel by puncturing the vessel wall with a needle and
inserting the guidewire through the lumen of the needle. The needle
is removed from around the guidewire after inserting the guidewire
through the vessel wall. An insertion tubing 222 containing a
central lumen 224 follows the periphery of the flared end 226 and
is adapted to pass a guidewire. The guidewire is fed through the
insertion tubing 222 to facilitate the screwing of the fitting past
the vessel wall. The insertion tubing 222 extends approximately 40%
to 80% around the flared end circumference. Alternatively, the
insertion tubing 222 may be configured in sections extending around
the circumference of the flared end such that a physician may
determine how far around the flared end the guidewire must extend
in order to rotate the flared end past the host vessel wall. A slot
228 through the distal flared end is adapted to accept the
thickness of the vessel wall and enables the screwing of the
fitting through the vessel wall. As the fitting 220 is advanced
over the guidewire and rotated, the fitting 220 simultaneously
expands the puncture through the vessel wall and inserts more of
the distal flared end into the vessel interior. Once the flared end
of the fitting 220 is inserted into the host vessel interior, the
guidewire is removed and the fitting 220 is secured to the vessel
wall using a compression ring and/or thermal securing. When using
thermal securing, the distal flared end (at least the side facing
the vessel wall) is made conductive and is attached to an energy
source to heat the vessel and to thermally secure the fitting 220
to the vessel wall.
[0094] The fittings may be configured to incorporate electrodes to
facilitate thermal securing of the fitting to the vessel wall. The
electrodes may be fabricated from stainless steel, nickel titanium,
platinum, platinum iridium, gold, titanium, tungsten, tantalum, or
other conductive material and may also be fabricated to provide
structural support to the bypass graft. Alternatively, the
electrodes may be deposited (e.g. ion beam assisted deposition,
sputter coating, solder, silk screen, pad printing, painting
conductive epoxy, or other process) on the fittings and/or bypass
graft such that the electrodes are thin and flexible and follow the
contours of the fittings and/or bypass graft. The thermal securing
properties may be the only attachment means required to provide a
fluid tight bond between the fitting and the vessel wall.
Alternatively, thermal securing may be augmented by attaching a
compression ring as described above, applying adhesives to the
bond, or suturing the fitting to the vessel wall. After securing
the bypass graft to the fitting and advancing the fitting into the
host vessel, the bypass graft and fitting combination may be
attached to the host vessel wall.
[0095] FIGS. 17a-b show a fitting 240 for performing an end-to-side
anastomosis. A bypass graft 16 is everted over the distal end of
the fitting 240. A retaining housing 242, similar to that shown in
FIGS. 6e-f, is used to secure the bypass graft to the fitting. This
retaining housing 242 permits radial expansion during placement
over the bypass graft 16 and fitting and has a preshaped memory to
compress around the bypass graft and fitting 240 to secure the
bypass graft. This retaining housing 242 has petals 244 at its
distal end, which compress into a low profile during delivery
through a sheath and expand radially once deployed into the vessel
38. The number of petals 244 depends on the size of the bypass
graft and the size of the host vessel. In this embodiment, eight
petals are used. After advancing the fitting through a sheath, the
fitting is advanced beyond the end of the sheath and is no longer
constrained by the sheath, and expands towards its resting
configuration. Then the bypass graft and fitting combination is
gently retracted to engage the interior vessel wall at the petals
244. For mechanical securing, a compression ring 246 is advanced
over the fitting thereby compressing the vessel wall 39 between the
petals 244 of the retaining housing and the compression ring 246.
The retaining housing may incorporate a threaded mechanism 248 to
screw on the compression ring and secure the compression ring
relative to the retaining housing. The threads are oriented only
along the sections of the retaining housing configured to engage
the compression ring. The slotted regions enabling the retaining
housing to radially expand and collapse do not include threads. The
compression ring 246 is alternatively locked in place using a screw
mechanism, a ratchet mechanism, adhesives, sutures, or other
attachment means to secure the compression ring in place. The
compression ring 246 incorporates two components: 1) a distal,
flexible o-ring or disk 250 designed to produce a fluid tight seal
and prevent damaging the vessel wall by excess compression; and 2)
a proximal, more rigid locking ring 252 used to maintain the
position of the o-ring or disk relative to the vessel wall. The
locking ring 252 is designed to match the threads incorporated in
the retaining housing. Mechanical securing may be replaced or
augmented with thermal securing.
[0096] FIGS. 18a-g show a fitting 260 used to produce an
end-to-side anastomosis, especially for medium to small diameter
vessels (e.g. peripheral vessels and coronary vessels). As shown in
FIG. 18a, four petals are collapsed into a low profile for
insertion through a sheath 262 during deployment into the vessel.
Once positioned, the sheath 262 is retracted enabling the petals to
expand toward their resting shape. This fitting 260 includes two
petals 264 designed to extend axially along the vessel and
pre-formed to contact the host vessel wall. The fitting also
includes two other petals 266 and 268 designed to extend radially
around a portion of the vessel. The petals provide a structure to
prevent the fitting from pulling out of the vessel, restrict
rotation of the fitting relative to the graft, ensure the host
vessel does not collapse or constrict at the anastomosis site, and
provide a support to compress the vessel wall between fitting
components. The petals 266 and 268 may be configured to return to a
closed configuration in their resting state, as shown in FIG. 18f.
Alternatively, the petals 266 and 268 may be configured to expand
beyond the closed configuration in their resting state, as shown in
FIG. 18e. This configuration helps the fitting petals exert radial
force on the host vessel to better support the fitting within the
host vessel and keep the host vessel open at the bond interface.
These end-side fittings may alternatively include more than 4
petals. FIG. 18g shows an end-side fitting having two axially
oriented petals, 270 and four radially oriented petals, 272. The
petals, 270, 272 are configured to expand beyond the closed
configuration in their resting state; alternatively, the petals may
be configured to return to a closed configuration in their resting
state. The fittings that produce end-to-side anastomoses may be
configured to produce an angle (A) between the bypass graft 16 and
the interior of the host vessel 38.
[0097] FIGS. 19a-f show an end-to-side fitting 290 that may be
folded to insert through a sheath with a smaller diameter than the
fitting. As shown in FIG. 19b, the foldable fitting 290 may be
fabricated from a sheet of metal material that has been chemically
etched, EDM, or laser drilled into the pattern shown. The opposite
ends 295 and 297 of the fitting 290 match so they may be bonded
together to form the expanded cross-section shown in FIG. 19c.
Alternatively, the fitting may be fabricated from a tubular metal
material using chemical etching, EDM, laser drilling, or other
manufacturing process to form the desired pattern.
[0098] In FIG. 19a, the petals 292 are preshaped to expand radially
outward once they have been deployed outside the introducing
sheath. In this configuration the vessel wall can be compressed
between the petals 292 and a compression ring. As shown in FIG.
19d, the fitting is designed to fold into a reduced diameter during
deployment and expand toward its resting shape once positioned
through the introducing sheath. The fitting includes links 294 that
are fabricated by reducing the thickness or width of the fitting
material and act as hinges for the fitting to fold into a low
profile. The foldable fitting embodiment shown in FIGS. 19a-f is
designed with 6 sides connected with links 293, 294 so two adjacent
sides are able to fold inward thereby reducing the diameter for
insertion through the delivery system. The foldable fitting may
further be configured so two more adjacent sides at the opposite
end of the initially folded sides are able to fold inward and
further decrease the profile for insertion through the delivery
system. The foldable fitting may alternatively have more than 6
sides and be configured so multiple adjacent sides fold inward to
reduce the profile for introduction.
[0099] In FIGS. 19e-f, the foldable fitting incorporates a
synthetic graft material 296 that is extruded, injection molded, or
dipped onto the fitting 290. The manufacturing process causes the
graft material to fill slots and holes 298 cut in the fitting 290.
This produces a more reliable bond between the synthetic graft
material and the expandable, foldable fitting. The covered fitting
290 will expand and fold as long as synthetic graft materials
having a high percent elongation characteristic is chosen. The
graft material may stretch along the folds incorporated in the
fitting. A biological bypass graft (e.g. harvested vessel) may be
sutured to the holes 298 incorporated in the fitting. The
manufacturing processes and materials for fabricating this fitting
290 may also be used to fabricate end-to-end fittings by excluding
the petals from the design. In addition, the foldable support
structure may extend throughout the length of the bypass graft and
be configured so that the sides rotate around the bypass graft at
specific points to increase the axial flexibility but maintain the
potential to fold into a reduced diameter.
[0100] FIGS. 20a-b show an end-to-side fitting 310 having petals,
and containing exposed electrodes 312 on the outside surface of the
petals facing the vessel wall once deployed. A signal wire 314 is
spot welded, crimped, attached using conductive adhesives, or
soldered to provide an electrical connection between the electrodes
312 of the petals and a radiofrequency generator (not shown). The
fitting 310 is fabricated by extruding, injection molding, or
otherwise applying a nonconductive, conformal coating (e.g.
elastomer) over an electrode structure 316 configured to include
petals. In a second operation, the outside surfaces of the petals
are removed exposing the electrodes 312. The petals are preshaped
so the outside surfaces defining the electrodes contact the vessel
wall, once deployed. As shown in FIG. 20a, a conduction ring 318 is
placed into contact with the electrode structure 316 on the
proximal end of the fitting and is bonded in place. A signal wire
314, used to transmit radiofrequency energy from a generator, is
bonded to the conduction ring 318. As a result, radiofrequency
energy transmitted to the conduction ring 318 will be routed to all
electrodes positioned on the petals simultaneously. Alternatively,
individual signal wires 314 may be attached to each petal electrode
312 and routed to a generator to independently energize each
electrode.
[0101] The signal wire 314 may be fabricated from platinum,
stainless steel, or a composite of materials (e.g. platinum and
silver combined by a drawn filled tubing process). The composite
signal wire uses the silver as the inner core to better transmit RF
energy to the electrode and platinum to ensure biocompatibility.
The signal wires may be fabricated with a circular, elliptical,
rectangular (flat), or other geometry depending on the design of
the electrode and space available in the delivery system. After
thermal securing the bypass graft to the host vessel, the signal
wire may be mechanically severed near the electrical connection
using a pair of dikes. Alternatively, the signal wire 314 may
incorporate a notch designed to separate when exposed to a desired
amount of tension or torque, less than that required to dislodge
the thermally secured bypass graft. Alternatively, the wire can be
separated by transmitting pulses of radiofrequency or direct
current energy through the signal wire capable of ionizing the
signal wire and causing breakdown of the material. A notch may be
incorporated in the signal wire to localize the breakdown point
along the signal wire.
[0102] FIGS. 21a-b show an end-to-side fitting 330 incorporating an
electrode structure 332 for thermally securing the fitting 330 to
the vessel wall 39. The fitting 30 has a flared distal end with at
least one electrode 332 exposed along the outside surface of the
fitting. A signed wire 333 to transmit radio frequency energy from
a generator may be attached to electrode 332. The at least one
electrode 332 extends around the fitting 330 and has axial
extensions adapted to orient the fitting along the vessel wall. The
extensions provide an additional support structure to prevent
rotation of the fitting relative to the vessel and reinforce the
bond by using a mechanical securing mechanism such as a compression
ring or other suitable means. The fitting 330 is manufactured from
a polymer dipped, deposited, coated, or injection molded over a
conductive structure such that only the distal outside surface of
the conductive structure is exposed. The electrical connection will
be established prior to dipping or injection molding of the
fitting. The distal end of the flared electrode structure has a
detent 334 to better secure the elastomer material to the electrode
structure 332. The flared end of the fitting 330 must be flexible
enough to be gathered into a low profile for introduction through a
sheath and must have enough stiffness to contact the vessel wall
and produce a fluid tight seal once secured in place.
[0103] FIGS. 21c-d show another end-to-side fitting 330
incorporating an electrode 332. This embodiment includes an
elastomer or other coating 336 around the distal, flared end of the
electrode 332. The electrode 332 is configured with petals 338 that
collapse during deployment of the fitting into the vessel. The
elastomer coating 336 masks the blood flow, maintains the
collapsibility of the fitting, and helps ensure a fluid tight bond
between the fitting and the vessel wall. The electrode 332 is
exposed on the outside surface of the distal, flared end of the
fitting. The electrode 332 provides mechanical support to the
fitting and enables thermal securing of the fitting 330 to the
vessel wall 39.
[0104] FIGS. 22a-b show an end-to-side fitting 350 incorporating an
electrode structure 332 that enables the fitting to collapse into a
low profile for insertion through an introducing sheath having a
smaller diameter than the fitting 350. The distal flared end of the
electrode structure 351 compresses forward and the body of the
fitting folds into a low profile for insertion through a sheath.
Once deployed outside the sheath, the fitting 350 returns to its
expanded, resting configuration. The flared, distal end contacts
the interior surface of the vessel wall and provides a structure to
compress the vessel wall using a compression ring. The electrode
structure is fabricated from a conductive material (preferably but
not limited to memory elastic materials) braided over a
thermoplastic, thermoset plastic, silicone, or other material and
is formed into a preshaped configuration having a flared end. The
braided electrode structure may alternatively be composed of a
memory elastic material such as nickel titanium for providing
structural support intertwined with a good conductor such as
platinum. Additionally, the braided material may be deposited with
a conductive material to increase conduction. Since the electrode
structure 351 is braided, the distal end of the electrode structure
351 is coated with an elastomer or other material 352 to prevent
unraveling of the braided material. This electrode structure 351
may also used to thermally secure the fitting to the vessel wall
once radiofrequency energy is transmitted to the electrode
structure from a generator.
[0105] FIG. 23 shows an end-to-end fitting 370 that permits
retrograde blood flow through the anastomosis site. The fitting 370
has holes 372 through the angled sections of the fittings to
preserve fluid flow through the vessel distal and/or proximal,
depending on the location of the fitting within the host vessel.
The bypass graft and fitting combination 374, after deployed within
and attached to the vessel maintains blood flow through the
stenosis as well as establishes a passage around the lesion 376.
The fitting 370 maintains blood flow to branching vessels proximal
to the anastomosis site.
[0106] FIGS. 24a-b show fitting 370 attached to the vessel at two
locations. The fitting 370 is placed within the vessel and contacts
the interior surface of the vessel along a substantial length. FIG.
24b shows that the fitting 370 may incorporate barbs 382 to prevent
axial dislodgment of the fitting from the host vessel 38. The barbs
may also provide a support to secure a retaining ring or suture to
mechanically secure the fitting to the host vessel. A second
attachment is located at the insertion site through the vessel wall
39. A compression ring or retaining ring may be used to compress
the vessel wall 39 around the fitting 370 and prevent fluid from
leaking at the insertion site. Electrodes may additionally or
alternatively be positioned around the fitting at the insertion
site 384 and/or at the distal end 386 of the fitting to thermally
secure the fitting to the vessel wall and provide a fluid tight
bond. The electrodes may be fabricated from stainless steel, nickel
titanium, platinum, platinum iridium, gold, titanium, tungsten,
tantalum, or other material and may also be fabricated to provide
structural support to the bypass graft. Alternatively, the
electrodes may be deposited (e.g. ion beam assisted deposition,
sputter coating, pad printing, silk screening, soldering, or
painting conductive epoxy) on the fittings and/or bypass graft,
such that the electrodes are flexible and follow the contours of
the fittings and/or bypass graft. Fitting 370 is particularly
useful for medium size diameter vessels (>3 mm) where synthetic
bypass grafts are used to supplement the blood flow through the
vessel or shunt the blood flow to other vessels or organs.
[0107] FIGS. 24c-h show additional end-end fitting embodiments that
permit retrograde blood flow. The fitting 380 incorporate a
modification to provide a short proximal extension that contacts
the vessel wall along the insertion site at the host vessel. This
provides a structure to attach a compression ring and produce a
fluid tight bond at the insertion site. A locking mechanism is
incorporated in the fitting design to enable securing a compression
ring to the fitting. Alternatively, FIGS. 24e-f show the fitting
380 may incorporate two electrodes, 388, 390 around the distal end
and proximal extension of the fitting. An electrode may also be
located around the leg of the fitting located at the insertion
site. The electrodes, 388, 390 may incorporate holes to improve
thermal securing of the electrodes to the host vessel wall.
[0108] FIGS. 24g-h show another end-end fitting 385 that permits
retrograde perfusion and incorporates electrodes, 392, 394 around
the distal end and proximal extension of the fitting. This fitting
also includes two separate lumens. Lumen 396 connects blood flow
from the bypass graft 16 to the host vessel. Lumen 398 connects
blood flow between regions of the host vessel proximal to the
anastomosis site and distal to the anastomosis site.
[0109] The inventions described in this patent application describe
embodiments that permit thermally securing bypass grafts to host
vessels. The inventions require localized transmission of energy to
precisely heat the interior surface of the host vessel and a
support structure to maintain contact between the bypass graft and
host vessel during and after the thermal securing process. The
coagulation of tissue and shrinkage of blood vessels results from
the application of heat and thermally secures the bypass grafts to
the host vessel.
[0110] A thermal securing mechanisms as shown in FIGS. 14 and 25 is
used to increase the strength of the mechanical bond, and ensure a
fluid tight seal between the bypass graft and host vessel.
Alternatively, thermal securing may be solely used to bond the
bypass graft fitting to the vessel wall. This feature may be
adapted to all fittings. Thermal securing is accomplished by
coagulating tissue to the electrodes and is enhanced by an induced
shrinking of the heated tissue region producing an interference fit
between the vessel and the fitting. These physiologic responses to
heating produce a secure bond between the electrode and the vessel
wall and prevent leaking around the fitting.
[0111] Coagulating tissue to thermally bond a patch of porous
material to the external surface of tissue has been described by
Fusion Medical Technologies, Inc. (U.S. Pat. Nos. 5,156,613;
5,669,934; 5,690,675; 5,749,895; and 5,824,015). A sheet of
collagen or similar porous material is placed over tissue and
sufficient energy from a radiofrequency inert gas source is
delivered over the patch to form coagulum at the tissue surface.
The coagulum fills the pores of the external patch and cools to
form a bond thereby producing hemostasis between the tissue and the
external patch. The Fusion Medical product is suited for
applications such as lung resections or reattaching transected
vessels where direct exposure to the wound enables positioning the
patch over the external surface of the tissue, and an energy source
may be used to grossly apply heat over the exterior of the
patch.
[0112] Published studies evaluating the response of vessels
(arteries and veins) to heat have focused on the ability to
permanently occlude vessels. Veins have been shown to shrink to a
fraction of their baseline diameter, up to and including complete
occlusion, at temperatures greater than 70.degree. C. for 16
seconds; the contraction of arteries was significantly less than
that of veins but arteries still contracted to approximately one
half of their baseline diameter when exposed to 90.degree. C. for
16 seconds (Gorisch et al. Heat-induced contraction of blood
vessels. Lasers in Surgery and Medicine. 2:1-13, 1982; Cragg et al.
Endovascular diathermic vessel occlusion. Radiology. 144:303-308,
1982). Gorisch et al also observed vessel relaxation within 8
minutes after exposure to heat with arteries relaxing more than
veins; even so, the final diameters of the contracted arteries and
veins were less than their baseline diameters. Embodiments of the
invention mitigate the concern for vessel relaxation by
incorporating a spring mechanism in the fitting and/or electrode
design to accommodate subtle changes in vessel diameter.
[0113] Gorisch et al explained the observed vessel shrinkage
response "as a radial compression of the vessel lumen due to a
thermal shrinkage of circumferentially arranged collagen fiber
bundles". These collagen fibrils were observed to denature, thus
shrink, in response to heat causing the collagen fibrils to lose
the cross-striation patterns and swell into an amorphous mass.
These published observations into the contraction of vessels due to
heat provide evidence to the proposed invention of using
radiofrequency energy to produce an interference fit between a
contracted vessel and a fitting.
[0114] FIG. 25 shows a schematic for a bypass graft 16
incorporating two end-to-end fittings and containing electrodes 400
designed to thermally secure the bypass graft to the vessel wall.
The electrodes 400 are secured to the fitting and are bonded to
signal wires, 402 and 404, which are routed to a generator 406.
Radiofrequency or d.c. current is transmitted to the electrodes
unipolar to an indifferent ground patch electrode 408 placed on the
patient, or bipolar between the electrodes.
[0115] Various features of the electrodes enhance the heating
response and improve the bonding between the electrodes and the
vessel wall. Contact between the electrode and the vessel is
important to ensure an adequate bond when thermally securing the
electrode to the vessel wall. The outer diameter of the electrode
in its expanded configuration should exceed the inner diameter of
the host vessel to ensure adequate contact between the vessel wall
and the fitting.
[0116] FIGS. 26a-b show an end-to-end fitting 420 incorporating an
electrode 422 into the design. The fitting 420 collapses into a low
profile during insertion into the vessel and expand towards its
resting state upon deployment into the vessel. Such an expandable,
collapsible fitting helps ensure contact between the electrode 422
and the vessel wall despite any mismatching of the bypass graft
size to that of the host vessel. The fitting may be extruded in a
multi-layer configuration. The electrode may be braided into a mesh
over an initial polymer layer 426. A second polymer 428 may be
extruded, injection molded, or dipped over the braided first layer.
To expose the electrode 422, a section of the outer layer is
removed. Alternatively, the section of exposed electrode may be
masked when extruding, injection molding, or dipping the outer
layer. A signal wire 424 is bonded to the braided mesh, before or
after fabricating the outer layer, to produce an electrical
connection that is routed to a generator.
[0117] FIGS. 27a-b show a bypass graft incorporating an electrode
430 that is designed to collapse into a low profile during
deployment and expand to contact the vessel wall once inserted into
the vessel. The electrode 430 is attached to a signal wire 432,
which is used to connect the electrode to a generator 434. This
electrode 430 is fabricated from a mesh of memory elastic material
formed over an initial polymer layer 436, and preshaped to have an
expanded region as shown. The regions proximal and just distal to
the expanded electrode have a tubular shape and are coated with a
thermoplastic or thermoset insulative material 438. This process
forms a fitting incorporating an expandable, collapsible electrode
that does not change the inner diameter of the bypass graft during
or after deployment.
[0118] Another important feature to thermally secure a fitting to a
host vessel is the current density profile transmitted from an
electrode to tissue. The configurations of the expandable retaining
rings, previously discussed in FIGS. 5a-d and FIGS. 6a-d, make them
more effective at thermally securing the retaining ring (electrode)
and the bypass graft and fitting combination, to the vessel wall.
These electrodes are designed with edges at the holes, notches, and
slots cut in the ring. These holes, notches, and slots may be
fabricated by laser drilling, EDM, milling, or other manufacturing
process. Deposited electrodes, when used, may be applied in
patterns that contain numerous edges. When radiofrequency energy is
transmitted to these electrodes, the edges produce high current
densities that locally heat the vessel wall. The small
cross-sectional diameters of the conductive material forming the
retaining rings ensures minimal depth of penetration, maintains
focuses heating of the vessel wall, and helps to prevent damage to
adjacent anatomy. In addition, the spaces defined by the electrode
holes, notches, and slots provide a place for the vessel to shrink
and coagulate. This increases the bond strength between the
electrode and the vessel wall. The electrodes may additionally be
covered with a porous material, such as collagen, fibrinogen,
gelatin, and urethane, to further define a structure incorporating
holes, notches, and slots for tissue to shrink and coagulate. The
use of materials containing holes, notches and slots may also be
used to encourage neointimal cell growth. Porous materials having a
low melting point (e.g. 60.degree. C.-120.degree. C.) may be chosen
to enhance thermal bonding between the bypass graft and host vessel
wall. Heating such porous materials causes them to soften, reform
and/or crosslink to coagulated tissue while heating the vessel wall
with the electrodes.
[0119] As previously discussed, electrodes may also be incorporated
in the end-to-side fittings. The electrode features described above
which improve thermal securing may be incorporated in the petals or
flared regions of the end-to-side fittings. These features are
designed to increase contact between the electrode and the interior
of the vessel wall, provide a structure to localize bonding between
the vessel wall and the electrode, and insulate the electrodes from
blood flow.
[0120] FIG. 28a shows cut-out areas 450 oriented along the
tear-away sheath 452 and distributed radially around the sheath 452
that permit blood to flow through the cut-out areas in the sheath
and past the distal lumen of the sheath. Alternative distributions
and geometries for the cut-out areas may be chosen based on
application and insertion requirements for the bypass graft. FIG.
28b shows a tear-away sheath incorporating an anchoring extension
454 at the distal end of the sheath. The extension 454 is designed
to maintain access between the tear-away sheath and the host vessel
when the sheath is positioned perpendicular to the host vessel. The
length of the sheath should be limited to that required to access
the interior of the host vessel while ensuring short bypass grafts
may be inserted past the distal end of the sheath, especially when
the bypass graft has been secured at the opposite end. To make the
sheath suitable for less invasive access, a long side arm extension
to the sheath may be incorporated to support the sheath during
manipulations. The side arm should also permit splitting into two
halves to remotely tear the sheath away from the bypass graft.
[0121] FIG. 29 shows a snap fitting 460 designed to facilitate
bonding the bypass graft to the fitting. A distal piece 462 of the
snap fitting incorporates extensions 464 designed to lock the
distal piece 462 to mating teeth 466 of the proximal snap fitting
piece 460. The proximal piece 460 is also tapered to accommodate a
range of bypass graft diameters. The bypass graft is inserted
through the proximal piece 460 and everted over the external
surface of the proximal piece; alternatively, the bypass graft is
positioned over the exterior surface of the proximal piece 460.
Then, the distal piece 462 is advanced over the bypass graft and
proximal piece interface, and is locked to the teeth thereby
securing the bypass graft to the proximal piece 460. The distal
piece 462 is configured for end-end anastomoses; however, it may be
modified with features described below to accommodate end-side
anastomoses. The bypass graft and snap fitting combination may be
thermally secured to a host vessel by delivering radio frequency
energy through the distal piece after placing the distal piece in
contact with the vessel wall, as will be described below.
Alternatively, an electrode secured to the proximal piece, or the
proximal piece also functioning as the electrode may be used to
thermally secure the host vessel to the bypass graft and snap
fitting combination.
[0122] FIGS. 30a-d shows an alternative snap fitting 480. The
distal and proximal pieces are integrated into one component. This
adaptation facilitates manipulation of the bypass graft relative to
the fitting since the operator only needs to hold the bypass graft
and single fitting; otherwise, the operator needs to hold the
proximal piece, distal piece, and bypass graft while securing the
bypass graft to the fitting. The distal piece 482 contains locking
hinges 484 designed to move axially along rails 486 incorporated in
the proximal piece 488. The locking hinges 484 move along the rails
486 but are unable to be separated from the proximal piece 488. One
way to accomplish this is by making the distal end of the locking
hinges, positioned inside the rail openings, wider than the rail
openings. The distal ends of the locking hinges also have
extensions that mate and lock teeth incorporated in the rails of
the snap fitting. In operation, the bypass graft is positioned
through the open snap fitting and is secured by closing the snap
fitting. With the snap fitting open, the bypass graft is inserted
through the lumen of the proximal piece 488 and is advanced over
the tapered end of the distal piece 482. Then, the snap fitting is
closed by moving the proximal piece along the locking hinges of the
distal piece thereby compressing the bypass graft between the
proximal piece and distal piece. The ends of the locking hinges are
secured to the mating teeth of the rails to secure the distal piece
relative to the proximal piece. The distal piece 482 as shown is
configured for end-end anastomoses; however, it may be modified
with features described below to accommodate end-side anastomoses.
As stated previously, the distal piece or proximal piece may
function as electrodes to permit thermally securing the fitting to
the vessel wall.
[0123] FIGS. 31a-d show an alternative snap fitting 500 that has a
central piece 502 and a lockable outer piece 504. The outer piece
is composed of a single cylindrical component or two distinct
sections that are designed to pivot about a hinge 506; the hinge
connects the central piece and the outer piece, using a tab 508, to
facilitate manipulating the snap fitting and the bypass graft. With
the snap fitting open, the bypass graft is fed over the central
piece 502 from the side of the snap fitting not containing the tab
508 connecting the hinge 506 to the central piece. The tab 508 is
located on one side of the central piece to facilitate advancing
the bypass graft over the central piece without having to cut an
incision through the distal end of the bypass graft. After the
bypass graft has been positioned over the central piece, the outer
piece is closed together compressing the bypass graft between the
outer piece and the central piece. A locking mechanism is designed
at the contacting ends of the outer piece and is configured to bond
the outer piece in a closed, cylindrical position to reliably
secure the bypass graft to the snap fitting. This may be achieved
by incorporating mating teeth on opposite ends of the outer piece
tailored to interlock when the ends overlap. The outer piece of
this snap fitting embodiment may function as at least one electrode
for thermally securing the fitting to the vessel wall.
[0124] FIG. 32a-b show snap fitting 520 including petals 522 or
other suitable modification. The fitting 520 may be used to produce
end-side anastomoses. The petals 522 of the snap fitting 520 may
function as at least one electrode for thermally securing the
fitting to the vessel wall.
[0125] Experimental studies of thermal securing were conducted by
positioning metallic fittings, into canine femoral arteries and
veins during 3 experimental procedures. Signal wires were bonded to
the metallic fittings and connected to a generator capable of
delivering radiofrequency energy having a frequency of 500 kHz and
a maximum power of 50 Watts. The generator was programmed to
terminate radiofrequency energy delivery when impedance exceeded
300.OMEGA., signaling completion of the thermal bond.
Radiofrequency energy was delivered between each fitting and an
indifferent ground patch electrode placed on the animals' thigh.
Radiofrequency power ranged between 5 and 20 Watts for a duration
of 5 to 60 seconds. The thermal anastomoses were acutely evaluated
for leak resistance, patency, and tensile strength.
[0126] All bypass grafts were patent after thermal securing to the
host vessel as evidenced by injection of contrast solution,
visualized using fluoroscopy, demonstrating continuous blood flow
through the bypass grafts. The thermal securing mechanism resisted
leaking at the fitting to host vessel interface as demonstrated by
hemostasis when the bypass graft was clamped thereby increasing the
blood pressure at the anastomoses. The tensile strength of the
thermal anastomoses reached 2 lbs. As a result, thermal securing
was effective at bonding bypass grafts to host vessels producing
end-to-end anastomoses exhibiting a fluid tight bypass graft to
host vessel interface capable of withstanding pressures exerted in
the vessel.
[0127] The above described embodiments of the invention are merely
descriptive of its principles and are not to be considered
limiting. Further modifications of the invention herein disclosed
will occur to those skilled in the respective arts and all such
modifications are deemed to be within the scope of the invention as
defined by the following claims.
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