U.S. patent application number 10/243543 was filed with the patent office on 2003-01-16 for anvil apparatus for anastomosis and related methods and systems.
Invention is credited to Blatter, Duane D..
Application Number | 20030014064 10/243543 |
Document ID | / |
Family ID | 23128792 |
Filed Date | 2003-01-16 |
United States Patent
Application |
20030014064 |
Kind Code |
A1 |
Blatter, Duane D. |
January 16, 2003 |
Anvil apparatus for anastomosis and related methods and systems
Abstract
The present invention relates to new and useful apparatus,
systems and methods for providing an effective tool for
intraluminally directed vascular anastomosis of a graft vessel to a
receiving blood vessel that is performed according to a minimally
invasive procedure. The intraluminally directed vascular
anastomosis does not require the interruption of blood flow in the
receiving blood vessel and it is versatile enough to suitably
combine a variety of cutting, welding, soldering, sealing, and
joining techniques. The intraluminally directed anvil apparatus
comprises an anvil and a wire used for signaling the optimal
anastomosis site; this signaling can be performed when the initial
exploration is performed. An anastomosis device is used in
conjunction with the intraluminally directed anvil apparatus for
opening the anastomosis fenestra and joining the anastomosed
structures.
Inventors: |
Blatter, Duane D.; (Salt
Lake City, UT) |
Correspondence
Address: |
STOEL RIVES LLP
201 SOUTH MAIN STREET
ONE UTAH CENTER
SALT LAKE CITY
UT
84111
US
|
Family ID: |
23128792 |
Appl. No.: |
10/243543 |
Filed: |
September 12, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10243543 |
Sep 12, 2002 |
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09293366 |
Apr 16, 1999 |
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Current U.S.
Class: |
606/153 ;
227/902; 606/219 |
Current CPC
Class: |
A61B 17/115 20130101;
A61B 17/320016 20130101; A61B 17/0644 20130101; A61B 17/1155
20130101; A61B 2017/22068 20130101; A61B 2017/1157 20130101; A61B
2017/1135 20130101; A61B 17/3403 20130101; A61B 17/00491 20130101;
A61B 17/11 20130101; A61B 2017/1107 20130101; A61B 17/32053
20130101; A61B 2017/22069 20130101; A61B 17/1152 20130101; A61B
2017/0641 20130101; A61B 17/0643 20130101; A61B 2017/00557
20130101 |
Class at
Publication: |
606/153 ;
606/219; 227/902 |
International
Class: |
A61B 017/08; A61D
001/00 |
Claims
1. An intraluminally directed anvil apparatus for anastomosing a
receiving blood vessel to a graft vessel in conjunction with an
anastomosis device, comprising: anvil means for engaging the intima
of the wall of a receiving blood vessel at an anastomosis site, the
anvil means being sized for movement within the receiving blood
vessel to an anastomosis site, the anvil means having a receiving
surface sized to correspond with an end of a graft vessel; a
piercing wire having a proximal end and a distal piercing end, the
proximal end extending from the anvil means, and the distal
piercing end being configured to pierce the wall of the receiving
blood vessel; positioning means for intraluminally positioning the
anvil means at the anastomosis site.
2. The intraluminally directed anvil apparatus recited in claim 1,
wherein the anvil means is selected from the group consisting of a
laser shield anvil, a soft anvil, a balloon anvil, a combination of
a balloon and a puncture resistant balloon sheath, an anvil with
abrasion resistant material, an anvil with puncture resistant
material, an anvil with distortion resistant material, and an anvil
with an effective radiation absorbing material.
3. The intraluminally directed anvil apparatus recited in claim 1,
wherein the anvil means has a deflecting surface with depressions
therein.
4. The intraluminally directed anvil apparatus recited in claim 1,
wherein the receiving surface is slanted.
5. The intraluminally directed anvil apparatus recited in claim 1,
wherein the anvil means is attached to the piercing wire.
6. The intraluminally directed anvil apparatus recited in claim 1,
further comprising a catheter apparatus that can be positioned in
the receiving blood vessel and is configured such that the anvil
means can move within the catheter apparatus.
7. The intraluminally directed catheter apparatus recited in claim
1, wherein the positioning means is a wire.
8. The intraluminally directed catheter apparatus recited in claim
1, wherein the positioning means is a hollow shaft.
9. The intraluminally directed catheter apparatus recited in claim
1, wherein the positioning means is integral with the piercing
wire.
10. An intraluminally directed anvil apparatus for anastomosing a
receiving blood vessel to a graft vessel in conjunction with an
anastomosis device, comprising: an anvil for engaging the intima of
the wall of a receiving blood vessel at an anastomosis site, the
anvil being sized for movement within a receiving blood vessel to
an anastomosis site, the anvil having a receiving surface sized to
correspond with an end of a graft vessel; a piercing wire having a
proximal end and a distal piercing end, the proximal end extending
from the anvil means, and the distal piercing end being configured
to pierce the wall of a receiving blood vessel; positioning stem
for intraluminally positioning the anvil means at the anastomosis
site, the positioning stem having a proximal end and a distal
control end, the proximal end extending from the anvil, the
positioning stem being configured to extend within the receiving
blood vessel and out of an opening such that a user can
intraluminally position the anvil by the distal control end.
11. An intraluminally directed anvil apparatus for anastomosing a
receiving blood vessel to a graft vessel in conjunction with an
anastomosis device, comprising: a balloon anvil for engaging the
intima of the wall of a receiving blood vessel at an anastomosis
site, the balloon anvil being sized for movement within a receiving
blood vessel to an anastomosis site, the balloon anvil having a
receiving surface sized to correspond with an end of a graft
vessel; a piercing wire having a proximal end and a distal piercing
end, the proximal end extending from the anvil means, and the
distal piercing end being configured to pierce the wall of a
receiving blood vessel; positioning stem for intraluminally
positioning the anvil means at the anastomosis site, the
positioning stem having a proximal end and a distal control end,
the proximal end extending from the anvil, the positioning stem
being configured to extend within the receiving blood vessel and
out of an opening such that a user can intraluminally position the
anvil by the distal control end.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 09/293,366 titled Methods, Systems And
Apparatus For Intraluminally Directed Vascular Anastomosis which
was filed on Apr. 16, 1999 on behalf of Duane D. Blatter, M.D. Ser.
No. 09/293,366 is incorporated herein by specific reference.
THE FIELD OF THE INVENTION
[0002] The present invention is directed generally to vascular
anastomosis methods, systems and related apparatus. More
specifically the present invention is directed to intraluminally
directed anastomosis methods, systems and apparatus.
RELEVANT TECHNOLOGY
[0003] An endoscope is an instrument for the examination of the
interior of a canal or hollow viscus. Most endoscopic procedures
operate according to passive techniques, namely exploring and
diagnosing. However, some endoscopic procedures have evolved so
that they operate according to active or interventional procedures.
In addition to exploring and diagnosing, active endoscopic
procedures perform corrective tasks such as therapeutic and/or
surgical tasks.
[0004] Active endoscopic procedures are highly effective because of
a plurality of reasons. These reasons include: (a) minimal invasion
of the patient's body; (b) reduced requirements of medical
facilities and medical skill, and (c) quasi-simultaneity, if so
desired, of the exploration, diagnosis, and corrective tasks.
[0005] For example, in merely a few hours, an active endoscopic
technique such as a colonoscopy permits the exploration of the
entire colon and rectum, the recording of selected images, the
localization of abnormalities such as intestinal polyps, the
removal of any polyp, and the extraction of any polyp for
additional examination. If the colonoscopy had not been performed
and any existing polyp had been left attached to the intestinal
wall, such polyp might have become a malignant tumor thus giving
rise to a perhaps lethal colorectal cancer. Such a colonoscopy is
performed without the administration of general anesthesia.
Furthermore, it is performed by a team that involves only a few
health practitioners who do not necessarily have to be trained in
the techniques that are required in surgical or other more invasive
procedures.
[0006] The preceding characterization of active endoscopic
procedures and the accompanying illustrative example aid in
explaining why active endoscopic procedures enjoy great acceptance.
This is because active endoscopic procedures lead to considerable
savings in time and resources, they are minimally invasive, they
can be repeatedly applied with minimal risk of undesirable side
effects, and the corrective action may provide preventive effects
that would otherwise be hard or even impossible to accomplish.
[0007] The foregoing description and characterization of active
endoscopic procedures is intended to encompass the characteristics
and advantages of peripheral techniques that do not necessarily
require the use of an endoscope. Endoscopic applications are
generally used in intracavity procedures such as intrathoracic and
intraabdominal procedures. Peripheral techniques are usually
employed in other body regions, such as arms and legs.
[0008] In short, it is a desirable goal to be able to provide by
active endoscopic or peripheral procedures a variety of medical
services that are currently provided by techniques that are more
invasive and more demanding in time and in medical resources and
skills. This goal is justified by the efficiency, effectiveness,
safety, low cost, and preventive accomplishments of active
endoscopic or peripheral procedures. In particular, this invention
provides new methods and systems for performing vascular
anastomoses by intraluminally directed active endoscopic or
peripheral procedures. The intraluminally directed or intravascular
part of the procedures of this invention is based on an examination
performed by, for example, fluoroscopy, and extraluminal
manipulation is performed endoscopically or according to a
peripheral technique.
[0009] One aspect of this invention encompasses the
quasi-simultaneity of the exploration, diagnosis and corrective
tasks that can be achieved in vascular anastomoses performed by the
intraluminally directed active endoscopic or peripheral procedures
of this invention. Another aspect of this invention includes the
minimally invasive character of the vascular anastomoses that are
performed by the active endoscopic or peripheral procedures of this
invention. These procedures are also characterized by comparatively
reduced requirements of medical facilities and skill. To more
effectively describe and enable the present invention, a review of
some basic terminology and related technology is offered in the
immediately following subsections.
[0010] 2.1. Terminology
[0011] An anastomosis is an operative union of two hollow or
tubular structures. Anastomotic structures can be part of a variety
of systems, such as the vascular system, the digestive system or
the genitourinary system. For example, blood is shunted from an
artery to a vein in an arteriovenous anastomosis, and from the
right pulmonary artery to the superior vena cava in a cavopulmonary
anastomosis. In other examples, afferent and efferent loops of
jejunum are joined in a Braun's anastomosis after
gastroenteroscopy; the ureter and the Fallopian tube are joined in
a ureterotubal anastomosis, and the ureter and a segment of the
sigmoid colon are joined in a ureterosigmoid anastomosis. In
microvascular anastomosis, very small blood vessels are anastomosed
usually under surgical microscope.
[0012] An anastomosis is termed end-to-end when the terminal
portions of tubular structures are anastomosed, and it is termed
end-to-side when the terminal portion of a tubular structure is
anastomosed to a lateral portion of another tubular or hollow
structure. In an end-to-side anastomosis, we often refer to the
structure whose end is anastomosed as the "graft vessel" while the
structure whose side wall is anastomosed is referred to as the
"receiving structure".
[0013] Anastomotic material typically includes autologous material,
but it can also include heterologous material or synthetic
material. An autologous graft is a graft in which the donor and
recipient areas are in the same individual. Heterologous material
is derived from an animal of a different species. The graft can be
made of a synthetic material such as expanded
polytetrafluoroethylene ("ePTFE"). Wolf Dieter Brittinger,
Gottfried Walker, Wolf-Dieter Twittenhoff, and Norbert Konrad,
Vascular Access for Hemodialysis in Children, Pediatric Nephrology,
Vol. 11 (1997) pp. 87-95. When both ends of the graft are attached
to a receiving structure, the configuration of the receiving
structure with the anastomosed graft is called a bypass.
[0014] Depending on the anastomotic cross-section, anastomoses are
termed bevelled or circular. In a bevelled anastomosis, the
structures are joined in an oblique fashion, whereas in a circular
anastomosis the structures are joined in a plane that is vertical
with respect to the ultimate flow through the structures.
[0015] A nonocclusive anastomosis is typically an end-to-side
anastomosis in which the flow of matter through the vessel that is
anastomosed in its side is not interrupted while the anastomosis is
performed. Most conventional techniques for vascular anastomosis
require the interruption of blood flow through the receiving vessel
while the anastomosis is performed.
[0016] Although the parts of a blood vessel are designated by
well-known terms in the art, a few of these parts are briefly
characterized here for introducing basic terminology. A blood
vessel is in essence a tubular structure. In general, the region
comprised within tubular walls, such as those defining a blood
vessel or the walls defining the tubular member of an endoscope, is
termed the lumen or the intraluminal space. A lumen that is not
occluded is a patent lumen and the higher the patency of a blood
vessel, the less disrupted the blood flow through such vessel is. A
reduction of a blood vessel's patency can be caused by a stenosis,
which is generally a stricture or narrowing of the blood vessel's
lumen. A hyperplasia, or tissue growth, can also reduce a blood
vessel's patency. Reduction of blood vessel patency, and in general
a disruption in a vessel's blood flow, can lead to ischemia, which
is a local lack of oxygen in tissue due to a mechanical obstruction
of the blood supply.
[0017] A stent is a device that can be used within the lumen of
tubular structures to assure patency of an intact but contracted
lumen. Placement of a stent within an occluded blood vessel is one
way of performing an angioplasty, which is an operation for
enlarging a narrowed vascular lumen. Angioplasty and bypass are
different ways for reestablishing blood supply, an operation that
is called revascularization.
[0018] A blood vessel is composed of three distinct layers. From
inside to outside, these layers include the intima, the media and
the adventitia. The intima is a single layer of flat cells that
collectively line the lumen. The media is a thick middle layer
composed of smooth muscle cells. The adventitia is an outer layer
that comprises fibrous covering.
[0019] Angiography is a technique for performing a radiography of
vessels after the injection of a radio-opaque contrast material.
This technique usually requires percutaneous injection of a
radio-opaque catheter and positioning under fluoroscopic control.
An angiogram is a radiograph obtained by angiography. Fluoroscopy
is an examination technique with an apparatus, the fluoroscope,
that renders visible the patterns of X-rays which have passed
through a body under examination.
[0020] 2.2 Related Technology
[0021] The operative union of two hollow or tubular structures
requires that the anastomosis be tight with respect to the flow of
matter through such structures and also that the anastomosed
structures remain patent for allowing an uninterrupted flow of
matter therethrough. For example, anastomosed blood vessels should
not leak at the anastomosis site, the anastomotic devices should
not significantly disrupt the flow of blood, and the anastomosis
itself should not cause a biological reaction that could lead to an
obstruction of the anastomosed blood vessels. In particular,
anastomosed blood vessels should remain patent and they should
ideally not develop hyperplasia, thrombosis, spasms or
arteriosclerosis.
[0022] Because anastomosed structures are composed of tissues that
are susceptible to damage, the anastomosis should furthermore not
be significantly detrimental to the integrity of these tissues. For
example, injury to endothelial tissue and exposure of subintimal
connective tissue should be minimized or even eliminated in
vascular anastomosis.
[0023] Because structures to be anastomosed are internal, an
anastomosis requires a degree of invasion. The invasive character
of an anastomosis, however, should be minimized subject to the
reliable performance of a satisfactory anastomosis. Accordingly,
there has been a noticeable trend during the last quarter of this
century towards less invasive surgical intervention, a surgical
style that is termed minimally invasive surgery. This style is
characterized by pursuing a maximal treatment effect with minimal
damage to surrounding and overlying normal structures. In addition,
successful minimally invasive procedures should procure patency and
they should minimize damage to the tissues of the anastomosed
structures themselves.
[0024] A plurality of factors provide a propitious environment for
this trend towards minimally invasive surgery. These factors
include the development of high-technology diagnostic devices, the
innate characteristics of human psychology and economic
imperatives.
[0025] High-technology diagnostic devices such as flexible
fiber-optic endoscopes and intravascular catheters have
considerably enhanced our ability for performing a reliable
spacio-temporal location of disease. More specifically, these
devices permit the early and accurate determination of disease
processes and their loci. Furthermore, it is known that the earlier
a tumor or growth can be identified, the more responsive it is to
therapy by a minimally invasive technique. See Rodney Perkins,
Lasers in Medicine in Lasers--Invention to Application, edited by
John R. Whinnery, Jesse H. Ausubel, and H. Dale Langford, p. 104,
National Academy of Engineering, National Academy Press,
Washington, D.C. 1987. (This work will hereinafter be referred to
as "Laser--Invention to Application"). See also Edward R.
Stephenson, Sachin Sankholkar, Christopher T. Ducko, and Ralph J.
Damiano, Robotically Assisted Microsurgery for Endoscopic Coronary
Artery Bypass Grafting, Annals of Thoracic Surgery, Vol. 66 (1998)
p. 1064. (This article will hereinafter be referred to as
"Endoscopic Coronary Artery Bypass Grafting").
[0026] Human psychology also contributes to the growing trend
towards minimally invasive techniques. This is attributed to the
accepted prevailing preference of a minimally invasive technique
with respect to a more invasive surgical technique whenever the
outcomes of these two techniques are equivalent.
[0027] Finally, minimally invasive techniques are generally cost
effective to insurers and to society in general because they are
performed on an outpatient basis or else they require comparatively
shorter hospitalization time. Furthermore, the less tissue is
invasively effected in a procedure, the more likely it is that the
patient will recover in a comparatively shorter period of time with
lower cost hospitalization. Therefore, economic factors also favor
the development of minimally invasive techniques because they can
be performed with lower morbidity risk and they satisfy economic
imperatives such as reduced cost and reduced loss of productive
time. See Rodney Perkins in Lasers--Invention to Application, p.
104; Endoscopic Coronary Artery Bypass Grafting, pp. 1064,
1067.
[0028] Particularly in the field of vascular anastomosis, it is
acknowledged that there is an increasing demand for an easier,
quicker, less damaging, but reliable procedure to create vascular
anastomosis. This demand is further revitalized by the movement of
vascular procedures towards minimally invasive procedures. See Paul
M. N. Werker and Moshe Kon, Review of Facilitated Approaches to
Vascular Anastomosis Surgery, Annals of Thoracic Surgery, Vol. 63
(1997) pp. S122-S127. (This work will hereinafter be referred to as
"Review of Facilitated Approaches to Vascular Anastomosis").
[0029] Conventional exploration and anastomosis techniques are not
always implemented in such a way as to satisfy the demand for an
easier, quicker, less damaging, but reliable vascular anastomosis.
The following overview of conventional exploration and anastomosis
techniques closes this background section on related
technology.
[0030] Exploration of a blood vessel typically provides necessary
information for locating and diagnosing vascular abnormalities such
as those that reduce vascular patency. This exploration is usually
performed with angiography, a procedure that detects vascular
abnormalities fluoroscopically. When it is concluded that the
appropriate corrective action requires an anastomosis, conventional
procedures ordinarily follow a sequence in which the anastomosis is
not performed at the time when the initial exploration and
diagnostic are performed, but at a later time and in a typically
different clinical setup. Accordingly, the time and resources that
are spent during the exploration and diagnostic phases are not
directly employed in the performance of an appropriate corrective
action, such as an anastomosis.
[0031] By performing an anastomosis considerably after the initial
exploration has taken place and in a different location and
clinical environment, these conventional procedures also waste a
significant part of the information acquired at the exploration
phase. Images obtained during an angiographic procedure are
typically recorded on film or digital medium. In current clinical
practice, these recorded images are reviewed in a subsequent
clinical setting and based upon a knowledge of external anatomy,
the lesion location and optimal site for anastomosis are estimated.
This process sacrifices potentially useful information.
[0032] Fluoroscopic visualization is no longer available without
repeating the angiogram procedure, and in conventional practice
external anatomic localization is used in correlation with
previously recorded images. In addition to this external
inspection, conventional procedures could rely on imaging for
determining the optimal anastomosis site when corrective action is
taken. However, having to reacquire information leads to a waste of
resources, it significantly increases the period of time from
exploration to corrective action, it is an additional burden on the
patient, and it enhances the invasive character of the treatment
that is administered to the patient. Furthermore, reacquisition of
information might have to be done in an environment that demands
higher skills and more resources than they would have been
otherwise needed. For example, the opening of a body cavity to
expose the anatomical region around a potential anastomosis site,
the determination of the optimal anastomosis site by external
inspection, and the surgical performance of the anastomosis are
part of a treatment that is more complex, requires practitioners
with more training, and may be more time and resource consuming
than the treatment provided by the methods, systems and apparatuses
of the present invention.
[0033] Vascular anastomosis techniques can be classified in a
plurality of groups. Although with various degrees of success, all
these techniques generally intend to provide leak-proof joints that
are not susceptible to mechanical failure, and they also intend to
minimize damage and reduce the undesirable effects of certain
operational features that may lead to post-anastomosis
complications. Damage to be minimized and operational features
whose undesirable effects should be reduced include endothelial
coverage injury, exposure of subintimal connective tissue, exposure
of an intraluminal foreign component, blood flow interruption,
irregularities at the junction, adventitial tissue stripping,
intimal injury, installment of a foreign rigid body, use of
materials that may have toxic effects, damage to surrounding
tissue, extensive vessel eversion, and tissue plane malalignment.
Post-anastomosis complications include intimal hyperplasia,
atherosclerosis, thrombosis, stenosis, tissue necrosis, vascular
wall thinning, and aneurism formation. In addition, vascular
anastomosis techniques are characterized by varying abilities to
successfully cope with the dilating character of the structures to
be anastomosed, their diversity in size, and the possibility that
at least one structure may grow after the anastomosis has been
performed. Other variables that partially determine the suitability
of a specific anastomosis technique include the nature of the
material to be anastomosed (for example, autologous, heterologous,
or synthetic), the desired reduction in operative time, the skill
requirements, and the healing time.
[0034] Each one of the techniques discussed hereinbelow for joining
anastomosed structures presents a compromise for reducing
undesirable effects in the practice of vascular anastomosis. High
standards in one or a few aspects of the anastomosis can sometimes
be achieved only at the expense of sacrificing what otherwise would
have been the benefits of other aspects of the anastomosis.
[0035] Since early in the 20th century when vessel anastomoses were
performed with an acceptable degree of reliability, the standard
for creation of a vascular anastomosis has been manual suturing.
Review of Facilitated Approaches to Vascular Anastomosis, p. S122.
Suturing devices and methods are still being developed with the aim
at performing less invasive surgical procedures within a body
cavity. See, for example, U.S. Pat. No. 5,860,992 disclosing
devices and methods for suture placement while performing less
invasive procedures.
[0036] Regarding the application of sutures in vascular
anastomoses, it has been generally reported that "the insertion of
transmural stitches, even in experienced hands that employ
atraumatic techniques and fine sutures, causes significant damage
to the vessel wall. As the result of this the subendothelial matrix
becomes exposed to the bloodstream and initiates the formation of a
thrombus. The same process takes place at the actual site of the
anastomosis in the case of intima-intima apposition. These
processes are multifactorial but can cause obstruction of the
complete anastomosis, especially in small vessels." Review of
Facilitated Approaches to Vascular Anastomosis, p. S122. In
addition to proximal occlusion, needle-and-suture-mediated intimal
penetration is believed to represent a source of platelet emboli,
which can cause distal embolization and thus a hazard in brain
revascularization and myocardial circulation. Patrick Nataf, Wolff
Kirsch, Arthur C. Hill, Toomas Anton, Yong Hua Zhu, Ramzi Ramadan,
Leonardo Lima, Alain Pavie, Christian Cabrol, and Iradj
Gandjbakhch, Nonpenetrating Clips for Coronary Anastomosis, Annals
of Thoracic Surgery, Vol. 63 (1997) p. S137. (This article will
hereinafter be referred to as "Nonpenetrating Clips for Coronary
Anastomosis"). Furthermore, it is considered that "suture
anastomosis of small vessels is time-consuming and tedious and
demands a long and continuous training if high patency rates are to
be regularly achieved." Willy D. Boeckx, Oliskevigius Darius, Bert
van den hof, and Carlo van Holder, Scanning Electron Microscopic
Analysis of the Stapled Microvascular Anastomosis in the Rabbit,
Annals of Thoracic Surgery, Vol. 63 (1997) p. S128. (This work will
hereinafter be referred to as "Microscopic Analysis of Stapled
Microvascular Anastomosis"). In contrast, in all specialties that
employ vascular surgery, "there is an increasing demand for a
simple, time-saving, but reliable automated, semiautomated, or at
least facilitated method to replace the process of manually sutured
anastomosis. The most important reason for this demand is the
movement of cardiac bypass surgery toward a minimally invasive and
possibly even an endoscopic procedure." Review of Facilitated
Approaches to Vascular Anastomosis, p. S122. In this respect,
improvement "may come from techniques that do not lead to exposure
of [a] damaged vessel wall to the bloodstream." Id., p. S122.
[0037] Besides the group that includes techniques which rely on
suturing, vascular anastomosis techniques can generally be
classified in four groups depending on how the tissue is joined and
on the type of device or material used for joining the tissue of
the anastomosed vessels. These groups are: Stapling and clipping
techniques, coupling techniques, pasting techniques, and laser
techniques. Id., pp. S122-S127.
[0038] 2.2.1. Stapling and Clipping Techniques
[0039] Although some staplers have been reported as providing leaky
joints, a variety of staplers have been developed for end-to-end
and for end-to-side anastomosis. U.S. Pat. No. 5,366,462 discloses
a method of end-to-side vascular anastomosis. According to this
method, the end of the graft blood vessel that is to be anastomosed
is everted by 180.degree.; one end of the staple pierces both
vessels with punctures exposed to the blood flow and the other end
of the staple pierces the outside of the receiving vessel. U.S.
Pat. No. 5,732,872 discloses a surgical stapling instrument that
comprises an expandable anvil for aiding in the stapling of a
180.degree. everted end of a graft vessel to a receiving vessel.
This patent also discloses a stapling instrument for joining the
180.degree. everted second end of a graft vessel whose opposite end
has already been anastomosed. To anastomose this second end, this
technique requires clearance around the area in which the
anastomosis is performed, exposure of the receiving blood vessel,
external anatomic identification, and significant external
manipulation in the open area around the anastomosis site. U.S.
Pat. No. 4,930,674 discloses methods of end-to-end and end-to-side
anastomosis and a surgical stapler that comprises a vessel gripping
structure for joining the 180.degree. everted end of a graft vessel
to another vessel. U.S. Pat. No. 5,695,504 discloses methods and a
system for performing an end-to-side vascular anastomosis, where
the system is applicable for performing an anastomosis between a
vascular graft and the ascending aorta in coronary artery bypass
surgery, particularly in port-access coronary artery bypass graft
surgery. This system includes a staple with a configuration that
combines the functions of an anchor member and a coupling member
into a one-piece anastomosis staple. U.S. Pat. No. 5,861,005
discloses an arterial stapling method and device for stapling an
opening in an anatomical structure, whether the opening is
deliberately formed or accidentally caused. This device employs a
balloon catheter that helps positioning the stapling mechanism
properly on the organ to be stapled.
[0040] Some stapling devices rely on access to the anastomosis area
through an opening that might be as big as or comparable to typical
openings that are required in surgical procedures. Furthermore, the
180.degree. eversion of vessel ends is viewed as an operation that
can be difficult, particularly in sclerotic vessels. Review of
Facilitated Approaches to Vascular Anastomosis, p. S123.
[0041] In general, clipping techniques rely on arcuate legged clips
for achieving a flanged, nonpenetrated, intimal approximation of
the anastomosed structures. Reportedly, the use of clips leads to a
biologically and technically superior anastomosis as compared to
the penetrating microsuture. Review of Facilitated Approaches to
Vascular Anastomosis, p. S123. By approximating the everted walls
of the two vessels to be anastomosed, a clipping technique avoids
stitching and reportedly the subsequent risk of intimal
hyperplasia. Gianfranco Lisi, Louis P. Perrault, Philippe Menasch,
Alain Bel, Michel Wassef, Jean-Paul Vilaine, and Paul M. Vanhoutte,
Nonpenetrating Stapling: A Valuable Alternative to Coronary
Anastomoses, Annals of Thoracic Surgery, Vol. 66 (1998) p. 1707. In
addition, maintenance of an uninjured endothelial coverage and
avoidance of exposure of subintimal connective tissue are
considered important features because "regenerated endothelium
presents selective dysfunction that may predispose to spasm and
atherosclerosis, thereby affecting both medium-term and long-term
graft patency" and the risk of thrombosis at the anastomotic site
can be reduced. Id., p. 1707.
[0042] Nonpenetrating vascular closure staples ("VCS") have been
used in anastomoses performed to provide access for dialysis, as
well as in kidney and pancreas transplantation. It has been
concluded in light of these anastomoses that "the fact that VCS
staples are interrupted and do not disrupt the endothelium or have
an intraluminal component makes them ideal" for achieving the goals
of kidney transplantation. V. E. Papalois, J. Romagnoli, and N. S.
Hakim, Use of Vascular Closure Staples in Vascular Access for
Dialysis, Kidney and Pancreas Transplantation, International
surgery, Vol. 83 (1998) p. 180. These goals include the avoidance
of post-operative thrombosis and the avoidance of renal artery
stenosis. As with kidney transplants, no anastomotic abnormalities
were detected in pancreatic transplants, where the avoidance of
arterial stenosis is also very important. Id., p. 180. The results
of anastomoses performed for providing vascular access for dialysis
were also reported successful. Id., p. 179. In addition, it has
been reported that the "VCS applier is easy to manipulate, is as
safe as hand-suture methods, and has time saving potential. VCS
clips are useful for vascular anastomoses of blood access." Hiroaki
Haruguchi, Yoshihiko Nakagawa, Yasuko Uchida, Junichiro Sageshima,
Shohei Fuchinoue and Tetsuzo Agishi, Clinical Application of
Vascular Closure Staple Clips for Blood Access Surgery, ASAIO
Journal, Vol. 44(5) (1998) pp. M562-M564.
[0043] In a study of microvascular anastomosis of rabbit carotid
arteries, some anastomosis were stapled using non-penetrating 0.9
mm microclips and some anastomosis were conventionally sutured.
Arcuate-legged, nonpenetrating titanium clips are applied according
to a clipping technique in an interrupted fashion to everted tissue
edges at high compressive forces. It is considered that this
technique "enables rapid and precise microvascular reconstructions,
but requires both training and evertable tissue walls."
Nonpenetrating Clips for Coronary Anastomosis, Annals of Thoracic
Surgery, p. S135. An example of this clip applier is the VCS
device, Autosuture, United States Surgical Corporation, Norwalk,
Conn. Nonpenetrating Clips for Coronary Anastomosis, pp. S135-S137.
U.S. Pat. No. 5,702,412 discloses a method and devices for
performing end-to-side anastomoses where the side wall of one of
the structures is cut from the intraluminal space of the graft
vessel and the anastomosed structures can be secured by a plurality
of clips or by suturing.
[0044] It has been concluded that stapled microvascular anastomosis
is fast and reliable and histomorphologic examination of the
anastomotic site revealed no major differences between sutured and
stapled groups. Microscopic Analysis of Stapled Microvascular
Anastomosis, p. S128. Furthermore, it has also been reported that
the "clipped anastomotic technique has a rapid learning curve, the
same safety as suture methods, and the potential for facilitating
endoscopic vascular reconstruction." Nonpenetrating Clips for
Coronary Anastomosis, p. S135. In a study undertaken to compare VCS
clips with sutured arterial end-to-end anastomosis in larger
vessels, it was concluded that this type of anastomosis "can be
performed more rapidly with VCS clips than continuous sutures", and
that VCS clips "are potentially useful situations where the clamp
time of the vessel is critical." Emmanouil Pikoulis, David Burris,
Peter Rhee, Toshiya Nishibe, Ari Leppaniemi, David Wherry and
Norman Rich, Rapid Arterial Anastomosis with Titanium Clips, The
American Journal of Surgery, Vol. 175 (1998) pp. 494-496.
[0045] Nevertheless, clipping may lead to irregularities at the
junction of the anastomosed vessels. In addition, it has been
reported that "both periadventitial tissue stripping and
microvascular clip application have deleterious effects in the
early postoperative period" and that "temporary clips with a lesser
width must be used in place of microvascular clips" while
performing microvascular anastomosis. S. Keskil, N.
.cedilla.eviker, K. Baykaner, . Uluo{haeck over (g)}lu and Z. S.
Ercan, Early Phase Alterations in Endothelium Dependent
Vasorelaxation Responses Due to Aneurysm Clip Application and
Related Manipulations, Acta Neurochirurgica, Vol. 139(1) (1997) pp.
71-76.
[0046] 2.2.2. Coupling
[0047] Tissue bonding by coupling with the aid of devices such as
stents, ferrules, or rings without staples is considered to be
older than stapling. Among the more recent devices and techniques,
U.S. Pat. No. 4,523,592 discloses anastomotic coupling means
capable of end-to-end and end-to-side anastomosis without resorting
to suturing. The vessels are coupled with a pair of coupling disc
members that cooperatively lock and secure the everted tissue from
the anastomosed structures. These everted tissues remain in
intima-intima contact with no foreign material exposed to the lumen
of the anastomosed vessels. U.S. Pat. Nos. 4,607,637, 4,917,090 and
4,917,091 also disclose the use of anastomosis rings and an
instrument for joining vessels or tubular organs which are threaded
to the annular devices before the joining. The instrument and the
anastomosis rings are shaped and adapted to be utilized mainly in
microsurgery. U.S. Pat. Nos. 4,657,019 and 4,917,087 disclose
devices, kits and methods for non-suture end-to-end and end-to-side
anastomosis of tubular tissue members that employ tubular
connection members and provide intima-intima contact at the
anastomosis site with no foreign material exposed to the lumen of
the vessels being joined. An annuli pair that provides an
anastomotic clamp and that is especially adapted for intraluminal
disposition is disclosed in U.S. Pat. No. 5,336,233. Because of the
intraluminal disposition, this device is exposed to the blood flow
in the anastomosed vessels. U.S. Pat. No. 4,907,591 discloses a
surgical instrument for use in the installation of an assembly of
interlocking coupling members to achieve compression anastomosis of
tubular structures. Other coupling devices include the use of
intraluminal soluble stents and extraluminal glues, such as
cyanoacrylates, for creating nonsuture anastomoses. Reportedly, 98%
patency was obtained with these soluble polyvinyl alcohol stents.
Review of Facilitated Approaches to Vascular Anastomosis, pp.
S124-S125. An absorbable anastomotic device for microvascular
surgery relies on the cuffing principle with injection-molding
techniques using the polymer polyglactin. Vessel ends that are
everted 180.degree. are joined in this technique by an
interconnecting collar so that an intima-intima seal is achieved.
Reportedly, 96% patency was obtained with these absorbable
interconnecting collars. Review of Facilitated Approaches to
Vascular Anastomosis, p. S125.
[0048] The major advantage of a coupling microvascular anastomotic
device has been reported to be the reduction in the time needed for
a venous anastomosis, which decreases the total ischemic time.
Maisie L. Shindo, Peter D. Constantino, Vincent P. Nalbone, Dale H.
Rice and Uttam K. Sinha, Use of a Mechanical Microvascular
Anastomotic Device in Head and Neck Free Tissue Transfer, Archives
of Otolaryngology--Head & Neck Surgery, Vol. 122(5) (1996) pp.
529-532. Although a number of coupling techniques do not place any
foreign body in the intraluminal space of the anastomosed vessels,
it is considered that the use of a foreign rigid body such as a
ring that encloses a dynamically dilating structure is a
disadvantage of this type of technique. Furthermore, this type of
technique is viewed as not being flexible enough for its
application to significant vessel size discrepancies in end-to-side
anastomosis, and the devices are characterized as being of limited
availability and needed in sets of different sizes. Microscopic
Analysis of Stapled Microvascular Anastomosis, p. S128. In
addition, most coupling techniques require considerable eversion,
incisions and mounting of the coupling devices that are difficult
or impossible to apply endoscopically.
[0049] 2.2.3. Adhesives
[0050] Pasting by applying adhesives or glues is widely employed in
medicine. Several glues have been tested in anastomotic procedures,
including fibrin glue, cyanoacrylic glues and photopolymerizable
glues.
[0051] Fibrin glue is a biological two-component sealant comprising
fibrinogen solution and thrombin combined with calcium chloride
solution. These components are typically available deep-frozen in
preloaded syringes, and they are mixed during application after
thawing. Commercially available fibrin glue Tissucol has reportedly
been approved by the Food and Drug Administration for use in the
United States. See, Thomas Menovsky and Joost de Vries, Use of
Fibrin Glue to Protect Tissue During CO.sub.2 Laser Surgery,
Laryngoscope Vol. 108 (1998) pp. 1390-1393. This article will
hereinafter be referred to as "Fibrin Glue in Laser Surgery."
[0052] The use of fibrin glue has been found to be practical in
telescoping anastomoses and in microanastomoses. Satoru Saitoh and
Yukio Nakatsuchi, Telescoping and Glue Technique in Vein Grafts for
Arterial Defects, Plastic and Reconstructive Surgery, Vol. 96(6)
(1995) pp. 1401-1408, (this article will hereinafter be referred to
as "Telescoping and Glue Technique"); Seung-Kyu Han, Sung-Wook Kim
and Woo-Kyung Kim, Microvascular Anastomosis With Minimal Suture
and Fibrin Glue: Experimental and Clinical Study, Microsurgery,
Vol. 18(5) (1998) pp. 306-311, (this article will hereinafter be
referred to as "Microvascular Anastomosis With Minimal Suture and
Fibrin Glue"). In contrast, it has been reported that the
application of thrombin-based fibrin sealant (fibrin glue) to
microvascular anastomoses can have noticeable deleterious effects,
particularly when used in venous anastomosis. Christopher A. Marek,
Lester R. Amiss, Raymond F. Morgan, William D. Spotnitz and David
B. Drake, Acute Thrombogenic Effects of Fibrin Sealant on
Microvascular Anastomoses in a Rat Model, Annals of Plastic
Surgery, Vol. 41(4) (199) pp. 415-419, (this article will
hereinafter be referred to as "Thrombogenic Effects of Fibrin
Sealant on Microvascular Anastomoses").
[0053] A biological procoagulant solution has been described as
promising. The mixture contains bovine microfibrillar collagen and
thrombin. Gary Gershony, John M. Brock and Jerry S. Powell, Novel
Vascular Sealing Device for Closure of Percutaneous Vascular Access
Sites, Catheterization and Cardiovascular Diagnosis, Vol. 45(1)
(1998) pp. 82-88; Ted Feldman, Percutaneous vascular Closure:
Plugs, Stitches, and Glue, Catheterization and Cardiovascular
Diagnosis, Vol. 45(1) (1998) p. 89; Zoltan G. Turi, Plugging the
Artery With a Suspension: A Cautious Appraisal, Catheterization and
Cardiovascular Diagnosis, Vol. 45(1) (1998) pp. 90-91. (The
immediately preceding three publications will hereinafter be
referred to collectively as "Novel Vascular Sealing Device").
[0054] Cyanoacrylic glues tested on vessels include methyl
cyanoacrylate and butyl cyanoacrylate, such as Histoacryl glue
(butyl-2-cyanoacrylate). The ultra-violet polymerizable glue
polyethyleneglycol 400 diacrylate has also been tested and reported
that it "is able to effectively seal vessel puncture sites and
anastomotic junctions without acutely augmenting local vascular
thrombogenicity." G. A. Dumanian, W. Dascombe, C. Hong, K. Labadie,
K. Garrett, A. S. Sawhney, C. P. Pathak, J. A. Hubbell and P. C.
Johnson, A new Photopolymerizable Blood Vessel Glue That Seals
Human Vessel Anastomoses Without Augmenting Thrombogenicity,
Plastic and Reconstructive Surgery, Vol. 95(5) (1995) pp. 901-907,
(this article will hereinafter be referred to as
"Photopolymerizable Blood Vessel Glue").
[0055] Glues used in anastomotic practice face the challenges
inherent to factors that include toxicity, thrombogenicity,
vascular wall thinning, and mechanical strength of the joint.
Review of Facilitated Approaches to Vascular Anastomosis, p. S125;
Henk Giele, Histoacryl Glue as a Hemostatic Agent in Microvascular
Anastomoses, Plastic and Reconstructive Surgery, Vol. 94(6) (1994)
p. 897, (this work will hereinafter be referred to as "Histoacryl
Glue as a Hemostatic Agent").
[0056] 2.2.4. Lasers
[0057] Lasers have been used in angioplastic revascularization
since about 1984. See for example, Markolf H. Niemz, Laser Tissue
Interactions, pp. 216-221, Springer Verlag 1996, (this work will
hereinafter be referred to as "Laser Tissue Interactions"); R.
Viligiardi, V. Gallucci, R. Pini, R. Salimbeni and S. Galiberti,
Excimer Laser Angioplasty in Human Artery Disease, in Laser Systems
in Photobiology and Photomedicine, edited by A. N. Chester, S.
Martellucci and A. M. Scheggi, pp. 69-72, Plenum Press, New York,
1991, (this work will hereinafter be referred to as "Excimer Laser
Angioplasty in Human Artery Disease"); Timothy A. Sanborn, Laser
Angioplasty, in Vascular Medicine, edited by Joseph Loscalzo, Mark
A. Creager and Victor Brounwald, pp. 771-787, Little Brown Co.,
(this work will hereinafter be referred to as "Laser Angioplasty").
Whereas balloon angioplasty typically fractures, compresses or
displaces plaque material, laser angioplasty typically removes
plaque material by vaporizing it. Lawrence I. Deckelbaum,
Cardiovascular Applications of Laser Technology, in Laser Surgery
and Medicine, edited by Carmen A. Puliafito, pp. 1-27, Wiley-Liss,
1996, (this work will hereinafter be referred to as "Cardiovascular
Applications of Laser Technology").
[0058] The refinement of anastomosis techniques that rely on laser
technology has been progressing since the reportedly first use of a
neodymium yttrium-aluminum-garnet laser ("Nd-YAG laser") on
vascular anastomosis in 1979. Particularly in an end-to-side
vascular anastomosis, the end of a graft in the form of a tubular
structure is connected to the side wall of a receiving vessel so
that the anastomosed end of the graft encompasses the anastomosis
fenestra, or artificial window, that has been formed into the side
wall of the receiving vessel. Consequently, lasers can be used in
anastomoses for welding the anastomosed structures and/or for
opening the anastomosis fenestra. In addition to YAG lasers, such
as Nd-YAG and Ho-YAG lasers, Excimer, diode, CO.sub.2 and argon
lasers have also been used in vascular anastomoses.
[0059] Laser welding has been defined as the process of using laser
energy to join or bond tissues. Typically, laser welding relies on
photothernnal effects, but efforts are being made to develop laser
welding that relies on photochemical effects, where the laser
radiation activates cross-linking agents that are expected to
produce stronger links than those produced by photothermal welding.
Lawrence S. Bass and Michael R. Treat, Laser Tissue Welding: A
Comprehensive Review of Current and Future Clinical Applications,
in Laser Surgery and Medicine, edited by Carmen A. Puliafito, pp.
381-415. (This work will hereinafter be referred to as "Laser
Tissue Welding").
[0060] Generally, the use of lasers in anastomotic practice faces
the challenges inherent to factors that include the cost of laser
purchase, maintenance and training, radiation damage to surrounding
tissue, aneurism formation, the need for about three or four
sutures (versus the nine or ten sutures applied in conventional
anastomosis), side effects of heat-induced tissue welding, and
mechanical failure at the anastomosis site. Review of Facilitated
Approaches to Vascular Anastomosis, pp. S125-S126; Laser Tissue
Welding, pp. 407-410; Brian C. Cooley, Heat-Induced Tissue Fusion
For Microvascular Anastomosis, Microsurgery, Vol 17(4) (1996) pp.
198-208 (this article will hereinafter be referred to as
"Heat-Induced Tissue Fusion For Microvascular Anastomosis"). It has
been reported, however, that the "nonocclusive Excimer
laser-assisted anastomosis technique is safe and yields a high
long-term patency rate in neurosurgical patients" and that there
might be indications for this method in coronary bypass surgery.
Cornelis A. F. Tulleken, Rudolf M. Verdaasdonk, and Hendricus J.
Mansvelt Beck, Nonocclusive Excimer Laser-Assisted End-to-Side
Anastomosis, Annals of Thoracic Surgery, Vol. 63 (1997) pp.
S138-S142. (This article will hereinafter be referred to as
"Nonocclusive Excimer Laser-Assisted End-to-Side Anastomosis"). In
addition, laser anastomosis is considered to offer moderately
reduced operative time, reduced skill requirements, faster healing,
ability to grow, and possibly reduced intimal hyperplasia. Laser
Tissue Welding, pp. 407-410 (further reporting on selected
microvascular anastomosis studies with lasers that include
CO.sub.2, argon, and diode lasers). Furthermore, research is being
done to replace some of the initial laser sources by other lasers
that are believed to be more suitable for clinical applications.
For example, recent work with the 980 nm diode laser indicates that
it may "replace in the near future laser sources of older
conception such as the Nd-YAG." W. Cecchetti, S. Guazzieri, A.
Tasca and S. Martellucci, 980 nm High Power Diode Laser in Surgical
Applications, in Biomedical Optical Instrumentation and
Laser-Assisted Biotechnology, edited by A. M. Verga Scheggi, S.
Martellucci, A. N. Chester and R. Pratesi, pp. 227-230, Kluwer
Academic Publishers, Dordrecht, The Netherlands, 1996. (This work
will hereinafter be referred to as "980 nm High Power Diode Laser
in Surgical Applications").
[0061] The CO.sub.2 laser can seal blood vessels, including small
blood vessels of about 0.5 mm in diameter or less and it has been
used in microvascular anastomosis such as in human lympho-venous
anastomosis. D. C. Dumitras and D. C. A. Dutu, Surgical Properties
and Applications of Sealed-off CO.sub.2 Lasers, in Biomedical
Optical Instrumentation and Laser-Assisted Biotechnology, edited by
A. M. Verga Scheggi, S. Martellucci, A. N. Chester and R. Pratesi,
pp. 231-239, Kluwer Academic Publishers, Dirdrecht, The
Netherlands, 1996. (This work will hereinafter be referred to as
"Surgical Properties and Applications of Sealed-off CO.sub.2
Lasers"). In addition to the CO.sub.2 laser which is an efficient
vaporizer of tissue, other lasers that effectively vaporize tissue
include the argon and the KTP/532 lasers. Lasers--Invention to
Application, p. 106.
[0062] The argon laser has been reported to offer advantages over
conventional end-to-end anastomosis procedures applied to growing
vessels. Eiji Chikamatsu, Tsunehisa Sakurai, Naomichi Nishikimi,
Takashi Yano and Yuji Nimura, Comparison of Laser Vascular Welding,
Interrupted Sutures, and Continuous Sutures in Growing Vascular
Anastomoses, Lasers in Surgery and Medicine, Vol. 16(1) (1995) pp.
34-40. (This article will hereinafter be referred to as "Comparison
of Laser Welding and Sutures in Vascular Anastomoses"). It has also
been reported that low temperature argon laser welding limits
anastomotic thrombogenicity, which is thought of as a factor that
may improve early patency of venous and small arterial bypass
grafts. Steven B. Self, Douglas A. Coe and James M. Seeger, Limited
Thrombogenicity of Low Temperature Laser-Welded Vascular
Anastomoses, Lasers in Surgery and Medicine, Vol. 18(3) (1996) pp.
241-247, (this article will hereinafter be referred to as "Low
Temperature Laser-Welded Vascular Anastomoses").
[0063] The use of lasers for medical purposes requires safety
measures for protecting health care practitioners who handle the
laser device and for shielding surrounding tissues and avoiding
unintended radiation induced damage. Laser shield materials include
layers of polymethylmethacrylate and tinfoil. See, Christine C.
Nelson, Krystyna A. Pasyk and Gregory L. Dootz, Eye Shield for
Patients Undergoing Laser Treatment, American Journal of
Ophthalmology Vol. 110 (1990) pp. 39-43. Laser shield materials are
known and they have been disclosed in a variety of sources such as
Alex Mallow and Leon Chabot, Laser Safety Handbook, Van Nostrand
Reinhold Co., New York (1978), and A. Roy Henderson, A Guide to
Laser Safety, Chapman & Hall, London (1997). In particular, for
example, the biological sealant fibrin glue can prevent severe
damage to tissue when accidentally exposed to CO.sub.2 laser
radiation and intraoperative coating with fibrin glue can serve as
a shield to protect arteries, veins, and nerves from accidental
CO.sub.2 laser exposure. Furthermore, it is considered that the use
of fibrin glue for laser radiation protective processes "is
especially attractive in . . . fields in which the glue is already
used for sealing." Fibrin Glue in Laser Surgery at p. 1393.
[0064] 2.2.5. Other Devices and Techniques
[0065] It is known that some anastomosis techniques combine
different approaches. For example, biological glues that are based
on proteins and other compounds are combined with laser radiation
in laser soldering. "Laser soldering is a bonding technique in
which a proteinaceous solder material is applied to the surfaces to
be joined followed by application of laser light to seal the solder
to the tissue surfaces." Laser Tissue Welding, pp. 389-392. Egg
albumin, heterologous fibrin glue, and human albumin have been used
as laser solders, also known as adjuvant materials for laser tissue
welding. Dix P. Poppas, Theodore J. Choma, Christopher T. Rooke,
Scott D. Klioze and Steven M. Schlossberg, Preparation of Human
Albumin Solder for Laser Tissue Welding, Lasers in Surgery and
Medicine, Vol. 13(5) (1993) pp. 577-580, (this article will
hereinafter be referred to as "Human Albumin Solder for Laser
Tissue Welding").
[0066] In an even newer technique, a chromophore is added to the
solder to achieve photoenhancement effects that lead to an enhanced
light absorption in the solder and not in the nontargeted tissue.
Id., p. 391. In laser sealing, also known as laser-activated tissue
sealing, sutured or stapled repairs are reinforced with laser
solder, which is expected to provide "the strength and security of
sutures and the watertightness of solder." Id., pp. 403-404.
[0067] The graft in a vascular anastomosis does not necessarily
have to be an autologous blood vessel. In addition to ePTFE tubular
grafts that have been referred to in a preceding subsection,
several synthetic materials for vascular grafts have been used or
are being developed.
[0068] Synthetic biomaterials that are being developed include
polymeric materials with the proteins elastin and fibronectin. A.
Maureen Rouhi, Contemporary Biomaterials, Chemical &
Engineering News, Vol. 77(3) (1999) pp. 51-63.
[0069] ePTFE has been used with a variety of coatings. One type of
coating includes fibrin glue that contains fibroblast growth factor
type 1 and heparin. John L. Gray, Steven S. Kang, Gregory C. Zenni,
Dae Un Kim, Petre I. Kim, Wilson H. Burgess, William Drohan,
Jeffrey A. Winkels, Christian C. Haudenschild and Howard P.
Greisler, FGF-1 Affixation Stimulates ePTFE Endothelialization
without Intimal Hyperplasia, Journal of Surgical Research, Vol.
57(5) (1994) pp. 596-612; Joseph I. Zarge, Vicki Husak, Peter Huang
and Howard P. Greisler, Fibrin Glue Containing Fibroblast Growth
Factor Type 1 and Heparin Decreases Platelet Deposition, The
American Journal of Surgery, Vol. 174(2) (1997) pp. 188-192; Howard
P. Greisler, Claire Gosselin, Dewei Ren, Steven S. Kang and Dae Un
Kim, Biointeractive Polymers and Tissue Engineered Blood Vessels,
Biomaterials, Vol. 17(3) (1996) pp. 329-336. Another coating
contains basic fibroblast growth factor in fibrin glue. M.
Lanzetta, D. M. Crowe and M. J. Hickey, Fibroblast Growth Factor
Pretreatment of 1-mm PTFE Grafts, Microsurgery, Vol. 17(11) (1996)
pp. 606-611.
[0070] Other grafts comprise a synthetic biodegradable tubular
scaffold, such as a vessel made of polyglactin/polyglycolic acid,
that has been coated with autologous cells from a tissue culture.
Toshiharu Shinoka, Dominique Shum-Tim, Peter X. Ma, Ronn E. Tanel,
Noritaka Isogai, Robert Langer, Joseph P. Vacanti and John E.
Mayer, Jr., Creation of Viable Pulmonary Artery Autografts Through
Tissue Engineering, The Journal of Thoracic and Cardiovascular
Surgery, Vol. 115(3) (1998) pp. 536-546.
[0071] A common feature of most conventional stapling, coupling and
clipping techniques, particularly when applied to small-diameter
vessels, is that they require a temporary interruption of the blood
stream in the recipient vessel, a disruption that is thought to be
not very well tolerated in cardiac bypass surgery. Review of
Facilitated Approaches to Vascular Anastomosis, p. S126. In
revascularization procedures of the brain, temporary occlusion of a
proximal brain artery may cause brain ischemia, and consequently a
nonocclusive anastomosis technique is required. Nonocclusive
Excimer Laser-Assisted End-to-Side Anastomosis, p. 141. As the
instrumentation that is needed at the anastomosis site becomes
complex and cumbersome, a wider open area is needed for accessing
the anastomosis site, thus leading to an increasingly invasive
procedure. Furthermore, conventional anastomosis techniques are
usually performed at a site that is determined by external
observation of the affected area. This observation is performed at
a time and in a medical setup that are different from the time and
medical setup of a previous exploratory or diagnosis procedure.
[0072] Techniques that require the perforation of blood vessel
tissue have raised concerns regarding intimal injury, adventitial
stripping, tissue plane malalignment, and anastomotic bleeding. In
addition, techniques that rely on devices that are exposed to the
blood flow may lead to technical problems associated with a
persistent intraluminal foreign body. These factors are thought to
"contribute to both early and late anastomotic failure,
particularly in the form of neointimal hyperplasia." Nonpenetrating
Clips for Coronary Anastomosis, p. S135.
[0073] The need for completely endoscopic anastomosis procedures
has been clearly expressed in the context of coronary artery bypass
grafting. For example, it is currently acknowledged that "the goal
of a completely endoscopic coronary artery bypass procedure has not
yet been realized, and will require further technological
advances." Endoscopic Coronary Artery Bypass Grafting, p. 1064.
Furthermore, totally endoscopic coronary artery bypass grafting "is
perceived by many as the ultimate surgical model of minimally
invasive coronary artery bypass grafting". Hani Shennib, Amr
Bastawisy, Michael J. Mack, and Frederic H. Moll, Computer-Assisted
Telemanipulation: An Enabling Technology for Endoscopic Coronary
Artery Bypass, Annals of Thoracic Surgery, Vol. 66 (1998) p.
1060.
[0074] Minimally invasive vascular grafting according to a
peripheral procedure is equally desirable, and intraluminally
directed minimally invasive active endoscopic or peripheral
methods, systems and apparatuses are specially desirable. These
methods, systems and apparatuses are specially desirable when, in
particular, they are versatile enough as to be able to incorporate
a plurality of the desirable features that have been
SUMMARY OF THE INVENTION
[0075] Conventional vascular anastomosis techniques do not rely on
intraluminally directed active endoscopic or peripheral procedures.
It is therefore desirable to provide methods, systems and
apparatuses for their implementation as active endoscopic or
peripheral procedures in vascular anastomosis.
[0076] An object of the present invention is to provide methods,
systems, and apparatuses for performing a minimally invasive
anastomosis by directly relying on the information acquired at the
time of performing an initial angiographic exploration.
[0077] Another object of this invention is to provide methods,
systems, and apparatuses such that the minimally invasive
anastomosis is performed under a catheter assisted active
endoscopic or peripheral procedure.
[0078] Additionally, another object of this invention is to provide
methods, systems, and apparatuses to enable the performance of
minimally invasive anastomoses that do not require the interruption
of blood flow in the receiving blood vessel.
[0079] Still another object of the present invention is to provide
methods, systems, and apparatuses that are versatile enough to be
able to suitably combine a variety of cutting, welding, and joining
techniques in the practice of vascular anastomosis.
[0080] A feature of the catheter assisted active endoscopic or
peripheral procedure of this invention is that catheter assistance
is provided following an intravascular approach. Accordingly, a
catheter is inserted into and along the intraluminal space of a
receiving blood vessel; characteristics of this catheter include
its use for signaling the optimal anastomosis site at the time of
performing an initial angiographic examination.
[0081] Another feature of the catheter assisted active endoscopic
or peripheral procedure of this invention is that the minimally
invasive anastomosis is performed with an extravascular endoscopic
or peripheral device that is typically introduced percutaneously,
and this is done in cooperation with an endovascular catheter. The
extravascular device can be endoscopic or nonendoscopic. An
extravascular endoscopic device is typically used in a procedure
such as an intraabdominal or intrathoracic procedure, whereas a
nonendoscopic extravascular device (hereinafter referred to as
"peripheral device") is typically used when there is no need to use
a visual aid, such as an endoscope, in a peripheral procedure.
[0082] One advantage of performing a minimally invasive anastomosis
under the catheter assisted active endoscopic or peripheral
procedure that is based on the methods, systems, and apparatuses of
the present invention is that its practice does not require the
same level of training in surgical methods and techniques that the
practice of surgery requires. Cross-specialty teams of
practitioners including those with training in endovascular
intervention as well as conventional surgical training can
consequently perform minimally invasive anastomoses according to
the methods, apparatuses, and systems of this invention.
[0083] Another feature of the catheter assisted active endoscopic
or peripheral procedure of this invention is that it directly
employs information while it is being acquired in an angiographic
examination. This efficient use of information, and in particular
imaging, has the advantage that the anastomosis is actually
performed in less time and without having to rely on the
correlation of previously recorded images with external anatomic
inspection for locating the optimal anastomosis site. The shorter
procedure according to this invention consequently requires less or
no hospitalization time and less medical resources.
[0084] Still another feature of the catheter assisted active
endoscopic or peripheral procedure of this invention is that it
requires no sutures, although it can be implemented in conjunction
with suturing. The avoidance of sutures has the advantages of
reducing the invasive character of the procedure, reducing the
number of mechanical elements in the practice of the anastomosis,
and shortening the time needed to perform the anastomosis.
[0085] By not requiring the interruption of blood flow in the
receiving blood vessel, the catheter assisted active endoscopic or
peripheral procedure of this invention advantageously reduces or
even eliminates the risk of ischemia in organs that receive their
main supply of blood through the receiving blood vessel.
Furthermore, the exposure of the anastomosis area is reduced
because no devices have to be introduced to temporarily interrupt
blood flow. This feature advantageously enhances the minimally
invasive character of the methods, systems, and apparatuses of this
invention and the intervention time for the practice of the
anastomosis.
[0086] The minimal disruption of blood flow in the receiving blood
vessel by the catheter assisted active endoscopic or peripheral
procedure of this invention advantageously makes it suitable in the
context of coronary artery bypass grafting (CABG), whether blood
circulation is intracorporeal or extracorporeal, and whether the
grafting is performed on a beating heart or an arrested heart.
[0087] Another feature of the catheter assisted active endoscopic
or peripheral procedure of this invention is the efficient use of
information and the simpler procedural and technical approach
relative to more invasive procedures. This feature advantageously
permits the reduction in the number of practitioners involved in
the anastomosis and consequently enhances the consistency of the
results, which become less operator-dependent.
[0088] The methods, systems, and apparatuses of this invention
enable the performance of minimally invasive vascular anastomosis
following a diagnostic catheter angiogram. The anastomosis is
preferably performed according to this procedure by inserting a
catheter into and along the intraluminal space of a receiving blood
vessel while an angiographic examination is taking place. The
catheter distal end is intravascularly placed at the optimal
anastomosis site and this site is signaled with the aid of one of
the catheter's features.
[0089] In a preferred embodiment, the anastomosis site is signaled
with a mechanical device such as a catheter wire that has an anvil
attached to it. The distal end of the catheter wire is pushed along
one of the catheter lumens so the wire's distal end pierces the
wall of the receiving blood vessel from the intima outward through
the media and adventitia. At the same time, a device such as an
intravascular anvil that is attached to the catheter wire abuts the
wall of the receiving blood vessel at the anastomosis site, shaping
the abutted portion of the wall at the site where the anastomosis
fenestra will be opened.
[0090] An endoscopic or peripheral device preferably carries the
graft vessel and engages the extravascular portion of the catheter
wire in such a way that the distal end of the graft vessel is
brought into contact with the abutted portion of the outer wall of
the receiving blood vessel. The anastomosis fenestra is
subsequently cut and the graft vessel is joined to the receiving
blood vessel.
[0091] As discussed in more detail hereinbelow, the opening of the
anastomosis fenestra can be performed mechanically or with the aid
of a radiation-based device. In addition, the graft vessel is
joined to the outer wall of the receiving blood vessel by any one
among a variety of techniques and combinations thereof. These
techniques include clipping, stapling, suturing, welding,
soldering, and gluing. Moreover, the signaling of the anastomosis
site is preferably performed with the aid of a mechanical device
such as the combination of a catheter wire and an anvil.
[0092] A feature of the catheter assisted endoscopic or peripheral
procedure of this invention is the versatility of the intravascular
catheter and of the extravascular device for signaling the
anastomosis site and cooperatively performing the anastomosis.
Accordingly, a variety of devices and techniques can be
advantageously combined in the context of this invention to enhance
the performance of its methods, systems and apparatuses.
[0093] To achieve the foregoing objects, and in accordance with the
invention as embodied and broadly described herein, the present
invention relates to new and useful apparatuses, systems and
methods for performing vascular anastomosis.
[0094] These and other objects and features of the present
invention will become more fully apparent from the following
description and appended claims, or may be learned by the practice
of the invention as set forth hereinafter.
[0095] Additional aspects and advantages of this invention will be
apparent from the following detailed description of preferred
embodiments thereof, which proceeds with reference to the
accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0096] In order to more fully understand the manner in which the
above-recited and other advantages and objects of the invention are
obtained, a more particular description of the invention will be
rendered by reference to a specific embodiment thereof which is
illustrated in the appended drawings. Understanding that these
drawings depict only a typical embodiment of the invention and are
not therefore to be considered to be limiting of its scope, the
invention in its presently understood best mode for making and
using the same will be described and explained with additional
specificity and detail through the use of the accompanying drawings
in which:
[0097] FIG. 1 is a partially cut-away view of the general
disposition of the intraluminally directed anvil apparatus, wire
and endoscopic or peripheral device of this invention.
[0098] FIG. 2A is a partial cut-away view of one of the ends of the
catheter shown in FIG. 1.
[0099] FIG. 2B is a partial cut-away view of another embodiment of
one of the ends of the catheter depicted in FIG. 1.
[0100] FIG. 3A shows an embodiment of the anvil of this invention
that is attached to the wire with the aid of two stoppers.
[0101] FIG. 3B shows another embodiment of the anvil of this
invention that is integrally attached to the wire and has concave
side features on its surface.
[0102] FIG. 3C shows another embodiment of the anvil of this
invention that is integrally attached to the wire and has side
surface features for bending staples or clips.
[0103] FIG. 3D shows another embodiment of the anvil of this
invention that is integrally attached to the wire and has another
set of side surface features for bending staples or clips.
[0104] FIG. 4 is a cross sectional view along plane 4 of the anvil
shown in FIG. 3B.
[0105] FIG. 5 is a cross sectional view along plane 5 of the anvil
shown in FIG. 3C.
[0106] FIG. 6 is a cross sectional view along plane 6 of the anvil
shown in FIG. 3D.
[0107] FIG. 7A is a perspective view of an embodiment of the anvil
of this invention with a slanted receiving surface.
[0108] FIG. 7B shows a cross sectional view of an embodiment of a
balloon anvil of this invention.
[0109] FIG. 8 shows an exploded view of an embodiment of the
peripheral device of this invention.
[0110] FIG. 9A shows an exploded view of an embodiment of the
staples, anvil, anastomosis ring and staple guide ring of the
embodiment of the peripheral device shown in FIG. 8.
[0111] FIG. 9B shows another exploded view of the embodiment shown
in FIG. 9A, when the perspective view is offered from the opposite
side to that shown in FIG. 9A.
[0112] FIG. 10 is a schematic perspective view of the embodiment of
the peripheral device shown in FIG. 8 in an assembled
configuration.
[0113] FIG. 11 shows a side view of the embodiment shown in FIG.
10.
[0114] FIG. 12 is a longitudinal cross sectional view of the
embodiment shown in FIG. 11 along plane 12.
[0115] FIG. 13 is a magnified view of the region indicated by arrow
13 in FIG. 12.
[0116] FIG. 14 is a cut away perspective view of the region shown
in FIG. 13.
[0117] FIG. 15A shows an embodiment of the anvil of this invention
abutting the receiving blood vessel from the receiving blood
vessel's intraluminal space.
[0118] FIG. 15B shows a cross sectional view of an embodiment of
the anvil of this invention abutting the receiving blood vessel at
the contact region of the receiving surface of the anvil with the
intima of the receiving blood vessel.
[0119] FIG. 15C is a partial perspective view of the embodiment of
the peripheral device shown in FIG. 7 showing part of the graft
vessel in the peripheral device, the receiving blood vessel abutted
by the anvil, and the wire piercing the receiving blood vessel and
extending longitudinally within and along the peripheral
device.
[0120] FIG. 15D is a cut away perspective view of an end of the
peripheral device shown in FIG. 15C holding the graft vessel in
contact with the receiving vessel at the anastomosis site.
[0121] FIG. 15E is a longitudinal cross sectional view of the
embodiment shown in FIG. 15D at a stage when the graft vessel is
being attached to the receiving blood vessel.
[0122] FIG. 15F is a perspective view like the view shown in FIG.
15D at another stage in the process of attaching the graft vessel
to the receiving blood vessel.
[0123] FIG. 15G is a longitudinal cross sectional view of the
embodiment shown in FIG. 15F with the graft vessel attached to the
receiving blood vessel.
[0124] FIG. 15H is a perspective view like the view shown in FIG.
15F showing the opening of the anastomosis fenestra according to
one embodiment of this invention.
[0125] FIG. 15I is a longitudinal cross sectional view of the
embodiment shown in FIG. 15H showing the anastomosis fenestra open
in the receiving blood vessel.
[0126] FIG. 15J is a longitudinal cross sectional view like the one
shown in FIG. 15I showing the anastomosed structures and an
embodiment of the peripheral device of this invention being pulled
away from the anastomosis site.
[0127] FIG. 15K is a longitudinal cross sectional view like the one
shown in FIG. 15J showing the anastomosed structures according to
one of the embodiments of this invention.
[0128] FIG. 15L shows a perspective cut away view of the
anastomosed structures shown in FIG. 15K.
[0129] FIGS. 16A-16H show a variety of embodiments of the staples
and clips of this invention.
[0130] FIG. 17A shows a cross sectional view of another embodiment
of the intraluminally directed anvil apparatus with a deflated
balloon anvil.
[0131] FIG. 17B shows a cross sectional view of the embodiment
shown in FIG. 17A where the balloon anvil is inflated and abutting
the receiving blood vessel.
[0132] FIG. 17C shows a cross sectional view of the embodiment of
the intraluminally directed anvil apparatus shown in FIGS. 17A-17B
while being operated in conjunction with a spring clip anastomosis
device.
[0133] FIG. 17D shows a front view along the logitudinal axis of an
embodiment of a spring clip anastomosis device like that shown in
FIG. 17C.
[0134] FIG. 17E shows a perspective view of the embodiment depicted
in FIG. 17D. Plane S-S' represents the plane along which the cross
sectional views shown in FIGS. 17C, 17F-17I are taken.
[0135] FIG. 17F is a cross sectional view analogous to that shown
in FIG. 17C while the anastomosis fenestra is being opened with a
laser device, where the cross section is taken along the plane S-S'
shown in FIG. 17E.
[0136] FIG. 17G is a cross sectional view analogous that shown in
FIG. 17F with an anastomosis fenestra in the receiving blood
vessel.
[0137] FIG. 17H is a cross sectional view analogous that shown in
FIG. 17G with the spring clips holding together the receiving blood
vessel and the graft vessel.
[0138] FIG. 17I is a cross sectional view analogous to that shown
in FIG. 17H after the laser device has been removed from the
anastomosis site.
[0139] FIG. 17J is a cross sectional view analogous to that shown
in FIG. 17I after the entire spring clip anastomosis device has
been removed from the anastomosis site.
[0140] FIG. 17K is a cross sectional view of two structures that
have been anastomosed with the intraluminally directed anvil
apparatus and the spring clip device of this invention.
[0141] FIG. 18 is a perspective view of the embodiment shown in
FIG. 8 where the cutter and centering core have been replaced by a
laser device.
[0142] FIG. 19 shows a partial perspective view of the distal end
of an exemplary embodiment of a laser device like that generically
shown in FIG. 18.
[0143] FIG. 20 shows a longitudinal cross sectional view in which
the cutter and centering core shown in FIG. 8 have been replaced by
a laser device.
[0144] FIG. 21 shows a longitudinal cross sectional view analogous
that shown in FIG. 20 with an applicator for a material such as
solder or glue, and a different way of holding the end of the graft
vessel to be anastomosed.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0145] The present invention relates to systems, methods and
apparatuses for intraluminally directed active endoscopic or
peripheral procedures, and more particularly to systems, methods
and apparatuses for performing intraluminally directed minimally
invasive vascular anastomosis.
[0146] In contrast to conventional procedures, this invention
provides for the direct utilization of the information acquired
during an initial angiographic exploration in the actual creation
of an anastomosis. Accordingly, this invention enables the
determination of an optimal anastomosis site with the information
acquired during the initial exploration and provides for an active
endoscopic or peripheral technique for performing a minimally
invasive anastomosis immediately following the initial angiographic
exploration and in the same clinical environment. Minimally
invasive anastomosis according to this invention is performed with
an integrated method and system that relies on intraluminally
directed active intervention and active endoscopic or peripheral
intervention.
[0147] As schematically shown in FIG. 1, an anastomosis according
to this invention is performed at a site that is signaled with the
aid of an imaging technique and an intraluminally directed anvil
apparatus that is embodied in this Figure by catheter apparatus
100. In FIG. 1, the anastomosis is performed with an anastomosis
device shown at 200 that generically and exemplarily represents an
embodiment of an extravascular device, whether endoscopic or
peripheral device. Anastomosis device 200 is operated in
conjunction with an intraluminally directed anvil apparatus, such
as catheter apparatus 100.
[0148] Specific examples of embodiments of the intraluminally
directed appartus and of anastomosis device 200 are given and
discussed hereinbelow. More specifically, FIGS. 2-7 are directed to
features of the intraluminally directed anvil apparatus; FIGS.
8-22I show different views of structural and operational features
of different embodiments of the anastomosis device.
[0149] Intraluminally Directed Anvil Apparatus
[0150] In one exemplary embodiment of this invention, the
intraluminally directed anvil apparatus is embodied by catheter
apparatus 100. Catheter apparatus 100 comprises tubular shaft 110,
positioning wire or stem 152, anvil 160, and piercing wire 150.
This embodiment of the intraluminally directed anvil apparatus is
referred to as a catheter apparatus. Other embodiments of the
intraluminally directed anvil apparatus without a tubular shaft
such as that shown at 110, however, are disclosed herein. These
embodiments are also utilized to signal the location of an
anastomosis site and to form an anastomosis in conjunction with an
anastomosis device.
[0151] Distal end 112 of tubular shaft 110 can be percutaneously
introduced in the intraluminal space 190 of receiving blood vessel
99 according to conventional catheterization techniques.
Catheterization techniques are described, for example, by
Constantin Cope and Stanley Baum, Catheters, Methods, and Injectors
for Superselective Catheterization, in Abrams' Angiography, edited
by Stanley Baum, 4th ed. (This work will hereinafter be referred to
as "Catheters, Methods, and Injectors", and it is hereby
incorporated by reference in its entirety). Tubular shaft 110 is
inserted along intraluminal space 190 until distal end 112 reaches
the proximity of a blood vessel occlusion or another abnormality
that has been detected by a conventional exploration technique.
With tubular shaft 110 so disposed, piercing wire 150 is introduced
into tubular shaft 110 through proximal end 114 and it extends
along tubular shaft 110. Piercing wire 150 is inserted within and
along tubular shaft 110 of catheter apparatus 100 so that distal
piercing end 154 punctures receiving blood vessel 99 from its
intraluminal space and it extends outwardly by protruding at the
optimally chosen anastomosis site. To facilitate this operation,
distal end 154 is preferably sharp enough as to be able to puncture
the wall of receiving blood vessel 99 from its intima outwards
without causing undue tearing around the puncture.
[0152] Piercing wire in the context of this invention, and in
particular when referring to piercing wire 150, refers to any thin
and elongated device that is used for penetrating the wall of a
blood vessel. A guidewire suited for inserting both diagnostic and
therapeutic catheters is disclosed in U.S. Pat. No. 4,846,186,
which is hereby incorporated by reference in its entirety, and
catheters and guidewires for vascular and interventional radiology
are disclosed in Catheters, Methods, and Injectors, at 155-174,
references which are hereby incorporated by reference in their
entirety. Piercing wire 150, however, is preferably pointed and
sharp to effectively puncture the wall of receiving blood vessel
99.
[0153] In the embodiment shown in FIG. 1, piercing wire 150 extends
from anvil 160 and positioning wire 162 extends also from anvil
160, but opposite to piercing wire 150. The combined length of
piercing wire 150 and positioning wire 152 varies depending on the
separation between the insertion site of catheter apparatus 100 and
the anastomosis site. For example, this combined length would be
approximately 180 cm long, depending on the patient's height, if an
anastomosis were to be performed in a blood vessel in the arm such
as the brachial artery, and catheter apparatus 100 were inserted
into the femoral artery.
[0154] Distal end 112 can be modified as shown in FIG. 2 to provide
a lateral exit to distal end 154 of piercing wire 150. In one
embodiment of catheter apparatus 100, shown in FIG. 2B, distal end
112 comprises deflecting surface 156 and lateral aperture 158 that
guide distal end 154 of piercing wire 150 towards the intima of
receiving blood vessel 99. Because distal end 154 is very sharp,
deflecting surface 156 is preferably a puncture and abrasion
resistant surface. In addition, distal end 112 can be provided with
an appropriate marker for imaging the orientation of the aperture
at distal end 112 and/or the position of distal end 112 itself.
Such radio-opaque markers can be any of the radio-opaque markers
known in the practice of angiography. Piercing wire 150 is
typically radio-opaque itself, although very thin embodiments of
this wire are preferably coated with a material such as gold or
barium to make them more visible. Catheter distal end
configurations for directing outwardly an elongated member have
been disclosed in U.S. Pat. Nos. 4,578,061, 4,861,336, 5,167,645,
5,342,394, and 5,800,450, which are hereby incorporated by
reference in their entirety.
[0155] In a preferred embodiment, the intraluminally directed anvil
apparatus, such as catheter apparatus 100, comprises an anvil that
is placed in intraluminal space 190. The anvil in this invention is
preferably fixed to piercing wire 150 at its proximal end.
Alternatively, the anvil of this invention could be slidably
mounted on and around piercing wire 150, in which case piercing
wire 150 and positioning wire 152 are typically an integral wire.
In one exemplary embodiment of the intraluminally directed anvil
apparatus, the anvil of this invention is embodied by anvil 160
that is integrally attached to and around piercing wire 150. Anvil
160 can also be attached to piercing wire 150 with the aid of any
other fastening device or devices that retain anvil 160 in a fixed
position relative to piercing wire 150, whether this wire is
inserted into or extracted from intraluminal space 190. Stoppers
180 shown in FIG. 3A are an exemplary embodiment of fastening
devices that facilitate the effective pushing on anvil 160 as
positioning wire 152 and piercing wire 150 are inserted through
proximal end 114 of tubular shaft 110 and facilitate also the
extraction of anvil 160 as positioning wire 152 is pulled out, thus
extracting piercing wire 150 through proximal end 114 of tubular
shaft 110.
[0156] The anvil of this invention provides a receiving surface,
such as receiving surface 162 of anvil 160, destined to be in
direct contact with the blood vessel's intima at the anastomosis
site when the anvil abuts the receiving blood vessel wall. Anvil
160 is sized so that it can slide within the lumen of tubular shaft
110 while presenting a receiving surface 162 that has an area
approximately matched to the cross-sectional area of the lumen of
the graft blood vessel. Anvil 160 and particularly receiving
surface 162 are preferably made of a puncture resistant material
that can withstand the abrasive action of the pointed end of a
device that bends upon having its pointed end deflected by
receiving surface 162. For example, anvil 160 is preferably made of
stainless steel when it is to withstand the abrasive action of a
cutting device or of a sharp pointed end. When cutting of the
anastomosis fenestra is made with radiant energy, the anvil of this
invention is preferably coated with radiation absorbing material
that prevents radiation scattering. Such coated anvil embodiments
are hereinafter referred to as a "laser shield anvil". In addition,
the anvil of this invention does not have to be puncture resistant
when the anastomosed structures are joined in a way that does not
require staples, such as clipping, gluing, welding or soldering.
This embodiment of the anvil of this invention is hereinafter
referred to as a "soft anvil".
[0157] In one embodiment of this invention, the anvil is made of
expandable material so that the deflated anvil can optionally be
moved within and along catheter apparatus 100 and it can be
inflated at the anastomosis site. This embodiment of the anvil of
this invention is hereinafter referred to as "balloon anvil". A
coating of laser shield material can be incorporated particularly
at the receiving surface of the anvil of this invention. One
example of a laser shield material is a shield consisting of a
sandwich of polymethylmethacrylate and tinfoil that is known to
provide corneal and retinal protection from inadvertent injury
during argon, Nd-YAG or dye laser treatment at the tested laser
power outputs.
[0158] In one embodiment of this invention, receiving surface 162
is destined to provide a stopping surface for a cutting blade and
deflecting surface 164 of anvil 160 is destined to receive the ends
of staples that bend upon being deflected by deflecting surface
164. Deflecting surface 164 and receiving surface 162 can in some
embodiments of anvil 160 be differentiated as two parts of anvil
160, whereas in some embodiments deflecting surface 164 is a
continuation of receiving surface 162. The terms "receiving
surface" and "deflecting surface" will collectively refer to the
surface of anvil 164. The constituent materials and/or the features
of receiving surface 162 are preferably different from those of
deflecting surface 164 when the anvil of this invention is
embodied, for example, by a balloon anvil. In other embodiments of
this invention, however, receiving surface 162 and deflecting
surface 164 are made of the same materials and/or have similar
features.
[0159] As shown in FIG. 3A, deflecting surface 164 of anvil 160 can
be smooth, or it can be provided with depressions as shown in FIGS.
3B-3D. These depressions are formed with the appropriate shape for
deflecting a pointed end such as the pointed end of a needle or a
staple, and they can include a variety of concave shapes such as
depressions 165 and 166, or a combination of concave and convex
shapes such as in 167. FIGS. 4, 5 and 6 show cross sections along
the lines 4-4', 5-5' and 6-6', respectively of the embodiments of
the anvil shown in FIGS. 3B-3D.
[0160] Although receiving surface 162 is schematically shown in
FIGS. 1-6 as a flat surface that is perpendicular to the
longitudinal axis of each one of the embodiments of the anvil of
this invention, other embodiments may have a slanted receiving
surface such as surface 168 when the anvil abutting the wall of the
receiving blood vessel has to cooperate in the formation of, for
example, a bevelled anastomosis. This shape of an embodiment of an
anvil according to this invention is schematically illustrated in
FIG. 7. Furthermore, the outer perimeter of a cross section
perpendicular to the longitudinal axis of an embodiment of an anvil
according to this invention can be shaped in anyone of a plurality
of curved figures, such as a circumference, an ellipse, an ovoid,
and combinations of arcuate portions.
[0161] Receiving surfaces 162 and 168 can additionally, or
alternatively, provide an absorbing medium for radiation directed
against it. Radiation to which receiving surfaces 162 and 168 might
be exposed to is radiation from one of the laser sources typically
used in surgical procedures. Materials that absorb this type of
radiation have been discussed hereinabove.
[0162] As shown in FIGS. 3A, 3D, 6 and 7A, base 170 of the anvil of
this invention does not necessarily have to form a flange or ledge
at the edge of a broad and generally flat surface, but it can also
be shaped with smooth rounded edges, have a shape generally
symmetrical to that of receiving surface 162, or be shaped in a
combination of curved and/or straight contours. Shapes of base 170
such as those shown in FIGS. 3D, 6 and 7A can be more useful for
diminishing the drag while the anvil is moved within and along the
receiving blood vessel.
[0163] In another embodiment of this invention, the anvil of this
invention can be embodied by a puncture resistant balloon. Puncture
and scratch resistant balloons have been disclosed in U.S. Pat.
Nos. 5,766,158, 5,662,580, 5,620,649, 5,616,114, 5,613,979,
5,478,320, 5,290,306, and 5,779,731, which are hereby incorporated
by reference in their entirety. In still another embodiment of this
invention, the anvil of this invention can be embodied by the
combination of a balloon and a puncture resistant balloon sheath. A
balloon plus balloon sheath combination has been disclosed in U.S.
Pat. No. 5,843,027 which is hereby incorporated by reference in its
entirety.
[0164] The dimensions of any of the embodiments of the anvil of
this invention are determined by the size of the lumen of the
receiving blood vessel and by the dimension of the passage that
will ensure the fluid communication between the graft vessel and
the receiving vessel after they have been anastomosed. The
inclination of receiving surface 168 in an embodiment of the anvil
of this invention as schematically shown in FIG. 7 is appropriately
chosen depending on the diameter of the graft vessel and on the
angle at which the graft vessel is to be anastomosed to the
receiving blood vessel. These dimensions are known to anyone with
ordinary skill in the art.
[0165] For example, when the anvil of this invention is embodied by
a device as one shown in any of FIGS. 3A-3D and a graft vessel of
about 4 mm in diameter is to be anastomosed to a receiving vessel
with an approximate lumen diameter of about 8 mm, the height from
base 170 to receiving surface 162 can typically range from about 3
mm to about 4 mm, and the diameter of a cross section parallel to
receiving surface 162 can typically range from about 3.5 mm to
about 4.5 mm. The methods, systems and apparatuses of this
invention are preferably used for anastomosing graft vessels whose
diameter ranges between about 2 mm and about 20 mm, but there is no
fundamental limitation for using embodiments of this invention with
graft vessels whose diameter is less than 2 mm.
[0166] In general, the material of which any of the exemplary
embodiments of the anvil of this invention is made is appropriately
chosen to be abrasion resistant, puncture resistant, distortion
resistant and/or an effective absorber of radiation depending on
whether it is to be exposed to the abrasive action of a cutting
device, to the perforating action of a sharp pointed end, to the
twisting or distorting action of a gripping device, or to
radiation. A cutting device can be, for example, a cutting blade; a
sharp pointed end can be, for example, the penetrating end of a
staple or the sharp end of a needle; a gripping device can be, for
example, a clip, and radiation can be emitted by, for example, a
surgical laser.
[0167] It is understood that the shapes, specific geometric
features and constitutive materials of the foregoing embodiments of
catheter apparatus 100 are given for exemplary purposes and they
and/or equivalents thereof can be suitably combined or varied by
one of ordinary skill in the art to satisfy the objectives of this
invention.
[0168] The proximal end of the intraluminally directed apparatus of
this invention, and in particular proximal end 114 of catheter
apparatus 100, can comprise one or a plurality of access ports or
luer fittings. For the purpose of simplicity, only one access port
is shown in the embodiment of catheter apparatus 100 schematically
shown in FIG. 1. Also for the purpose of showing a simple sketch,
the embodiment of catheter apparatus 100 as schematically shown in
FIG. 1 only displays one lumen, but catheter apparatus 100, and
more generally the intraluminally directed anvil apparatus, can
also have a plurality of lumens. The manufacture and handling of an
apparatus with a plurality of lumens and a plurality of access
ports are part of the ordinary skill in the art. For example, U.S.
Pat. Nos. 5,662,580 and 5,616,114, which have herein been
incorporated by reference in their entirety, disclose catheters
with a plurality of access ports or luer fittings and a plurality
of lumens.
[0169] Another exemplary embodiment of the intraluminally directed
anvil apparatus of this invention is given by catheter apparatus
500 as shown in FIGS. 17A and 17B comprises tubular shaft 505,
positioning shaft 550, piercing wire 554, and balloon anvil 560.
Dilation of balloon anvil 560 from its collapsed configuration
shown in FIG. 17A to its expanded configuration shown in FIG. 17B
is accomplished by conventional methods and implements such as
inflation with the aid of an additional inflation lumen (not shown
in FIGS. 17A and 17B). Although balloon anvil 560 is hereinbelow
described as being "inflated" or "deflated", this terminology
merely illustrates one possible way of expanding and contracting an
embodiment of the balloon anvil of this invention.
[0170] Deflated balloon anvil 560 is inserted into the intraluminal
space of receiving blood vessel 99 as shown in FIG. 17A and it is
inflated at the anastomosis site so that receiving surface 562 of
balloon anvil 560 abuts the wall of receiving blood vessel 99 from
its intraluminal space. Receiving surface 562 is preferably made of
a laser absorbing material when the anastomosis fenestra is to be
opened by laser radiation. In addition, the structure of the wall
of balloon 560 is such that groove 564 forms when balloon anvil 560
is inflated as shown in FIG. 17B.
[0171] Balloon anvil 560, positioning wire 550, and piercing wire
554 are provided with an engagement feature that can be embodied by
an attachment 563 as shown in FIGS. 17A and 17B. Attachment 563 can
be embodied by any other engagement feature that prevents balloon
anvil 560 to slide along positioning wire 550 when extravascular
pressure is applied against receiving blood vessel 99 and receiving
surface 562.
[0172] Another preferred characteristic of balloon anvil 560 is
that its dimensions and shape are such that, when inflated, balloon
anvil 560 will provide an effective fluid tight seal at the
anastomosis site, so that the anastomosis can be performed without
interruption of blood flow along the lumen of receiving blood
vessel 99. Although not shown in any of FIGS. 17A and 17B, piercing
wire 554 has a distal piercing end, like piercing distal end 154 of
piercing wire 150, which is sharp enough to pierce the wall of
receiving blood vessel 99 at the abutted portion 566.
[0173] In another embodiment of a balloon anvil of this invention,
an inflatable balloon is provided as shown in FIG. 7B with a
surface feature that is shaped like the combination of receiving
surface 162 and deflecting surface 164. This feature is formed on
the surface of the balloon and it is destined to abut the receiving
blood vessel wall as any other of the embodiments of the anvil of
this invention does. This inflatable balloon is preferably attached
to a multilumen catheter with expansion/contraction lumen 181 for
inflating and deflating the balloon, positioning shaft 182 for
housing the balloon insertion guide wire, and piercing shaft 183
for housing the piercing wire. Piercing shaft 183 is curved within
the balloon towards and through the anvil formed on the balloon
surface so that it provides a passage that directs the piercing
wire towards the intima of the receiving blood vessel.
[0174] Like any other embodiment of the anvil of this invention,
this balloon anvil can be designed so that the blood flow through
the receiving blood vessel will preferably not be interrupted
during the anastomosis. However, the design can be such that the
blood flow is interrupted when this feature is desired. In a
preferred embodiment, the balloon anvil shown in FIG. 7B is
designed so that it completely occludes the blood flow within
receiving blood vessel 99. With this design, the wall of receiving
blood vessel 99 is abutted by the anvil when the balloon anvil is
inflated even if the balloon anvil is not attached to the piercing
wire.
[0175] The term "anvil" in the context of this invention is meant
to encompass balloon anvils. The intraluminally directed anvil
apparatus of this invention comprises a piercing wire, a conduit
for housing this piercing wire, and an anvil. Consequently, a
balloon anvil is understood as an anvil whose base is so modified
as to be able to be expanded and contracted by, for example,
inflation and deflation. The terms "balloon anvil" will still be
used when referring to a specific embodiment such as the one shown
in FIG. 7B.
[0176] The herein disclosed exemplary embodiments of intraluminally
directed anvil apparatus of this invention are introduced into the
receiving blood vessel and subsequently positioned at the
anastomosis site according to different techniques. Typically, a
catheter is introduced into the receiving blood vessel with the aid
of a guide wire, which is removed once the catheter is properly
positioned. It is within and along this catheter that a piercing
wire with an anvil attached thereto, as shown in the embodiments
depicted in FIGS. 1, 17A, and 17B, is introduced and placed at the
anastomosis site. This procedure can also be used to properly place
a balloon anvil as shown in FIG. 7B. In this case, positioning
lumen 182 can be omitted or it can be used in conjunction with the
guide wire. With or without retracting the guide wire, a piercing
wire is introduced within and along piercing shaft 183 of the
embodiment shown in FIG. 7B to pierce the wall of the receiving
blood vessel at the anastomosis site. Alternatively, a deflated
balloon anvil such as the embodiment shown in FIG. 7B can
optionally be directly introduced into the receiving blood vessel
along a guide wire that is housed in positioning lumen 182 without
resorting to the passage of the balloon anvil within and along any
other additional foreign tubular structure such as tubular shaft
110 of catheter 100. With the balloon anvil so positioned and
inflated at the anastomosis site, the receiving blood vessel is
then pierced with a piercing wire.
[0177] Anastomosis Device
[0178] In an embodiment of this invention, the length of wire 150
that extends outside the receiving blood vessel signals the chosen
anastomosis site. This wire is used for cooperatively performing
the anastomosis of a graft vessel with anastomosis device 200.
[0179] Another example of an anastomosis device is shown in FIGS.
8-14 as a peripheral device whose primary components comprise
centering core 207, cutter 213, staple pushing device 219,
activation sheath 233, staples 308, and two rings: staple guide
ring 300 and anastomosis ring 350.
[0180] Distal end 154 of wire 150 is introduced in the embodiment
shown in FIG. 8 through anastomosis ring 350, staple guide ring 300
and through conduit 205 that extends coaxially within centering
core 207 from its distal coupling end 209 to its proximal control
end 211. The length of wire 150 that extends outside the receiving
blood vessel is sufficient to allow distal end 154 to sufficiently
project beyond proximal control end 211 for an operator to be able
to hold and pull wire 150 from the region near distal end 154.
[0181] In one embodiment of the anastomosis device of this
invention, proximal control end 211 comprises a "flow switch" 212
as exemplarily shown in FIGS. 11 and 12. A flow switch is a device
that provides a releasable locking mechanism. Flow switches are
well known commercially available devices. One example of such
device is the flow switch that is marketed under the name FloSwitch
by Boston Scientific Corporation. Other devices that provide a
locking mechanism can be used instead of flow switch 212.
[0182] As shown in FIG. 8, centering core 207 is coaxially aligned
within hollow cutter 213, whose length from proximal end 215 to
distal cutting end 217 is less than the length of centering core
207 from its proximal control end 211 to its distal coupling end
209. Distal cutting end 217 is provided in this exemplary
embodiment of the invention with a sharp cutting edge along the
entire perimeter of the generally cylindrical cutter 213 at cutting
end 217. Furthermore, distal cutting end 217 is made of metals or
alloys that are suitable for providing such sharp cutting edge
and/or distal cutting end 217 can be coated with a material or
materials that prevent the tissue being cut from adhering onto it.
An example of such material is teflon.
[0183] Centering core 207 is shown in FIG. 8 as a solid core with
conduit 205 extending coaxially therethrough. In other embodiments
of this invention, centering core can be embodied by an axially
extending tube, guide or any other similar passage that provides a
housing for extending the piercing wire therethrough.
[0184] In turn, the embodiment of this invention shown in FIG. 8
shows cutter 213 coaxially disposed within the staple engaging
device 219. For example, staple engaging device 219 comprises a
hollow cylindrical portion 221 at its proximal end 223. This hollow
cylindrical portion 221 facilitates the coaxial fitting of staple
engaging device 219 and it provides support in this particular
embodiment to staple pushing arms 225 and to retention arms 228.
Both staple pushing arms 225 and retention arms 228 extend from
their respective proximal ends 226 and 229 to their respective
distal pushing ends 227 and retention ends 230.
[0185] Although eight pushing arms and eight retention arms are
shown in the exemplary embodiment depicted in FIGS. 8 and 9C and
consequently the numbers of troughs 310 and notches 322 in
anastomosis ring 350 and the numbers of staple grooves 302 and
notches 320 in staple guide ring 300 are also eight, other
embodiments of the anastomosis device of this invention may rely on
more or less than eight of any of these corresponding elements.
Reliance on less than eight staples with their corresponding
troughs 310 and staple grooves 302 may be adequate when the
anastomosed structures are joined by the combined effect of a
mechanical device such as staples or clips and radiation welding,
gluing or soldering. Reliance on more than eight staples with their
corresponding troughs 310 and staple grooves 302 may be suitable
for the larger anastomosed structures whose joining is performed
with staples only.
[0186] Each retention arm 228 is generally disposed longitudinally
from its proximal end 229 to its retention end 230 approximately
parallel to the longitudinal axis of centering core 207 and cutter
213. In contrast, each staple pushing arm 225 is tension loaded so
that, absent a constraint, the locus of each distal pushing end 227
will be part of an approximately circular perimeter whose diameter
is greater than the diameter of the approximately circular
perimeter that is defined by the locus of each retention end 230.
Proximal ends 226 and 229 of staple pushing arms 225 and retention
arms 228 are respectively attached to affixing end 231 of hollow
cylindrical portion 221. Proximal ends 226 and 229 are preferably
integrally attached to affixing end 231, but they can also be
affixed to affixing end 231 by welding or with the aid of a
fastener. Alternatively, proximal ends 226 and 229 can be
integrally attached to a mount that threadably engages preferably
the inner surface of hollow cylindrical portion 221 at affixing end
231. In a preferred configuration of the embodiment of this
invention shown in FIG. 8, the distance from proximal end 223 of
the hollow cylindrical portion 221 to any distal pushing end 227 is
such that staple engaging device 219 is slightly shorter than
cutter 213.
[0187] Although in the preferred embodiment shown in FIG. 8 staple
pushing arms 225 and retention arms 228 are attached to hollow
cylindrical portion 221, retention arms 228 could in other
embodiments of this invention be attached by their proximal ends to
a hollow cylindrical portion. Similarly, pushing arms 225 could be
attached by their proximal ends to another generally co-axial and
independent cylindrical portion.
[0188] Other exemplary embodiments of the anastomosis device of
this invention do not rely on retention arms 228. These embodiments
are otherwise similar to those herein described.
[0189] Each distal pushing end 227 preferably has a feature that
aids in the effective driving by distal pushing end 227 of a staple
or similar fastening device. This feature can be an indentation
such as indentation 241 shown in FIG. 8, a series of indentations,
an arcuate or hooked feature or any other feature that is suitable
for this purpose and whose design is part of the ordinary skill in
the art.
[0190] The embodiment shown in FIG. 8 also comprises activation
sheath 233 that is coaxially disposed outside and around staple
engaging device 219. Activation sheath 233 is shorter than any
staple pushing arm 225 or retention arm 228. In a preferred
embodiment of activation sheath 233, sleeve 235 extends from
guiding distal end 236 to handling proximal end 237, which in turn
extends outwardly as flange 238.
[0191] In the embodiment of activation sheath 233 shown in FIG. 8,
flange 238 extends along the entire perimeter of handling proximal
end 237 that is preferably and generally shaped like a
circumference. The purpose of flange 238 is to aid in the handling
of activation sheath 233, and in particular to aid in the sliding
back and forth of activation sheath 233. Consequently, it is
understood that flange 238 can be shaped in any of a plurality of
shapes that are not shown in FIG. 8. For example, flange 238 can be
embodied by a pair of approximately opposed flat flanges, handles,
or by a pair of approximately opposed rings. These features are
commonly found in syringes at or near the end through which the
syringe piston is inserted and no further discussion of such
features or their equivalents is provided because they and their
forms of attachment to sleeve 235 are within the ordinary skill in
the art. Instead of flange 238, a groove along the perimeter of
proximal end 237 can provide in other embodiments of activation
sheath 233 the necessary grip for pushing or pulling activation
sheath 233. Furthermore, an activation sheath 233 with a smooth
outer surface of sleeve 235 or with rugosities in outer surface of
sleeve 235 as shown in FIG. 8 can still be part of an embodiment of
activation sheath 233 with no flange 238.
[0192] The forward motion of activation sheath 233 causes distal
pushing end 227 of each staple engaging device 219 to move radially
inwards. This is predominantly achieved by the slidable engagement
of inner surface 239 of guiding distal end 236 with each staple
pushing arm 225. Although not shown in FIG. 8, indentations or
grooves in inner surface 239 facilitate the slidable engagement of
inner surface 239 with each staple pushing arm 225.
[0193] The exemplary embodiment shown in FIGS. 8, 9A-9C also
comprises staple guide ring 300 and anastomosis ring 350. A
plurality of staple grooves 302 are disposed in retention side 303,
preferably equally spaced and radially extending from outer side
wall 304 to inner side wall 306 of staple guide ring 300. In a
preferred embodiment, a staple 308 slides within each staple groove
302 upon being driven radially inwards from outer side wall 304 to
inner side wall 306 by each distal pushing end 227.
[0194] A plurality of troughs 310 are preferably disposed in
anastomosis ring 350, each corresponding with a staple groove 302.
Each trough 310 is perforated by preferably two staple prong
passages 311 extending radially from outer side wall 312 to inner
side wall 314.
[0195] Anastomosis ring 350 is so dimensioned that it
concentrically fits within the space limited by inner side wall 306
of staple guide ring 300. When anastomosis ring 350 and staple
guide ring 300 are properly held in a concentric configuration,
each staple 308 can radially slide upon being driven by distal
pushing end 227 acting on driving portion 309. Each staple 308
thereby slides along each staple groove 302 so that each staple
prong 307 moves radially inwards along a corresponding staple prong
passage 311. When staple 308 is fully driven into anastomosis ring
350, driving portion 309 remains within trough 310 and each
puncturing end 305 inwardly protrudes through each corresponding
staple prong passage opening 311 into the space defined by inner
side wall 314. A deflecting surface such as any of surfaces 164-167
of an anvil such as any of the embodiments of an anvil shown in
FIGS. 3-7 will cause each staple prong 307 to bend according to the
shape imposed by the deflecting pattern which in turn is determined
by the geometric features of the deflecting surface. A few examples
of such geometric features are shown in FIGS. 3-7, but no
additional embodiments of such features are offered here because
the choice of the geometric features of a deflecting surface to
achieve a specific staple bending pattern is within the ordinary
skill in the art. A plurality of notches 320 are preferably equally
spaced along the inner perimeter of staple guide ring 300.
[0196] Anastomosis ring 350 can be shaped in any one of a variety
of equivalent configurations that can be designed with the aid of
ordinary skill in the art consistently with the purposes of the
anastomosis ring of this invention. These purposes include
providing support to the structures being anastomosed, providing
support to the staples being driven through the vessels, causing
the anastomosed structures to conform around the anvil of this
invention if an anvil is used, and forcing the surfaces of the
graft vessel and the receiving blood vessel against each other.
Anastomosis ring 350 is preferably made of titanium, but it can
also be made of any other biocompatible material that is resilient
enough to perform according to the purposes of the anastomosis ring
of this invention. In particular, anastomosis ring 350 can be made
of the same materials of which coupling anastomosis devices are
made. In other embodiments of this invention, the anastomosis ring
is a removable ring that can be taken away from the anastomosed
structures once they have healed into a leak-proof joint.
[0197] Staple guide ring 300 and anastomosis ring 350 are
preferably held with respect to each other in a concentric and
fixed position. This is preferably achieved in the embodiment shown
in FIGS. 8, 9A-9C with the aid of a plurality of notches 320 and
322 which are best viewed in FIG. 9B. Notches 320 are disposed in
inner side wall 306 of staple guide ring 300, preferably equally
spaced on retention side 303. Notches 322 are disposed in inner
side wall 314 of anastomosis ring 350, preferably equally spaced on
retention side 324 and corresponding with respective notches 320 in
staple guide ring 300. Each pair of corresponding notches 320 and
322 so disposed defines a retention slot that receives retention
end 230 of retention arm 228. When each retention end 230 is so
engaged with each corresponding retention slot, staple guide ring
300 and anastomosis ring 350 are concentrically fixed with respect
to each other to permit the sliding of staples 308 along staple
grooves 302 into troughs 310 and through staple prong passages
311.
[0198] Staple guide ring 300 and anastomosis ring 350 as shown in
FIGS. 8 and 9A-9C are mating structures with outer side wall 312 of
anastomosis ring 350 destined to be in contact engagement with
inner side wall 306 of staple guide ring 300. In other embodiments
of the staple guide ring and anastomosis ring of this invention,
these two rings can be aligned with respect to each other with the
aid of mating keys on one of the rings and slots on the other ring.
In one configuration, the key or keys in these keyed rings are
located on inner side wall 306 of staple guide ring 300 and the
mating slots are located on outer side wall 312 of anastomosis ring
350. In another configuration, the key or keys are located on outer
side wall 312 and the mating slots are located in inner side wall
306. One or a plurality of keys can be used for aligning
anastomosis ring 350 and staple guide ring 300, and these keys can
be shaped in the form of protuberances such as lugs, corrugations
or other features that can be mated with complementary features
such as slots or indentations.
[0199] Other embodiments of anastomosis device 200 can operate with
no reliance on anastomosis ring 350. Instead, staples 308 are
delivered directly from staple guide ring 300 that more tightly
fits around graft vessel 98 near its partially everted end 97. With
this embodiment, staples 308 are preferably inserted through staple
prong passages that allow the driving portion of each staple to
reach or almost reach inner sidewall 314 of anastomosis ring 350.
Still in other embodiments of this invention, the staples are
preloaded in an anastomosis ring that is hereinafter referred to as
"preloaded anastomosis ring", in which case the anastomosis can be
performed with no reliance on staple guide ring 300.
[0200] In other embodiments of anastomosis device 300, one of a
variety of biocompatible anastomosis rings that are eventually
dissolved is used as the anastomosis ring. For example, one of such
dissolvable materials is marketed by Boston Scientific Corporation
under the name TempTip. The dissolvable rings manufactured
according to the invention preferably comprise a bioabsorbable
material, which can be absorbed over time and replaced with living
tissue. An example of a preferred bioabsorbable material that could
be used to manufacture the bioabsorvable rings of the present
invention is a poly-l-lactic acid polymer, also known as "PLLA".
Other bioabsorbable materials known in the art are described in
detail in U.S. Pat. No. 4,643,734, which is hereby incorporated by
reference in its entirety.
[0201] Although the general configuration of staple guide ring 300
and that of anastomosis ring 350 shown in FIG. 9 correspond to
rings with generally circular features, in which case the rings are
referred to as "circumferential rings", these rings and their
lumens 327 and 328, respectively, can be shaped in other curved
shapes, such as ellipsoidal, ovoidal or with a combination of
arcuate features. These rings are hereinbelow referred to as
"non-circumferential rings". Furthermore, staple grooves 302,
troughs 310, and staple prongs passages 311 as shown in FIG. 9 are
arranged so that the stapled sites generally define a plane that is
orthogonal to the longitudinal axis of centering core 207, and then
rings 300 and 350 are termed "orthogonal rings". However, these
elements can be arranged in the embodiments of this Example so that
the stapled sites generally define a plane that is not orthogonal
to the longitudinal axis of centering core 207. These
configurations (not shown in FIG. 9) may be particularly useful in
the practice of bevelled anastomoses. Rings with these
configurations are hereinbelow referred to as "non-orthogonal
rings".
[0202] A function performed by the embodiments of the staple guide
ring or the anastomosis ring of this invention is to properly
orient the staples according to a predetermined configuration.
[0203] FIG. 10 shows a perspective view of the assembled embodiment
whose components are shown in FIGS. 8 and 9. A side view of the
same embodiment is shown in FIG. 11, where wire 150 is inserted
through the full length of centering core 207 and anvil 160 is
inserted into anastomosis ring 350 which in turn is concentrically
placed within staple guide ring 300. FIG. 12 shows a cross section
along plane 12-12' as indicated in FIG. 10 of the embodiment whose
side view is shown in FIG. 11. FIG. 13 shows an enlarged view of
region 13-13' as indicated in FIG. 12 and FIG. 14 shows a
perspective view of the area whose cross section is shown in FIG.
13. In addition, anvil 160 in FIG. 14 shows a series of depressions
169 for deflecting a pointed end.
[0204] FIGS. 15A and 15B show an embodiment of the anvil of this
invention abutting the wall of receiving blood vessel 99 from
intraluminal space 190. FIG. 15A shows distal end 154 of wire 150
having perforated the wall of receiving blood vessel 99 while
surface 162 of anvil 160 contacts intima 191 of receiving blood
vessel 99. FIG. 15B shows a cross section of anvil 160 effectively
abutting the wall of receiving blood vessel 99.
[0205] FIG. 15C shows a perspective view of the embodiment whose
components are shown in FIGS. 8 and 9 with a perspective and
cut-away view of receiving vessel 99 and graft vessel 98 with its
partially everted end 97 over bottom side 325 of anastomosis ring
350 and bottom side 326 of staple guide ring 300.
[0206] In the context of this invention, graft vessel 98 can be an
autologous blood vessel or a synthetic graft made of biomaterials
that have been named in the foregoing discussion of devices and
techniques under the general heading Relevant Technology in the
Background section of this Specification.
[0207] An anastomosis with embodiment 200A shown in FIGS. 8, 10-12
with graft vessel 98 disposed as indicated in FIG. 15C is
preferably performed as follows. Embodiment 200A is approached to
the abutted side wall of receiving blood vessel 99 by holding the
portion of wire 150 that extends beyond proximal control end 211.
The embodiment shown in FIGS. 11-12 is slid along wire 150 until
the abutted portion of receiving blood vessel 99 is within graft
vessel 98 as indicated in the perspective cut-away view shown in
FIG. 15D.
[0208] During the practice of an end-to-side anastomosis according
to this invention with anastomosis device 200A, graft vessel 98 is
generally coaxially disposed outside and around cutter 217 so that
it is generally coaxially located between cutter 213 and the set of
longitudinally extending retention arms 228. In addition, graft
vessel 98 is partially disposed through anastomosis ring 350 so
that the graft vessel's anastomosis end 97 is partially everted on
bottom side 325 of anastomosis ring 350 and on bottom side 326 of
staple guide ring 300. Accordingly, the anastomosis ring 350
maintains an end of graft vessel 98 in a desired position for
anastomosis. With graft vessel 98 so configured, FIG. 15D shows the
anvil of this invention abutting the wall of receiving vessel 99
into intraluminal space 96 of graft vessel 98, near its partially
everted end 97 which in turn is surrounded by inner side wall 314
of anastomosis ring 350. Consequently, the outer wall of receiving
blood vessel 99 and the inner wall of graft vessel 98 are in
contact with each other while they are held between inner side wall
314 of anastomosis ring 350 and an embodiment of the anvil's
surface such as any of surfaces 164-167.
[0209] The stapling action with the exemplary embodiment 200A is
achieved by sliding activation sheath 233 forward from proximal end
233 of staple engaging device 219 towards distal pushing ends 227
of staple pushing arms 225. This motion causes distal pushing ends
227 that are engaged with corresponding staple grooves 302 to move
radially inwards from outer side wall 304 towards inner side wall
306, thus forcing staples 308 to slide within anastomosis ring 350
as described in the foregoing discussion, pierce through graft
vessel 98 and receiving blood vessel 99, and staple together
anastomosis ring 350, receiving blood vessel 99 and graft vessel 98
at the anastomosis site. This action is illustrated in FIG. 15E by
showing, within staple grooves 302, distal pushing ends 227 in
contact with driving portions 309 of corresponding staples 308 that
are inserted into corresponding troughs 310 and staple prong
passages 311 of anastomosis ring 350. As shown in FIGS. 15E, 15F,
and 15G, puncturing ends 305 pierce graft vessel 98 and receiving
blood vessel 99 to be subsequently bent upon deflection against
anvil 160.
[0210] The operation of cutting an opening into the abutted portion
of receiving blood vessel 99 can be performed according to the
methods of this invention prior to or after the attachment of graft
vessel 98 to receiving blood vessel 99. FIG. 15H illustrates the
operation of cutting this opening after anastomosis ring 350,
receiving blood vessel 99 and graft vessel 98 have been stapled as
shown in FIGS. 15E-15G. In this particular embodiment, cutting is
achieved by coaxially inserting cutter 213 until distal cutting end
217 is in contact with receiving blood vessel 99. As indicated by
arrow A in FIG. 15H, cutter 213 is then preferably turned about its
longitudinal axis or pushed with sufficient force from its proximal
end 215 so that distal cutting end 217 cuts through the wall of
receiving blood vessel 99 until it is stopped by receiving surface
162 of anvil 160. During this operation, anvil 160 is not
significantly displaced backwards into the intraluminal space of
receiving blood vessel 99 because a portion of wire 150 extending
beyond proximal control end 211 is held so as to effectively
counteract any pushing caused by cutter 213.
[0211] After anastomosis ring 350 is stapled at the anastomosis
site as shown in FIGS. 15H and 15I, centering core 207, cutter 213,
and staple device 202 with staple engaging device 219 and
activation sheath 233 are pulled backwards slidably along wire 150
and away from the anastomosis site as shown in FIG. 15J. This
operation also leads to the extraction of staple guide ring 300
that is engaged at notches 320 with corresponding retention ends
230 of retention arms 228. The portion 99A of the abutted wall of
receiving blood vessel 99 that is cut upon opening of the
anastomosis fenestra is preferably extracted when centering core
207, cutter 213, staple engaging device 219 and activation sheath
233 are pulled backwards. This can be achieved by applying suction
at proximal control end 211 to induce in conduit 205 the necessary
rarefaction to cause cut out fragment 99A of the wall of receiving
blood vessel 99 to attach itself to distal coupling end 209 and
thus be extracted upon extraction of centering core 207. In
addition, or alternatively, surface 240 of distal coupling end 209
can be provided with a series of axially extending hooked sharp
features (not shown in FIG. 15J) that can attach to and facilitate
the extraction of fragment 99A upon removal of centering core
207.
[0212] Although not shown in FIGS. 15D-15I, distal coupling end 209
of centering core 207 is preferably kept in contact engagement with
receiving blood vessel 99 and in a fixed position with respect to
wire 150 with the aid of a locking mechanism such as a flow switch
that is preferably located at proximal control end 211.
Accordingly, centering core 207 is preferably fixed prior to the
joining of the structures to be anastomosed and prior to the
opening of the anastomosis fenestra. Because the locking mechanism
that fixes centering core 207 can be released and re-locked at will
several times, one or a plurality of devices with a conduit that
can house wire 150 can be approached to the anastomosis site.
[0213] The joining of the structures to be anastomosed is
exemplarily shown in FIGS. 15D-15J as an operation that precedes
the opening of the anastomosis fenestra. However, the structures to
be anastomosed can be joined after the anastomosis fenestra is
opened in the receiving blood vessel. In addition, FIGS. 15D-15J
exemplarily show that the structures to be anastomosed are joined
by stapling and that the anastomosis fenestra is opened with a
mechanical device such as a cutter. As it will be further disclosed
hereinbelow, other procedures can be used in the context of this
invention for joining the structures to be anastomosed and for
opening the anastomosis fenestra.
[0214] FIGS. 15K and 15L show graft vessel 98 anastomosed to
receiving blood vessel 99 according to the procedure disclosed in
the foregoing discussion of FIGS. 15A-15J. As shown in FIGS. 15K
and 15L, anastomosis ring 350 is stapled outside and around the
anastomosis site and provides support to the anastomosed structures
and to staples 308 used in this particular anastomosis
procedure.
[0215] Hooked or prebent staples used in these embodiments have
features such as those illustrated in FIGS. 16A-16E and
combinations of these or similar features that are not explicitly
shown in FIGS. 16A-16E but that are within the ordinary skill in
the art may be particularly useful with embodiments of anastomosis
device 200 that do not rely on anastomosis ring 350. These types of
staples generally have prongs 330 that are shorter than prongs 307
of the corresponding staples 308. Hooked staples also have at least
one hooked puncturing end 331 instead of merely penetrating
puncturing ends 305. Some embodiments of this type of staples have
a pre-bent prong such as prong 332. Hooked puncturing ends and/or
pre-bent prongs fasten and hold instead of merely penetrating the
structures through which they are inserted. Accordingly, the hooked
or pre-bent staples require upon insertion no bending of their
prongs for holding the vessels being anastomosed together.
[0216] Hooked or prebent staples such as those exemplarily depicted
in FIGS. 16A-16E may be particularly useful when the presence in
the intraluminal space of the anastomosed structures of the
terminal portions of prongs 307 and the sharp puncturing ends 305
is not acceptable. In addition, these embodiments would also be
preferred when it is desirable to minimize or avoid damage to the
intima of the receiving blood vessel, which may result through the
use of staples with puncturing ends 305. The practice of this
invention with these described embodiments requires the careful
determination of the thickness of the graft vessel wall and of the
receiving blood vessel wall combined and the subsequent use of
hooked staples with the appropriate prong length, so that the
intima of the receiving blood vessel is not pierced by the hooked
staples.
[0217] Other exemplary embodiments of anastomosis device 200 of
this invention employ hooked staples that do not pierce the intima
of the receiving blood vessel. In addition, these embodiments use
anastomosis ring 350 to provide additional support to the
anastomosed vessels at the anastomosis site.
[0218] These embodiments would be preferred when the anastomosis
requires the support of a structure such as anastomosis ring 350.
To avoid the piercing of the intima of the receiving blood vessel,
the practice of this invention with these embodiments involves the
careful determination or estimation of the combined thickness of
three structures: that of the graft vessel wall, that of the
receiving blood vessel wall, and that of the support structure,
such as the distance between outer side wall 312 and inner side
wall 314 of anastomosis ring 350.
[0219] Other exemplary embodiments of anastomosis device 200 of
this invention employ staples or clips that hold and support
without the need of being bent upon insertion. Whether the staples
are hooked or not, these embodiments of staples predominantly rely
on the clipping effect of prongs that spontaneously tend to restore
an equilibrium position from which they have previously been
distorted, and they are referred to as "memory staples" and "memory
clips", respectively.
[0220] Operationally, these embodiments of staples and clips use a
device like that illustrated in FIGS. 8-14, but staples 308 are
replaced by staples with prongs that are curved inwards, such as
the staples that are shown for example in FIGS. 16F and 16G. These
staples are representative of a class of staples whose prongs 333
have been pre-bent towards each other. In addition to the shapes
shown in FIGS. 16F and 16G, staples in this class can have one
hooked end or two hooked ends, and prongs 333 can be mostly
rectilinear such as those of the staple shown in FIG. 16F or mostly
curved such as those of the staple or clip shown in FIG. 16G. It is
understood that curved portions can have different curvature
degrees in addition to those shown in FIGS. 16F and 16G.
[0221] When pre-bent staples slide down staple grooves 302 and
their prongs slide down staple prong passages in the anastomosis
ring, the pre-bent prongs are slightly distorted so that the space
between their ends is widened with respect to the equilibrium
separation. To avoid irreversible distortion of the staple's shape,
this widening is within the elastic compliance of the material used
to manufacture the staples of this embodiment. Staple prong
passages in the anastomosis ring of this embodiment are so disposed
that the prongs of the staples penetrate the graft blood vessel and
part of the receiving blood vessel while the space between the ends
of the prongs is widened, but the staples are eventually left
essentially free to restore or revert to their undistorted shape.
This restoration leads effectively to the clipping of the
anastomosed vessels without damaging the intima of the receiving
blood vessel. Anastomosis ring 350 and in particular staple prong
passages 311 are, in these embodiments, appropriately modified for
elastically distorting the width of the staples and for allowing
them to essentially restore to their initial shape.
[0222] Staples and clips used in the context of this invention are
preferably made of titanium, titanium alloys or other biocompatible
material. In one embodiment of this invention, the anvil is made of
tempered stainless steel, although it can be made of other
materials that are appropriately selected for resisting the
abrasive action of staples. Selection of the appropriate materials
can be made by considering the relative hardness of the material
that is to be used for the staples or clips and that of the
material to be used for the anvil. For example, known scales of
relative hardness, such as the Rockwell B scale, provide useful
information for this purpose.
[0223] Another example of an anastomosis device is shown in FIGS.
17C-17K as a peripheral device 200B hereinafter referred to as a
"spring clip anastomosis device" whose primary components comprise
laser device 700, and clipping device 650, which in turn includes
holding arms 652, sleeve 660, guiding element 670, and memory clips
695. FIG. 17C shows the general disposition of catheter 500 with
positioning wire 550 and balloon anvil 560 and spring clip
anastomosis device 200B at the anastomosis site.
[0224] As shown in FIGS. 17D-17E, guiding element 670 comprises at
its anastomosis end a series of sectors 672 which are radially
disposed around the periphery of longitudinally extending central
lumen 671; sectors 672 are separated by slots 674 that are also
radially arranged around the periphery of longitudinally extending
central lumen 671. Preferably the number of sectors and
corresponding slots is eight as shown in FIGS. 17D-17E, but other
embodiments can have less than or more than eight sectors and
corresponding slots.
[0225] A ledge 676 in each sector 672 provides support for a
holding arm 652 whose holding end 677 is preferably so shaped as to
provide a mating feature 678 with corresponding ledge 676. This
mating feature 678 can be shaped like a ledge that is complementary
to ledge 676 as shown in FIGS. 17D-17E, or as a tooth, lip, flange
or any other protuberance that can provide detachable contact
engagement with ledge 676. Analogously, ledge 678 can have contact
engagement with a feature such as a tooth, lip, or flange in sector
672 that is equivalent to ledge 676 and provides detachable contact
engagement with ledge 678.
[0226] Holding end 677 extends generally radially towards the
anastomosis site along and within slot 674 to form holding lug 679.
Each sector 672 is provided with at least one protuberance 680 or
an equivalent feature thereof that is located on the same side 682
as the ledge 676. Two of such protuberances are shown in each slot
674 in FIG. 17D. Protuberance 680 can be shaped as a flange, lip,
elongated lug, handle, or any similar protruding feature. With
holding end 677 of holding arm 652 in contact engagement with
sector 672 at ledge 676, lug 679 and protuberances 680 preferably
hold memory clip 695 in a distended position as shown in FIGS.
17D-17E. In another embodiment, memory clip 695 can be provided
with a notch or a similar feature for detachable contact engagement
with lug 679 or any equivalent feature to lug 679 at holding end
677. An embodiment of memory clip 695 is shown in FIG. 16H, with
memory prongs 333, and preferably partially penetrating end 334 and
pinching end 335.
[0227] Holding arm 652 is spring loaded, so that upon turning
holding arms 652 as shown by arrow B (or by turning guiding element
670 in the sense opposite to that shown by arrow B) in FIG. 17D,
holding end 677 falls off ledge 676, thereby disengaging arm 652
from sector 672 and releasing the prong that ends at partially
penetrating end 695 of memory clip 334. When this operation takes
place, each one of the memory clips placed in slots 674 is
simultaneously released in the same manner.
[0228] Subsequent to, prior to, or simultaneously with the release
of memory clip 695, optical fibers 702 deliver radiation that opens
the anastomosis fenestra in receiving blood vessel 99, as shown in
FIG. 17E by arrows 705. In the particular embodiment shown in FIG.
17E, the opening of the anastomosis fenestra is being performed
prior to the release of memory clips 695.
[0229] Embodiments of laser device 700 generally have a
configuration similar to that of laser device 400 as shown in FIG.
20. The embodiment of laser device 400 as shown in particular in
FIGS. 17C-17J extends coaxially along and within sleeve 660 and it
comprises a plurality of lumens for optical fibers 702, for
piercing wire 554, and optionally for a connection (not shown) to a
vacuum pump or vacuum line. The space between sleeve 660 and laser
device 700 defines longitudinally extending lumen with an annular
cross-section that is configured for receiving graft vessel 98 as
shown in FIGS. 17C-17H.
[0230] The end of graft vessel 98 that is to be anastomosed is held
in place in spring clip anastomosis device 200B by pinching ends
335 of memory clips 695 and protuberances 680 as shown in FIGS.
17C-17H. Upon rotation of holding arms 652 as indicated by arrow B
in FIG. 17D (or upon rotation of guiding element 670 in the sense
opposite to that indicated by arrow B), the removal of
protuberances 680 from the space between memory clips 695 and
partially everted end 97 of graft vessel 98 allows memory clips 695
to pinch or clip graft vessel 98 as memory clips 695 are restored
to their equilibrium configurations. In the embodiment shown in
FIGS. 17D-17E, each memory clip 695 slides past each corresponding
pair of protuberances 680. In an embodiment with only one
protuberance 680 in each slot 674 (not shown in FIGS. 17D-17E),
each memory clip 695 slides past the corresponding protuberance
680. This change from the distended configuration of memory clip
695 shown in FIGS. 17C-17F to its restored equilibrium
configuration is illustrated in FIGS. 17G-17I, which show holding
arms 652 at different stages of their movement towards the
anastomosis site while memory clips 695 bring in tight contact
engagement the intima of receiving blood vessel 99 and the inner
surface of graft vessel 98. This tight contact engagement is
achieved in this particular embodiment by the restoring force of
memory clip 695, and by the holding provided by partially
penetrating end 334 and pinching end 335 of memory clip 695.
[0231] FIGS. 17C-17D, 17F-17I do not show the remaining features of
sleeve 660 and holding arms 652 because these features are
analogous to corresponding features of the embodiment shown in
FIGS. 8, 10-12, and 15C. In addition, some of these features are
partially shown in FIG. 17E.
[0232] After memory clips 695 have been released and they
effectively clip the anastomosed structures in tight contact
engagement as shown in FIG. 171, spring clip anastomosis device
200B is pulled away from the anastomosis area which is left as
shown in FIG. 17J. The end of graft vessel 98 opposite to end 97 is
then further joined, for example, in a subsequent anastomosis, or
it is treated according to the practice of the procedure being
performed. Once graft vessel 98 is in the desired final
configuration, balloon anvil 560 is deflated and extracted together
with catheter apparatus 500, leaving eventually the anastomosis
site as shown in FIG. 17K. Piercing wire 554 can be extracted at
any convenient time after the anastomosis fenestra has been opened
and graft vessel 98 has been joined to receiving blood vessel 99
with memory clips 695.
[0233] Signaling of the appropriate anastomosis site and the
anastomosis itself with the embodiments of this invention can be
performed without interruption of blood flow within receiving blood
vessel 99. In addition, the methods, systems and apparatuses of
this invention do not require a 180.degree. eversion of the end of
the graft vessel being anastomosed, but at most partial eversion is
only needed.
EXAMPLES OF THE PREFERRED EMBODIMENTS
[0234] Several examples of the present invention are presented as
merely illustrative of some embodiments of the present invention.
These examples are not to be construed as limiting the spirit and
scope of the invention as these hypothetical examples were produced
in furtherance of reducing the present invention to practice.
Example 1
[0235] In common hemodialysis practice, an artery is shunted to a
vein with a vessel that channels the blood flow from the artery to
the vein. This vessel is anastomosed at one end to the artery and
at the other end to the vein, and it is used in hemodialysis for
extracting and subsequently injecting the blood that is dialyzed.
Embodiment 200A is used for anastomosing the ends of the vessel
that provides the artery-to-vein shunt.
[0236] More particularly, only one end or both ends of the graft
vessel can be anastomosed with embodiment 200A. When the graft
vessel is anastomosed at both of its ends with embodiment 200A, an
end of a graft vessel is anastomosed to the receiving blood vessel
while the other end is left open, and another graft is similarly
anastomosed at a different site of the receiving blood vessel. The
open ends are then joined with a sleeve according to standard
practice.
Example 2
[0237] Embodiment 200B is also used for anastomosing structures to
facilitate hemodialysis in similar fashion as disclosed in Example
1 regarding embodiment 200A. Embodiment 200B, however, relies on
clips that do not penetrate the walls of the anastomosed structures
and consequently are not exposed to the blood flow, a feature that
should minimize the risk of clot formation.
Example 3
[0238] To describe this exemplary embodiment of anastomosis device
200 of this invention, reference is made to FIGS. 8-14. In this
embodiment, staple engaging device 219, activation sheath 233,
staple guide ring 300 with staples 308, and anastomosis ring 350 in
the embodiments shown in FIGS. 8-14 are replaced by hand suturing
or by a suturing device such as the suturing device disclosed for
example in U.S. Pat. No. 5,860,992 which has been herein
incorporated by reference in its entirety. The anvil of this
invention, such as anvil 160, provides an abrasion resistant
surface that deflects the sharp end of a suturing needle.
[0239] Suturing is a technique that has been practiced for a long
time, and its features and characteristics are fairly well known.
When compared to one of the anastomosis devices herein disclosed,
however, suturing sometimes requires a more invasive procedure, it
requires comparatively more intensive and specialized training, and
it does not provide for the standardization that would enable a
broader group of practitioners to utilize it.
Example 4
[0240] To describe this exemplary embodiment of anastomosis device
200 of this invention, reference is made to FIGS. 8-14, 15A-15H and
18. In this embodiment, graft vessel 98 is joined to receiving
blood vessel 99 with the aid of laser welding. Laser radiation such
as radiation from a Nd-YAG laser is preferably delivered
circumferentially for heating at sub-vaporization temperatures to
smooth, seal, or weld the structures to the anastomosed.
[0241] It is known that a correlation exists between thermal weld
strength and adventitial tissue temperature. Moreover, an
incremental ramped laser dosimetry has been developed to maintain
tissue temperatures within an appropriate range. See, for example,
Cardiovascular Applications of Laser Technology, p. 11.
[0242] When the anastomosis fenestra is opened with the relevant
components of an embodiment as shown in FIGS. 8-14 and 15A-15H,
with any of their equivalents or with an embodiment according to
any of the relevant Examples herein discussed, laser welding with
one of the embodiments of this Example can be used in addition to
or instead of the use of mechanical devices such as staples, clips,
or sutures. Alternatively, welding with an embodiment according to
this Example can be performed prior to the opening of the
anastomosis fenestra.
[0243] For example, the welding of the edge of the anastomosis
fenestra to the inner wall of graft vessel 98 can be used to
supplement a significantly reduced number of mechanical devices
such as staples, clips, or sutures. This welding could in fact be
the only anastomosis joint when receiving blood vessel 99 and graft
vessel 98 are such that welding provides the necessary seal for the
anastomosis. An advantage of the embodiment according to this
Example is that welding requires no eversion of the end of graft
vessel 98 to be anastomosed. Additionally, laser welding provides a
seal between the two vessels.
[0244] After the anastomosis fenestra has been opened in the wall
of receiving vessel 99 by a mechanical device such as cutter 213,
centering core 207 and cutter 213 are pulled away from the
anastomosis site and a laser welding device is inserted in their
place until the terminal end of this device is placed near the edge
of the anastomosis fenestra. Welding can then proceed by
administering the appropriate dosage of laser radiation.
[0245] As shown in FIGS. 18 and 19, an embodiment 400 of a laser
device according to this Example is generally and preferably
configured like a catheter or like an endoscope with one or a
plurality of lumens. In this Example, laser device 400 represents a
laser welding device. It is understood that the laser device is
preferably provided with a central and axially extending conduit
analogous to conduit 205 for accommodating a wire such as wire 150.
This conduit is hereinafter referred to as centering lumen.
[0246] When an embodiment of a laser welding device according to
this Example entirely performs the anastomosis sealing, graft
vessel 98 can be held as shown in FIG. 18 by a ring or by a
cylindrical structure in a manner analogous to the way anastomosis
ring 350 and staple guide ring 300 hold it in the embodiment shown
in FIG. 18. Alternatively, an embodiment according to this Example
can be provided with a peripheral lumen of annular cross-section
extending along the length of an embodiment of laser device 400
such as that shown in FIG. 18, with the distal end of such lumen
appropriately designed for holding graft vessel 98. Additionally,
welding with an embodiment according to this Example can take place
before the anastomosis fenestra is open, in which case centering
core 207 and cutter 213 or an equivalent cutting device can be
inserted in place of and subsequently to the use of laser device
400, as in the exemplary embodiment shown in FIG. 18.
[0247] Instrument characteristics, radiation dosages, and
techniques for implementing laser applications for clinical welding
are disclosed in Cardiovascular Applications of Laser Technology,
p. 11; R. D. Jenkins and J. R. Spears, Laser Balloon Angioplasty,
Circulation, Vol. 81 (Suppl. IV) (1990) pp. 101-108; Laser Tissue
Welding, pp. 381-415; Surgical Properties and Applications of
Sealed-Off CO.sub.2 Lasers, pp. 231-239; 980 nm High Power Diode
Laser in Surgical Applications, pp. 227-230; Robert T. V. Kung,
Robert B. Stewart, David T. Zelt, Gilbert J. L'Italien and Glen M.
LaMuraglia, Absorption Characteristics at 1.9 .mu.m: Effect on
Vascular Welding, Lasers in Surgery and Medicine, Vol. 13 (1993)
pp. 12-17; Comparison of Laser Welding and Sutures in Vascular
Anastomosis, pp. 34-40; Low Temperature Laser-Welded Vascular
Anastomosis, pp. 241-247, and Heat Induced Tissue Fusion for
Microvascular Anastomosis, pp. 198-208, which are hereby
incorporated by reference in their entirety.
[0248] It is understood that any of the embodiments of the
anastomosis device that are disclosed in the discussion of
exemplary embodiments of this invention can further include
additional probes extending along the same lumen that is used for
delivering the radiation or along another lumen in a suitable
probe, whether the radiation is used for sealing, opening the
anastomosis fenestra or for any other purpose. These additional
probes include an infrared thermometer or any other type of device
that is used for measuring temperature, imaging probes for direct
visualization of the anastomosis site, light carriers for
illuminating the anastomosis site, fiberoptic biosensors including
transducer sensors, all-fiber sensors, and spectrometric sensors,
probes such as those used in endoscopic photodynamic therapy, and
mechanical devices such as forceps, cutters or retrievers of
biological material.
[0249] The transducer biosensors further include optic biosensors
which change their own optical properties according to the physical
or chemical parameter being tested, such as temperature, pressure,
chemical characteristics including pH, O.sub.2 concentration,
CO.sub.2 concentration, glucose concentration, immunological agent
concentration, and properties related thereto. All-fiber biosensors
use modified tips which are sensitive because of core doping or
cladding, or because of having a chemically modified fiber end.
Parameters tested with all-fiber biosensors include temperature and
pH and these biosensors are also used for immunological assays.
Spectroscopic biosensors typically rely on measurements of
reflectance, fluorescence or absorption for measuring concentration
of substances such as O.sub.2, for drug dosimetry, for reflux
monitoring, and for pharnacokinetic measurements.
[0250] Instrument characteristics and designs for these additional
probes are known in the art. For example, probes of this type have
been disclosed in Frank D. D'Amelio, Steven T. DeLisi, and Anthony
Rega, Fiber Optic Angioscopes, Proceedings of SPIE-The
International Society for Optical Engineering, Vol. 494 (1984), pp.
44-51, (this article will hereinafter be referred to as "Fiber
Optic Angioscopes"); Optical Fibers in Biomedical Sensing, pp.
233-245; D. A. Russell, P. Nadeau, R. H. Pottier, G. Jori, and E.
Reddi, A Comparison of Laser and Arc-Lamp Spectroscopic Systems for
In-Vivo Pharmacokinetic Measurements of Photosensitizers Used in
Photodynamic Therapy, in Laser Systems for Photobiology and
Photomedicine, edited by A. N. Chester, S. Martellucci, and A. M.
Scheggi, pp. 193-199, Plenum Press (1991), and P. Spinelli, M. Dal
Fante, and A. Mancini, Endoscopic Photodynamic Therapy: Clinical
Aspects, in Laser Systems for Photobiology and Photomedicine,
edited by A. N. Chester, S. Martellucci, and A. M. Scheggi, pp.
149-155, Plenum Press (1991), which are hereby incorporated by
reference in their entirety.
[0251] It is further understood that when laser radiation is
discussed in the context of the disclosed exemplary embodiments of
this invention, pulsed lasers are included among the possible laser
radiation sources.
Example 5
[0252] To describe the exemplary embodiment of anastomosis device
200 of this invention, reference is made to Example 4. In this
embodiment, graft vessel 98 is joined to receiving blood vessel 99
with the aid of non-laser welding radiation, such as radiofrequency
radiant energy. Other than the source of radiation, the
characteristic features of embodiments of these Examples are
analogous to the features and modifications introduced in the
embodiment shown in FIGS. 8-14, as discussed Example 4.
[0253] For a more detailed description of known features of this
technique, reference is made to K. Yamashita, S. Satake, H. Ohira,
K. Ohtomo, Radiofrequency Thermal Balloon Coronary Angioplasty: A
New Device for Successful Percutaneous Transluminal Coronary
Angioplasty, JACC, Vol. 23(2) (1994) pp. 336-340; D. B. Fram, L. D.
Gillam, T. A. Aretz, R. V. Tangco, J. F. Mitchell, J. T. Fisher, B.
W. Sanzobrino, F. J. Kiernan, S. Nikulasson, A. Fieldman, and R. G.
McKay, Low Pressure Radiofrequency Balloon Angioplasty: Evaluation
of Porcine Peripheral Arteries, J. Am. Coll. Cardiol. Vol. 21(6)
(1993) pp. 1512-1521, which are hereby incorporated by reference in
their entirety.
[0254] Because this Example relies on radiation, its performance is
expected to be comparable to that of the preceding Example. The use
of radiation for welding as disclosed in this Example or in the
preceding Example may lead to a simpler anastomosis device because
the number of mechanical parts is reduced, but in general clinical
devices that deliver radiation are currently more expensive than
counterparts that perform comparable tasks by mechanical
mechanisms.
Example 6
[0255] To describe this exemplary embodiment of anastomosis device
200 of this invention, reference is made to FIGS. 8-15, 15A-15H,
18, 19, and 20. In this embodiment, the anastomosis fenestra is
opened in the wall of receiving blood vessel 99 with the aid of
radiation, such as laser radiation. FIG. 19 shows distal end 140 of
an exemplary embodiment according to this Example that can
generally and schematically be represented by laser device 400
shown in FIG. 18. Tip 141 exposes the ends of optical fibers 142
and grid 143 with openings 144. Optical fibers 142 are such that
they deliver the appropriate radiation for effectively ablating the
perimeter of a generally circular region from the outside of
receiving blood vessel 99, thus cutting open the anastomosis
fenestra. Openings 144 provide the suitable rarefaction for
retaining by suction the fragments and any product resulting from
the ablation, burning, or vaporization caused by the irradiation of
the wall of receiving blood vessel 99. To this effect, openings 144
are the ends of a plurality of conduits, or the screened end of a
single conduit, to a vacuum pump or a vacuum line.
[0256] When the anastomosis fenestra is opened with the relevant
components of an embodiment as shown in FIGS. 8-14 and 15A-15H,
with any of their equivalents, or with an embodiment according to
any of the relevant Examples herein discussed, tip 141 of an
embodiment according to this Example is brought near the
anastomosis site in a fashion similar to that described in the
foregoing discussion regarding centering core 207 and cutter 213 as
illustrated in FIG. 18. In an operational mode, an embodiment as
shown in FIGS. 8-14 is used with an embodiment according to this
Example replacing centering core 207 and cutter 213 as shown in the
cross-sectional view of FIG. 20. An embodiment according to this
Example preferably has the general configuration and overall
features of the embodiment shown in FIG. 18 as discussed in the
context of Example 5.
[0257] Although not shown in FIG. 19, an embodiment according to
this Example is preferably provided with a centering lumen. This is
the lumen that is longitudinally occupied by wire 150 in the
cross-sectional view shown in FIG. 20.
[0258] Instrument characteristics, radiation dosages, and
techniques for implementing laser applications for clinical cutting
or ablating are disclosed in Fiber Optic Angioscopes, pp. 44-51;
Cardiovacular Applications of Laser Technology, pp. 1-27; Laser
Angioplasty, pp. 771-787; Surgical Properties and Applications of
Sealed Off CO.sub.2 Lasers, pp. 231-239; Laser Tissue Interactions,
pp. 45-47 and 216-221; Excimer Laser Angioplasty in Human Artery
Disease, pp. 69-72; R. A. Kirschner, The Nd-YAG Laser-Applications
in Surgery, in Laser Systems for Photobiology and Photomedicine,
edited by A. N. Chester, S. Martellucci, and A. M. Scheggi, pp.
53-56, Plenum Press (1991); and Nonocclusive Excimer Laser-Assisted
End-to-Side Anastomosis, pp. S138-S142.
[0259] The cauterizing effects of radiation may offer an advantage
over mechanical cutters. As indicated in the discussion of the
preceding Example, however, a mechanical cutter is expected to be
currently less costly than a device that relies on radiation.
Example 7
[0260] To describe this exemplary embodiment of the anastomosis
device of this invention, reference is made to Examples 4-6 and
FIG. 20. In this embodiment, graft vessel 98 is joined to receiving
blood vessel 99 with the aid of welding such as laser welding or
non-laser welding discussed in Examples 4 and 5, and the
anastomosis fenestra is opened with the aid of radiation such as
laser radiation, as discussed in Example 6. An embodiment according
to this Example preferably has the general configuration and
overall features of laser device 400 shown in FIG. 18 as discussed
in the context of Example 4. In this case, laser device 400 is
preferably a multilumen probe that comprises radiation guides for
cutting and for welding as discussed in Examples 4-6.
[0261] Consistent with the discussion of the preceding Examples,
the use of radiation for joining the anastomosis structures and for
opening the anastomosis fenestra can lead to a considerable
simplification of the anastomosis device because of the significant
reduction in mechanical and moving parts, but anastomosis devices
that rely on radiation for joining the anastomosis structures and
for opening the anastmosis fenestra are likely to be more expensive
than mechanical counterparts.
Example 8
[0262] To describe this exemplary embodiment of the anastomosis
device of this invention, reference is made to Examples 4 and 5 and
FIG. 21. In this embodiment, a source of radiation such as a laser
welding device as described in Example 4, is supplemented with a
soldering material. A solder such as proteinaceous material is
preferably applied to the site where receiving blood vessel 99 is
to be joined to graft vessel 98 and then laser light is applied to
seal the solder to the tissue surfaces. It has been reported that
blood loss is reduced in human PTFE arteriovenous fistulae sealed
with solder, Laser Tissue Welding, page 400.
[0263] Solders used in embodiments of this Example are preferably
biological glues that are based on proteins. In one embodiment
according to this Example, albumin is used as solder.
[0264] Solder can be applied to the anastomosis area with an
applicator that is built into the laser welding device as shown in
FIG. 21 or with an applicator that is separately handled. Whether
built as part of a laser welding device or not, clinical solder
applicators are devices which, like clinical glue applicators, are
well known in the art.
[0265] In other embodiments of this Example, soldering is enhanced
by photoenhancement. Photoenhanced laser soldering relies on a
chromophore that is added to the solder to focus light absorption
in the solder and thus avoid or reduce radiation damage to the
anastomosed vessels. Indocyanine green, is a preferred chromophore
for enhancing vascular welding with near infrared diode laser.
[0266] An embodiment according to this Example preferably has the
general configuration and overall features of laser device 400
shown in FIG. 18 as discussed in the context of Example 4 and it
more specifically can be represented by laser device 401 shown in
FIG. 20. In this case, laser device 400 can be supplemented with at
least one lumen for a solder applicator. In particular, FIG. 21
shows a longitudinal cross section of an embodiment of the end of a
laser device near the anastomosis site. In this exemplary
embodiment, solder 173 is supplied through lumen 174 and it is
directed by tip 172 to the contact region 175 between graft vessel
98 and receiving blood vessel 99. As more precisely described in
other Examples, glue is delivered in one embodiment of this
invention as solder 173 is delivered in the embodiment shown in
FIG. 21. Device, 179 can be one or a plurality of devices that
deliver radiation for cutting, sealing or soldering. Devices 171
represents a cross-sectional view of conduits 144 shown in FIG. 19
and discussed in Example 6, they represent in other embodiments of
the invention the guides that deliver radiation for opening the
anastomosis fenestra as discussed in Example 7, or, in still other
embodiments, a combination of both.
[0267] FIG. 21 schematically illustrates an exemplary embodiment of
a device that holds graft vessel 98 to be anastomosed. This is
accomplished in the embodiment shown in FIG. 21 by tubular graft
vessel holder 177 that has a feature or plurality of features that
releasably hold graft vessel 98 near its end. In particular, this
feature can be penetrating point 178, but it can be embodied by any
other feature that detachably holds graft vessel 98.
[0268] Instrument characteristics, compositions, changes in tensile
strengths, and techniques for implementing laser solder have been
disclosed in Laser Tissue Welding, pp. 389-392, and in Human
Albumin Solder for Laser Tissue Welding, pp. 577-580, publications
which have been incorporated herein in their entirety by
reference.
[0269] By combining the effects of radiation and that of solder,
this Example illustrates a feature of the several mechanical,
radiation-based and chemical devices discussed in the exemplary
embodiments of this invention. This feature is the combination of
several procedures in the practice of vascular anastomosis
according to this invention. Consistently with this feature, a
mechanical procedure that relies on staples, clips or suture can be
combined with a radiation-based procedure or with a procedure that
relies on chemical effects for joining anastomosed structures. The
plurality of possible combinations used in opening the anastomosis
fenestra and/or joining the anastomosed structures is not described
in further detail because these combinations can be performed in
light of this disclosure, preferred embodiments and illustrative
Examples.
Example 9
[0270] To describe this exemplary embodiment of anastomosis device
200 of this invention, reference is made to Examples 6 and 7.
Whether the anastomosis fenestra is opened with a mechanical device
such as cutter 213 or with radiant energy such as with an
embodiment according to Example 6, a biocompatible adhesive or glue
can be used for sealing graft vessel 98 to receiving blood vessel
99. After or before the anastomosis fenestra is opened, glue is
applied to the anastomosis area around the anastomosis fenestra
with an applicator that is built into the device used for opening
the anastomosis fenestra or with an applicator that is separately
handled. Clinical glue applicators are devices that, whether
designed to be handled separately or as a part of a mechanical or
laser guide device, are well known in the art. In particular, glue
can be delivered to the anastomosis area as solder is delivered and
with applicators that are similar to those discussed in the context
of Example 8. The exemplary embodiment of laser device 401 shown in
FIG. 21 illustrates a possible embodiment according to this Example
in which applicator 174 delivers glue rather than solder 173.
[0271] More specifically, the cross-sectional view of FIG. 21
schematically shows part of an embodiment according to this Example
with a series of devices 171 for delivering radiation, an
applicator 174 for delivering glue or solder 173, and graft vessel
98 held by penetrating point 178 within an annular lumen between
graft vessel holder 177 and the anastomosis device of this Example.
This annular lumen is an exemplary illustration of the annular
lumen referred to in Example 4. Devices 171 for delivering
radiation are preferably optical fibers for delivering laser
radiation for opening the anastomosis fenestra. Applicator 174 for
delivering glue or solder can comprise a cartridge (not shown) and
an applicator mechanism (not shown) for releasing the glue or
solder in a controlled manner. Partially everted end 97 of graft
vessel 98 is preferably and temporarily held with the aid of
attachment device 177 while the anastomosis is being performed. In
a specific embodiment, the cartridge can be a suitably modified
syringe similar to the preloaded syringes in which fibrin glue
Tissucol is commercially available.
[0272] Instrument characteristics, compositions, and techniques for
clinical sealing with glue have been disclosed in Histoacryl Glue
as a Hemostatic Agent, p. 897; Photopolymerizable Blood Vessel
Glue, pp. 901-907; Telescoping and Glue Technique, pp. 1401-1408;
Microvascular Anastomosis With Minimal Suture and Fibrin Glue, pp.
306-311; Thrombogenic Effects of Fibrin Sealant on Microvascular
Anastomoses, pp. 415-419; and Novel Vascular Sealing Device, pp.
82-91.
[0273] The use of fibrin glue can have a dual purpose in the
context of this invention because it can be used as an adhesive for
sealing graft vessel 98 to receiving blood vessel 99 and
alternatively, or in addition, it can be used for its properties as
a laser shield to protect tissue from certain laser radiation. On
the other hand, a number of glues that effectively join anastomosed
structures do not offer the required degree of biocompatibility and
can lead to tissue necrosis.
[0274] Summary of Preferred Embodiments
[0275] The elements of the embodiments of this invention disclosed
hereinabove, equivalents thereof, and their functionalities can be
expressed as means for performing specified functions as described
hereinbelow.
[0276] Any one of a plurality of devices such as an anvil formed
from a hard material such as tempered stainless steel, a laser
shield anvil, a soft anvil, a balloon anvil, a combination of
balloon and puncture resistant balloon sheath, an anvil with
abrasion resistant material, an anvil with puncture resistant
material, an anvil with distortion resistant material, and an anvil
with an effective radiation absorbing material are exemplary
embodiments of anvils. Note, however, that a tempered stainless
steel anvil is preferred for ease of use. Additionally, each anvil
is an example of anvil means for engaging the intima of the wall of
a receiving blood vessel. Note that the balloon anvils disclosed
herein are also examples of balloon anvil means for engaging the
intima of a receiving blood vessel after being inflated.
[0277] The intraluminally directed anvil apparatus of this
invention can have one or a plurality of access ports or luer
fittings, and it can have one or a plurality of lumens.
Additionally some embodiments of the intraluminally directed anvil
apparatus can be utilized without a catheter tube to be moved
within a blood vessel or other lumen to an anastomosis site.
[0278] Embodiments of the intraluminally directed anvil apparatus
of this invention are provided with a positioning means for
intraluminally positioning the anvil at the anastomosis site.
Examples of this positioning means are provided by a positioning
wire such as wire 152, by positioning shaft 182, and in embodiments
of a balloon anvil with no positioning lumen such as balloon anvil
500, by positioning shaft 550. The positioning wire 152,
positioning shaft 182, and positioning shaft 550 are also examples
of a positioning stem.
[0279] Memory staples, memory clips, clips, staples with
penetrating puncturing ends, staples with hooked puncturing ends,
and staples with pre-bent prongs, staples with geometric
modifications of the shapes thereof, and combinations thereof are
exemplary embodiments of staple means for joining graft vessel 98
to receiving blood vessel 99 of this invention. Staple means,
suture thread and combinations thereof are examples of means for
mechanically joining graft vessel 98 to receiving blood vessel 99
of this invention.
[0280] Biocompatible adhesives or glue, solder, biological
procoagulant solution, a combination of a chromophore and solder,
and combinations thereof are exemplary embodiments of means for
chemically joining graft vessel 98 to receiving blood vessel 99 of
this invention.
[0281] Tissue welding radiation, such as laser radiation or
radiofrequency radiation, the combination of substances and
radiation for laser sealing, and combinations thereof are exemplary
embodiments of radiation-based means for joining graft vessel 98 to
receiving blood vessel 99 of this invention.
[0282] Means for mechanically joining graft vessel 98 to receiving
blood vessel 99, and combinations thereof, means for chemically
joining graft vessel 98 to receiving blood vessel 99, and
combinations thereof, radiation-based means for joining graft
vessel 98 to receiving blood vessel 99 of this invention and
combinations thereof, and combinations of such mechanical means,
such chemical means, and such radiation-based means for joining
graft vessel 98 to receiving blood vessel 99 are exemplary
embodiments of the means for joining graft vessel 98 to receiving
blood vessel 99 of this invention.
[0283] Circumferential staple guide rings, non-circumferential
staple guide rings, orthogonal staple guide rings, non-orthogonal
staple guide rings, pre-loaded anastomosis rings, and combinations
thereof are exemplary embodiments of the staple guide means for
guiding staple means of this invention.
[0284] Circumferential anastomosis rings, orthogonal anastomosis
rings, non-circumferential anastomosis rings, non-orthogonal
anastomosis rings, pre-loaded anastomosis rings, and combinations
thereof are exemplary embodiments of the anastomosis ring means for
maintaining an end of a graft vessel in a desired position for
end-to-side anastomosis. Permanent anastomosis rings, biocompatible
dissolvable anastomosis rings, and removable anastomosis rings are
also examples of such anastomosis ring means. However, permanent
anastomosis rings are also examples of anastomosis ring means for
maintaining an end of a graft vessel in a desired position and for
providing support around the opening formed in the receiving blood
vessel after the end of the graft vessel is attached to the
receiving blood vessel at the anastomosis site.
[0285] Graft vessel holding tubes as discussed in Examples 8 and 9
are examples of tubular graft vessel holding means for holding an
end of a graft vessel in a desired position for end-to-side
anastomosis. Such holding tubes are particularly useful when
joining is achieved by chemical means or radiation-based means for
joining a graft vessel to a receiving blood vessel. Such graft
vessel holding tubes as well as anastomosis rings are examples of
graft vessel holding devices. Additionally, tubular graft vessel
holding means and anastomosis ring means are both examples of graft
vessel holding means for holding an end of a graft vessel in a
desired position for end-to-side anastomosis.
[0286] Embodiments of the attachment means for attaching the wall
of the receiving blood vessel to the end of the graft vessel of
this invention include staple delivery means for delivering staple
means such as the staple devices disclosed herein for joining the
graft vessel to the receiving blood vessel; means for suturing an
end of the graft vessel to the wall of the receiving blood vessel
such as the suturing devices disclosed herein; means for clipping
an end of the graft vessel to the wall of the receiving blood
vessel such as the clipping devices disclosed herein; means for
radiation welding an end of the graft vessel to the wall of the
receiving blood vessel such as the devices for radiation welding
disclosed herein and in particular the laser welding devices
disclosed in Example 4 and radiofrequency radiation welding devices
disclosed in Example 5; means for laser sealing an end of the graft
vessel to the wall of the receiving blood vessel such as the laser
sealing devices disclosed herein; means for soldering an end of the
graft vessel to the wall of the receiving blood vessel such as the
devices for soldering disclosed in Example 8; and means for gluing
an end of the graft vessel to the wall of the receiving blood
vessel such as the devices for gluing disclosed herein.
[0287] Centering core 207, a centering lumen, an axially extending
tube, guide or any other similar passage that provides a housing
for extending the piercing wire therethrough and, in general, a
conduit disposed for receiving the wire of this invention are
exemplary embodiments of the centering means for centering the
staple delivery means over the anastomosis site by receiving the
piercing wire of an intraluminally directed anvil apparatus.
[0288] Cutter 213 and devices that deliver radiation for opening
the anastomosis fenestra as disclosed in Examples 4-5, and 7;
combinations of a cutter and such devices are exemplary embodiments
of the cutting means for forming an opening in the wall of the
receiving blood vessel of this invention.
[0289] As indicated hereinabove, a staple delivery device is an
example of staple delivery means for delivering staple means for
joining graft vessel 98 to receiving blood vessel 99. The staple
delivery means comprises staple engaging means for engaging the
staples and activation means for acting on the staple engaging
means to enable the staple engaging means to push the staples
through the end of the graft vessel, through the receiving blood
vessel around the opening in the receiving blood vessel, and
through the anastomosis ring means. Staple engaging device 219 and
functionally corresponding mechanisms are exemplary embodiments of
the staple engaging means for engaging staples.
[0290] Activation sheath 233 and functionally corresponding parts
in staple delivery devices are exemplary embodiments of the
activation means for acting on the staple engaging means of this
invention.
[0291] Exemplary embodiments of the means for anastomosing the wall
of the receiving blood vessel with the end of a graft vessel
according to this invention are provided by the set comprising
attachment means and cutting means; by the set comprising
attachment means, cutting means and centering means; by the set
comprising staple delivery means, centering means, anastomosis ring
means, and cutting means; by the set comprising clipping means,
centering means and cutting means; by the set comprising suturing
means, centering means, and cutting means; by the set comprising
radiation welding means, centering means and cutting means; by the
set comprising laser sealing means, centering means and cutting
means; by the set comprising soldering means, centering means and
cutting means; by the set comprising gluing means, centering means,
and cutting means; and by any of the previously discussed
embodiments with additional probes such as sensors and mechanical
devices such as forceps, cutters and extractors.
[0292] The exemplary embodiments shown in FIGS. 1-21 and disclosed
in the preceding discussion are not meant to be mutually exclusive.
On the contrary, features of these exemplary embodiments can be
suitably combined to generate embodiments of intraluminally
directed anvil apparatus and of anastomosis means that are
additional exemplary embodiments of the present invention. These
additional combinations, however, can be performed with the aid of
the objectives and teachings herein contained and ordinary skills
in the art; thus no other combinations are offered as additional
explicit examples.
[0293] The present invention may be embodied in other specific
forms without departing from its spirit or essential
characteristics. The described embodiments are to be considered in
all respects only as illustrative and not restrictive. The scope of
the invention is, therefore, indicated by the appended claims
rather than by the foregoing description. All changes which come
within the meaning and range of equivalency of the claims are to be
embraced within their scope.
[0294] It will be obvious to those having skill in the art that
many changes may be made to the details of the above-described
embodiments of this invention without departing from the underlying
principles thereof. The scope of the present invention should,
therefore, be determined only by the following claims.
* * * * *