Passive fixation anastomosis method and device

A passive fixation device, defined by a generally elongated body with proximal and distal ends, and a connecting member to connect the two, is used for the anastomosis of body lumens without sutures. The proximal and distal ends are non-deployed in a non-deployed position, and are deployed in a deployed position. While in the non-deployed positions, the passive fixation device is inserted into one or more body lumens. After insertion, both the proximal and distal ends are deployed and become expanded. One end is first deployed, and then the other. The deployed proximal end becomes retained in a first lumen, and the deployed distal end becomes retained in a second lumen. In one embodiment, the first lumen is the urethra, and the second lumen is the bladder. The two lumens are permitted to become anastomized without sutures. The passive fixation device may be made of different materials and can have coiled proximal and distal ends that are expanded to their deployed positions by a Foley catheter. Additionally, the passive fixation device can be a tightly wound coil that is self-deployed when it is advanced out of a delivery catheter. The coil can also be made of a shaped memory metal. At certain temperatures, it becomes deployed. With a change in temperature, either higher or lower, the coil collapses, and is then removed from the respective body lumen.

BACKGROUND OF THE INVENTION 
1. Field of the Invention 
This invention relates to a method and apparatus for joining together two 
or more hollow body lumens, and more particularly, to a method and 
apparatus for anastomosis of body lumens without the use of sutures, 
staples or clamps. 
2. Description of Related Art 
There are many surgical procedures requiring the connection of vessels, 
hollow organs and other structures, collectively body lumens. Coronary 
surgery is an example of such a procedure. In certain heart operations 
where bypass surgery is performed, sections of a coronary artery to the 
heart may either by completely replaced, or actually bypassed during heart 
bypass surgery. While some of these arteries are large, and more easily 
manipulated by the surgeon, other body lumens are smaller and more 
difficult to manipulate and hold in position while joining ends thereof 
after a transectional operation. These procedures typically use devices 
that employ staples, clamps or sutures. 
More specifically to surgical procedures involving the prostate, radical 
retropubic prostatectomy is an established method for the treatment of 
patients with localized carcinoma of the prostate gland. Additionally, a 
prostatectomy may be performed for a variety of different medical reasons. 
Complications include intraoperative hemorrhage, postoperative erectlie 
impotence, stricture formation as well as possible disruption of the 
urogenital diaphragm which can render the patient incontinent. 
Unfortunately, impotence and incontinence are frequent occurrences 
resulting from many known radical prostatectomy procedures. 
Prostatectomy usually involves division of the urethra at the apex of the 
prostate and removal of the prostate, and the stump of the urethra can 
retract into the adjacent tissue, the urogenital diaphragm. Two 
significant challenges to the surgeon are reexposure of the urethra, as 
well as avoiding nicking the urogenital diaphragm while performing an 
anastomosis of the urethra to the bladder. 
Essentially, the procedures performed to date require that the surgeon 
grasp the end of the transected urethra and stretched it to the mating end 
of the urethra at the bladder with one hand, and with the other hand 
perform delicate suturing with tiny, fine needles. Microsurgery of this 
nature is highly dependent on the skill of the surgeon. Some are much 
better at this kind of delicate surgery than others. 
A number of different microsurgery solutions, many of which are suitable to 
a variety of surgical procedures, have been proposed. In U.S. Pat. No. 
4,553,543, a plurality of flexible suture needles are held in place in 
slots in a flared core by a sleeve that extends about the flexible suture 
needles and the core. The suture needles, and attached threads, penetrate 
the walls of a body duct, such as a blood vessel, by inserting the flared 
end of the core into the severed body duct. Needles are then forced to 
move longitudinally in the slots against the flared end of the core so 
that they bend outwardly, and are driven through the wall of the duct. 
A number of patents have issued relating to anastomosis and tissue 
ligation, including: U.S. Pat. Nos. 2,897,820; 4,784,139; 4,911,164; and 
5,209,725. Patents that directed to urethra and bladder anastomosis 
include: U.S. Pat. Nos. 4,848,367; 4,873,977; and 5,047,039. 
The patents for urethra and bladder anastomosis involve suturing or other 
non-passive fixation techniques. As previously mentioned, if the 
urogenital diaphragm is nicked, as can occur with sutures, then the 
patient may become incontinent. Accordingly, it would be desirable to 
provide a passive fixation device and method which does not require 
sutures or other types of invasive treatment. Such an apparatus and method 
would be useful in a variety of surgical procedures where it is necessary 
to join two body lumens. 
SUMMARY OF THE INVENTION 
Accordingly, it is an object of the present invention to provide a passive 
fixation method and apparatus for general use in the anastomosis of body 
ducts, vessels, organs, and other structures, collectively body lumens, 
without the use of sutures, staples or clamps. 
Another object of the present invention is to provide a passive fixation 
method and apparatus for anastomosis of the urethra to the bladder without 
the use of sutures, staples or clamps. 
Still a further object of the present invention is to provide a method and 
apparatus for anastomosis of body lumens without sutures, staples or 
clamps, that is removable from the body once anastomosis is complete. 
Another object of the present invention is to provide a method and 
apparatus for anastomosis of body lumens that dissolves or is absorbed by 
the body once anastomosis is complete. 
Yet another object of the present invention is to provide an anastomosis 
device that includes a passive fixation device and a catheter that 
activates the passive fixation device once it is inside the desired lumen, 
with the catheter being removed after the passive fixation device has 
become retained in the lumen. 
These and other objects of the present invention are achieved with a 
passive fixation device defined by a generally elongated body with a 
proximal end and a distal end. The ends are connected by a connecting 
member. Both ends are non-deployed in a non-deployed position, and are 
deployed in a deployed position. While in the non-deployed positions, the 
passive fixation device is inserted into one or more body lumens. After 
insertion, both the proximal and distal ends are deployed and become 
expanded. One end is first deployed, and then the other. The deployed 
proximal end becomes retained in a first lumen, and the deployed distal 
end becomes retained in a second lumen. 
In one embodiment, the first lumen is the bladder, and the second lumen is 
the urethra. The passive fixation device is positioned around a Foley type 
catheter that includes two inflatable balloons. The catheter, with the 
passive fixation device, is inserted into the urethra. The first balloon 
is inflated, causing the proximal end of the passive fixation device to 
become expanded to its deployed position and become retained in the 
urethra. At this time, the distal end of the catheter is either in the 
bladder, or if not then it is moved towards the bladder. Because the 
expanded deployed proximal end is now retained in the urethra, the urethra 
is also moved towards the bladder. The catheter passes through the 
urogenital diaphragm without causing any nicks or disruptions to its 
structure. After the proximal end of the passive fixation device has been 
introduced into the bladder in its non-deployed position, it becomes 
deployed, expanded and retained in the bladder. The urethra and bladder 
are now positioned in a contact or almost contact relationship so that the 
two can become anastomized. After each end of the passive fixation device 
is deployed, the associated balloon of the catheter is deflated. Once the 
proximal end of the passive fixation device is positioned and retained in 
the bladder, the catheter is then removed. Because the connecting member 
is of a much smaller size than either of the proximal or distal ends, 
typically only a single strand of wire or small sheet or material, its 
interaction with the urogenital diaphragm is very limited. The risk of 
incontinence is minimized. 
The passive fixation device can have coiled proximal and distal ends that 
are connected with a single strand of wire. Alternatively, it can be made 
of one or more sheets of material that can be expanded to the deployed 
positions. Preferably, the sheets include a plurality of perforations so 
that after anastomosis is complete the sheets can be gently unraveled 
along the perforations for easy removal through the urethra. When the coil 
is used, it becomes uncoiled after anastomosis and is also easily removed 
through the urethra with a resectoscope. Additionally, the proximal and 
distal ends of the passive fixation device can have different geometric 
configurations, depending on the application. Each may be conical, 
cylindrical as well as other geometries that are suitable for positioning 
and retaining the respective end in a desired body lumen. 
The passive fixation device may consist of a tightly wound coil that 
becomes self-deployed as it is advanced out of a delivery catheter. 
Additionally, the passive fixation device can be made of a shaped memory 
metal. At either elevated or lower temperatures the coil is deployed, or 
it collapses, allowing it to be removed through itself. 
A variety of different materials can be used for the passive fixation 
device. The coil can constitute different gauges of wire, depending on the 
body lumens to be anastomized. Both non-metals and metals can be used. 
Memory metals are suitable, as well as materials that are absorbable and 
dissolvable. Some dissolvable materials gradually dissolve as anastomosis 
proceeds, and can be passed through the urine when the application is the 
anastomosis of the bladder to the urethra. Other dissolvable materials can 
be activated with an initiating media such as ultra-sound. 
Advantageously, the present invention provides a method and apparatus for 
the anastomosis of body lumens without the use of sutures, staples or 
clamps. It is particularly useful for the anastomosis of the urethra and 
bladder following prostatectomy because the urogenital diaphragm is not 
disrupted and the change of nicking it are greatly reduced. The present 
invention is suitable with other surgical and microsurgical applications, 
particularly when it is desirable to avoid suturing.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
A passive fixation device, suitable for the anastomosis of vessels, ducts, 
organs, or other body structures, collectively body lumens, is illustrated 
in FIGS. 1 through 3. For purposes of the present invention, a passive 
fixation device is one where ends or areas of body lumens are brought 
together in an adjacent, or nearly adjacent relationship, held there a 
sufficient length of time in order to permit anastomosis of the lumens to 
occur without the use, or alternatively the minimal use of sutures, 
staples, clamps, or other invasive retaining structures. Preferably, 
anastomosis proceeds without the use of such invasive retaining materials. 
A generally elongated body 10 with a proximal end 12, a distal end 14 and a 
connecting section 16. Ends 12 and 14 can be in deployed and non-deployed 
positions. In FIGS. 1 through 3, ends 12 and 14 are illustrated as being 
in non-deployed positions. In the non-deployed positions, passive fixation 
device 10 is inserted into a desired body lumen, including but not limited 
to the urethra and bladder. The non-deployed positions provide for the 
easy introduction of passive fixation device 10 into the body lumen, 
without damaging the lumen. If passive fixation device 10 is introduced 
into the body lumen in a deployed position, then it is far more difficult 
to insert device 10 into the lumen without cutting, shearing, tearing or 
imparting some other sort of damage to the lumen. 
In FIG. 1, passive fixation device 10 is made of a coiled proximal end 12, 
coiled distal end 14 and a single strand of connecting medium, including 
but not limited to a wire-like structure. Coiled ends 12 and 14 are shown 
as being generally cylindrical in the non-deployed positions, but other 
geometric configurations are possible. In FIG. 2, passive fixation device 
10 is made of a generally solid material, which may consist of one or more 
sheets. Preferably, the solid material includes a plurality of 
perforations in order to facilitate the removal of passive fixation device 
10 from the confined area once anastomosis is complete, or nearly 
complete, as more fully explained hereafter in this specification. Ends 12 
and 14 are connected by a generally narrow, connecting section 16, made of 
preferably the same material as ends 12 and 14. FIG. 3 shows that instead 
of a completely solid structure, passive fixation device 10 can be made of 
a generally solid material. In FIG. 3, one embodiment is shown where the 
solid material is semi-solid and includes a plurality of apertures and 
perforations. The solid material has sufficient structural integrity so 
that it can be expanded to the deployed position and remain deployed so 
that ends 12 and 14 become retained in their respective lumens. Thus 
instead of the coiled structure of FIG. 1, it is possible to employ a 
solid structure, or one that is nearly solid, so long as in the deployed 
position ends 12 and 14 remain sufficiently expanded and deployed to be 
retained in the desired lumen. 
FIGS. 4 through 8 show ends 12 and 14 in different deployed geometric 
configurations. In FIG. 4, proximal end 12 is deployed to a generally 
cylindrical shape while distal end 14 is expanded to a conical 
configuration. Proximal and distal ends 12 and 14 are expanded to conical 
geometries in FIG. 5, while in FIG. 6, proximal and distal ends 12 and 14 
are expanded to generally cylindrical shapes. In FIGS. 7 and 8, passive 
fixation device 10 is made of a substantially solid material and proximal 
and distal ends 12 and 14 are expanded to conical and cylindrical 
geometries respectively. 
While proximal and distal ends 12 and 14 are inserted into desired body 
lumens, they are usually in the non-deployed positions in order to permit 
easy insertion with minimum disruption to the body lumen. In deployed 
positions, each end 12 and 14 is expanded so that least a portion of the 
end has a diameter that is greater than at least a portion of the body 
lumen where it is deployed. In this manner, proximal and distal ends 12 
and 14 are retained within the lumens and become temporary fixed therein 
until anastomosis is complete, or complete enough so that passive fixation 
device 10 can be removed from the lumen. Sufficient expansion in the 
deployed position is produced in order to achieve the desired retaining 
effect. For example, if two vessels are to be joined, proximal and distal 
ends 12 and 14 are initially positioned in the two vessels in non-deployed 
positions. They are subsequently deployed, causing each end 12 and 14 to 
have at least a portion with a diameter that is greater than at least a 
portion of the lumen's diameter in which ends 12 or 14 become retained. If 
the lumen is a body organ, either proximal or distal end 12 or 14 is 
inserted into the organ in the non-deployed position, and then expanded to 
the deployed position with at least a portion of its diameter greater than 
at least the diameter of one section of the organ, permitting the deployed 
end to become "seated" in the organ. 
Referring once again to FIG. 1, and without limiting the scope of the 
present invention, in one embodiment passive fixation device 10 has a 
proximal end 12 with length of about 1.5 cm, connecting member 16 length 
of about 2.5 cm and distal end 14 length of about 2.5 cm. The coil is made 
of 32 French wire. 
A variety of materials can be used for passive fixation member 10, 
including but not limited to materials suitable for coiling such as 
different gauges of wire. The wire can be made of biocompatable materials 
including various metals such as copper, nitinol and memory wire. 
Additionally, a wire like structure can become coiled with the application 
of a first current, and uncoiled when a second is applied. Different solid 
materials, or semi-solid materials, that can be used include but are not 
limited to plastics, polyester, polyolefin, nylon, polyurethane, and the 
like. Other suitable materials are absorbable by the body once anastomosis 
is sufficiently completed that passive fixation device 10 is no longer 
needed. Additionally, dissolvable materials, that can pass through the 
body, for example with different body fluids such as blood, urine, and the 
like, can be used. Some of the materials can be dissolved upon the 
application of an activating mechanism including but not limited to 
ultra-sound. A tab 12 can incorporated into either end of proximal or 
distal ends 12 and 14, in order to facilitate remove of passive fixation 
device 10 from the body structure. The tab can be in the form of a turned 
up bead that can be lifted up away from its point of contact with a body 
lumen, and then it is pulled out through itself. This is particularly 
useful when distal end 14 is unseated and the coil pulls through itself 
with minimal disruption of body lumens. The tab can also serve the 
purpose, in certain applications, of being seated within the body lumen so 
as to engage and retain proximal or distal ends 12 and 14 therein. 
Passive fixation device 10 can be inserted into a body lumen with the use 
of a catheter, such as a Foley catheter 18 of FIG. 9. Foley catheter 18 is 
particularly useful for urology applications, but it will be appreciated 
that the present invention is not limited to urology. For purposes of the 
following discussion, the use of Foley catheter 18 will be for anastomosis 
of a urethra with a bladder following a prostatectomy. 
Catheter 18 has en elongated tube 20 that has a proximal end 22 that 
remains outside of a patient's body, and a distal end 24 that is 
eventually placed in the patient's bladder. Catheter 18 is inserted 
through the urethra as shown in FIG. 12. Elongated tube 20 includes a main 
lumen 26 extending from an inlet opening 28, located at distal end 24 of 
catheter 18, to proximal end 22. 
An inflation lumen 30 extends through elongated tube 20 connecting a source 
of fluid located at the exterior to the patient's urethra (not shown) at 
proximal end 22 to a balloon 32. Inflation lumen 30 terminates in an 
inflation outlet 34 formed in elongated tube 20. Introduction of fluid 
causes balloon 32 to inflate, and it deflates when the fluid is removed. 
As shown in FIG. 11, catheter 18 includes two balloons, 34 and 36 which are 
inflated by one or more inflation lumens 30 and 38. This embodiment is 
particularly suitable for use of passive fixation device 10 following 
prostatectomy for the anastomosis of the urethra with the bladder in a 
sutureless procedure. Passive fixation device 10 is positioned around the 
exterior of elongated tube 20 in FIG. 12. In FIG. 13, passive fixation 
device 10 is positioned so that balloons 32 and 36 are inflated, causing 
proximal end 12 and distal end 14 to be expanded to their deployed 
positions. 
Catheter 18 can also include one or more distensible members that are 
mechanically extended and retracted in order to deploy proximal and distal 
ends 12 and 14 of passive fixation device. An actuator causes the 
distensible members to become mechanical distended. After proximal and 
distal ends are deployed, the distended ends are retracted. The 
distensible members can be used in place of balloons 32 and 36. 
The geometry of balloons 32 and 36 can be such that when inflated they 
impart various geometrical configurations that are then used to expand 
proximal and distal ends 12 and 14. As shown in FIG. 13, balloon 32 is 
inflated to a conical shape, causing distal end 14 to become expanded to 
the conical coil shown in FIG. 4. Balloon 36 expands spherically, causing 
proximal end 12 to become cylindrically expanded, as also shown in FIG. 4. 
Other geometries of balloons 32 and 36 are possible, depending on the 
desired deployed shape of distal end 14 and proximal end 12. It will be 
appreciated that the deployed proximal and distal ends 12 and 14 of 
passive fixation device 10 can be initially formed such that when an 
expanding force, such as imparted by either balloon 32 or 36, is applied 
to ends 12 and 14 they will form the desired deployed geometries. For 
example, a coil may be wound with various degrees of winding intensity 
such that with an even application of force, such as with a spherical 
balloon, it will become deployed in a conical geometry. 
With reference again to FIG. 12, catheter 18 and passive fixation device 10 
are inserted into the urethra, as shown in FIG. 10, following the removal 
of the prostate. While inserted into the urethra, proximal and distal ends 
12 and 14 of passive fixation device are in non-deployed positions. As 
proximal end 12 is near the distal end of the urethra it is deployed and 
expands to a cylindrical, conical or other geometric configuration, such 
that proximal end 12 becomes retained in the urethra. Balloon 36 can then 
be deflated. At this time, distal end 14 of passive fixation device 10 may 
already be within the bladder. If not, then catheter 18 is advanced 
further, without disrupting the urogenital diaphragm, with distal end 24 
of catheter 18, and distal end 14 of passive fixation device, entering the 
bladder. Balloon 32 is then deployed, causing distal end 14 to become 
deployed in a conical or other suitable geometry so that distal end 14 
becomes retained within the bladder. As catheter 18 is advanced into the 
bladder, the distal end of the urethra is moved in a position adjacent, or 
nearly adjacent to the bladder. As shown in FIG. 14, upon deployment of 
distal end 14 of passive fixation device 10, the bladder and distal end of 
the urethra are urged towards each other in a relationship that permits 
anastomosis between the two. Now that passive fixation device 10 is 
retained in both the urethra and bladder, catheter 18 can be removed, or 
it can remain for a desired time to permit drainage of urine through 
catheter 18. 
After a time period, such as for example, but not limited to thirty (30) 
days, anastomosis is essentially complete. Passive fixation device 10 can 
then be removed. Alternatively, it may have already become absorbed by the 
body or dissolved and passed through the urine. 
Passive fixation device 10 is readily removed by using a resectoscope, or 
other suitable instrumentation, to physically grab either proximal or 
distal end 12 and 14 and pull. The unwinding of the coil is shown in FIG. 
16. It will be appreciated that distal end 14 of passive fixation device 
10 can be uncoiled when a resectoscope, cystoscope, or the like grabs 
distal end 14 at the turned up bead portion, unseats the bead from the 
interior of the body lumen, distal end is then pulled out through passive 
fixation device 10 and readily is uncoiled, removed through itself with 
minimal disruption to body lumens. FIG. 17 illustrates that the coil 
becomes generally elongated as it is unwound and is readily removed 
through the urethra. If passive fixation device 10 is made of a solid 
material with perforations, then the resectoscope grabs the solid material 
and unwinds it along the perforations as the resectoscope is pulled away 
from the bladder. 
It will be appreciated that the present invention is applicable to a 
variety of body lumens other than the urethra and bladder. 
In another embodiment of the invention, passive fixation device 10 has 
proximal and distal ends 12 and 14 respectively, that are tight coils in 
the non-deployed (deactivated) states, and each end becomes self expanded 
in the deployed (activated) state. In this embodiment, passive fixation 
device 10 is a tight coil when it is positioned and delivered through the 
use of a delivery catheter 40 (FIG. 18). Passive fixation device 10 can be 
placed in the desired body lumen, and its position can be determined by 
including a platinum, gold, or the like marker at distal end 14. Through 
the use of ultra sound, or the like, the position of distal end 14 is then 
determined. Passive fixation device 10 can be a coil, cone or the like, 
however, for ease of discussion will be referred to as a coil, is wound 
tightly and is in non-deployed (deactivated) state and must be contained 
or it will become deployed without the use of balloons or some mechanism 
to expand it. The coil fits easily within the lumen of delivery catheter 
40. Delivery cathode 40 is then pulled away from the desired body lumen 
where the coil is to be positioned, and with the removal of delivery 
cathode 40 the coil begins to unwind to its deployed (activated) state. 
The unwinding of the coil, with the removal of delivery catheter 40 is 
illustrated in FIG. 19. Optionally, delivery catheter 40 can include a 
mandrel 42 which pushes the coil out of delivery catheter 40. Mandrel 42 
is of sufficient size to occlude the lumen, like a ram rod, yet remain 
longitudinally manipulable over the tortuous course of a body lumen like 
the urethra or other delivery path. Delivery catheter 40 can be still, to 
aid in the positioning of the coil. As is shown in FIG. 20, the coil is 
fully deployed once delivery catheter 40 is removed. It will be 
appreciated that a solid sheet of material, in place of the wound coil, 
can also be employed with this embodiment. 
As previously mentioned, the coil can be made of a shaped memory metal, 
such as nickel titanium, available from Raychem, Menlo Park, Calif. In one 
embodiment, the coil is heated and expanded. Additionally, the coil can be 
preloaded so at a temperature, such as 37 degrees C, it is expanded. At 20 
degrees C, it remains as a tight coil and non-deployed. In this instance, 
the body lumen itself provides the heat to deploy the coil. It is 
initially at this lower temperature. When introduced into the desired body 
lumen, it becomes deployed with the heat from the body lumen. The coil can 
be cooled before insertion and activated with an electrical current. It is 
also possible to heat the coil to a temperature above the body lumen 
temperature, e.g., 45 degrees C, before insertion. After insertion, the 
body lumen brings the coil's temperature down to about 37 degrees C. In 
any of this embodiments, temperature, current, and the like are used to 
cause the tight coil to become activated, deployed, positioned, and seated 
in the respective body lumens. This enables the coil to take its deployed 
shape. In all of these embodiments, the reverse temperature parameter is 
applied to the coil when it is removed. This causes a collapse of the 
coil. 
While particular embodiments of the present invention have been shown and 
described, it will be obvious to those skilled in the art that changes and 
modifications may be made without departing from this invention in its 
broader aspects and, therefore, the appended claims are to encompass 
within their scope all such changes and modifications as fall within the 
true spirit and scope and this invention.