U.S. patent application number 10/886072 was filed with the patent office on 2005-01-06 for method and apparatus for vessel harvesting.
Invention is credited to Suval, William D..
Application Number | 20050004586 10/886072 |
Document ID | / |
Family ID | 33553138 |
Filed Date | 2005-01-06 |
United States Patent
Application |
20050004586 |
Kind Code |
A1 |
Suval, William D. |
January 6, 2005 |
Method and apparatus for vessel harvesting
Abstract
The present invention is a method and device for harvesting a
vessel. The vessel harvester comprises an internal stenting
catheter with proximal and distal ends, a sheath catheter with
proximal and distal ends, and a cylindrical cutting tube that is
attachable to the distal end of the sheath catheter. The vessel
harvester is used to harvest vesseal such as the greater and lesser
saphenous veins, the basilic vein, the cephalic vein, and the
radial artery.
Inventors: |
Suval, William D.; (Apple
Valley, CA) |
Correspondence
Address: |
BRIAN M BERLINER, ESQ
O'MELVENY & MYERS, LLP
400 SOUTH HOPE STREET
LOS ANGELES
CA
90071-2899
US
|
Family ID: |
33553138 |
Appl. No.: |
10/886072 |
Filed: |
July 6, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10886072 |
Jul 6, 2004 |
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09905735 |
Jul 12, 2001 |
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Current U.S.
Class: |
606/159 |
Current CPC
Class: |
A61B 2017/00969
20130101; A61B 17/00008 20130101 |
Class at
Publication: |
606/159 |
International
Class: |
A61D 001/02; A61B
017/22 |
Claims
1-22. (Cancelled)
23. A method for harvesting a vessel from a patient, the method
comprising: opening a vessel in the patient, thereby defining a
vessel portion extending between an opened proximal end and an
opened distal end; threading a flexible elongate member entirely
through the vessel portion until a distal end of the flexible
elongate member protrudes from the distal end of the vessel portion
while a proximal end of flexible elongate member protrudes from the
proximal end of the vessel portion, wherein the flexible elongate
member comprises an elongate guide component slidably coupled to an
elongate pulling component that is substantially coextensive
therewith; coupling a terminal member to the elongate pulling
component of the flexible elongate member distal to the distal end
of the vessel portion, wherein the terminal member is configured to
sever the vessel portion from surrounding tissue of the patient
when drawn along a length of the vessel portion; and drawing the
terminal member through the patient to the proximal end of the
vessel portion, by pulling the elongate pulling component out the
proximal end of the vessel portion while holding the elongate guide
component distal to the distal end of the vessel portion, thereby
severing the vessel portion from surrounding tissue of the
patient.
24. The method of claim 23, further comprising maintaining tension
in the elongate guide component during the drawing step.
25. The method of claim 23, further comprising splitting the
elongate pulling component after it is drawn out the proximal end
of the vessel portion during the drawing step.
26. The method of claim 23, further comprising rotating the
elongate pulling component and the terminal member coupled thereto,
while the pulling component is being drawn out the proximal end of
the vessel portion during the drawing step.
27. The method of claim 26, wherein the rotating step further
comprises causing rotation of the elongate pulling component by
splitting the pulling component along a helical path after it is
drawn out the proximal end of the vessel portion.
28. The method of claim 23, further comprising cutting around an
outer perimeter of the vessel portion using the terminal member,
during drawing step.
29. The method of claim 23, further comprising collecting the
vessel portion in a receptacle connected to the terminal member,
during the drawing step.
30. The method of claim 23, wherein the threading step further
comprises threading the flexible elongate member comprising a
sheath catheter disposed around a stenting catheter.
31. An apparatus for harvesting a length of vessel from a patient,
the apparatus comprising: a flexible elongate guide member longer
than the length of vessel to be harvested; a flexible elongate
pulling member longer than the length of vessel to be harvested and
shorter than the guide member, slidably coupled to the guide member
and substantially coextensive therewith; and a coupling connected
to a distal end of the pulling member, and configured to permit the
guide member to extend past the coupling, the coupling further
configured to couple to a terminal member, wherein the guide
member, the pulling member, and the coupling together comprise an
assembly configured for threading through the length of vessel and
that, when coupled to the terminal member, is configured to sever
the length of vessel from the patient when the terminal member is
drawn along the length of vessel by the pulling member, while at
least a distal end of the guide member is substantially fixed
relative to the patient.
32. The apparatus of claim 31, wherein the pulling member comprises
a sheath catheter.
33. The apparatus of claim 31, wherein the guide member comprises a
stenting catheter.
34. The apparatus of claim 31, wherein the pulling member comprises
a stenting catheter.
35. The apparatus of claim 31, wherein the guide member comprises a
wire.
36. The apparatus of claim 31, further comprising the terminal
member coupled to the coupling.
37. The apparatus of claim 36, wherein the terminal member
comprises a cutter configured to cut around an outer periphery of
the length of vessel.
38. The apparatus of claim 37, wherein the cutter comprises a
circular blade having an inside diameter greater than an outside
diameter of the length of vessel.
39. The apparatus of claim 36, further comprising a receptacle
connected to a distal portion of the terminal member, configured
for collecting the length of vessel.
40. The apparatus of claim 39, wherein the terminal member and the
receptacle together comprise a cylindrical cutting tube.
41. The apparatus of claim 31, wherein the pulling member comprises
a peel-away catheter.
42. The apparatus of claim 31, wherein the pulling member comprises
a peel-away catheter configured to peel along a helix.
43. A vessel harvesting device comprising a flexible elongate guide
member, a pulling member disposed over the guide member and having
proximal and distal ends, and a cutter connectable to the distal
end of pulling member, wherein the guide member and the pulling
member are arranged to be inserted through a length of vessel in an
organism, and the cutter is connectable to the pulling member for
movement relative to a fixed distal end of the guide member along
the outside of the vessel.
44. The apparatus of claim 43, wherein the pulling member comprises
a sheath catheter.
45. The apparatus of claim 43, wherein the guide member comprises a
stenting catheter.
46. The apparatus of claim 43, wherein the pulling member comprises
a stenting catheter.
47. The apparatus of claim 43, wherein the guide member comprises a
wire.
48. The apparatus of claim 43, wherein the cutter comprises a
circular blade having an inside diameter greater than an outside
diameter of the vessel.
49. The apparatus of claim 43, further comprising a receptacle
connected to a distal portion of the pulling member and disposed
behind the cutter, configured for collecting the length of
vessel.
50. The apparatus of claim 49, wherein the cutter and the
receptacle together comprise a cylindrical cutting tube.
51. The apparatus of claim 43, wherein the pulling member comprises
a peel-away catheter.
52. The apparatus of claim 43, wherein the pulling member comprises
a peel-away catheter configured to peel along a helix.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to an apparatus and method for
harvesting vessels, especially veins, for use in bypass grafting
surgical procedures.
BACKGROUND OF THE INVENTION
[0002] Atherosclerosis is a disease that affects hundreds of
thousand of people each year. The disease can occur anywhere
throughout the body including the lower extremities, the carotid
arteries and the heart. When it affects the blood supply to the
heart it is called coronary artery disease. Vascular complications
produced by atherosclerosis, such as stenosis, aneurysm, rupture or
occlusion oftentimes call for surgical intervention. If the disease
is extensive, the affected artery or vessel is no longer reliable
and is often replaced or bypassed around by a bypass graft, usually
referred to as an "autograft." To this end, the involved section of
the vessel is bypassed with an autograft surgically attached
proximal to the lesion and at a point distal to the lesion to
provide a bypass path for blood flow. In a patient who undergoes
coronary artery bypass grafting (CABG) surgery, a non-critical
vessel (artery or vein) is harvested from elsewhere in the body and
is sewn into place in such a manner that reestablishes the flow of
blood to the heart region that had lost or diminished its supply of
blood because of the atherosclerotic lesion.
[0003] The saphenous vein in the leg is a vessel that is commonly
harvested for use as a bypass graft in coronary artery surgery. It
is also common to use the saphenous vein for bypass surgery in the
lower extremity to bypass lesions in the femeral or popliteal
arteries. However, typical procedures for harvesting a saphenous
vein autograft are tedious, time consuming, and cause undesirable
patient trauma. In one harvesting procedure, an incision is made
along the leg for a length corresponding to the length of the
autograft required, wherein the vein is transected and is stripped
from the leg. The incision then must be sutured or stapled along
its length. In some patients, the incision must be made along the
entire length of the leg. The surgery required for harvesting a
vessel in this manner is traumatic to the patient, increases
recovery time, increases the patient's hospital confinement, and
adds to the cost of the coronary artery surgery.
[0004] Another method of harvesting a saphenous vein is by use of
an endoscope. In this method, a few small incisions are made on the
leg over the saphenous vein. The saphenous vein is transected and
ligated at its ends and the endoscope is inserted into the small
incisions. While visualizing the vein with the endoscope, the
entire length of the vein is harvested by slow dissection. The
endoscope is advanced under the skin along the saphenous vein's
length while transecting and ligating its connecting branches until
the entire segment of the saphenous vein is free and is able to be
removed. This method is more advantageous to the patient in that
only a few small incisions are made and much less scarring occurs.
However, the endoscopic harvesting of the vein is a difficult
procedure and takes a substantial amount of time. The increased
time in the operating room increases the cost of the procedure and
increases the risk of infection and complications to the
patient.
[0005] Other vessels are often used as well in bypass surgical
procedures. For example, the radial arteries are often used as
coronary conduits. The lesser saphenous, basilic, and cephalic
veins are also used.
[0006] Accordingly, it would be highly desirable to provide a less
invasive procedure for harvesting vessels, especially the saphenous
vein, which avoids the need for a long incision, is easy to use,
and does not require a substantial amount of time to complete.
SUMMARY OF THE INVENTION
[0007] The present invention provides a fast, uniform, and
inexpensive way to harvest a vessel for bypass surgery. An
embodiment of the present invention comprises an internal stenting
catheter with proximal and distal ends, a sheath catheter with
proximal and distal ends, and a cylindrical cutting tube that is
attachable to the distal end of the sheath catheter. The stenting
catheter is located within the sheath catheter and is used as a
stent to straighten out the vein and to guide the cylindrical
cutting tube around the vein. The sheath catheter is used to pull
the cylindrical cutting tube under the skin and around the vein,
cutting the side branches as it is pulled along the length of the
vein and collecting the vein within the lumen of the cylindrical
cutting tube.
[0008] The present invention is used in the following manner. The
patient is prepared for surgery in standard manner and placed under
proper anesthesia (local or general). A small skin incision is made
at the distal end of the vessel. Next, a small skin incision is
made at the proximal end of the vessel. Using a cut-down technique,
for example the Seldinger Technique, the vessel is isolated and the
vessel is ligated. The stenting catheter and the sheath catheter
are then introduced within the vessel through the distal incision
at the vessel's distal end and advanced to the vessel's proximal
end where it exits the vessel and the proximal skin incision. Next,
the cylindrical cutting tube is placed over the distal end of the
sheath catheter and locked into place. The proximal and distal ends
of the stenting catheter which are outside of the vessel and the
skin are then placed into clamping devices and tension is placed on
the stenting catheter until the catheter is straight. The
cylindrical cutting tube is then advanced through the proximal skin
incision and around the proximal end of the vessel to be harvested.
The sheath catheter is used to pull the cutting tube distally down
around the vessel cutting connective tissue and branches along the
way. The vessel being harvested is collected within the collection
lumen of the cutting tube as it is being cut free from the
connective tissue and branches. Once the cutting tube has been
pulled completely through the course of the vessel, the cutting
tube is then removed from the distal skin incision. The cutting
tube is then cut free from the stenting catheter and the remains of
peel-away catheter. The harvested vessel is then removed from the
lumen of the cutting tube, dilated, and the cut branches are
sutured or clipped according to standard bypass grafting
techniques. The vessel is now ready for the bypass grafting
procedure (CABG or other bypass surgery). The area where the vessel
was removed is then wrapped with elastic wraps to seal the cut
edges and minimize swelling. At the end of the bypass procedure,
the skin incisions are cleaned, any hematomas are expelled, and the
wounds are closed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] For a better understanding of the invention, reference is
now made to the drawings where like numerals represent similar
objects throughout the figures where:
[0010] FIG. 1 is a perspective schematic view of an embodiment of
the present invention for harvesting a vessel;
[0011] FIG. 2 is a cross-sectional view of the embodiment of FIG.
1;
[0012] FIG. 3 is a detailed schematic view of the cutting tube of
FIG. 2;
[0013] FIG. 4 is a cross-sectional view of an alternate embodiment
of the present invention;
[0014] FIG. 5 is a schematic view of a lower extremity of a patient
and the greater saphenous vein;
[0015] FIG. 6 is a schematic view of incisions made on the lower
extremity to harvest the greater saphenous vein;
[0016] FIG. 7 is a schematic view of the stenting catheter and
peel-away catheter passed through the greater saphenous vein;
[0017] FIG. 8 is a schematic view of the stenting catheter with
tension and the cutting tube connected to the distal end of the
peel-away catheter; and
[0018] FIG. 9 is a schematic view of the peel-away catheter being
pulled apart and the cutting tube advancing distally along the
greater saphenous vein cutting connective tissue and side branches
of the vein.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0019] Turning now to FIGS. 1 and 2, the vessel harvester of the
present invention is illustrated. The vessel harvester comprises a
stenting catheter 11 with proximal and distal ends, a sheath
catheter 13 with proximal and distal ends, and a cylindrical
cutting tube 15 with a proximal cutting edge 43 and a distal
connecting port 33. The stenting catheter is located within the
lumen of the sheath catheter. Both the stenting catheter and the
sheath catheter are illustrated within the lumen of a vessel 17
with side branches 18. The cutting tube, on the other hand, is
located around the outside of the vessel. The cutting tube is
connectably attached to the distal end 35 of the sheath catheter
via the connecting port and the connecting prongs 29 and 31 located
on the sheath catheter.
[0020] The stenting catheter 11 can be made out of an appropriately
strong biocompatible material. The catheter can be made from an
extruded biocompatible plastic such as polyurethane or polyethyl
terephtalate, a biocompatible metal such as surgical stainless
steel wire or wire braids, a combination of wire and plastic, or
other readily available materials known in the art. The catheter
has to have enough flexibility to navigate the curved path of the
vessel to be harvested, but also needs to have enough strength such
that when axial tension is applied to straighten out the vessel,
the catheter will not break. The size of the stenting catheter can
vary depending on the length of the vessel to be harvested. For the
greater saphenous vein, the length of the stenting catheter is
about 36 to about 48 inches. For smaller veins, such as the lesser
saphenous vein, the length of the stenting catheter is about 12 to
about 36 inches. The diameter of the stenting catheter is about 1
to about 3 mm. The diameter has to be small enough to fit within
the sheath catheter. Additionally, the catheter has to be fairly
lubricious to allow for the sheath catheter to easily travel along
its axial length when the vessel is being harvested. To this end
the stenting catheter can be coated with a lubricious surface such
as Teflon.RTM. or the like. The distal end of the stenting tube is
provided with a rounded bullet nose member 39 for ease in threading
the stenting catheter through the vein to be harvested.
Additionally, the bullet nose can be used to fit in a clamping
member 19 for placing tension on the stenting catheter once it has
been threaded through the vein. The proximal end of the stenting
catheter can also be placed in a clamping member 21 for opposing
the tension placed by clamping member 19.
[0021] In the preferred embodiment, the sheath catheter 13 is a
peel-away catheter which has two pull tabs 23 that have two notches
24 located on opposite sides for easy separation. Typical peel-away
catheters have axial scoring along their length such that the
catheter can peel away into two halves. It is contemplated in the
present invention that this type of scoring can be used. If this
type of scoring is used, then when the peel-away catheter is pulled
apart, the cutting tube 15 attached to the distal end of the peel
away catheter 35 is pulled straight down the stenting catheter.
However, it is also contemplated in the present invention that the
cutting tube is more effective when it is rotated while being
pulled down. To achieve this rotation, the scoring 25 of the
peel-away catheter is in a spiral configuration. Thus, when the
peel-away catheter is pulled apart at its proximal end, the distal
end of the peel-away catheter rotates, which in turn causes the
rotation of the cutting tube. The peel away catheter can be made
out of biocompatible plastics such as polyurethane, PET, or the
like by extrusion and/or molding techniques or other means well
known in the art. The peel-away catheter can also be reinforced
with stainless steel wire to provide it strength for the rotational
force needed to rotate the cutting tube within the patient. The
size of the peel-away catheter can vary depending on the length of
the vein to be harvested. For the greater saphenous vein, the
length of the peel-away catheter is about 24 to about 48 inches.
For smaller veins, such as the lesser saphenous vein, the length of
the peel-away catheter is about 6 to about 36 inches. The diameter
of the peel-away catheter is about 2 to about 4 mm.
[0022] The cylindrical cutting tube 15 is a hollow tube with a vein
collecting lumen 47 in the proximal portion of the tube. The
proximal edge of the cutting tube is a sharp circular blade 43
which can cut connective tissue and vessel branches. The blade is
created by bevel 45 which is bevelled radially outward instead of
inward. This beveling configuration prevents the cutting tube from
cutting the vessel to be harvest if the tube axially torques and
rubs against the side of the vessel. Instead, the cutting edge acts
like a razor blade traveling along the surface of the vessel and
cutting the connective tissue and vessel branches. The distal end
of the cutting tube has a smaller lumen 49 for closely fitting over
the peel-away catheter. Turning now to FIGS. 2 and 3, the smaller
lumen 49 is provided with a taper 51 near the distal end which then
narrows to the distal opening 33. The distal end of the cutting
tube is also provided with two connecting channels 53 and 55 that
are located radially outward from the distal lumen 33. The
peel-away sheath catheter 13 is provided with a taper 59 to a
smaller lumen 60 for closely fitting over the stenting catheter 11.
Additionally, the peel-away catheter's outer diameter through this
section remains the same until the taper 63 nearer the distal end
which fits within the taper 51 of the cutting tube. This provides a
thick area 61 where the peel-away catheter is thicker and stiffer
to support the cutting tube and track over the stenting catheter to
help prevent axial torqueing of the cutting tube while it is pulled
down along the vessel. The peel-away catheter is also provided with
connecting prongs 29 and 31 for insertion into the connecting ports
53 and 55 of the cutting tube. The connecting prongs of the sheath
catheter are passed through a channel 34 in the cutting tube (see
FIG. 1) and then rotated 90 degrees for insertion into the
connecting ports. Once the connecting prongs are inserted into the
connecting channels, pulling apart the peel-away catheter allows
for the pulling of the cutting tube down the vessel and the
rotation of the cutting tube if a spiral scoring of the peel-away
catheter is used.
[0023] The cutting tube can come in different sizes depending on
the size and length of the vessel to be harvested. For the greater
saphenous vein, the length of the cutting tube is about 7 to about
20 cm and the length of the vessel collecting lumen is about 5 to
about 15 cm. For smaller vessels, such as the lesser saphenous vein
or the radial artery, the length of the cutting tube is about 5 to
about 15 cm and the length of the vessel collecting lumen is about
3 to about 10 cm. The diameter of the cutting tube can vary from
about 3 to about 15 mm depending on the size of the vessel being
harvested.
[0024] Turning now to FIG. 4 an alternate embodiment is illustrated
in cross-section. In this embodiment, the sheath catheter 13 is a
peel-away catheter which is longitudinally scored and has the same
outer diameter until the very distal end where a beveled flange 75
is provided. The flange is inserted through a small lumen 71 of the
cutting tube 15 until it rests within a larger lumen 73 of the
cutting tube at its distal end. In the center of the peel away
catheter is a stenting catheter 11 with a bullet nose member 39 at
its distal end. Additionally, within the center of the peel away
catheter are a plurality of guide wires (two being illustrated 77
and 79) for helping to keep the cutting tube aligned when it is
being pulled down under the skin of the patient. The guide wires
are secured at both ends of the patient in clamping member 19 and
21. The stenting catheter on the other hand is inserted into a
lumen 89 in a larger bullet member 81 for actually pulling the
cutting tube under the skin. The guide wires travel though the
bullet member 81 in small channels 83 and 85 that help to keep the
cutting tube aligned while harvesting the vein.
[0025] To harvest the vessel using the embodiment of FIG. 4, the
stenting catheter is used to pull the cutting tube while the peel
away catheter is used as a sheath for covering the guide wires and
stenting catheter during the procedure. The vessel 17 is collected
in the large lumen 47 of the cutting tube and the side branches 18
are cut with the cutting edge 43.
[0026] Turning now to FIGS. 5-9, the method of harvesting a vessel
is illustrated. FIG. 5 schematically illustrates a greater
saphenous vein 17 with side branches 18 in a leg of a patient. As
can be seen, the greater saphenous vein is a curved vein located on
the medial to anterior parts of the leg. Two skin incisions 91 and
93 are made along the course of the vein (see FIG. 6). As would be
apparent, one skin incision is located at the distal end 93 of the
vein and one is at the proximal end 91 of the vein. The location of
the skin incisions can vary depending on the length of saphenous
vein needed. Using a cut-down procedure such as the Seldinger
technique, the saphenous vein is isolated and ligated.
[0027] Turning now to FIG. 7, the stenting catheter 11 is then
inserted into the sheath catheter 13 which is then inserted into
the proximal end of the vein through incision 93 and then exits the
vein at the distal incision 91. As illustrated in FIG. 8, the
cutting tube is then inserted over the distal end of the peel-away
catheter and locked into place using connecting tabs 29 and 31. The
stenting catheter is then pulled taught and inserted into the
clamping members 19 and 21. These clamping members are ideally
secured to the operating table to allow for the tension to be
maintained throughout the cutting process. When the stenting
catheter is pulled taught, the saphenous vein 17 becomes straight.
The cutting tube 15 is then inserted under the skin through the
skin incision 91. The sheath catheter is a peel away catheter which
is then broken apart at the tabs 23 on the proximal end and pulled
apart at the serrations. While pulling the peel-away catheter
apart, the cutting tube is pulled under the skin of the patient
around the saphenous vein 17. As the cutting tube is being pulled,
side branches 18 are cut by the cutting edge 43 of the cutting
tube. If needed, the cutting tube can be manually manipulated from
outside the skin of the patient to help keep it straight to prevent
axial torquing and continue the harvesting of the vein. Eventually,
the cutting tube is pulled all the way to the proximal incision 93
where the tube is removed from the patient. The peel-away catheter
and the stenting catheter are then cut and removed from the cutting
tube. The vein is then removed from the cutting tube and the cut
side branches are sutured or clamped. The vein is then prepared for
being a bypass conduit using standard techniques and then is used
as a bypass conduit as needed.
[0028] The skin incisions 91 and 93 are then closed using standard
surgical closure techniques and the leg of the patient is then
wrapped with tight leg wrapping to seal the cut vein branches. The
leg is monitored to insure that there is appropriate blood flow and
proper recovery. If need be, hematomas are removed.
[0029] Similar methods are used for harvesting other vessels such
as the lesor saphenous vein, the basilic vein, the cephalic vein,
the radial artery and the like.
[0030] The vein harvesting device and method of the present
invention may be embodied in other specific forms without departing
from the teachings or essential characteristics of the invention.
The described embodiments are therefore to be considered in all
respects as illustrative and not restrictive, the scope of the
invention being indicated by the appended claims rather than by the
foregoing description, and all changes which come within the
meaning and range of equivalency of the claims are therefore to be
embraced therein.
* * * * *