U.S. patent application number 13/277167 was filed with the patent office on 2012-08-16 for catheter system and method for boring through blocked vascular passages.
Invention is credited to Himanshu Patel, John Simpson.
Application Number | 20120209112 13/277167 |
Document ID | / |
Family ID | 41215723 |
Filed Date | 2012-08-16 |
United States Patent
Application |
20120209112 |
Kind Code |
A2 |
Patel; Himanshu ; et
al. |
August 16, 2012 |
CATHETER SYSTEM AND METHOD FOR BORING THROUGH BLOCKED VASCULAR
PASSAGES
Abstract
A rotating cutting head catheter for passage through chronic
total occlusions or other refractory atherosclerotic plaque from
diseased arteries is disclosed. The catheter's rotating cutting
head is designed to reside safely within an outer protective sheath
when not in use. The outer protective sheath contains one or more
helical grooves or slots, and the cutting head contains protruding
blades or projections that fit into these helical grooves or slots.
Application of torque to an inner catheter or wire attached to the
cutting head applies spin to the cutting head, and the force of the
sheath's helical grooves or slots against the cutting head's
protruding blades or projections advances the cutting head outward
from the protective sheath. Once extended, the cutting head may now
rotate freely. The device may use a guidewire to direct the cutting
head to the desired position.
Inventors: |
Patel; Himanshu; (Redwood
City, CA) ; Simpson; John; (Redwood City,
CA) |
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20120041307 A1 |
February 16, 2012 |
|
|
Family ID: |
41215723 |
Appl. No.: |
13/277167 |
Filed: |
October 19, 2011 |
Current U.S.
Class: |
600/435; 604/508;
606/14; 606/159; 606/33 |
Current CPC
Class: |
A61B 2017/00398
20130101; A61B 2017/22094 20130101; A61B 17/22012 20130101; A61B
18/1492 20130101; A61B 17/320758 20130101; A61B 18/24 20130101;
A61B 17/32002 20130101; A61B 17/32075 20130101; A61B 2017/00336
20130101 |
Class at
Publication: |
600/435; 606/159;
604/508; 606/014; 606/033 |
International
Class: |
A61B 17/34 20060101
A61B017/34; A61B 18/00 20060101 A61B018/00; A61B 18/18 20060101
A61B018/18; A61M 25/09 20060101 A61M025/09; A61B 6/00 20060101
A61B006/00 |
Claims
1. A method of delivering a guidewire across an atherosclerotic
occlusion or lesion in a vascular lumen while protecting the
vascular lumen, said method comprising: passing a distal end of a
catheter tube through the vascular lumen to the occlusion or
lesion; rotating a rotatable cutting head at the distal end of the
catheter tube, wherein the cutting head comprises one or more
helical cutting surfaces extending proximally along the cutting
head; advancing said rotating cutting head across said occlusion or
lesion to pass through occluding material without removing the
occluding material; and passing a guidewire through a guidewire
passageway extending through the catheter tube after the distal end
of the catheter tube has passed beyond the atherosclerotic
occlusion so that the guidewire spans the atherosclerotic occlusion
or lesion.
2. The method of claim 1, wherein the rotatable cutting head is
rotated by rotation of a drive shaft extending the length of the
catheter.
3. The method of claim 1, further comprising varying the direction
of rotation of the rotatable cutting head as it is advanced across
the occlusion or lesion.
4. The method of claim 1, further comprising alternately rotating
the rotatable cutting head clockwise and counterclockwise as the
rotating cutting head is advanced across the occlusion or
lesion.
5. The method of claim 1, further comprising dispensing a
therapeutic agent or visualization dye agent through the catheter
tube.
6. The method of claim 1, wherein the occlusion or lesion is cut by
one or more helical protrusions on said rotatable cutting head.
7. The method of claim 1, further comprising applying ultrasonic
vibration, radiofrequency (RF) energy, or light energy to the
cutting head, occlusion, or lesion.
8. The method of claim 1, further comprising using the guidewire
spanning the atherosclerotic occlusion or lesion to treat the
occlusion or lesion by atherectomy, stenting, or balloon
angioplasty during the same procedure.
9. The method of claim 1, further comprising extending the
rotatable cutting head out of a protective housing having a
plurality of slots or grooves through the protective housing into
which the helical cutting surfaces reside.
10. The method of claim 1, further comprising imaging the vascular
lumen as the rotatable cutting head is advanced.
11. A method of delivering a guidewire across an atherosclerotic
occlusion or lesion in a vascular lumen while protecting the
vascular lumen, said method comprising: passing a distal end of a
catheter tube through the vascular lumen to the occlusion or
lesion; rotating a rotatable cutting head at the distal end of the
catheter tube alternately clockwise and counterclockwise, wherein
the cutting head comprises one or more helical cutting surfaces
extending proximally along the cutting head; advancing said
rotating cutting head across said occlusion or lesion to pass
through occluding material without removing the occluding material;
imaging the vascular lumen as the rotatable cutting head is
advanced; and passing a guidewire through a guidewire passageway
extending through the catheter tube after the distal end of the
catheter tube has passed beyond the atherosclerotic occlusion so
that the guidewire spans the atherosclerotic occlusion or
lesion.
12. A method of delivering a guidewire across an atherosclerotic
occlusion or lesion in a vascular lumen while protecting the
vascular lumen, said method comprising: passing a distal end of a
catheter tube through the vascular lumen to the occlusion or
lesion; extending a rotatable cutting head from a sheath head at
the distal end of the catheter tube, wherein the sheath head
comprises one or more helical slots through the wall of the sheath
head configured for shielding one or more helical cutting surfaces
of a rotatable cutting head from contact with the vascular lumen
when the cutting head is retracted; rotating the rotatable cutting
head, wherein the rotatable cutting head comprises one or more
helical cutting surfaces extending proximally along the cutting
head; advancing said rotating cutting head across said occlusion or
lesion to pass through occluding material without removing the
occluding material; and passing a guidewire through a guidewire
passageway extending through the catheter tube after the distal end
of the catheter tube has passed beyond the atherosclerotic
occlusion so that the guidewire spans the atherosclerotic occlusion
or lesion.
13. The method of claim 12, wherein the rotatable cutting head is
rotated by rotation of a drive shaft extending the length of the
catheter.
14. The method of claim 12, further comprising varying the
direction of rotation of the rotatable cutting head as it is
advanced across the occlusion or lesion.
15. The method of claim 12, further comprising dispensing a
therapeutic agent or visualization dye agent through the catheter
tube.
16. The method of claim 12, further comprising applying ultrasonic
vibration, radiofrequency (RF) energy, or light energy to the
cutting head, occlusion, or lesion.
17. The method of claim 12, further comprising using the guidewire
spanning the atherosclerotic occlusion or lesion to treat the
occlusion or lesion by atherectomy, stenting, or balloon
angioplasty during the same procedure.
18. The method of claim 12, further comprising imaging the vascular
lumen as the rotatable cutting head is advanced.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 12/108,433, filed on Apr. 23, 2008, entitled
"CATHETER SYSTEM AND METHOD FOR BORING THROUGH BLOCKED VASCULAR
PASSAGES", which is incorporated herein by reference in its
entirety.
INCORPORATION BY REFERENCE
[0002] All publications and patent applications mentioned in this
specification are herein incorporated by reference to the same
extent as if each individual publication or patent application was
specifically and individually indicated to be incorporated by
reference.
BACKGROUND
[0003] A number of vascular diseases, such as coronary artery
disease and peripheral vascular disease, are caused by the build-up
of fatty atherosclerotic deposits (plaque) in the arteries. These
deposits limit blood flow to the tissues that are supplied by that
particular artery. Risk factors for this type of disease include
advanced age, diabetes, high blood pressure, obesity, history of
smoking, and high cholesterol or triglycerides.
[0004] When these deposits build up in the arteries of the heart,
the problem is called coronary artery disease (CAD). When these
deposits build up in the arteries of a limb, such as a leg, the
condition is called peripheral artery disease (PAD). Symptoms of
CAD--angina, heart disease, and heart attacks, are well known.
Symptoms of PAD can include pain on walking, and wounds that do not
heal. If PAD is not treated, it can eventually produce critical
limb ischemia (CLI), gangrene, and loss of limb. Roughly 30% of the
population over the age of 70 suffers from PAD.
[0005] When the plaque builds up to the point where an artery is
totally occluded, the obstruction is referred to as a Chronic Total
Occlusion (CTO). CTOs can confound the treatment of CAD, because
the sudden loss of heart muscle can lead to sudden death. A CTO
that occludes the peripheral arteries for PAD patients is also
extremely serious. PAD patients that suffer from a CTO often enter
a downward spiral towards death. Often the CTO in a peripheral
artery results in limb gangrene, which requires limb amputation to
resolve. The limb amputation in turn causes other complications,
and roughly half of all PAD patients die within two years of a limb
amputation.
[0006] For both CAD and advanced PAD, prompt treatment of such
blockages is thus essential. Here, less invasive angioplasty or
atherectomy procedures have many advantages. In these procedures, a
catheter is inserted into the diseased artery and threaded to the
blocked region. There the blockage may be either squeezed into a
hopefully more open position by pressure from an inflated catheter
balloon (balloon angioplasty), the blocked region may be kept open
by a stent, or alternatively a physician may use a catheter to
surgically remove the plaque from the inside of the artery
(atherectomy).
[0007] As an example, for the treatment of PAD, atherectomy devices
such as the Fox Hollow (now ev3) SilverHawk.TM. catheter (U.S. Pat.
No. 6,027,514), are often used. These catheters may be threaded
(usually with the aid of a guidewire) up the artery to a blocked
region. There, the physician will usually position the catheter to
make multiple passes through the blocked region of the artery, each
time shaving a way a ribbon of plaque. The shaved ribbons of plaque
are stored in the hollow nose of the device. By making multiple
passes, the plaque may be substantially reduced, blood circulation
may be restored to the limb, and the limb in turn saved from
amputation.
[0008] In order to effectively treat the plaque, however, most
modern catheters need to be threaded past the blocked region of the
artery. This is because the active portions of most catheters,
which are used to treat the blockage, are usually located on the
side of the catheter, rather than on the tip of the catheter. This
is due to simple mechanical necessity. The tip of the catheter must
have a very small surface area, and thus is able to treat only a
very small portion of the diseased artery. By contrast, the side of
the catheter has a much larger surface area, and the catheter side
thus conforms nicely to the sides of the diseased artery. Thus
stents, balloons, atherectomy cutting tools, etc., are usually
mounted on the sides of the catheter. The catheter must be threaded
past the blocked portion of the artery in order to function
properly.
[0009] When the artery is only partially blocked by plaque, the
catheter can usually be maneuvered past the obstruction, and the
active portions of the catheter can thus be brought into contact
with the diseased portion of the artery. However when the artery is
totally blocked, as is the case with a CTO, this option is no
longer possible. The tip of the catheter encounters the
obstruction, and further forward motion is blocked.
[0010] Simply trying to force a typical catheter past the
obstruction usually isn't possible. The obstructions are typically
composed of relatively tough fibrous material, which often also
includes hard calcium deposits as well. Often, when physicians
attempt to force guidewires or catheters past such obstructions,
the guidewire or catheter device may instead exit the artery and
enter the lumen outside the artery. This further damages the
artery, further complicates the procedure, and decreases the chance
of success. As previously discussed, the consequences of such
procedure failures have a high mortality rate. Thus improved
methods to allow catheters and guidewires to more readily penetrate
through hardened plaque and CTO are thus of high medical
importance.
[0011] A good summary of the present state of the art may be found
in an article by Aziz and Ramsdale, "Chronic total occlusions--a
stiff challenge requiring a major breakthrough: is there light at
the end of the tunnel?" Heart 2005; 91; 42-48.
[0012] Previous attempts to produce devices for cutting through
hardened plaque include U.S. Pat. Nos. 5,556,405 to Lary, 6,152,938
to Curry, and 6,730,063 to Delaney et. al.
[0013] U.S. Pat. No. 5,556,405 teaches an incisor catheter which
features a bladed head stored in a catheter housing, which contains
a number of slits though which the blades protrude. The blade is
activated by a push-pull catheter. When the push-pull catheter is
pushed, the bladed head protrudes through the slits in the housing,
and the blade thus comes into contact with hardened plaque
material. The blade does not rotate, but rather delivers linear
cuts.
[0014] U.S. Pat. No. 6,152,938 teaches a general purpose catheter
drilling device for opening a wide variety of different blocked
(occluded) tubes. The device anchors the tip of the drill head
against a face of the occlusion, and partially rotates the drill
head using a rein attached to the drill head so that the drill head
faces at an angle.
[0015] U.S. Pat. No. 6,730,063 teaches a catheter device for
chemically treating calcified vascular occlusions. The device is a
fluid delivery catheter that delivers acidic solutions and other
fluids to calcified plaque with the objective of chemically
dissolving the calcified material.
[0016] Several catheter devices for traversing CTO obstructions are
presently marketed by Cordis Corporation, FlowCardia Technology,
Kensey Nash Corporation, and other companies. Cordis Corporation, a
Johnson and Johnson Company, produces the Frontrunner.RTM. XP CTO
catheter (formerly produced by LuMend Corporation). This catheter,
discussed in U.S. Pat. No. 6,800,085 and other patents, has a front
"jaw" that opens and closes as it traverses the catheter. The jaw
itself does not cut, but rather attempts to pry open the CTO as the
catheter passes.
[0017] Other catheter devices use various forms of directed energy
to traverse CTOs. For example, FlowCardia Technology, Sunnyvale
Calif., produces the Crosser system, taught in U.S. Pat. No.
7,297,131 and other patents. This system uses an ultrasonic
transducer to deliver energy to a non-cutting catheter head. This
catheter head itself has a relatively small diameter and does not
have any blades. Rather, the head, through rapid (ultrasonic)
vibration is able to push its way through a variety of different
occlusions.
[0018] Kensey Nash Corporation, Exton Pa. (formerly Intraluminal
Therapeutics, Inc.), produces the Safe-Cross CTO system. This
system, taught in U.S. Pat. Nos. 6,852,109 and 7,288,087, uses
radiofrequency (RF) energy. The catheter itself is also directed in
its movement by an optical (near-infrared light) sensor which can
sense when the tip of the catheter is near the wall of the artery.
The optical sensor tells the operator how to steer the catheter,
and the RF ablation unit helps the operator ablate material and
cross occluded regions.
[0019] Although ingenious, the success rates with these devices
still leave much to be desired. According to Aziz, the best
reported success rates of overcoming CTOs with prior art devices
range from 56% to 75%. Aziz further teaches that the average
success rates are only in the 50-60% range. Given the huge negative
impact that unsuccessfully cleared CTO's have on patient morbidity
and mortality, clearly further improvement is desirable. An
additional problem with these prior art CTO clearing devices is
that simply cutting a small channel though the CTO may not be
sufficient to totally resolve the medical problem. Occasionally,
the device that traverses the CTO should also remove (debulk) a
substantial portion of the occlusion. This is because as previously
discussed, removal of a substantial portion of the occlusion may be
required in order to allow catheters with side mounted stents,
balloons, and atherectomy cutting tools to get access to the
damaged portions of the artery and make more lasting repairs. Thus
improved CTO "unclogging" devices that can do the more substantial
amount of CTO debulking required to allow other types of catheters
to pass are also desirable.
[0020] Thus there remains a need for devices that can effectively
traverse CTOs and remove more substantial amounts of hardened or
calcified plaque. Such devices would enable stents and other
devices, such as SilverHawk atherectomy catheters, balloon
catheters, etc. to be more successfully used in high occlusion
situations. This in turn should lead to improved patient outcomes
and a reduction in patient morbidity and mortality.
SUMMARY OF THE DISCLOSURE
[0021] The present invention teaches a novel rotating cutting head
catheter for creating a passage through refractory material, such
as chronic total occlusions, refractory atherosclerotic plaque,
gallstones, kidney stones, etc. from diseased arteries, veins, or
other body lumens. The catheter's rotating cutting head is designed
to reside safely within an outer protective sheath head when not in
use, and this sheath head is mounted on the distal end of the
catheter.
[0022] The outer protective sheath head contains one or more
helical grooves or slots, and the cutting head contains protruding
blades or projections that fit into these helical grooves or slots.
Application of torque to an inner torque communicating connector (a
catheter or wire or coil, or any torque communicating mechanism
attached to the cutting head) applies spin to the cutting head, and
the force of the sheath head's helical grooves against the cutting
head's protruding blades or projections advances the cutting head
outward from the protective sheath. Once extended, the cutting head
may now rotate freely. In some embodiments, the center of the
catheter and even the cutting head itself may be hollow, and the
device may use a guidewire to direct the catheter and the cutting
head to the desired position. Alternatively the guidewire may be
attached to a guide that is attached to the outside of the catheter
tube. In at least some embodiments, this sheath head acts as motion
stop, and may contain one or more motion stop elements (such as a
mechanical barrier) designed to restrict the forward extension of
the cutting head.
[0023] Depending upon the angle and nature of the cutting head's
protruding blades, the blades may either be designed to simply cut
thorough the occluding material, without actually dislodging the
occluding material from the body lumen, or alternatively the blades
may be designed to both cut through the occluding material, and
sever its link to the body lumen, thereby dislodging the occluding
material from the body lumen. In this case, the cutting head can
act to actually remove (debulk) a substantial portion of the
occlusion.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] FIG. 1 shows an overview of the catheter device including
the handle, the catheter, and the catheter head.
[0025] FIG. 2 shows the exterior of the catheter head with the
cutting head extended out from the sheath head.
[0026] FIG. 3 shows a drawing of the catheter head (mounted on a
guidewire) with the cutting head extended and cutting into a CTO
plaque in an occluded artery.
[0027] FIG. 4 shows a diagram of the cutting head unscrewing from
protective shroud of the catheter head's sheath head.
[0028] FIG. 5 shows a close up of the catheter head showing the
cutting head screwed into a stored position inside the catheter
head's protective sheath head.
[0029] FIG. 6 shows a close up of a cutting head with an alternate
protruding blade design.
DETAILED DESCRIPTION
[0030] Although, throughout this discussion, applications of this
device for creating a passage through refractory atherosclerotic
plaque from arteries, particularly coronary or peripheral limb
arteries, are frequently used as examples, it should be understood
that these particular examples are not intended to be limiting.
Other applications for the present technology may include removal
of kidney stones, in which case the device will be intended to
traverse the ureters; gallstones, in which case the device will be
intended to traverse the bile duct; enlarged prostate blockage of
the urethra, in which case the device will be intended to traverse
the urethra; blocked fallopian tubes, in which case the device will
be intended to traverse the fallopian tubes; treatment of blood
clots, removal of material trapped in the lungs, etc. In general,
any unwanted material occupying space in a body lumen may be
surgically removed by these techniques. Similarly, although use in
human patients is cited in most examples, it should be evident that
the same techniques may be useful in animals as well.
[0031] Helical drill bits and self-tapping screw bits are widely
known to be highly effective at penetrating through materials as
soft as wax and as refractory as rock and metal, and indeed such
devices are widely used for such purposes. Although effective,
drill bits are typically considered to be both powerful and
extremely crude. As anyone who has ever attempted to use an
electric drill can attest, drill devices, although admittedly
effective at removing material, would seem to be totally unsuited
for delicate vascular surgery, particularly at sites hidden deep
within the body. Helical self-tapping screw bits are designed
slightly differently. Although just as effective at cutting through
various materials, drill bits are configured to both cut and then
remove the material, while self-tapping screw bits are designed
primarily for cutting a passage through the material. For either
type of device, the problem is not the efficacy of cutting or
occlusion removal; the problem is one of preventing inadvertent
damage to the surrounding artery.
[0032] Surprisingly however, the present invention teaches that if
the prejudice against such crude and powerful methods is overcome,
and suitable protection and control devices are devised to control
the crude and apparently overwhelming power of such "drill bit"
devices, catheter "drill bit" devices suitable for delicate
vascular surgery, which are both powerful at cutting or removing
occlusions, yet specific enough to avoid unwanted damage to artery
walls, may be produced.
[0033] Thus, in a first aspect of the present invention, the
superior material cutting/removing properties of a "drill bit" like
material removal device (or self-threading helical screw bit) are
combined with suitable protection and catheter guidance mechanisms
which allow such powerful cutting devices to be safely and
effectively used within the confines of delicate arteries and other
body lumens.
[0034] To do this, precise control must be exerted over the cutting
edge of the "drill bit". The bit or "cutting head" should normally
be sheathed or shielded from contact with artery walls, so that
inadvertent damage to artery walls can be avoided while the head of
the catheter is being threaded to the artery to the occluded
region. Once at the occlusion, the cutting portion of the cutting
head (bit) should be selectively exposed only to the minimal extent
needed to perform the relevant occlusion cutting activity. The
rotation direction of the cutting head may optionally be varied,
for example by rotating the head counter-clockwise to produce a
blunt dissection through the obstacle or occlusion, and then
clockwise while pulling back on the entire assembly. Once the
desired cuts are made, the cutting head should then be quickly
returned to its protective sheath. The entire device should operate
within the millimeter diameters of a typical artery, and should be
capable of being threaded on a catheter for a considerable distance
into the body.
[0035] Suitable techniques to achieve these objectives are taught
in the following figures and examples.
[0036] FIG. 1 shows an overview of the catheter device (100)
including the catheter body (102), the catheter handle (104), and
the catheter head (106). The catheter body and catheter head, and
often even the cutting head, are often hollow and are capable of
accommodating a guidewire (not shown). A magnified view of the
catheter head, showing the rotating cutting head in an extended
configuration (108), extended outside of the sheath portion of the
catheter head (here this sheath is called the "sheath head") (106)
is also shown.
[0037] FIG. 2 shows the exterior of the sheath head portion of the
catheter head (106) with the cutting head (108) extended. This
cutting head will normally have one or more projecting side blades
or with cutting edges (202), and additionally will often have
cutting edges on the front (204) as well. The center of sheath head
portion of the catheter head (106) and catheter (102) may be hollow
to accommodate a guidewire. In some embodiments, the guidewire will
exit the sheath portion of the catheter head (106) on the side of
catheter head (106) prior to cutting head (108) by a side opening
(not shown). In other embodiments, cutting head (108) will itself
be hollow and the guidewire will exit the end of cutting head (108)
through opening (206).
[0038] In the closed configuration, the rotating cutting head (108)
is retracted inside the sheath head portion of catheter head (106)
and the cutting edges or projections (202) from the cutting head
(108) fit into helical slots or grooves (208). This sheathed
configuration prevents projecting side cutting edges (202) and
front cutting edges (204) from accidentally contacting the walls of
the artery.
[0039] FIG. 3 shows a drawing of the catheter head (106) (with the
cutting head extended from the sheath head) cutting into a CTO
(304) in an occluded artery (306). In this example, the catheter
and catheter head are mounted on and guided by a guidewire (302),
however this will not always be the case.
[0040] As should be clear, the cutting edge of the "drill
bit/screw-thread" like cutting head can easily damage artery lining
(306). In order to avoid such accidental damage, precise control
over the extent of cutting head exposure is needed. Methods to
achieve such precise control are shown in FIG. 4.
[0041] FIG. 4 shows some of the details of how the cutting head
(108) is unscrewed from the helical slots or grooves (208) of the
sheath head portion of catheter head (106), thus exposing cutting
edges (202) and (204). In (402), the cutting head (108) is shown
fully exposed. The cutting head has become fully unscrewed from
helical slots (208) and is fully extended. An optional projecting
post or guide (404) mounted on cutting head (108) may act to guide
the rotating cutting head into and out of the helical screw-like
slots (208). The coupling (406) that couples cutting head (108)
with a torque transmitting (torque communicating connector) inner
catheter tube or cable (408) is in the extreme distal position
inside of the sheath head portion of catheter head (106).
[0042] In (410), the cutting head is shown in its fully retracted
position. Normally the cutting head will be stored in this fully
retracted position so that it can be introduced into the artery via
a guidewire, and be directed to the occlusion or plaque region,
without damaging non-target regions of the artery. Note that the
coupling (406) is in the fully distal position in the sheath head
portion of catheter head (106), and that the protruding cutting
blades (202) of cutting head (108) are fully screwed into helical
screw slots (208).
[0043] In some situations, a guidewire [FIG. 3 (302)] leading to
the obstruction will already have been introduced. In fact, a
previous attempt to perform atherectomy may have already been made,
and this attempt may have been frustrated by refractory plaque,
such as a plaque covered with hard calcium deposits, whereupon the
physician may make a decision to use the present cutting device to
punch through this refractory plaque.
[0044] In use, the catheter head (106) and catheter tube (102) are
attached to the guidewire and are then introduced into the artery
via an appropriate incision. The catheter handle (104) will remain
outside of the body. The location of the obstruction will generally
be known, and in fact the obstruction may be imaged by fluoroscopy
or other technique. Catheter head (106) is brought up against the
obstruction, and the operator will then apply torque, often via a
device mounted on catheter handle (104). This torque is usually
transmitted to the catheter head (106) via an inner torque
conducting catheter or wire (408), here termed a "torque
communicating connector". Usually outer catheter (102) will not
conduct torque. Outer catheter (102) remains approximately
stationary (i.e. does not rotate) and similarly the sheath head
portion of catheter head (106) and the helical screw slots or
grooves (208) also do not rotate.
[0045] The torque is communicated via coupling (406) to cutting
head (108). This torque essentially causes cutting head (108) to
"unscrew" from its retracted position in the sheath head portion of
catheter head (106) via the action of the protruding blade edges
(202) against helical slots or grooves (208). This "unscrewing"
circular motion is shown by the curved arrow (412). As cutting head
(108) unscrews, it starts to advance and protrude outside of the
protective sheath head shroud.
[0046] In (420), the cutting head (108) is now shown in a partially
unscrewed or partially extended position. Note that the protruding
blade edges (202) have moved relative to the helical sheath head
screw slots or grooves (208). Thus the blade edges (202) are now
partially unscrewed from the helical screw slots (208) and are
partially exposed. Cutting head (108) now is protruding out from
the sheath head portion of catheter head casing or shroud (106),
and the coupling (406) has moved partially toward the distal end of
the catheter.
[0047] It should be evident that by reversing the direction of the
torque, the cutting head may be again retracted into the sheath
head when this is desired. The catheter can be repositioned for
another cut, and the process of cutting head extension, cutting,
and retraction can be repeated as many times as necessary.
[0048] Thus the present invention controls the aggressive cutting
power of the "drill bit" cutting head by exposing only as much of
the cutting head at a time as needed for the task at hand.
[0049] FIG. 5 shows a close up of the sheath head portion of the
catheter head showing the cutting head screwed into a stored
position inside the protective sheath head shroud. This angle
allows the helical screw slots or grooves (208) to be easily seen,
and cutting head (108) can also be seen inside of the sheath head
portion of catheter head (106).
[0050] FIG. 6 shows a close up of an alternate design cutting head
(108) with spiral shaped protruding cutting edges (202).
[0051] The sheath head portion of catheter head (106) will normally
be between about 1 to 2.2 millimeters in diameter, and the catheter
body (102) will typically also have a diameter of approximately 1
to 3 millimeters (3-9 French), and a length between 50 and 200 cm.
The sheath head may be made from various materials such as hard
plastics, metals, or composite materials. Examples of such
materials include NiTi steel, platinum/iridium or stainless
steel.
[0052] Although sheath head (106) contains slots or grooves
designed to impart forward motion to cutting head (108) when
cutting head is rotated, and although these slots or grooves are
referred to as "helical" grooves or slots, due to the short length
of the sheath head and overall catheter head, the slots or grooves
do not have to be in the exact mathematical shape of a helix. In
fact a variety of shapes that differ somewhat from a mathematically
pure helix configuration will suffice. In general, the slot or
groove must be such that torque applied to the cutting head causes
the cutting head to both rotate and advance, and any such slot or
groove is here designated as a "helical" slot or groove. Also, for
this discussion, a "slot" is considered to be an opening that
extends from the inside to the outside of the hollow catheter head
(106), while a "groove" is similar to a rifle groove in that a
"groove" does not extend all the way from the inside of the hollow
sheath head to the outside, but rather only penetrates partway
through the sheath head material.
[0053] The cutting head (108) will often be made of materials such
as steel, carbide, or ceramic. The blades of the cutting head
(202), (204) can optionally be hardened by coating with tungsten
carbide, ME-92, etc. Materials suitable for this purpose are taught
in U.S. Pat. Nos. 4,771,774; 5,312,425; and 5,674,232. The angle of
the blades and the details of their design will differ depending
upon if the head is intended to simply cut through the occluding
material, of if it is intended to cut through and actually remove
(debulk) portions of the occlusion. For example, blades intended
for to remove material may curve at an angle such that they will
tend to sever the link between the occluding material and the body
lumen, while blades intended just for cutting will have an
alternate angle that tends not to sever this link.
[0054] In some embodiments, the catheter may be composed of two
different tubes. In this configuration, there may be an outer
catheter tube (102), which will often be composed of a flexible
biocompatible material. There may also be an inner tube (408)
chosen for its ability to transmit torque from the catheter handle
(104) to the cutting head (108) (via coupling (406)). The inner
torque transmitting tube (which is one possible type of "torque
communicating connector") is able to twist relative to the outer
catheter tube so that when torque is applied to the inner tube at
the handle end (104), the cutting head (108) will rotate, but the
catheter sheath head itself, which is connected to the outer
catheter tube, will remain roughly stationary. Alternatively a
cable may be used in place of inner tube (408).
[0055] The outer catheter body (102) may often be made from organic
polymer materials extruded for this purpose, such as polyester,
polytetrafluoroethylene (PTFE), polyurethane, polyvinylchloride,
silicon rubber, and the like. The inner torque conducting catheter
(408) may be composed of these materials or alternatively may be
composed from metal coils, wires, or filaments.
[0056] In many embodiments, the catheter will be designed to be
compatible with a monorail guidewire that has a diameter of about
0.014'', or between 0.010'' and 0.032''. For example, the outer
catheter jacket may contain attached external guides for the
monorail guidewire. In this case, the guidewire may exit these
external guides either prior to the catheter head, or midway
through the catheter head. Alternatively, the catheter may be
hollow, and be located over the guidewire for the entire length of
the catheter.
[0057] The catheter handle (104) will normally attach to both outer
catheter tube (102), and inner tube or cable (408). Usually handle
(104) will contain at least a knob, dial, or lever that allows the
operator to apply torque to the inner torque transmitting tube or
cable (408). In some embodiments, sensors may be used to determine
how much the cutting head (108) has rotated or extended relative to
the sheath head portion of catheter head (106), and these sensors,
possibly aided by a mechanical or electronic computation and
display mechanism, may show the operator how much the cutting head
has rotated and or extended.
[0058] In some embodiments, the catheter handle (104) will be
designed with knobs or levers coupled to mechanical mechanisms
(such as gears, torque communicating bands, etc.) that manually
rotate and advance/retract the catheter tip, and the operator will
manually control the tip with gentle slow rotation or movement of
these knobs or levers. In other embodiments the catheter handle
will contain a mechanism, such as an electronic motor, and a
control means, such as a button or trigger, that will allow the
user to rotate and advance the cutting head in a precise and
controlled manner. This mechanism may, for example, consist of a
microprocessor or feedback controlled motor, microprocessor, and
software that may act to receive information from a cutting head
rotation or extension sensor, and use this rotation feedback data,
in conjunction with operator instructions delivered by the button
or trigger, to advance or retract the cutting head by a precise
amount for each operator command. This way the operator need not
worry about any errors induced by the spring action of the inner
torque transmitting tube or cable (408). The microprocessor (or
other circuit) controlled motor can automatically compensate for
these errors, translate button or trigger presses into the correct
amount of torque, and implement the command without requiring
further operator effort. Alternatively non-microprocessor methods,
such as a vernier or a series of guided markings, etc., may be used
to allow the operator to compensate for differences in the rotation
of the torque communicating connector and the rotation of the
cutting head, or for the extent that which said cutting head exits
said hollow sheath head.
[0059] In some embodiments, the catheter head may be equipped with
additional sensors, such as ultrasonic sensors to detect calcified
material, optical (near infrared) sensors to detect occlusions or
artery walls, or other medically relevant sensors. If these sensors
are employed, in some cases it may be convenient to locate the
driving mechanisms for these sensors in the catheter handle (104)
as well.
[0060] Additional means to improve the efficacy of the cutting head
may also be employed. Thus the cutting head may be configured to
vibrate at high (ultrasonic) frequency, perform radiofrequency (RF)
tissue ablation, generate localized areas of intense heat, conduct
cutting light (e.g. laser or excimer laser), or other directed
energy means.
[0061] The cutting head may be composed of alternative designs and
materials, and these designs and materials may be selected to pick
the particular problem at hand. As an example, a cutting head
appropriate for use against a calcified obstruction may differ from
the cutting head appropriate for use against a non-calcified
obstruction. Similarly the cutting head appropriate for use against
a highly fibrous obstruction may be less appropriate against a less
fibrous and fattier obstruction. The length or size of the
obstruction may also influence head design.
[0062] Although multiple catheters, each composed of a different
type of cutting head, may be one way to handle this type of
problem, in other cases, a kit composed of a single catheter and
multiple cutting heads (108) and optionally multiple sheath heads
(106) may be more cost effective. In this type of situation, the
cutting heads (108) may be designed to be easily mounted and
dismounted from coupling (406). A physician could view the
obstruction by fluoroscopy or other technique, and chose to mount
the cutting head design (and associated sheath head design) best
suited for the problem at hand. Alternatively, if the blades (202),
(204) on cutting head (108) have become dull or chipped from use
during a procedure, a physician may chose to replace dull or
chipped cutting head (108) with a fresh cutting head, while
continuing to use the rest of the catheter.
[0063] For some applications, it may also be useful to supply
various visualization dyes or therapeutic agents to the obstruction
using the catheter. Here, the dye or therapeutic agent may be
applied by either sending this dye up to the catheter head through
the space between the exterior catheter (102) and the interior
torque catheter (408), or alternatively if torque catheter (408) is
hollow, through the interior of torque catheter (408). If cutting
head (108) also has a hollow opening (206), then the dye or
therapeutic agent may be applied directly to the obstruction, even
while cutting head (108) is cutting through the obstruction.
[0064] Examples of useful dyes and therapeutic agents to apply
include fluoroscopic, ultrasonic, MRI, fluorescent, or luminescent
tracking and visualization dyes, anticoagulants (e.g. heparin, low
molecular weight heparin), thrombin inhibitors, anti-platelet
agents (e.g. cyclooxygenase inhibitors, ADP receptor inhibitors,
phosphodiesterase inhibitors, Glycoprotein IIB/IIIA inhibitors,
adenosine reuptake inhibitors), anti-thromboplastin agents,
anti-clot agents such as thrombolytics (e.g. tissue plasminogen
activator, urokinase, streptokinase), lipases, monoclonal
antibodies, and the like.
[0065] In some embodiments, it may be useful to construct the
cutting head out of a material that has a radiopaque signature
(different appearance under X-rays) that differs from the material
used to construct the hollow sheath head portion of the catheter
head. This will allow the physician to directly visualize, by
fluoroscopic or other x-ray imaging technique, exactly how far the
cutting head has advanced outside of the catheter sheath head.
* * * * *