U.S. patent application number 10/979233 was filed with the patent office on 2005-03-24 for catheter assembly.
This patent application is currently assigned to SCIMED LIFE SYSTEMS, INC.. Invention is credited to Crank, Justin, Hawk, Matthew, Larson, Scott, Slaker, Bradley.
Application Number | 20050065474 10/979233 |
Document ID | / |
Family ID | 24546375 |
Filed Date | 2005-03-24 |
United States Patent
Application |
20050065474 |
Kind Code |
A1 |
Larson, Scott ; et
al. |
March 24, 2005 |
Catheter assembly
Abstract
A catheter assembly is disclosed. This assembly may include a
first elongate member having an internal lumen and a distal
portion, a second elongate member, slidable within the first
elongate member, and a spacer positioned between the second
elongate member and the first elongate member. In this example, the
spacer may be positioned at bendable portions of the first elongate
member and the second elongate member such that the spacer
maintains a substantially uniform spacing between the second
elongate member and the first elongate member when the first
elongate member and the second elongate member are in a curved
orientation.
Inventors: |
Larson, Scott; (St. Louis
Park, MN) ; Crank, Justin; (Minneapolis, MN) ;
Hawk, Matthew; (Otsego, MN) ; Slaker, Bradley;
(Greenfield, MN) |
Correspondence
Address: |
KENYON & KENYON
1500 K STREET, N.W., SUITE 700
WASHINGTON
DC
20005
US
|
Assignee: |
SCIMED LIFE SYSTEMS, INC.
|
Family ID: |
24546375 |
Appl. No.: |
10/979233 |
Filed: |
November 3, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10979233 |
Nov 3, 2004 |
|
|
|
09635083 |
Aug 8, 2000 |
|
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Current U.S.
Class: |
604/164.01 |
Current CPC
Class: |
A61M 25/0043 20130101;
A61M 2025/0089 20130101; A61M 25/0084 20130101; A61M 25/0023
20130101; A61M 25/0021 20130101 |
Class at
Publication: |
604/164.01 |
International
Class: |
A61M 005/178 |
Claims
What is claimed is:
1. A catheter assembly comprising: a first elongate member having
an internal lumen and a distal portion, the first elongate member
sized for insertion into a body of a patient; a second elongate
member, the second elongate member also having an internal lumen,
the second elongate member slidable within the first elongate
member, the second elongate member having a delivery end extendible
outside of the distal portion of the first elongate member, a
spacer positioned between the second elongate member and the first
elongate member, the spacer positioned at bendable portions of the
first elongate member and the second elongate member, the spacer
maintaining a substantially uniform spacing between the second
elongate member and the first elongate member when the first
elongate member and the second elongate member are in a curved
orientation.
2. The catheter system of claim 1 wherein the distance of insertion
of a proximal end of the second elongate member is substantially
equal to the distance of extension of the delivery end of the
second elongate member away from the distal portion of the first
elongate member when the first elongate member and the second
elongate member are in a curved orientation.
3. The catheter system of claim 1 wherein the delivery end of the
second elongate member is a piercing tip.
4. The catheter system of claim 1 wherein the first elongate member
and the second elongate member are tubes having circular
cross-sections.
5. The catheter system of claim 1 further comprising: a scale, the
scale coupled to the first elongate member, the containing indices
that reflect the length of extension of the delivery end of the
second elongate member from the distal portion of the first
elongate member.
6. The catheter system of claim 1 wherein the delivery end of the
second elongate member contains a marker.
7. The catheter system of claim 6 wherein the marker is a
radiopaque marker.
8. The catheter system of claim 1 wherein the spacer extends along
at least half of the length of second elongate member.
9. The catheter system of claim 1 wherein the spacer is mounted to
the first elongate member.
10. The catheter system of claim 1 wherein the spacer is mounted to
the second elongate member.
11. The catheter system of claim 1 wherein the spacer extends along
the entire length of the first elongate member.
12. The catheter syst6em of claim 1 wherein the second elongate
member is coupled to a source of therapeutic.
13. The catheter of claim 1 wherein the spacer defines uniform gaps
along bendable portions of the first elongate member and bendable
portions of the second elongate member, the gaps being uniform when
the first elongate member is straight and the second elongate
member is straight.
14. The catheter of claim 1 wherein the spacer comprises a
plurality of individual contact points between the first elongate
member and the second elongate member.
15. The catheter system of claim 1 wherein the first elongate
member is sized to fit within arterial lumens of a human.
16. The catheter system of claim 1 wherein the spacer maintains a
uniform spacing between the second elongate member and the first
elongate member when the first elongate member and the second
elongate member are in a curved orientation.
17. The catheter system of claim 1 further comprising: a second
spacer positioned between the second elongate member and the first
elongate member, the second spacer positioned at bendable portions
of the first elongate member and the second elongate member, the
second spacer maintaining a substantially uniform spacing between
the second elongate member and the first elongate member when the
first elongate member and the second elongate member are in a
curved orientation.
Description
RELATED APPLICATIONS
[0001] This application is a Continuation of application Ser. No.
09/635,083, filed on Aug. 8, 2000, now U.S. Pat. No. ______. That
application is incorporated, in its entirety, by reference.
FIELD OF THE INVENTION
[0002] The present invention relates generally to intravascular
catheters for performing medical procedures. More particularly, the
present invention relates to shaft assemblies for use in
intravascular catheters. Still, more particularly, the present
invention relates to catheter shaft assemblies for use in injection
catheters.
BACKGROUND OF THE INVENTION
[0003] Intravascular catheters are currently utilized in a wide
variety of minimally invasive or percutaneous medical procedures.
Generally, an intravascular catheter enables a physician to
remotely perform a medical procedure by inserting the catheter into
the vascular system of the patient at an easily accessible location
and navigating the tip of the catheter to a desirable target site.
By this method, virtually any target site in the patient's vascular
system may be remotely accessed.
[0004] Typically, a percutaneous procedure begins with the step of
inserting a distal portion of the catheter into the patient's
vasculature at a convenient location. Once the distal portion of
the catheter has entered the patient's vascular system the
physician may urge the distal tip forward by applying longitudinal
forces to the proximal portion of the catheter. Frequently the path
taken by a catheter through the vascular system is tortuous,
requiring the catheter to change direction frequently. While
advancing the catheter through the tortuous path of the patient's
vasculature, the physician must steer the distal end of the
catheter. During a percutaneous procedure, the physician typically
is not able to manipulate the distal portion of the catheter
directly. For this reason, physicians typically must steer the
distal end of the catheter by applying torsional forces to the
proximal portion of the catheter.
[0005] Injection catheters are a type of catheter which may be used
to inject therapeutic or diagnostic agents into various target
tissues within the human body. An advantage of injection catheters
is that the target tissue may be accessed utilizing minimally
invasive surgical techniques. As with other types of catheters, the
physician typically is not able to manipulate the distal portion of
an injection catheter directly.
[0006] In many applications the target tissue is within a wall of
an organ such as the stomach or the heart. When the target tissue
is within the wall of an organ it is often desirable to inject the
therapeutic or diagnostic agent into the tissue proximate the
center of the organ wall. If the needle of the injection catheter
inadvertently passes through the wall, the therapeutic or
diagnostic agents dispensed from the distal end of the needle will
not be effectively delivered to the target tissue.
[0007] One example of a medical procedure involving the delivery of
a therapeutic and/or diagnostic agent to a targeted portion of a
patient's body is the treatment of esophageal varices. This is a
condition in which blood vessels of the esophagus are enlarged and
may potentially burst. For such a procedure, a therapeutic agent is
injected into the varix. When treating an esophageal varix, the
agent may be a coagulant such as sodium morrhuate. When a coagulant
is injected into a varix, it causes it to occlude. An injection
catheter may be used to deliver the therapeutic agent in order to
minimize the invasive nature of the procedure.
[0008] In a similar procedure, an injection catheter may be
utilized in the treatment of ulcers in the stomach lining. With
such treatment, an injection catheter may be used to deliver drugs
such as sclerosing or vasoconstrictive agents. These drugs
typically clot or occlude the bleeding tissue to stop bleeding or
to reduce the possibility of a blood vessel bursting.
[0009] Injection catheters may also be used to inject therapeutic
or diagnostic agents into the heart. Examples of agents delivered
to the heart include genes, proteins, or drugs. In the case of
injecting a therapeutic agent into the heart, 27 or 28 gauge
needles are generally used to inject solutions carrying genes,
proteins, or drugs directly into the myocardium. A typical volume
of an agent delivered to an injection site is about 100
microliters.
[0010] Therapeutic and diagnostic agents may be delivered to a
portion of the heart as part of a percutaneous myocardial
revascularization (PMR) procedure. PMR is a procedure which is
aimed at assuring that the heart is properly oxygenated. Assuring
that the heart muscle is adequately supplied with oxygen is
critical to sustaining the life of a patient. To receive an
adequate supply of oxygen, the heart muscle must be well perfused
with blood. In a healthy heart, blood perfusion is accomplished
with a system of blood vessels and capillaries. However, it is
common for the blood vessels to become occluded (blocked) or
stenoic (narrowed). A stenosis may be formed by an atheroma, which
is typically a harder, calcified substance which forms on the walls
of a blood vessel.
[0011] Historically, individual stenotic lesions have been treated
with a number of medical procedures including coronary bypass
surgery, angioplasty, and atherectomy. Coronary bypass surgery
typically involves utilizing vascular tissue from another part of
the patient's body to construct a shunt around the obstructed
vessel. Angioplasty techniques such as percutaneous transluminal
angioplasty (PTA) and percutaneous transluminal coronary
angioplasty (PTCA) are relatively non-invasive methods of treating
a stenotic lesion. These angioplasty techniques typically involve
the use of a guidewire and a balloon catheter. In these procedures,
a balloon catheter is advanced over a guidewire such that the
balloon is positioned proximate a restriction in a diseased vessel.
The balloon is then inflated and the restriction in the vessel is
opened. A third technique which may be used to treat a stenotic
lesion is atherectomy. During an atherectomy procedure, the
stenotic lesion is mechanically cut or abraded away from the blood
vessel wall.
[0012] Coronary by-pass, angioplasty, and atherectomy procedures
have all been found effective in treating individual stenotic
lesions in relatively large blood vessels. However, the heart
muscle is perfused with blood through a network of small vessels
and capillaries. In some cases, a large number of stenotic lesions
may occur in a large number of locations throughout this network of
small blood vessels and capillaries. The tortuous path and small
diameter of these blood vessels limit access to the stenotic
lesions. The sheer number and small size of these stenotic lesions
make techniques such as cardiovascular by-pass surgery,
angioplasty, and atherectomy impractical.
[0013] When techniques which treat individual lesions are not
practical, percutaneous myocardial revascularization (PMR) may be
used to improve the oxygenation of the myocardial tissue. A PMR
procedure generally involves the creation of holes, craters or
channels directly into the myocardium of the heart. In a typical
PMR procedure, these holes are created using radio frequency energy
delivered by a catheter having one or more electrodes near its
distal end. After the wound has been created, therapeutic agents
are sometimes ejected into the heart chamber from the distal end of
a catheter.
[0014] Positive clinical results have been demonstrated in human
patients receiving PMR treatments. These results are believed to be
caused in part by blood flowing within a heart chamber through
channels in myocardial tissue formed by PMR. Increased blood flow
to the myocardium is also believed to be caused in part by the
healing response to wound formation. Specifically, the formation of
new blood vessels is believed to occur in response to the newly
created wound. This response is sometimes referred to as
angiogenesis. After the wound has been created, therapeutic agents
which are intended to promote angiogenesis are sometimes ejected
into the heart chamber. A limitation of this procedure is that the
therapeutic agent may be quickly carried away by the flow of blood
through the heart.
[0015] In addition to promoting increased blood flow, it is also
believed that PNM improves a patient's condition through
denervation. Denervation is the elimination of nerves. The creation
of wounds during a PMR procedure results in the elimination of
nerve endings which were previously sending pain signals to the
brain as a result of hibernating tissue.
SUMMARY OF THE INVENTION
[0016] The present invention relates generally to intravascular
catheters for performing medical procedures. More particularly, the
present invention relates to shaft assemblies for use in
intravascular catheters. Still, more particularly, the present
invention relates to catheter shaft assemblies for use in injection
catheters.
[0017] This assembly may include a first elongate member having an
internal lumen and a distal portion, a second elongate member,
slidable within the first elongate member, and a spacer positioned
between the second elongate member and the first elongate member.
In this example, the spacer may be positioned at bendable portions
of the first elongate member and the second elongate member such
that the spacer maintains a substantially uniform spacing between
the second elongate member and the first elongate member when the
first elongate member and the second elongate member are in a
curved orientation.
[0018] A shaft assembly in accordance with an exemplary embodiment
of the present invention may also comprise a first elongate shaft
having an inner surface defining a lumen, a second elongate shaft
slidingly disposed within the lumen of the first elongate shaft,
and an interstitial member disposed between the inner surface of
the first elongate shaft and the outer surface of the second
elongate shaft.
[0019] In one embodiment of a shaft assembly in accordance with the
present invention a plurality of longitudinal ribs extend beyond an
inner surface of the first elongate shaft. These longitudinal ribs
preferably contact the outer surface of the second elongate
shaft.
[0020] In an additional embodiment of a shaft assembly in
accordance with the present invention a radial rib extends beyond
the inner surface of the first elongate shaft. The radial rib
preferably contacts the outer surface of the second elongate shaft.
When the radial rib is in contact with outer surface of second
elongate shaft there is preferably no substantial gap between the
radial rib and the outer surface of the second elongate shaft.
[0021] An additional embodiment of a shaft assembly in accordance
with the present invention includes a coil comprising a wire
forming a plurality of turns. Each turn of the coil is disposed
between the inner surface of the first elongate shaft and the outer
surface of the second elongate shaft.
[0022] In an additional embodiment of a shaft assembly in
accordance with the present invention the second elongate shaft has
a plurality of projections extending beyond the outer surface of
the second elongate shaft. When the second elongate shaft is
disposed within the lumen defined by the first elongate shaft,
these projections preferably contact the inner surface of the first
elongate shaft.
[0023] An injection catheter in accordance with an exemplary
embodiment of the present invention includes a first elongate shaft
having an inner surface defining a lumen. A second elongate shaft
having an outer surface is slidingly disposed within the lumen of
the first elongate shaft. In this exemplary embodiment, the second
elongate shaft includes a point and an injection orifice proximate
it's distal end. Also in this exemplary embodiment, an interstitial
member is disposed between the inner surface of the first elongate
shaft and the outer surface of the second elongate.
[0024] In many applications it is desirable to advance the distal
end of the second elongate shaft by a known distance relative to
the distal end of the first elongate shaft. For example, when a
physician wishes to inject a fluid into the wall of an organ. In
one embodiment of a catheter in accordance with the present
invention, a slider is fixed to the second elongate shaft proximate
the proximal end thereof. Also in this embodiment, a portion of the
slider is disposed within a cavity defined by a housing which is
preferably fixed to the first elongate shaft proximate the proximal
end thereof. Also in a preferred embodiment, a plurality of indicia
are disposed on a face of the housing proximate the slider.
[0025] A physician utilizing the catheter in a surgical procedure
may move the distal end of the second elongate shaft a known
distance relative to the distal end of the first elongate shaft.
For example, a physician may urge the slider distally while
visually observing the travel of the slider relative to the indicia
of the housing. The movement of the slider is translated via the
second elongate shaft to the distal end thereof.
[0026] In a preferred embodiment there is substantially a
one-to-one relationship between the movement of the slider relative
to the indicia of the housing and the movement of the distal. end
of the second elongate shaft relative to the distal end of the
first elongate shaft. In a particularly preferred embodiment, the
presence of an interstitial member between the outer surface of the
second elongate shaft and the inner surface of the first elongate
shaft directs the motion of the second elongate shaft in a
substantially longitudinal direction. Also in a particularly
preferred embodiment, the presence of the interstitial member
between the outer surface of the second elongate shaft and the
inner surface of the first elongate shaft substantially precludes
lateral movement of the second elongate shaft relative to the first
elongate shaft. Thus, it is assured that there will be
substantially a one-to-one relationship between the movement of the
slider relative to the indicia of the housing and the movement of
the distal. end of the second elongate shaft relative to the distal
end of the first elongate shaft.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] FIG. 1 is a plan view of a catheter including a shaft
assembly in accordance with the present invention;
[0028] FIG. 2 is a diagrammatic view including the catheter of FIG.
1 and a patient;
[0029] FIG. 3 is a lateral cross section view of the shaft assembly
of the catheter of FIG. 1 and FIG. 2;
[0030] FIG. 4 is a partial cross section view of an additional
embodiment of a shaft assembly in accordance with the present
invention;
[0031] FIG. 5 is a partial cross section view of an additional
embodiment of a shaft assembly in accordance with the present
invention;
[0032] FIG. 6 is a partial cross section view of an additional
embodiment of a shaft assembly in accordance with the present
invention;
[0033] FIG. 7 is a partial cross section view of an additional
embodiment of a shaft assembly in accordance with the present
invention;
[0034] FIG. 8 is a plan view of an additional embodiment of a
catheter in accordance with the present invention;
[0035] FIG. 9 is a cross sectional view of a distal. portion of a
catheter in accordance with the present invention;
[0036] FIG. 10 is a plan view of a catheter including a shaft
assembly in accordance with the present invention;
[0037] FIG. 11 is a partial cross section view of a distal portion
of the catheter of FIG. 10; and
[0038] FIG. 12 is a partial cross section view of a distal portion
of the catheter of FIG. 10.
DETAILED DESCRIPTION OF THE INVENTION
[0039] The following detailed description should be read with
reference to the drawings, in which like elements in different
drawings are numbered in like fashion. The drawings which are not
necessarily to scale, depict selected embodiments and are not
intended to limit the scope of the invention. In some cases, the
drawings may be highly diagrammatic in nature. Examples of
constructions, materials, dimensions, and manufacturing processes
are provided for various elements. Those skilled in the art will
recognize that many of the examples provided have suitable
alternatives which may be utilized.
[0040] FIG. 1 is a plan view of a catheter 120 including a shaft
assembly 122 in accordance with the present invention. Shaft
assembly 122 comprises a first elongate shaft 124 having a distal
end 134, a proximal end 144, and an inner surface 154 defining a
lumen 132. Shaft assembly 122 also includes a second elongate shaft
126 slidingly disposed within lumen 132 of first elongate shaft
124. Catheter 120 also includes a distal end 130, and a proximal
end 140.
[0041] Second elongate shaft 126 has an outer surface 138, distal
end 136, and a proximal end 146. In many applications it is
desirable to advance distal end 136 of second elongate shaft 126 by
a known distance relative to distal. end 134 of first elongate
shaft 124. In the embodiment of FIG. 1, a slider 142 is fixed to
second elongate shaft 126 proximate proximal end 146 thereof. In
the embodiment of FIG. 1, a portion of slider 142 is disposed
within a cavity 148 defined by a housing 150. In a presently
preferred embodiment, housing 150 is fixed to first elongate shaft
124 proximate proximal end 144 thereof. Also in a preferred
embodiment, a plurality of indicia 152 are disposed on a face 154
of housing 150 proximate slider 142.
[0042] A physician utilizing catheter 120 in a surgical procedure
may move distal end 136 of second elongate shaft 126 a known
distance relative to distal end 134 of first elongate shaft 124.
For example, a physician may urge slider 142 distally while
visually observing the travel of slider 142 relative to indicia 152
of housing 150. The movement of slider 142 is translated via second
elongate shaft 126 to distal end 136 thereof.
[0043] In a preferred embodiment there is substantially a
one-to-one relationship between the movement of slider 142 relative
to indicia 152 of housing 150 and the movement of distal end 136 of
second elongate shaft 126 relative to distal end 134 of first
elongate shaft 124. In a particularly preferred embodiment, the
presence of an interstitial member 156 between outer surface 138 of
second elongate shaft 126 and inner surface 154 of first elongate
shaft 124 directs the motion of second elongate shaft 126 in a
substantially longitudinal direction. Also in a particularly
preferred embodiment, the presence of interstitial member 156
between outer surface 138 of second elongate shaft 126 and inner
surface 154 of first elongate shaft 124 substantially precludes
lateral movement of second elongate shaft 126 relative to first
elongate shaft 124. Thus, it is assured that there will be
substantially a one-to-one relationship between the movement of
slider 142 relative to indicia 152 of housing 150 and the movement
of distal end 136 of second elongate shaft 126 relative to distal
end 134 of first elongate shaft 124.
[0044] In the embodiment of FIG. 1, second elongate shaft 126 forms
a point 158 proximate distal end 136 thereof. Second elongate shaft
also defines an injection port 160 proximate point 158. A hub 164
is disposed about second elongate shaft 126 proximate proximal end
146 thereof. Hub 164 defines a proximal port 166. In a preferred
embodiment, proximal port 166 is in fluid communication with
injection port 160 via an injection lumen 162 defined by second
elongate shaft 126.
[0045] Catheter 120 of FIG. 1 may be generally referred to as an
injection catheter. It is to be appreciated that a catheter in
accordance with the present invention may comprise various types of
catheters without deviating from the spirit and scope of the
present invention.
[0046] In a preferred embodiment, second elongate shaft 126 of
catheter 120 comprises hypodermic tubing. Second elongate shaft 126
may comprise various metallic and non-metallic materials without
deviating from the spirit and scope of the present invention.
Examples of metallic materials which may be suitable in some
applications include stainless steel, and nickel-titanium alloy.
Examples of non-metallic materials which may be suitable in some
applications are included in the list below which is not
exhaustive: polycarbonate, poly(L-lactide) (PLLA),
poly(D,L-lactide) (PLA), polyglycolide (PGA),
poly(L-lactide-co-D,L-lactide) (PLLA/PLA),
poly(L-lactide-co-glycolide) (PLLA/PGA), poly(D,
L-lactide-co-glycolide) (PLA/PGA), poly(glycolide-co-trimethylene
carbonate) (PGA/PTMC), polyethylene oxide (PEO), polydioxanone
(PDS), polycaprolactone (PCL), polyhydroxylbutyrate (PHBT),
poly(phosphazene), polyD,L-lactide-cocaprola- ctone) (PLA/PCL),
poly(glycolide-co-caprolactone) (PGA/PCL), polyanhydrides (PAN),
poly(ortho esters), poly(phoshate ester), poly(amino acid),
poly(hydroxy butyrate), polyacrylate, polyacrylamid,
poly(hydroxyethyl methacrylate), polyurethane, polysiloxane and
their copolymers.
[0047] In a preferred embodiment, first elongate shaft 124 of
catheter 120 comprises an elongate tubular member including a
reinforcement member (e.g., braided or coiled wire). Second
elongate shaft 126 may comprise various metallic and non-metallic
materials without deviating from the spirit and scope of the
present invention. Examples of metallic materials which may be
suitable in some applications include stainless steel, and
nickel-titanium alloy. Examples of non-metallic materials which may
be suitable in some applications include: polyethylene (PE),
polypropylene (PP), polyvinylchloride (PVC), polyurethane,
polytetrafluoroethylene (PTFE), polyether block amide (PEBA),
polyamide, and polyimide.
[0048] FIG. 2 is a diagrammatic view including catheter 120 of FIG.
1 and a patient 20. Patient 20 has a heart 22 and a vascular system
24 including a blood vessel 26 defining a blood vessel lumen 28. Am
access sheath 30 is partially disposed within a leg 32 of patient
20. A distal end of access sheath 30 is disposed within blood
vessel lumen 28 of blood vessel 26. Access sheath 30 may aid in the
introduction of catheter 120 into blood vessel lumen 28.
[0049] As shown in FIG. 2, a portion of catheter 120 is disposed
within blood vessel lumen 28 of blood vessel 26. Distal end 130
(not visible in FIG. 2) of catheter 120 is disposed within heart 22
of patient 20. In a preferred embodiment, distal end 130 of
catheter 120 is disposed proximate a wall of heart 22.
[0050] In the embodiment of FIG. 2, a fluid source 34 is coupled to
hub 164 disposed about second elongate shaft 126 of catheter 120.
In the embodiment of FIG. 2, fluid source 34 includes a variable
volume chamber 36 defined by a body 38. In a preferred embodiment,
variable volume chamber 36 is in fluid communication with injection
lumen 162 of second elongate shaft 126. A plunger 40 is slidingly
disposed within variable volume chamber 36. Urging the plunger
distally has the effect of urging fluid into injection lumen 162 of
second elongate shaft 126. A number of energy sources may be
utilized to urge plunger 40 distally. Energy sources which may be
suitable in some applications include springs, compressed gas, a
human being, and electricity. Various additional embodiments of
fluid source 34 are possible without deviating from the spirit and
scope of the present invention. Examples of fluid sources which may
be suitable in some applications include syringes, peristaltic
pumps, and an I.V. bag with pressure applied to an outer surface
thereof.
[0051] A method of injecting a fluid into heart 22 of patient 20
may be described with reference to FIG. 2. The distal end of access
sheath 30 may be inserted into blood vessel lumen 28 of blood
vessel 26. Distal end 130 of catheter 120 may be inserted into the
lumen of access sheath 30. Distal end 130 of catheter 120 may be
advanced through access sheath 30 and into blood vessel lumen 28 of
blood vessel 26. Catheter 120 may be urged forward through vascular
system 24 of patient 20 until distal end 130 is proximate the
target tissue (e.g., a wall of heart 22). I n FIG. 2 it may be
appreciated that shaft assembly 122 of catheter 120 is bent in a
plurality of locations to conform with a tortuous path defined by
vascular system 24.
[0052] In a preferred method, distal end 136 of second elongate
shaft 126 is disposed within lumen 132 of first elongate shaft 124
during the above steps. Once distal end 130 of catheter 120 is
positioned proximate the target tissue, second elongate shaft 126
may be advanced so that point 158 penetrates the bodily tissue at
the target site. With injection port 160 of second elongate shaft
126 disposed within the target tissue, fluid may be urged into the
target tissue. For example, force may be applied to plunger 40
urging fluid out of fluid source 34 and into injection lumen 162 of
second elongate shaft 126. he addition of fluid from fluid source
34 results in the injection of fluid into the target tissue.
[0053] In many applications it is desirable to advance point 158
and injection port 160 into the target tissue by a known distance.
A physician may advance point 158 and injection port 160 into the
target tissue by urging slider 142 distally. A physician may
determine the depth of penetration by visually observing the travel
of slider 142 relative to indicia 152 of housing 150.
[0054] The movement of slider 142 is translated via second elongate
shaft 126 to point 158 formed by second elongate shaft 126
proximate the distal end 136 thereof. In a preferred embodiment
there is substantially a one-to-one relationship between the
movement of slider 142 relative to indicia 152 of housing 150 and
the movement of distal end 136 of second elongate shaft 126
relative to distal end 134 of first elongate shaft 124. In a
particularly preferred embodiment, the presence of interstitial
member 156 between outer surface 138 of second elongate shaft 126
and inner surface 154 of first elongate shaft 124 directs the
motion of second elongate shaft 126 in a substantially longitudinal
direction.
[0055] The fluid injected into the target area may include various
therapeutic or diagnostic agents adapted to treat the medical
condition which the physician is treating. It is to be appreciated
that methods in accordance with the present invention may be used
in the treatment of a number of medical conditions. For example,
methods and devices of performing percutaneous myocardial
revascularization (PMR) in accordance with the present invention
have been envisioned. For example, a plurality of wounds may be
created in hibernating tissue of the heart. These wounds may be
created by injecting a fluid into the tissue of the heart. As a
result of these wounds, there will be increased blood flow to the
myocardium caused in part by the body's healing response to the
wound. One healing response of the body is sometimes referred to as
angiogenesis. In addition to promoting increased blood flow, it is
also believed that PMR improves a patient's condition through
denervation. Denervation is the elimination of nerves. The creation
of wounds during this procedure results in the elimination of nerve
endings which were previously sending pain signals to the brain as
a result of hibernating tissue.
[0056] Suitable wounds may be created by injecting a fluid such as
water, saline, or ringers solution into the heart tissue. Wound
formation and revascularization of myocardial tissue may enhanced
by injecting a fluid including a therapeutic agent into the tissue
of the heart. Examples of therapeutic agents which may be suitable
include growth factors, drugs and caustic agents. The fluid
injected into the heart tissue may also include a radiopaque
material. Injecting a radiopaque material into the wound
effectively marks the locations which have been treated. This will
aid the physician in procedures which are being performed
percutaneously using fluoroscopic equipment.
[0057] In the exemplary embodiment of FIG. 2, catheter 120 may be
utilized to inject fluid into heart 22 of patient 20. It is to be
appreciated that catheter 120 may be utilized in the treatment of
various medical conditions occurring in various locations in the
body. For example, catheter 120 may be used in the treatment of
esophageal varices, a condition in which blood vessels of the
esophagus are enlarged and may potentially burst. For such a
procedure, injection port 160 would be disposed proximate the
enlarged varix and an appropriate agent would be injected into the
varix. When treating an esophageal varice, the agent may be a
coagulant such as sodium morrhuate. When a coagulant is injected
into a varix, it causes the occlusion thereof.
[0058] FIG. 3 is a lateral cross section view of shaft assembly 122
of catheter 120 of 5 FIG. 1 and FIG. 2. As described above, shaft
assembly 122 includes second elongate shaft 126 which is disposed
within lumen 132 defined by first elongate shaft 124. In FIG. 3 it
may be appreciated that a plurality of interstitial members 156
extend between first elongate shaft 124 and second elongate shaft
126. In the embodiment of FIG. 3, each interstitial member
comprises a longitudinal rib 168. Each longitudinal rib 168 extends
beyond an inner surface 154 of first elongate shaft 124 and
contacts an outer surface 138 of second elongate shaft 126. Since
longitudinal ribs 168 are in contact with outer surface 138 of
second elongate shaft 126 it may be appreciated that there is
substantially no gap between longitudinal ribs 168 and second
elongate shaft 126. In a presently preferred embodiment, the gap
between second elongate shaft 126 and each longitudinal rib 168 is,
for example, between zero and 0.05 mm. Embodiments of the present
invention are possible in which there is an interference fit
between longitudinal ribs 168 and second elongate shaft 126. In
FIG. 3, it may also be appreciated that second elongate shaft 126
defines an injection lumen 162.
[0059] FIG. 4 is a partial cross section view of an additional
embodiment of a shaft assembly 222 in accordance with the present
invention. Shaft assembly 222 includes a second elongate shaft 226
disposed within a lumen 232 defined by an inner surface 254 of a
first elongate shaft 224. First elongate shaft 224 also includes a
plurality of interstitial members 256 extending beyond inner
surface 254 of first elongate shaft 224. In the embodiment of FIG.
4, each interstitial member comprises a radial rib 270. As shown in
FIG. 4, each radial rib 270 contacts an outer surface 238 of second
elongate shaft 226. Since radial ribs 270 are in contact with outer
surface 238 of second elongate shaft 226 it may be appreciated that
there is substantially no gap between radial ribs 270 and second
elongate shaft 226. In a presently preferred embodiment, the gap
between second elongate shaft 226 and each radial rib 270 is, for
example, between zero and 0.05 mm. Embodiments of the present
invention are possible in which there is an interference fit
between radial ribs 270 and second elongate shaft 226.
[0060] FIG. 5 is a partial cross section view of an additional
embodiment of a shaft assembly 322 in accordance with the present
invention. Shaft assembly 322 includes a first elongate shaft 324
having a lumen 332 defined by an inner surface 354 thereof. A
second elongate shaft 326 and an interstitial member 356 are
disposed within lumen 332 of first elongate shaft 324. In the
embodiment of FIG. 5, interstitial member comprises a coil 372
comprising a wire 376 forming a plurality of turns 374. As shown in
FIG. 5, each turn 374 of coil 372 is disposed between inner surface
354 of first elongate shaft 324 and outer surface 338 of second
elongate shaft 326. I n the embodiment of FIG. 5, each turn 374 is
in contact with inner surface 354 of first elongate shaft 324 and
outer surface 338 of second elongate shaft 326.
[0061] FIG. 6 is a partial cross section view of an additional
embodiment of a shaft assembly 422 in accordance with the present
invention. Shaft assembly 422 includes a first elongate shaft 424
having a lumen 432 defined by an inner surface 454 thereof. A
second elongate shaft 426 and an interstitial member 456 are
disposed within lumen 432 of first elongate shaft 424. In the
embodiment of FIG. 6, interstitial member comprises a coil 472
comprising a wire 476 forming a plurality of turns 474.
[0062] In the embodiment of FIG. 6, coil 472 has a first pitch
diameter A and a second pitch diameter B. In the embodiment of FIG.
6, coil 472 is preferably adapted to contact outer surface 438 of
second elongate shaft 426 with a plurality of turns 474. Also in
the embodiment of FIG. 6, coil 472 is preferably adapted to contact
inner surface 454 of first elongate shaft 424 with a plurality of
turns. For example, first pitch diameter A may be pre-selected such
that a plurality of turns 474 of coil 472 will contact outer
surface 438 of second elongate shaft 426. By way of a second
example, second pitch diameter B may be pre-selected such that a
plurality of turns 474 of coil 472 will contact inner surface 454
of first elongate shaft 424.
[0063] FIG. 7 is a partial cross section view of an additional
embodiment of a shaft assembly 522 in accordance with the present
invention. Shaft assembly 522 includes a first elongate shaft 524
having a lumen 532 defined by an inner surface 554 thereof. A
second elongate shaft 526 is disposed within lumen 532 of first
elongate shaft 524. Second elongate shaft 526 includes an outer
surface 538 and a plurality of interstitial members 556. In the
embodiment of FIG. 7, each interstitial member 556 comprises a
projection 578 extending beyond outer surface 538 of second
elongate shaft 526.
[0064] FIG. 8 is a plan view of an additional embodiment of a
catheter 620 in accordance with the present invention. Catheter 620
has a distal end 630, a proximal end 640, and a shaft assembly 622.
Shaft assembly 622 comprises a first elongate shaft 624 having a
distal end 634, a proximal end 644, and an inner surface 654
defining a lumen 632. Shaft assembly 622 also includes a second
elongate shaft 626 slidingly disposed within lumen 632 of first
elongate shaft 624.
[0065] Second elongate shaft 626 has an outer surface 638, a distal
end 636, and a proximal end 646. In many applications it is
desirable to advance distal end 636 of second elongate shaft 626 by
a known distance relative to distal end 634 of first elongate shaft
624. In the embodiment of FIG. 8, a plurality of indicia 652 are
disposed on outer surface 638 of second elongate shaft 626
proximate a point 658 of second elongate shaft 626. In a preferred
embodiment, indicia 652 are comprised of a radiopaque material.
Examples of materials which may be suitable in some applications
include gold, platinum, tungsten, iron, silver, and thermoplastic
material loaded with a radiopaque filler. Examples of radiopaque
filler which may be suitable in some applications include barium
sulfate, bismuth subcarbonate, bismuth trioxide, bismuth
oxychloride, tungsten, and depleted uranium.
[0066] A radiopaque reference 680 is disposed proximate distal end
634 of first elongate shaft 624. During surgery a radiopaque
reference 680 and indicia 652 may be viewed on a fluoroscopy
screen. The image viewed on the fluoroscopy screen may be utilized
to determine the depth which point 658 has penetrated into the
target tissue.
[0067] FIG. 9 is a cross sectional view of a distal portion 782 of
a catheter 720 in accordance with the present invention. Catheter
720 comprises a first elongate shaft 724 having an inner surface
754 defining a lumen 732. A ferrule 784 is disposed within lumen
732 proximate a distal end 734 of first elongate shaft 724. In a
preferred embodiment, ferrule 784 is fixed to first elongate shaft
724. A needle 786 is slidingly disposed within a ferrule lumen 794
defined by ferrule 784. A piston member 788 is disposed about a
proximal portion 791 of needle 786. Piston member 788 forms a
sliding seal with inner surface 754 of first elongate shaft 724. A
spring 792 is disposed within lumen 732 of first elongate shaft
724. In the embodiment of FIG. 9, the distal end of spring 792 is
seated against ferrule 784 and the proximal end of spring 792 is
seated against piston member 788.
[0068] In FIG. 9, a fluid 790 is disposed within lumen 732 of first
elongate shaft 724 and a needle lumen 796 defined by needle 786.
Catheter 720 of FIG. 9 may be utilized to inject fluid 790 into a
target tissue. A fluid source may be utilized to urge additional
fluid 790 into lumen 732 of first elongate shaft 724 and a needle
lumen 796 defined by needle 786. In a preferred method, the
additional fluid 790 is urged into lumen 732 with a velocity which
is sufficient to create a pressure differential across piston
member 788. In this preferred method, the pressure differential
across piston member 788 is sufficient to compress spring 792 and
urge an injection port 760 of needle 786 into the target tissue. In
this manner a dose of fluid 790 may be injected into the target
tissue. When the flow of fluid 790 stops, spring 792 will urge
piston member 788 back to the position shown in FIG. 9.
[0069] Those of skill in the art will appreciate that many
embodiments of the fluid source are possible without deviating from
the spirit and scope of the present invention. For example, the
fluid source may include a variable volume chamber in fluid
communication with lumen 732 of first elongate shaft 724. In this
exemplary embodiment, the fluid source may further include a
plunger slidingly disposed within the variable volume chamber.
Urging the plunger distally preferably has the effect of urging
fluid into lumen 732 of first elongate shaft 724. A number of
energy sources may be utilized to urge the plunger distally. Energy
sources which may be suitable in some applications include springs,
compressed gas, a human being, and electricity.
[0070] FIG. 10 is a plan view of a catheter 920 in accordance with
the present invention. Catheter 920 includes a distal. end 930, a
proximal end 940, and a shaft assembly 922. Shaft assembly 922
comprises a first elongate shaft 924 having a distal end 934, a
proximal end 944, and an inner surface 954 defining a lumen 932.
Shaft assembly 922 also includes a second elongate shaft 926
slidingly disposed within lumen 932 of first elongate shaft 924,
which may function as the interstitial member described above. A
third elongate shaft 970 is slidingly disposed within a lumen
defined by second elongate shaft 926. In the embodiment of FIG. 10,
a proximal portion 945 of second elongate shaft 926 extends beyond
proximal end 944 of first elongate shaft 924. Proximal portion 945
of second elongate shaft 926 terminates with a proximal end 946.
Also in the embodiment of FIG. 10, a slider 942 is fixed to second
elongate shaft 926 proximate proximal end 946 thereof. A portion of
slider 942 is disposed within a cavity 948 (also referred to as a
chamber) defined by a housing 950 (also referred to as a hub). In a
presently preferred embodiment, housing 950 is fixed to first
elongate shaft 924 proximate proximal end 944 thereof. Also in a
preferred embodiment, a plurality of indicia 952 are disposed on a
face 954 of housing 950 proximate slider 942.
[0071] FIG. 11 is a partial cross section view of a distal portion
of catheter 920 of FIG. 10. As described previously, catheter 920
includes a first elongate shaft 924, a second elongate shaft 926,
and a third elongate shaft 970. In a preferred embodiment, third
elongate shaft 970 forms a point 958 proximate a distal. end 976
thereof. Third elongate shaft 970 also defines an injection port
960 in fluid communication with an injection lumen. A flange 972 is
disposed about third elongate shaft 970. Flange 972 cooperates with
a mechanical stop 974 in order to limit the travel of third
elongate shaft 970. In a preferred embodiment, mechanical stop 974
is fixed to second elongate shaft 926 proximate to distal end 936
thereof, forming an interstitial member between first elongated
shaft 924 and the third elongate shaft 970. The depth which third
elongate shaft 970 will penetrate into a target tissue (e.g., a
heart wall) may be adjusted by moving distal end 936 of second
elongate shaft 926 a known distance relative to distal end 934 of
first elongate shaft 924. For example, a physician utilizing
catheter 920 may urge slider 942 distally while visually observing
the travel of slider 942 relative to indicia 952 of housing 950. In
a preferred embodiment there is substantially a one-to-one
relationship between the movement of slider 942 relative to indicia
952 of housing 950 and the movement of distal end 936 of second
elongate shaft 926 relative to distal end 934 of first elongate
shaft 924. In the embodiment of FIG. 11, there is, preferably,
interference fit between first elongate shaft 924 and second
elongate shaft 926 to eliminate any slop, whether second elongated
shaft 926 is tubular or comprises radial ribs, as illustrated in
FIG. 11.
[0072] FIG. 12 is a partial cross section view of a distal portion
of catheter 920 of FIG. 10 and FIG. 11. In the embodiment of FIG.
12, distal end 936 of second elongate shaft 926 has been moved to a
new position relative to distal. end 934 of first elongate shaft
924. The position of second elongate shaft 926 illustrated in FIG.
12 may be referred to as a second position, and the position of
second elongate shaft illustrated in FIG. 11 may be referred to as
a first position. It is to be appreciated that second elongate
shaft 926 may be urged proximally and distally to a plurality of
positions. An injection may be performed by urging point. 958 of
third elongate shaft 970 distally into a target tissue. The
advancement of third elongate shaft 970 into the target tissue may
be stopped when flange 972 seats against mechanical stop 974.
[0073] Having thus described the preferred embodiments of the
present invention, those of skill in the art will readily
appreciate that yet other embodiments may be made and used within
the scope of the claims hereto attached. Numerous advantages of the
invention covered by this document have been set forth in the
foregoing description. It will be understood, however, that this
disclosure is, in many respects, only illustrative. Changes may be
made in details, particularly in matters of shape, size, and
arrangement of parts without exceeding the scope of the invention.
The invention's scope is, of course, defined in the language in
which the appended claims are expressed.
* * * * *