U.S. patent application number 14/282293 was filed with the patent office on 2014-09-11 for kerstpiek tip for medical devices.
The applicant listed for this patent is BOSTON SCIENTIFIC SCIMED, INC.. Invention is credited to James M. Anderson, Robert Chang, Jan Weber.
Application Number | 20140257180 14/282293 |
Document ID | / |
Family ID | 48903521 |
Filed Date | 2014-09-11 |
United States Patent
Application |
20140257180 |
Kind Code |
A1 |
Weber; Jan ; et al. |
September 11, 2014 |
KERSTPIEK TIP FOR MEDICAL DEVICES
Abstract
An apparatus may include a medical device including an elongate
shaft disposed about a guidewire, and a distal tip including a
plurality of rounded protrusions, wherein adjacent protrusions are
fixed directly to each other by a relatively flexible connector.
The plurality of protrusions may decrease in size from a
proximalmost protrusion distally to distalmost protrusion.
Inventors: |
Weber; Jan; (Maastricht,
NL) ; Anderson; James M.; (Fridley, MN) ;
Chang; Robert; (Belmont, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BOSTON SCIENTIFIC SCIMED, INC. |
Maple Grove |
MN |
US |
|
|
Family ID: |
48903521 |
Appl. No.: |
14/282293 |
Filed: |
May 20, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13754175 |
Jan 30, 2013 |
8740842 |
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14282293 |
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61595825 |
Feb 7, 2012 |
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Current U.S.
Class: |
604/96.01 |
Current CPC
Class: |
A61M 25/104 20130101;
A61M 25/1011 20130101; A61M 29/00 20130101; A61M 25/0068 20130101;
A61M 25/09 20130101; A61M 25/10 20130101; A61M 2025/1093 20130101;
A61M 25/0043 20130101 |
Class at
Publication: |
604/96.01 |
International
Class: |
A61M 25/10 20060101
A61M025/10 |
Claims
1. An apparatus, comprising: a medical device including an elongate
shaft disposed about a guidewire; and a distal tip including a
plurality of rounded protrusions, wherein adjacent protrusions are
coupled to each other by a relatively flexible connector; wherein
each relatively flexible connector includes a maximum outer
diameter that is greater than a maximum outer diameter of the
guidewire, further wherein the plurality of rounded protrusions
provide a generally tapered distal profile from a proximalmost
protrusion distally to a distalmost protrusion.
2. The apparatus of claim 1, wherein the plurality of rounded
protrusions and the relatively flexible connectors therebetween
cooperate such that at a predetermined bending angle, adjacent
protrusions of the plurality of rounded protrusions will come into
contact with each other and thus prevent further bending of the
relatively flexible connector between those adjacent protrusions
that are in contact with each other.
3. The apparatus of claim 1, wherein the rounded protrusions of the
plurality of rounded protrusions are selected from rounded
protrusions which are substantially spherical, ellipsoidal, or
ovoid.
4. The apparatus of claim 1, wherein adjacent protrusions are fixed
to each other by one discrete, relatively flexible connector.
5. The apparatus of claim 1, wherein the distal tip is disposed on
the guidewire.
6. The apparatus of claim 1, wherein the plurality of rounded
protrusions each decrease in size from the proximalmost protrusion
distally to the distalmost protrusion.
7. The apparatus of claim 6, wherein a maximum outer extent of the
proximalmost protrusion is sized at about 50% of a maximum outer
extent of the medical device measured radially from a central
longitudinal axis thereof
8. The apparatus of claim 1, wherein the plurality of rounded
protrusions is relatively rigid.
9. The apparatus of claim 8, wherein the plurality of rounded
protrusions is formed from a metallic material.
10. The apparatus of claim 8, wherein the plurality of rounded
protrusions is formed from a ceramic material.
11. The apparatus of claim 1, wherein each connector is formed from
a polymer material.
12. The apparatus of claim 1, wherein the plurality of rounded
protrusions is substantially radiopaque.
13. The apparatus of claim 1, wherein the distal tip is integrally
formed with the elongate shaft.
14. The apparatus of claim 1, wherein the distal tip is axially
slidable relative to the elongate shaft.
15. The apparatus of claim 14, wherein the distal tip is configured
to mate with a distal end of the elongate shaft.
16. The apparatus of claim 1, wherein the medical device includes a
balloon catheter.
17. The apparatus of claim 16, wherein the distal tip is integrally
formed with the balloon catheter.
18. The apparatus of claim 1, wherein the plurality of rounded
protrusions is inflatable.
19. The apparatus of claim 18, wherein the distal tip forms a
generally conical shape when the plurality of rounded protrusions
is in a deflated condition.
20. The apparatus of claim 1, further comprising one or more
additional protrusions, wherein a maximum outer extent of the
distalmost additional protrusion is sized at about 50% of a maximum
outer extent of the medical device measured radially from a central
longitudinal axis thereof
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 13/754,175, filed Jan. 30, 2013, which claims the benefit of
U.S. application Ser. No. 61/595,825, filed Feb. 7, 2012.
TECHNICAL FIELD
[0002] The disclosure relates generally to percutaneous medical
devices and more particularly to percutaneous medical devices
having a large size.
BACKGROUND
[0003] Percutaneous medical devices may vary across a broad range
of sizes, from the very small (in length, cross-section, or sheer
bulk) to the very large. As the size of a medical device increases,
the risk or potential for navigational difficulty through the
vasculature and/or abrasion or injury to the walls of the vessel(s)
through which the medical device travels also increases. For
example, a large medical device, such as some used in certain
angioplasty, atherectomy, stent-deployment, transcatheter aortic
valve implantation (TAVI), valvectomy, valvuloplasty, or other
intravascular procedures, may be difficult to navigate through
tortuous vasculature. Similarly, such large medical devices may
also present increased risk of abrasion to the vessel walls as they
navigate turns or narrowing lumens. A continuing need exists for
improved percutaneous medical devices and methods.
SUMMARY
[0004] An apparatus may comprise a medical device including an
elongate shaft disposed about a guidewire, and a distal tip
including a plurality of rounded protrusions, wherein adjacent
protrusions are fixed directly to each other by a discrete,
relatively flexible connector. The plurality of protrusions may
each decrease in size from a proximalmost protrusion distally to
distalmost protrusion.
[0005] Although discussed with specific reference to use within the
coronary vasculature of a patient, for example a tortuous aorta,
medical devices and methods of use in accordance with the
disclosure can be adapted and configured for use in other parts of
the anatomy, such as the digestive system, the respiratory system,
or other parts of the anatomy of a patient.
BRIEF DESCRIPTION OF THE FIGURES
[0006] FIG. 1 is a schematic partial cross-sectional view of an
example of a tortuous vessel;
[0007] FIG. 2 is a schematic partial cross-sectional view of an
example of a stenosed vessel lumen;
[0008] FIG. 3 is a schematic persective view of an example
apparatus including a medical device;
[0009] FIG. 4 is a schematic persective view of an example
apparatus including a medical device and an example kerstpiek
tip;
[0010] FIG. 5 is a schematic persective view of an example
apparatus including a medical device and an example kerstpiek
tip;
[0011] FIG. 6A is a schematic partial side view of an example
kerstpiek tip in a straightened condition;
[0012] FIG. 6B is a schematic partial side view of an example
kerstpiek tip in a bent condition;
[0013] FIG. 7 is schematic partial cross-sectional view of an
example apparatus including a medical device and an example
kerstpiek tip;
[0014] FIG. 8 is schematic partial cross-sectional view of an
example apparatus including a medical device and an example
kerstpiek tip; and
[0015] FIG. 9 is a schematic perspective view of an example
apparatus including a medical device and an example kerstpiek
tip.
[0016] While the invention is amenable to various modifications and
alternative forms, specifics thereof have been shown by way of
example in the drawings and will be described in greater detail
below. It should be understood, however, that the intention is not
to limit the invention to the particular embodiments described. On
the contrary, the intention is to cover all modifications,
equivalents, and alternatives falling within the spirit and scope
of the invention.
DETAILED DESCRIPTION
[0017] For the following defined terms, these definitions shall be
applied, unless a different definition is given in the claims or
elsewhere in this specification.
[0018] The terms "upstream" and "downstream" refer to a position or
location relative to the direction of blood flow through a
particular element or location, such as a vessel (i.e., the aorta)
or vessel lumen, a heart valve (i.e., the aortic valve), and the
like.
[0019] The term "kerstpiek" generally refers to a traditional
holiday (i.e., Christmas) tree ornament placed at the top or peak
of the tree. A kerstpiek may sometimes be distinguished by one or
more rounded protrusions along a tapered body of the ornament. As
used herein, a kerstpiek tip may generally refer to a tip or
element having a shape resembling that of a traditional
kerstpiek.
[0020] All numeric values are herein assumed to be modified by the
term "about," whether or not explicitly indicated. The term "about"
generally refers to a range of numbers that one of skill in the art
would consider equivalent to the recited value (i.e., having the
same function or result). In many instances, the term "about" may
include numbers that are rounded to the nearest significant
figure.
[0021] Weight percent, percent by weight, wt %, wt-%, % by weight,
and the like are synonyms that refer to the concentration of a
substance as the weight of that substance divided by the weight of
the composition and multiplied by 100.
[0022] The recitation of numerical ranges by endpoints includes all
numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3,
3.80, 4, and 5).
[0023] As used in this specification and the appended claims, the
singular forms "a", "an", and "the" include plural referents unless
the content clearly dictates otherwise. As used in this
specification and the appended claims, the term "or" is generally
employed in its sense including "and/or" unless the content clearly
dictates otherwise.
[0024] The following description should be read with reference to
the drawings wherein like reference numerals indicate like elements
throughout the several views. The detailed description and drawings
are intended to illustrate but not limit the claimed invention.
[0025] A number of ailments were originally treated, if they were
treatable at all, through invasive surgical techniques. Over time,
less-invasive, percutaneous-access surgical techniques and medical
devices have been developed to treat certain conditions. Some of
those medical devices may be of substantial size, in length,
cross-section, or sheer bulk, and may be relatively stiff along
their length, further limiting the flexibility and navigability of
the medical device(s) through tortuous vasculature, such as that
illustrated in FIG. 1. As seen in FIG. 1, a tortuous vessel 10
and/or a lumen 20 thereof may include one or more sharp bends 30
requiring an apparatus 90 including a medical device 100 traversing
the vessel 10 and/or lumen 20 to make turns or changes in
direction. A large medical device 100 passing through the lumen 20
may scrape against a vessel wall 40 as the medical device 100
navigates the bend(s), causing injury to the vessel wall 40.
Additionally, a large medical device 100 navigating through a sharp
bend 30 along a guidewire 140 may cause a sharp angle to form
between the guidewire 140 and the medical device 100 that may cause
a kink to form in the guidewire 140 as the medical device 100
naturally wants to follow a straight path while the guidewire 140
follows the bend(s) 30 of the vessel lumen 20. A kink in the
guidewire 140 may create a sharp edge or corner that could nick the
vessel wall 40, thereby causing injury. Additionally, delivery of
the medical device 100 over the guidewire 140 may transfer enough
force to the guidewire 140, through side loading for example, to
cause the guidewire 140 to cut or slice through the vessel wall 40
and/or other surrounding tissue(s) around the bend(s) 30.
[0026] Further, while not explicitly illustrated, the discussion
above may apply equally to the chamber(s) and/or other passages of
the heart in embodiments where a medical device 100 is being
advanced into and/or through the heart.
[0027] In some treatment procedures, an apparatus 90 including a
medical device 100 may need to traverse or treat a stenosed or
diseased vessel lumen 20, such as that illustrated in FIG. 2. With
or without the aid of a guidewire 140, a large medical device 100
may scrape or directly impact a lesion or stenosis 50 disposed
within the vessel lumen 20 adjacent or attached to the vessel wall
40, which may therefore cause vulnerable plaque, embolic material
or debris, and the like to be released into the bloodstream.
[0028] FIG. 3 schematically illustrates an apparatus 90 including a
percutaneously-deployable medical device 100. The medical device
100 may include a portion having a large profile. Some examples of
a percutaneously-deployable medical device 100 may include, but are
not limited to, an angioplasty device, an atherectomy device, a
balloon catheter, a stent-deployment or delivery device, a
transcatheter aortic valve implantation
[0029] (TAVI) device, a valvectomy device, a valvuloplasty device,
or other suitable intravascular devices. A medical device 100 may
include an elongate shaft 110 having a lumen 120 extending
therethrough and a central longitudinal axis 130. In some
embodiments, a guidewire 140 may be disposed within the lumen 120.
In some embodiments, the lumen 120 may be coincident with,
concentric with, and/or parallel to the central longitudinal axis
130. The medical device 100 may define an outer or radial extent
measured radially outward from the central longitudinal axis 130.
The medical device 100 may include a maximum outer or radial extent
defined by a portion of the medical device 100 extending radially
farthest from the central longitudinal axis 130 at an angle normal
to the central longitudinal axis 130. In some embodiments, the
portion of the medical device 100 extending radially farthest from
the central longitudinal axis 130 may be disposed at a distal end
of the medical device 100 or along the length of the medical device
100 at a location proximal of a distal end of the medical device
100.
[0030] FIG. 4 schematically illustrates an example medical device
100 including an elongate shaft 110 disposed about a guidewire 140.
In some embodiments, the medical device 100 may include a distal
tip 200 (i.e., a kerstpiek tip) disposed distally of the elongate
shaft 110. In some embodiments, a distal tip 200 may include a
lumen (not shown) extending therethrough so as to be axially
slidable on, along, or about the guidewire 140 and relative to the
elongate shaft 110. The distal tip 200 may include a plurality of
relatively rigid, rounded protrusions 210. As the rounded
protrusions 210 are a part of the distal tip 200, the plurality of
rounded protrusions 210 may also have a lumen extending
therethrough.
[0031] In some embodiments, the plurality of rounded protrusions
210 may be substantially spherical in shape, although other
suitable rounded shapes including but not limited to elliptical,
ovoid, or egg-shaped protrusions are also contemplated. In some
embodiments, the plurality of rounded protrusions 210 may each
decrease in size from a proximalmost protrusion 212 distally to a
distalmost protrusion 214, such that the proximalmost protrusion
212 is the largest of the plurality of protrusions 210 and the
distalmost protrusion 214 is the smallest of the plurality of
protrusions 210. In some embodiments, a maximum outer extent of the
proximalmost protrusion 212 may be sized at about 100%, 75%, 50%,
25%, or less of the maximum outer extent of the medical device 100,
as measured radially from the central longitudinal axis 130.
[0032] In some embodiments, the plurality of rounded protrusions
210 may be formed of a relatively rigid and/or radiopaque material.
In some embodiments, the plurality of rounded protrusions 210 may
be formed of or include a metallic material, a metallic alloy, a
ceramic material, a rigid or high performance polymer, a
metallic-polymer composite, combinations thereof, and the like.
Some examples of some suitable materials may include metallic
materials and/or alloys such as stainless steel (e.g. 304v
stainless steel or 316L stainless steel), nickel-titanium alloy
(e.g., nitinol, such as super elastic or linear elastic nitinol),
nickel-chromium alloy, nickel-chromium-iron alloy, cobalt alloy,
nickel, titanium, platinum, or alternatively, a polymer material,
such as a high performance polymer, or other suitable materials,
and the like. The word nitinol was coined by a group of researchers
at the United States Naval Ordinance Laboratory (NOL) who were the
first to observe the shape memory behavior of this material. The
word nitinol is an acronym including the chemical symbol for nickel
(Ni), the chemical symbol for titanium (Ti), and an acronym
identifying the Naval Ordinance Laboratory (NOL).
[0033] In some embodiments, the plurality of rounded protrusions
210 may be mixed with, may be doped with, may be coated with, or
may otherwise include a radiopaque material. Radiopaque materials
are understood to be materials capable of producing a relatively
bright image on a fluoroscopy screen or another imaging technique
such as X-ray during a medical procedure. This relatively bright
image aids the user of device in determining its location. Suitable
radiopaque materials may include, but are not limited to, bismuth
subcarbonate, iodine, gold, platinum, palladium, tantalum, tungsten
or tungsten alloy, and the like.
[0034] In some embodiments, the plurality of rounded protrusions
210 may include one or more relatively flexible connectors 216
disposed between adjacent protrusions. In some embodiments,
adjacent protrusions may be coupled to each other by a discrete,
relatively flexible connector 216. In some embodiments, adjacent
protrusions may be spaced apart by and fixed directly to each other
by one discrete, relatively flexible connector 216. In other words,
there may be no other elements connecting or attaching adjacent
protrusions together. Similar to the rounded protrusions 210, since
the flexible connector(s) 216 are a part of the distal tip 200, the
flexible connector(s) 216 may also have a lumen extending
therethrough. In some embodiments, the flexible connector(s) 216
may be tubular. In some embodiments, each discrete, relatively
flexible connector 216 includes a maximum outer diameter that is
greater than a maximum outer diameter of the guidewire and less
than a minimum outer diameter of the elongate shaft 110. In some
embodiments, one, some, or each of the plurality of rounded
protrusions 210 may be axially translatable relative to each other.
Axial translation of the flexible connector(s) 216 may permit
self-alignment of the plurality of rounded protrusions 210 and
adaptable flexibility.
[0035] In some embodiments, the flexible connector(s) 216 may be
formed of a relatively flexible material. In some embodiments, the
flexible connector(s) 216 may be formed of or include a polymeric
material, a metallic or metallic alloy material, a metallic-polymer
composite, combinations thereof, and the like. Examples of suitable
polymers may include polyurethane, a polyether-ester such as
ARNITEL.RTM. available from DSM Engineering Plastics, a polyester
such as HYTREL.RTM. available from DuPont, a linear low density
polyethylene such as REXELL.RTM., a polyamide such as DURETHAN.RTM.
available from Bayer or CRISTAMID.RTM. available from Elf Atochem,
an elastomeric polyamide, a block polyamide/ether, a polyether
block amide such as PEBA available under the trade name PEBAX.RTM.,
silicones, polyethylene, Marlex high-density polyethylene,
polyetheretherketone (PEEK), polyimide (PI), and polyetherimide
(PEI), a liquid crystal polymer (LCP) alone or blended with other
materials.
[0036] In some embodiments, the distal tip 200 may be made from,
may be mixed with, may be coated with, or may otherwise include a
material that provides a smooth, slick outer surface. In some
embodiments, the distal tip 200, the plurality of rounded
protrusions 210, and/or the flexible connector(s) 216 may include
or be coated with a lubricious coating, a hydrophilic coating, a
hydrophobic coating, a drug-eluting material, an anti-thrombus
coating, or other suitable coating depending on the intended use or
application.
[0037] In some embodiments, a distal tip 200 may include a proximal
end 220 configured to mate with a distal end of the elongate shaft
110 when the distal tip 200 is translated toward and into contact
with the elongate shaft 110. In some embodiments, at least a
portion of the proximal end 220 may be configured to abut the
distal end of the elongate shaft 110. In some embodiments, the
proximal end 220 may include a stepped configuration such that at
least a portion of the distal tip 200 fits within the distal end of
the elongate shaft 110 and/or within the lumen 120 in a mating
relationship. Although not explicitly shown, in some embodiments,
the distal tip 200 may include a tapered distal end distal of the
distalmost protrusion 214.
[0038] In some embodiments, the distal tip 200 may be integrally
formed with or as the distal end of the elongate shaft 110, such
that the elongate shaft 110 and the distal tip 200 form a single
monolithic structure, such as that shown in FIG. 5. In some
embodiments, a lumen extending through the distal tip 200 may be
integrally formed with the lumen 120 of the elongate shaft 110 such
that a single continuous lumen extends through the entire apparatus
90, medical device 100, elongate shaft 110, and/or distal tip
200.
[0039] FIG. 6A illustrates an example distal tip 200 (i.e. a
kerstpiek tip) in a straightened condition. As discussed above, a
distal tip 200 may include a plurality of rounded protrusions 210
and one or more flexible connectors 216 disposed between adjacent
protrusions. Distal tip 200 may be configured to substantially
follow or slide along a guidewire 140 disposed within a lumen (not
shown) extending through the distal tip 200. In operation, an
apparatus 90 including the distal tip 200 may be advanced through a
vessel 10, a vessel lumen 20, bend(s) 30, and/or lesion or stenosis
50. The plurality of rounded protrusions 210 may serve to guide the
medical device 100 through the vessel 10, vessel lumen 20, bend(s)
30, and/or lesion or stenosis 50. As discussed above, the
relatively large profile of medical device 100 may scrape against
vessel wall 40 and/or lesion or stenosis 50 as it is advanced
distally. The generally tapered profile of the plurality of rounded
protrusions 210 may provide a tapered distal profile to the medical
device 100 thereby permitting the medical device 100 to more easily
navigate the vessel 10, the vessel lumen 20, the bend(s) 30, and/or
the lesion or stenosis 50 without excessive or injurious scraping
of the vessel wall 40 and/or the lesion or stenosis 50.
[0040] FIG. 6B illustrates an example distal tip 200 (i.e. a
kerstpiek tip) in a bent condition, such as would occur when
navigating tortuous vasculature (i.e. bends 30 of vessel 10, as
seen in FIG. 1) along a guidewire 140. As can be seen from FIG. 6B,
the plurality of rounded protrusions 210 and the flexible
connectors 216 cooperate such that at a predetermined bending
angle, adjacent protrusions will come into contact with each other
and thus prevent further bending of the flexible connector 216
between those adjacent protrusions that are in contact with each
other. Construction of the distal tip 200 in this manner may
distribute the bending along a longer section of the apparatus 90
and/or distal tip 200, so as to avoid forming a sharp angle between
a guidewire 140 and a medical device 100, thereby preventing a kink
from forming in the guidewire 140 which may damage or cause injury
to a vessel wall 40.
[0041] In some embodiments, at least a portion of the distal tip
200 may be inflatable. In some embodiments, the plurality of
protrusions 210 may be inflatable. In some embodiments, the distal
tip 200 may form a generally conical shape tapering toward a distal
end thereof when the plurality of protrusions 210 is in a deflated
or collapsed condition, such as that shown for example in FIG. 7.
In an inflated or expanded condition, each of the plurality of
protrusions 210 may form a generally spherical shape, or other
suitable shape as previously discussed, such as that shown for
example in FIG. 8. In some embodiments, the distal tip 200 may be
in fluid communication with an inflation lumen (not shown)
extending proximally through the apparatus 90, the medical device
100, and/or the elongate shaft 110.
[0042] In some embodiments, an inflatable distal tip 200 may be
used as a pre-dilatation device, a guide member, or as an
atraumatic distal tip for a medical device 100. In some
embodiments, an inflatable distal tip 200 may be used as an
anchoring element to help prevent axial movement of the medical
device 100. In some embodiments, each of the plurality of
protrusions 210 of the inflatable distal tip 200 may have
substantially the same internal pressures, substantially different
internal pressures, or may have progressive internal pressures,
when in the inflated condition. For example, the distalmost
protrusion 214 may be inflated to a pressure of about 0.5
atmosphere (atm), about 1 atm, about 2 atm, about 3 atm, or other
suitable pressure(s), while the proximalmost protrusion 212 may be
inflated to a pressure of about 10 atm, about 12 atm, about 15 atm,
about 18 atm, or other suitable pressure(s). The pressures provided
herein are merely exemplary, and variation, changes, or
modifications may be made without departing from the scope of the
disclosure. Intervening protrusions, that is, protrusions disposed
between the proximalmost protrusion 212 and the distalmost
protrusion 214 may be inflated to a pressure between that of the
proximalmost protrusion 212 and the distalmost protrusion 214 and
at progressively lower pressures in each protrusion toward the
distalmost protrusion 214. This arrangement may also permit a
variation in stiffness of the plurality of protrusions 210
according to the inflation pressures. That is, a protrusion
inflated to a relatively higher pressure may be stiffer or more
rigid than a protrusion inflated to a relatively lower
pressure.
[0043] In some embodiments, the medical device 100 may include a
balloon catheter having an inflation lumen in fluid communication
with a balloon disposed at, on, or near a distal end of the
elongate shaft 110. In some embodiments, an apparatus 90 may
include a medical device 100 including a balloon catheter and an
inflatable distal tip 200. In some embodiments, an inflatable
distal tip 200 may be integrally formed with a balloon catheter. In
embodiments having both a balloon catheter and an inflatable distal
tip 200, the balloon catheter and the distal tip 200 may have a
shared inflation lumen, or each may have a separate, discrete
inflation lumen. In some embodiments having a balloon catheter and
an inflatable distal tip 200, the distal tip 200 may function as a
pre-dilatation device for preparing a lesion for crossing of the
main balloon body.
[0044] Similar to the discussion above regarding distal advancement
of the medial device 100 and the distal tip 200, withdrawal of the
medical device 100 proximally through a vessel 10, vessel lumen 20,
bend(s) 30, and/or lesion or stenosis 50 may also result in
inadvertent or undesired scraping and/or dislodging of debris. In
ways similar to those that the plurality of protrusions 210
provides advantages during distal advancement, one or more rounded
protrusions 150 may be added to the elongate shaft 110 proximal of
the medical device 100 to provide (at least) the same advantages
during proximal withdrawal or retraction, as seen in FIG. 9. While
FIG. 9 illustrates a single rounded protrusion 150, the skilled
artisan art will recognize that a plurality of rounded protrusions
150 may be added or used in the same or similar manner as the
plurality of rounded protrusions 210 described above. In some
embodiments having a plurality of rounded protrusions 150, the
plurality of protrusions 150 may each decrease in size from a
distalmost protrusion proximally to a proximalmost protrusion, such
that the distalmost protrusion is the largest of the plurality of
protrusions 150 and the proximalmost protrusion is the smallest of
the plurality of protrusions 150. In some embodiments, a maximum
outer extent of the distalmost protrusion may be sized at about
100%, 75%, 50%, 25%, or less of the maximum outer extent of the
medical device 100, as measured radially from the central
longitudinal axis 130 (not shown).
[0045] It should be understood that although the above discussion
was focused on a medical device and methods of use within the
vascular system of a patient, other embodiments of medical devices
or methods in accordance with the disclosure can be adapted and
configured for use in other parts of the anatomy of a patient. For
example, devices and methods in accordance with the disclosure can
be adapted for use in the digestive or gastrointestinal tract, such
as in the mouth, throat, small and large intestine, colon, rectum,
and the like. For another example, devices and methods can be
adapted and configured for use within the respiratory tract, such
as in the mouth, nose, throat, bronchial passages, nasal passages,
lungs, and the like. Similarly, the apparatus and/or medical
devices described herein with respect to percutaneous deployment
may be used in other types of surgical procedures as appropriate.
For example, in some embodiments, the medical devices may be
deployed in a non-percutaneous procedure, such as an open heart
procedure. Devices and methods in accordance with the invention can
also be adapted and configured for other uses within the anatomy.
It should be understood that this disclosure is, in many respects,
only illustrative.
[0046] Changes may be made in details, particularly in matters of
shape, size, and arrangement of steps 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.
* * * * *