U.S. patent application number 14/511255 was filed with the patent office on 2015-01-29 for lead assembly with porous polyethylene cover.
The applicant listed for this patent is Cardiac Pacemakers Inc.. Invention is credited to Rebecca Aron, Kevin J. Ely, Mohan Krishnan.
Application Number | 20150027621 14/511255 |
Document ID | / |
Family ID | 37102505 |
Filed Date | 2015-01-29 |
United States Patent
Application |
20150027621 |
Kind Code |
A1 |
Aron; Rebecca ; et
al. |
January 29, 2015 |
LEAD ASSEMBLY WITH POROUS POLYETHYLENE COVER
Abstract
This document discusses, among other things, a lead assembly
including a porous polyethylene cover. In an example, the cover
includes sections that have differing pore sizes. In an example, a
section of the cover near a distal end portion of a lead assembly
includes pores that are large enough to allow tissue ingrowth. In
another example, a lead assembly includes two or more polyethylene
covers having different porosities.
Inventors: |
Aron; Rebecca; (Ann Arbor,
MI) ; Krishnan; Mohan; (Shoreview, MN) ; Ely;
Kevin J.; (Youngsville, NC) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Cardiac Pacemakers Inc. |
St. Paul |
MN |
US |
|
|
Family ID: |
37102505 |
Appl. No.: |
14/511255 |
Filed: |
October 10, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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12686035 |
Jan 12, 2010 |
8903511 |
|
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14511255 |
|
|
|
|
11150549 |
Jun 10, 2005 |
7650193 |
|
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12686035 |
|
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Current U.S.
Class: |
156/162 ;
156/185 |
Current CPC
Class: |
B29K 2105/256 20130101;
A61N 1/0565 20130101; B29C 65/16 20130101; A61N 1/056 20130101;
A61N 1/0563 20130101; B29K 2105/04 20130101; B29C 65/022 20130101;
B29L 2009/00 20130101; B29K 2023/06 20130101; B29C 65/1412
20130101; B29L 2031/753 20130101; B29C 65/7473 20130101 |
Class at
Publication: |
156/162 ;
156/185 |
International
Class: |
A61N 1/05 20060101
A61N001/05; B29C 65/16 20060101 B29C065/16; B29C 65/74 20060101
B29C065/74; B29C 65/02 20060101 B29C065/02; B29C 65/14 20060101
B29C065/14 |
Claims
1. A method comprising: wrapping a porous polyethylene material
around a portion of a lead assembly under tension such that
adjacent portions of the porous polyethylene material form a
spirally overlapping cover around the lead assembly; controlling
pore sizes in the porous polyethylene material by varying the
tension during wrapping such that pore size in a first section of
the porous polyethylene material is larger than pore size in a
second section of the porous polyethylene material; fusing the
adjacent portions of the porous polyethylene material together by
applying heat.
2. The method of claim 1, wherein controlling the pore sizes
further comprises applying a first tension in controlling pore
sizes in the first section of the porous polyethylene material and
applying a second tension in controlling pore sizes in the second
section of the porous polyethylene material, the first tension
being higher than the second tension.
3. The method of claim 2, wherein controlling the pore sizes
further comprises controlling pore size in the first section in the
first piece of the polyethylene material to allow tissue ingrowth,
and controlling pore size in the second section in the first piece
of the polyethylene material having pores that inhibit tissue
ingrowth.
4. The method of claim 1, wherein fusing the first portion of the
first piece of polyethylene material to the second portion of the
first piece of polyethylene material comprises heating the
polyethylene material to between 80 and 150 degrees.
5. The method of claim 4, wherein fusing the adjacent portions of
comprises heating the polyethylene material via a laser, infrared
(IR) wand, heat gun, or oven.
6. The method of claim 1, wherein wrapping the porous polyethylene
material comprises wrapping the porous polyethylene material having
a thickness between 0.0001 and 0.010 inches, and a width between
0.1 and 8 inches
7. The method of claim 1, wherein controlling the pore sizes in the
porous polyethylene comprises controlling pore sizes to be between
0.1 micron and 15 microns.
8. The method of claim 1, further comprising wrapping a second
piece of porous polyethylene material around the first recited
porous polyethylene material, the second piece of porous
polyethylene material having pores that are larger than the pore
size in a second section of the porous polyethylene material.
9. The method of claim 8, further comprising fusing the second
piece of porous polyethylene material to the first recited porous
polyethylene material by applying heat.
10. A method comprising: wrapping a porous polyethylene material
around a first portion of a lead assembly; controlling pore sizes
in the porous polyethylene material by laser drilling the porous
polyethylene material; and fusing a first portion of the porous
polyethylene material to a second portion of the porous
polyethylene material.
11. The method of claim 10, wherein controlling differing pore
sizes in the polyethylene material further comprises applying
tension and adjusting the tension during wrapping.
12. The method of claim 11, wherein controlling differing pore
sizes in the polyethylene material further comprises concurrently
applying tension and laser drilling the porous polyethylene
material.
13. The method of claim 11, wherein controlling differing pore
sizes in the polyethylene material comprises sequentially applying
tension and laser drilling the porous polyethylene material.
14. The method of claim 10, wherein controlling differing pore
sizes in the porous polyethylene material comprises laser drilling
pores in a pattern.
15. The method of claim 10, wherein controlling differing pore
sizes further comprises providing pores in a first section and in a
second section of the polyethylene material, and wherein the pores
in the first section are larger than the pores in the second
section of the polyethylene material.
16. The method of claim 15, wherein controlling differing pore
sizes further comprises providing a first section in the
polyethylene material having pores that allow tissue ingrowth, and
providing a second section in the polyethylene material having
pores that inhibit tissue ingrowth.
17. A method comprising: wrapping a porous polyethylene material
around a first portion of a lead assembly and controlling pore
sizes in the polyethylene material; hydrophilicly treating at least
a portion of the porous polyethylene; and securing a first portion
of the porous polyethylene material to a second portion of the
porous polyethylene material.
18. The method of claim 17, wherein hydrophilicly treating the
portion of the porous polyethylene comprises wetting the portion of
the porous polyethylene using a plasma technique.
19. The method of claim 17, wherein hydrophilicly treating the
portion of the porous polyethylene comprises using a chemical
hydrophilic treatment that includes at least one of polyvinyl
acetate (PV A) and polyethylene glycol (PEG).
20. The method of claim 17, wherein hydrophilicly treating the
portion of the porous polyethylene comprises using at least one of
glycol, acrylic acid, allyl amine, isopropyl alcohol (IPA),
ethanol, and methanol.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of U.S. application Ser.
No. 12/686,035, filed Jan. 12, 2010, which is a divisional of U.S.
application Ser. No. 11/150,549, filed Jun. 10, 2005, now U.S. Pat.
No. 7,650,193, issued Jan. 19, 2010, the specification of which is
herein incorporated by reference in its entirety.
TECHNICAL FIELD
[0002] This patent document pertains generally to medical device
lead assemblies, and more particularly, but not by way of
limitation, to porous polyethylene covers for a medical device lead
assembly.
BACKGROUND
[0003] Medical devices such as pacers and defibrillators typically
include at least one lead assembly. In a defibrillator, for
example, a lead assembly typically includes at least one
defibrillation electrode, such as a defibrillation coil. Some lead
assemblies include a cover that extends over at least a portion of
the outer surface of the lead assembly. A cover may extend over a
defibrillation coil, for example. Covers are used, for example, to
prevent tissue ingrowth.
[0004] United States Published Patent Application No.
2003/0023294A1 describes an expanded polytetrafluoroethylene
(ePTFE) cover. Expanded polytetrafluoroethylene has a high melting
point (over 300 degrees C.) and a high melt viscosity. The
application of an ePTFE cover to a defibrillation electrode can
involve sintering at high temperatures. Improved coverings for lead
assemblies are needed.
SUMMARY
[0005] An example lead assembly includes a lead body, a conductor
extending through the lead body, an electrode coupled to the
conductor, and a cover formed from porous polyethylene extending
over the electrode. In an example, the cover includes a first
section having tissue ingrowth allowing pores and a second section
having tissue ingrowth inhibiting pores. In an example, the cover
is formed from at least one piece of polyethylene wrapped around at
least a portion of the electrode, the first section of the cover
wrapped with a first tension, and the second section wrapped with a
second tension that is different from the first tension. In an
example, the piece of porous polyethylene is laser-sintered to
itself. In an example, the cover extends over substantially all of
the lead body.
[0006] In another example, a lead assembly includes a lead body, a
conductor extending through the lead body, an electrode coupled to
the conductor, and a piece of mechanically stretched ultra high
molecular weight polyethylene wrapped around at least a portion of
the electrode. In an example, the piece of ultra high molecular
weight polyethylene has a consistent pore size. In an example, the
piece of mechanically stretched ultra high molecular weight
polyethylene is hydrophilic.
[0007] An example method includes wrapping a first piece of porous
polyethylene material around a first portion of a lead assembly,
and fusing a first portion of the first piece of porous
polyethylene material to a second portion of the first piece of
porous polyethylene material. In an example, the wrapping includes
wrapping the piece of porous polyethylene material under tension
and controlling the size of the pores in the polyethylene. In an
example, controlling the size of the pores in the polyethylene
includes adjusting the tension. In an example, the method further
includes wrapping a second piece of porous polyethylene material
around a second portion of the lead assembly, the second portion
having pores that are larger than pores in the first piece of
porous polyethylene material. In an example, the method further
includes joining the second piece of porous polyethylene to the
first piece of porous polyethylene. In an example, fusing the piece
of porous polyethylene includes heating the piece of porous
polyethylene to between 80 and 150 degrees. In an example, the
method further includes hydrophilicly treating at least a portion
of the first piece of porous polyethylene.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] In the drawings, which are not necessarily drawn to scale,
like numerals describe substantially similar components throughout
the several views. The drawings illustrate generally, by way of
example, but not by way of limitation, various embodiments
discussed in the present document.
[0009] FIG. 1 shows an example system for monitoring and
stimulating a heart.
[0010] FIG. 2A shows a medical device lead assembly that includes a
cover over an electrode.
[0011] FIG. 2B shows a medical device lead assembly that includes a
cover over two electrodes.
[0012] FIGS. 3A and 3B show a polyethylene cover wrapped around a
portion of a medical device lead assembly.
[0013] FIG. 4 shows a piece of polyethylene material wrapped around
a portion of a medical device lead assembly to form a cover.
[0014] FIG. 5 shows a porous cover having pores of different sizes
in different regions of the cover.
[0015] FIG. 6A shows a lead assembly and porous covers that have
pores of different sizes.
[0016] FIG. 6B shows a lead assembly and a porous cover that has
pores in a distal portion of the cover that are larger than pores
elsewhere in the cover.
[0017] FIG. 7 is a flow chart that illustrates a method of applying
polyethylene material to a lead assembly.
DETAILED DESCRIPTION
[0018] The following detailed description includes references to
the accompanying drawings, which form a part of the detailed
description. The drawings show, by way of illustration, specific
embodiments in which the invention may be practiced. These
embodiments are also referred to herein as "examples." The drawings
and following detailed description is not to be taken in a limiting
sense, and the scope of the present invention is defined by the
appended claims and their equivalents.
[0019] A lead assembly includes a porous polyethylene cover
extending over at least a portion of the length of the lead
assembly. FIG. 1 shows an example system for monitoring and
stimulating a heart that includes a lead assembly having a porous
polyethylene cover. FIGS. 2, 3A-3B, 4, 5, and 6A-6B show lead
assemblies and example porous polyethylene covers. FIG. 7 is a
flowchart that illustrates a method of applying a cover.
[0020] Referring now to FIG. 1, an example system for monitoring
and stimulating a heart 105 includes a medical device 110 and at
least one lead assembly. In an example, the lead assembly is a
pacing lead, defibrillation lead, or neurological lead. In an
example, the medical device 110 is a pacer, defibrillator, or
stimulator. In an example, the medical device 110 is coupled to two
lead assemblies, as shown in FIG. 1. In FIG. 1, one lead assembly
115 extends into the right side of the heart. The other lead
assembly 120 extends into the left side of the heart. Each lead
assembly includes at least one porous polyethylene cover 125, 130.
In another example, the medical device 110 is coupled to a single
lead assembly that extends, for example, into either the right or
left side of the heart. In other examples, a lead assembly extends
on or around the heart, or on or around a nerve truck or other
anatomical target.
[0021] FIG. 2A shows an example medical device lead assembly 205.
The lead assembly 205 includes one or more conductors extending
through a lumen in a lead body 210. In an example, the lead body
210 is made of silicone. In an example, the lead body is a silicone
tube. A proximal end 215 of the lead assembly 205 is connectable to
a medical device. A distal end portion 220 of the lead assembly is
implantable in, on, or around a heart. The conductors in the lead
assembly are electrically coupled to one or more electrodes. In an
example, the lead assembly includes a first defibrillation
electrode 230, a second defibrillation electrode 235, and a
sensing/pacing electrode 240. A porous polyethylene covering 245
extends over at least one of the defibrillation electrodes. In an
example, a first covering 250 extends over the first defibrillation
electrode 230 and a second covering 255 extends over the second
defibrillation electrode 235. The coverings are shown partially
cut-away in FIG. 2A to show the electrodes beneath the coverings.
In an example, the coverings are spaced apart on the lead assembly.
In another example, the coverings touch or overlap, and are
optionally joined together. In an alternative example, a single
covering 260 extends over both the first defibrillation electrode
230 and the second defibrillation electrode 235, as shown in FIG.
2B.
[0022] In an example, the thickness of the polyethylene covering is
between 0.0001 and 0.010 inches, the width of the covering is
between 0.1 and 8 inches, and the pore size is between 0.1 micron
and 15 microns. In an example, the polyethylene covering shown in
FIG. 2A or 2B has a tensile strength of about 1000 pounds per
square inch (psi) and pore size of about 2 microns.
[0023] In an example, a porous polyethylene covering is applied to
an electrode in line with other manufacturing processes. Examples
polyethylene materials have a processing temperature of around
130-150.degree. C., which allows application of the polyethylene
covering in a manufacturing line. In contrast, materials such as
PTFE can have processing temperatures in excess of 300.degree. C.
To accommodate the high-temperature sintering, a PTFE covering is
typically added to a lead assembly in a post process. Forming a
cover from polyethylene allows the cover to be applied in-line with
other manufacturing steps because of the 130-150.degree. C.
processing temperatures associated with polyethylene. For example,
polyethylene can be applied by spray coating, dip coating, plasma
deposition, laser deposition, or chemical vapor deposition.
[0024] Referring now to FIGS. 3A and 3B, an example method of
forming a polyethylene covering on a lead assembly is shown. A
piece of porous polyethylene material 305 is wrapped around at
least a portion of a lead assembly 315. The piece includes a first
edge 325 and a second edge 330. The first edge 325 meets or
overlaps with the second edge 330, as shown in FIG. 3B. In an
example, the piece of porous polyethylene material 305 is wrapped
around an electrode 310. In an example, the electrode 310 includes
a wire 320 wrapped into a coil, and the polyethylene material
covers the entire coil. In an example, the piece of porous
polyethylene also extends over at least a portion of a lead body
335. In an example, the cover extends over most or all of the lead
assembly.
[0025] The polyethylene cover 305 is secured on the lead assembly,
for example, by connecting the cover to itself. In an example, at
least a portion of the polyethylene cover 305 is heated to fuse the
porous polyethylene material to itself. In an example, the heating
also conforms the polyethylene to the outer shape of the electrode
or lead body. In an example, the polyethylene material 305 is
sintered proximate the first edge 325 to hold the material 305 in a
generally tubular shape that extends over the electrode, as shown
in FIG. 3B. In an example, the porous polyethylene covering is
sintered with a laser, infrared (IR) wand, heat gun, or oven.
[0026] Referring now to FIG. 4, another method of applying a
polyethylene covering is shown. A piece 405 of polyethylene
material 406 is wrapped around a lead assembly 415 in a spiral. In
an example, the piece 405 is wrapped around an electrode 410. In an
example, a first edge 420 of the piece 405 meets or overlaps with a
second edge 425 of the piece from a previous wrap around the lead
assembly. The spiral-wrapped piece of polyethylene forms a
polyethylene tube 430 that extends over the electrode.
[0027] In an example, spiral-wrapped polyethylene material as shown
in FIG. 4 extends past the electrode to cover a portion of the lead
assembly, or all of the lead assembly. Covering the lead assembly
protects the lead assembly and facilitates extraction, for example
by limiting or preventing tissue ingrowth around portions of the
lead.
[0028] Referring now to FIG. 5, a polyethylene covering 505
includes pores 510. The size of the pores is exaggerated for the
purpose of illustration. In an example, the pore size in the porous
polyethylene covering is controlled to control tissue ingrowth into
the covering. In an example, the pores 515 in a first portion 520
of the polyethylene covering 505 are smaller than the pores 525 in
a second portion 530 of the polyethylene covering. For the purpose
of illustration, a dotted line is provided FIG. 5 to distinguish
the first portion 520 of the covering from the second portion 530.
In an example, the pores 515 in the first portion 520 are large
enough to allow at least some tissue ingrowth, and the pores 525 in
the second portion 530 are small enough to substantially inhibit
tissue ingrowth. In an example, the tissue ingrowth into the pores
515 in the first portion 520 secures the lead to body tissue. In an
example, the covering 505 is formed around the lead assembly using
the technique illustrated in FIGS. 3A-3B or the technique
illustrated in FIG. 4.
[0029] The size of pores in the polyethylene material can be
controlled using one or more of a variety of techniques. In an
example, pieces of polyethylene material are manufactured to have
differing pore sizes by controlling parameters such as tension or
heat during the manufacturing process. In an example, different
polyethylene pieces are used at different locations on the lead
assembly to allow tissue growth at particular locations on the
lead, such as at a distal end portion.
[0030] In another example, pore size is controlled by adjusting
tension applied to the polyethylene material as the material is
assembled onto the lead assembly. In an example, a polyethylene
cover is made using a spiral winding technique, as illustrated in
FIG. 4, and the pore size is controlled by varying the tension on
the piece of material 305. In another example, pore size is varied
through application of heat during or after the application of the
polyethylene material to the electrode. In an example, two or more
of the preceding techniques are used concurrently or sequentially
to control the pore size at one or more locations in the
polyethylene material. In an example, laser drilling is used to
form pores in a specific size and pattern.
[0031] Referring now to FIG. 6A, a lead assembly 605 includes a
first porous polyethylene cover 610 proximate a distal end portion
615 of the lead assembly and a second polyethylene cover 620
proximate a middle portion 625 of the lead assembly. In an example,
the lead assembly includes a third cover 630 that extends between
the first cover 610 and second cover 620. Other examples include
additional polyethylene covers. In an example, covers extend over
most or all of the outer surface of the lead assembly. In an
example, some or all of the polyethylene covers are fused together
using heat. In an example, the ends of adjacent covers are fused
together using a laser.
[0032] In an example, a portion of the polyethylene cover 610
proximate the distal end portion of the lead assembly 605 includes
pores that are large enough to permit tissue growth. The tissue
growth secures the distal end portion of the lead to local tissue.
For example, when the lead is implanted in the heart, the tissue
growth secures the distal end portion of the lead to the heart.
[0033] In an example, pore size is controlled within one or both of
the covers 610, 620, which allows for selective tissue ingrowth at
locations on the cover. In the example shown in FIG. 6B, a cover
635 includes a first portion 640 that includes pores that are large
enough to allow tissue ingrowth, and a second portion 645 that has
pores that do not allow tissue ingrowth. In an example, the first
portion 640 is formed having larger pores than the second portion
645 by varying parameters such as tension and/or heat during
application of the polyethylene to the lead assembly. In another
example, the first portion 640 is made from a separate piece of
polyethylene material that has been pre-processed to have larger
pores than the second portion 645. In an example, the separate
piece is applied to the lead in a separate operation and then
sintered to the second portion to form a continuous cover.
[0034] In an example, the covering is hydrophilicly treated. In an
example, the covering is wetted using a plasma technique. In
another example, the covering is wetted using a plasma-assisted
chemical vapor deposition technique. In an example, the covering is
treated using, glycol, acrylic acid, allyl amine, an alcohol such
as isopropyl alcohol (IPA), ethanol, or methanol. In an example,
the covering is treated with a laser after the covering is wetted
to preserve the hydrophilic state of the covering. In an example,
the wavelength, pulse duration, and/or power are adjusted to
actuate the polymer surface and promote development of a
hydrophilic state. In another example, a chemical hydrophilic
treatment is used. In an example, the chemical hydrophilic
treatment uses polyvinyl acetate (PV A) or polyethylene glycol
(PEG).
[0035] In an example, when the pores are filled with a conductive
substance, such as body fluid, the pores in the polyethylene
provide a conductive pathway for a defibrillation current. In
another example, the polyethylene includes particles of conductive
matter to make the covering itself conductive. In another example,
a conductive material is deposited on the polyethylene to provide a
conductive pathway for a defibrillation current. FIG. 7 is a flow
chart that illustrates a method of applying a polyethylene material
to a lead assembly. At 705, a piece of porous polyethylene material
is wrapped around a first portion of a lead assembly. In an
example, the stock polyethylene material is porous before it is
wrapped. In another example, pores are created in the polyethylene
when the polyethylene is wrapped. At 710, the size of the pores in
the polyethylene is controlled by adjusting a tension in the
polyethylene during wrapping. Applying a higher tension to the
polyethylene results in more stretching of the material and larger
pores. At 715, a first portion of the piece of porous polyethylene
is fused to a second portion of the piece of polyethylene. In an
example, the polyethylene is wrapped spirally onto the lead
assembly, and adjacent portions of the material (i.e. adjacent
windings) are fused together. In an example, the polyethylene is
fused by heating, for example with a laser. In an example, the
porous polyethylene is heated to between 80 and 150 degrees C.
[0036] Referring again to FIG. 7, at 720, a second piece of porous
polyethylene is wrapped around a second portion of the lead
assembly. In an example, the second piece of polyethylene has pores
that are larger than the pores in the first piece of porous
polyethylene. In an example, the second piece of porous
polyethylene is wrapped onto the lead assembly before the first
piece of porous polyethylene is wrapped onto the lead assembly. At
725, the second piece of porous polyethylene is joined to the first
piece of porous polyethylene. In an example the second piece of
porous polyethylene is fused to the first piece of porous
polyethylene by heating the polyethylene, for example with a
laser.
[0037] At 730, at least a portion of at least one piece of porous
polyethylene is hydrophilically treated. In an example, a
hydrophilic agent is deposited on one or both of the pieces of
porous polyethylene. In an example, a hydrophilic agent is
deposited in a plasma-assisted chemical vapor deposition process.
In an example, hydrophilicly treating at least a portion of the
piece of porous polyethylene includes treating the first piece of
polyethylene with a laser. In an example, laser treating the porous
polyethylene preserves hydrophilicity imparted by a hydrophilic
agent. In an example, hydrophilicly treating at least a portion of
the piece of porous polyethylene includes chemically treating the
first piece of polyethylene. In an example, the chemical treatment
preserves hydrophilicity imparted by a hydrophilic agent. In an
example, the chemical hydrophilic treatment uses polyvinyl acetate
(PYA) or polyethylene glycol (PEG).
[0038] Polymer lead coverings having varied material properties are
also described in copending application Ser. No. 11/150,021, filed
Jun. 10, 2005, now issued as U.S. Pat. No. 7,366,573 to Knapp et
al., entitled Polymer Lead Covering with Varied Material
Properties, which is incorporated by reference in its entirety.
[0039] It is to be understood that the above description is
intended to be illustrative, and not restrictive. Since many
embodiments of the invention can be made without departing from the
scope of the invention, the invention resides in the claims
hereinafter appended.
* * * * *