U.S. patent application number 16/537130 was filed with the patent office on 2019-11-28 for tools and methods for implantation of implantable medical lead extensions or catheters.
The applicant listed for this patent is Medtronic, Inc.. Invention is credited to Bruce A. Behymer, Charles T. Bombeck, Douglas S. Cerny, Darrin E. Dickerson, Jeffrey R. Dixon, Phillip C. Falkner, Evan M. Gustafson, Scott M. Hanson, Raymond F. McMullen, Thomas I. Miller, Joseph P. Ricci, Adam J. Rivard.
Application Number | 20190358446 16/537130 |
Document ID | / |
Family ID | 51530985 |
Filed Date | 2019-11-28 |
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United States Patent
Application |
20190358446 |
Kind Code |
A1 |
Hanson; Scott M. ; et
al. |
November 28, 2019 |
TOOLS AND METHODS FOR IMPLANTATION OF IMPLANTABLE MEDICAL LEAD
EXTENSIONS OR CATHETERS
Abstract
Tips for use on a tunneling tool provide the ability to pull an
implantable medical lead extension or catheter body through a
subcutaneous tunnel. The tips may include a pin with a barb, where
the barb is inserted within a compliant portion of a connector body
of the lead extension or a catheter body to create an interference
fit that allows the connector body or catheter body to be pulled
through the tunnel. The tips may include a carrier that has a
cavity for the connector body, where the tunneling is performed
with the carrier present on the tunneling tool. A body is
positioned within the cavity of the carrier to prevent tissue from
snagging on and collecting within the carrier. The body may include
a tip portion that performs the tunneling function. The carrier may
also provide tunneling and/or may be attached to the tunneling tool
during tunneling.
Inventors: |
Hanson; Scott M.; (Savage,
MN) ; Behymer; Bruce A.; (Grant, MN) ;
Bombeck; Charles T.; (Lino Lakes, MN) ; Cerny;
Douglas S.; (Minneapolis, MN) ; Dickerson; Darrin
E.; (Blaine, MN) ; Dixon; Jeffrey R.;
(Andover, MN) ; Falkner; Phillip C.; (Minneapolis,
MN) ; Gustafson; Evan M.; (Golden Valley, MN)
; McMullen; Raymond F.; (Shorewood, MN) ; Miller;
Thomas I.; (Blaine, MN) ; Ricci; Joseph P.;
(Ham Lake, MN) ; Rivard; Adam J.; (Blaine,
MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medtronic, Inc. |
Minneapolis |
MN |
US |
|
|
Family ID: |
51530985 |
Appl. No.: |
16/537130 |
Filed: |
August 9, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14179716 |
Feb 13, 2014 |
10391303 |
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16537130 |
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61781653 |
Mar 14, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 25/0068 20130101;
A61B 17/00234 20130101; A61M 25/0069 20130101; A61M 25/0662
20130101; A61B 2017/320056 20130101; A61M 25/0194 20130101; A61N
1/0551 20130101; A61B 2017/0046 20130101; A61B 17/3415
20130101 |
International
Class: |
A61N 1/05 20060101
A61N001/05; A61B 17/34 20060101 A61B017/34; A61M 25/01 20060101
A61M025/01; A61M 25/06 20060101 A61M025/06; A61B 17/00 20060101
A61B017/00 |
Claims
1. An assembly, comprising: an implantable medical lead extension
having a connector body located on a distal end, the connector body
defining a bore and a compliant distal portion; and a tip
comprising a pin having an end that is present within the bore of
the connector body, the tip further comprising a barb positioned on
the pin and spaced axially from the end of the pin, the barb having
an interference fit within the compliant distal portion of the
connector body.
2. The assembly of claim 1, further comprising: a handle; and a
shaft having a first end and a second end, the first end being
coupled to the handle and the second end being coupled to the
tip.
3. The assembly of claim 2, wherein the handle and shaft are
constructed in a unitary manner.
4. The assembly of claim 3, wherein the tip is detachable from the
second end of the shaft.
5. The assembly of claim 4, wherein the pin includes a first
section positioned axially between the barb and the end having a
first diameter, a second section positioned axially between the
first section and the end so as to align with a set screw within
the bore of the connector body, the second section having a second
diameter that is smaller than the first diameter of the first
section.
6. The assembly of claim 5, wherein the pin includes a third
section on a side of the barb closer to the shaft that has a third
diameter and wherein the pin includes a fourth section extending
axially from an end of the first section and to an edge of the barb
that has a fourth diameter that is smaller than the third diameter
of the third section.
7. The assembly of claim 6, wherein the third diameter of the third
section is a same diameter as a diameter of the barb.
8. The assembly of claim 7, wherein the diameter of the fourth
section is larger than the diameter of the first section.
9. The assembly of claim 7, wherein the barb is tapered on a side
closer to the end and blunt on a side closer to the shaft.
10. The assembly of claim 9, wherein the tip is constructed of a
biocompatible metal.
11. A method of implanting an implantable medical lead extension,
comprising: providing a tool that has a shaft that is located
within a subcutaneous tunnel between a first incision and a second
incision in a patient with a handle on one end of the shaft that is
present externally of the subcutaneous tunnel in proximity to the
first incision and with a pull-through tip on the other end of the
shaft that is present externally of the subcutaneous tunnel in
proximity to the second incision, wherein the tip comprises a pin
having an end and a barb positioned on the pin and spaced axially
from the end of the pin; inserting the pin into a bore of a
connector body located on a distal end of the implantable lead
extension while inserting the barb within a compliant distal
portion of the connector body to create an interference fit of the
barb to the compliant distal portion; pulling the tool including
the tip through the subcutaneous tunnel and out of the first
incision to thereby pull the connector body and the implantable
lead extension through the subcutaneous tunnel; and after pulling
the tool out of the first incision, removing the pin from the bore
of the connector body while removing the barb from within the
compliant distal portion.
12. The method of claim 11, further comprising tightening a set
screw of the connector body onto the pin prior to pulling the tool
and loosening the set screw after pulling the tool and prior to
removing the pin from the bore.
13. A tool for pulling an implantable medical lead extension
through a subcutaneous tunnel, comprising: a handle; a shaft having
a first end and a second end, the first end being coupled to the
handle; a tip coupled to the second end of the shaft, the tip
comprising a carrier body that forms a partial cylindrical wall
with a cavity being defined by the partial cylindrical wall; and a
body that is removably positioned within the cavity that creates an
interference fit with the tip.
14. The tool of claim 13, wherein the body comprises a tip portion
that is located externally of the cavity and forms an end opposite
the handle.
Description
TECHNICAL FIELD
[0001] Embodiments relate to the implantation of implantable lead
extensions or catheters. More particularly, embodiments relate to
kits and related methods used when implanting an implantable lead
extension.
BACKGROUND
[0002] When a patient is a candidate for an implantable therapy, an
implantable lead or catheter may be implanted and a lead extension
or a catheter extension may also be necessary depending upon the
location of the therapy site. For example, with stimulation therapy
such as sacral nerve stimulation therapy, spinal cord stimulation
therapy and the like that may be used to treat conditions such as
incontinence or chronic pain, it is often desirable to conduct a
trial period of stimulation. This trial period allows an external
stimulator to be used so that the patient is not required to
undergo a full stimulation device implantation procedure but calls
for a lead extension to extend between the lead and the external
stimulator. If the trial is successful, then an implantable
stimulator is fully implanted into the patient.
[0003] When implanting the trial system, an implantable medical
lead is implanted with a distal end being routed to the stimulation
site. The proximal end of the lead is routed to a pocket away from
the entry site. An implantable lead extension is typically then
routed subcutaneously from the location of the proximal end of the
implanted medical lead to an exit site nearby the location where
the external stimulator will be mounted to the patient. An external
lead extension is then used to interconnect the exposed proximal
end of the implantable lead extension to the external stimulator.
Alternatively, the implantable lead extension may be provided with
enough length to reach the external stimulator and is further
provided with a connector for direct connection to the external
stimulator.
[0004] During the implantation of the lead extension or a catheter
extension, the lead extension or catheter extension is pulled
through a subcutaneous tunnel. One manner of doing this is to
utilize a carrier on the end of the tunneling tool, where a
connector body of the lead extension is placed within a cavity of
the carrier. However, this requires the carrier to be removed from
the tunneling tool during the tunnel creation to avoid the cavity
of the carrier snagging on and collecting tissue and then attached
prior to pulling the lead extension through the tunnel. This adds
unwanted steps to the surgical procedure. Another approach is to
place a cover around the carrier while the carrier is on the
tunneling tool, but in some cases the approach creates a larger
diameter around the carrier during tunneling which may make the
tunneling process more difficult.
[0005] Rather than a carrier, a pin located on the tunneling tool
may be inserted into a lead bore of the connector but this requires
a set screw or other fastener to be manually tightened onto the pin
in order to create an engagement of the pin to the connector which
further complicates the implantation procedure. Furthermore, the
pin does not provide adequate coupling in order to successfully
pull a catheter extension through a subcutaneous tunnel.
SUMMARY
[0006] Embodiments address issues such as these and others by
providing tools and methods that allow for the connector and
associated lead extension or for the catheter extension to be
pulled through the subcutaneous tunnel while alleviating issues
associated with using a pin or carrier. With respect to a pin,
features such as a barb are present at the pin to create an
interference fit with a compliant portion of the connector body or
catheter extension body so that the pin does not require any
further manipulation to engage the connector body during the
pull-through procedure. With respect to a carrier, embodiments
provide a body that is positioned within the cavity to prevent
tissue from snagging or being collected during tunneling, where the
body is then easily removed from the cavity. Furthermore, the body
may provide a tip portion that performs the tunneling action.
[0007] Embodiments provide a tool for pulling an implantable
medical lead extension through a subcutaneous tunnel. The tool
includes a handle and a shaft having a first end and a second end
with the first end being coupled to the handle. The tool further
includes a pull-through tip coupled to the second end of the shaft,
the tip comprising a pin having an end that is sized to be inserted
into a bore of a connector body located on a distal end of the
implantable lead extension. The tip further includes a barb
positioned on the pin and spaced axially from the end of the pin,
the barb being sized to create an interference fit within a
compliant distal portion of the connector body.
[0008] Embodiments provide an assembly that includes an implantable
medical lead extension having a connector body located on a distal
end, the connector body defining a bore and a compliant distal
portion. The assembly further includes a pull-through tip
comprising a pin having an end that is present within the bore of
the connector body, the tip further comprises a barb positioned on
the pin and spaced axially from the end of the pin. The barb has an
interference fit within the compliant distal portion of the
connector body.
[0009] Embodiments provide a method of implanting an implantable
medical lead extension. The method involves providing a tool that
has a shaft that is located within a subcutaneous tunnel between a
first incision and a second incision in a patient with a handle on
one end of the shaft that is present externally of the subcutaneous
tunnel in proximity to the first incision. A pull-through tip is on
the other end of the shaft and is present externally of the
subcutaneous tunnel in proximity to the second incision, wherein
the tip comprises a pin having an end and a barb positioned on the
pin and spaced axially from the end of the pin. The method further
involves inserting the pin into a bore of a connector body located
on a distal end of the implantable lead extension while inserting
the barb within a compliant distal portion of the connector body to
create an interference fit of the barb to the compliant distal
portion. The method also involves pulling the tool including the
tip through the subcutaneous tunnel and out of the first incision
to thereby pull the connector body and the implantable lead
extension through the subcutaneous tunnel. Additionally, the method
involves, after pulling the tool out of the first incision,
removing the pin from the bore of the connector body while removing
the barb from within the compliant distal portion.
[0010] Embodiments provide a tool for pulling an implantable
medical lead extension through a subcutaneous tunnel. The tool
includes a handle and a shaft having a first end and a second end,
the first end being coupled to the handle. The tool further
includes a pull-through tip coupled to the second end of the shaft,
the tip comprising a carrier body that forms a partial cylindrical
wall with a cavity being defined by the partial cylindrical wall.
The tool also includes a body that is removably positioned within
the cavity that creates an interference fit against an inner
surface of the partial cylindrical wall.
[0011] Embodiments provide a method of implanting an implantable
medical lead extension that involves providing a tool that has a
shaft that is located within a subcutaneous tunnel between a first
incision and a second incision in a patient with a handle on one
end of the shaft that is present externally of the subcutaneous
tunnel in proximity to the first incision. A pull-through tip is on
the other end of the shaft and is present externally of the
subcutaneous tunnel in proximity to the second incision. The tip
comprises a carrier body that forms a partial cylindrical wall with
a cavity being defined by the partial cylindrical wall and wherein
a body is positioned within the cavity and creates an interference
fit against an inner surface of the partial cylindrical wall. The
method further involves removing the body from the cavity and
inserting the connector body located on a distal end of the
implantable lead extension into the cavity. Additionally, the
method involves pulling the tool including the tip through the
subcutaneous tunnel and out of the first incision to thereby pull
the connector body in the cavity and the implantable lead extension
connected to the connector body through the subcutaneous tunnel.
The method also involves, after pulling the tool out of the first
incision, removing the connector body from the cavity.
[0012] Embodiments provide a tool for pulling an implantable
medical lead extension through a subcutaneous tunnel. The tool
includes a handle and a shaft having a first end and a second end,
the first end being coupled to the handle. The tool further
includes a tip coupled to the second end of the shaft, the tip
comprising a carrier body that forms a partial cylindrical wall
with a cavity being defined by the partial cylindrical wall, the
carrier body defining a longitudinal slot and a lateral groove
about the circumference of the carrier. The tool also includes a
conical tunneling cover with a large diameter end seated in the
groove so as to be able to swivel between an open position that
exposes the longitudinal slot and a closed position that covers the
longitudinal slot.
[0013] Embodiments provide a tool for pulling an implantable
medical lead extension through a subcutaneous tunnel. The tool
includes a handle and a shaft having a first end and a second end,
the first end being coupled to the handle. The tool further
includes a tip coupled to the second end of the shaft, the tip
comprising a conical portion having a longitudinal slot extending
through an area of maximum diameter of the conical portion, the
slot being sized to receive a distal connector of the lead
extension.
[0014] Embodiments provide a tool for pulling an implantable
medical lead extension through a subcutaneous tunnel. The tool
includes a handle and a shaft having a first end and a second end,
the first end being coupled to the handle. The tool further
includes a tip coupled to the second end of the shaft, the tip
comprising a carrier body that includes a first end defining a
receptacle that receives a first end of a connector of the lead
extension, a second end defining a receptacle that receives a
second end of the connector, and a strip interconnecting the first
end and the second end.
[0015] Embodiments provide a tool for pulling an implantable
medical lead extension through a subcutaneous tunnel. The tool
includes a handle and a shaft having a first end and a second end,
the first end being coupled to the handle. The tool further
includes a tunneling tip coupled to the second end of the shaft and
a carrier that is removably attached to the shaft while being
tethered to the shaft.
[0016] Embodiments provide a tool for pulling an implantable
medical lead extension through a subcutaneous tunnel. The tool
includes a handle and a shaft having a first end and a second end,
the first end being coupled to the handle. The tool further
includes a tunneling tip coupled to the second end of the shaft and
a carrier that is removably attached to the shaft while being
pivotably coupled to the shaft.
[0017] Embodiments provide a tool for pulling an implantable
medical catheter extension through a subcutaneous tunnel. The tool
includes a handle and a shaft having a first end and a second end,
the first end being coupled to the handle. The tool further
includes a tip coupled to the second end of the shaft, the tip
comprising a pin having an end that is sized to be inserted into a
bore of a catheter extension body, the tip further comprising a
barb positioned on the pin and spaced axially from the end of the
pin, the barb being sized to create an interference fit within a
compliant portion of the catheter extension body.
DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 shows an exemplary first stage of an implantation
procedure where a tunnel is being created using a tunneling tip
mounted to a tunneling rod tool.
[0019] FIG. 2 shows an exemplary second stage of the implantation
procedure where an implantable lead extension is pulled through the
tunnel using a pull-through tip that is mounted to the tunneling
rod.
[0020] FIG. 3 shows an exemplary third state of the implantation
procedure where the implantable lead extension is ready for
connection to an external stimulator.
[0021] FIG. 4 shows an exemplary first example of a tip for a
tunneling rod tool that includes a pin with a barb to create an
interference fit with the connector body.
[0022] FIG. 5 shows an exemplary second example of a tip for a
tunneling rod tool that includes a pin with a barb to create an
interference fit with the connector body.
[0023] FIG. 6 shows an exemplary cross-sectional view of a
connector body with the tip including the pin and barb inserted
into the connector body.
[0024] FIG. 7 shows an exemplary tip for a tunneling rod tool that
is a carrier that includes a cavity for the connector body.
[0025] FIG. 8 shows an exemplary first view of a first example of a
body to be positioned within the cavity of the carrier during
tunneling.
[0026] FIG. 9 shows an exemplary second view of the body of FIG.
8.
[0027] FIG. 10 shows the body of FIG. 8 positioned within the
cavity of the carrier.
[0028] FIG. 11 shows an exemplary second example of a body to be
positioned within the cavity of the carrier during tunneling.
[0029] FIG. 12 shows the body of FIG. 11 positioned within the
cavity of the carrier.
[0030] FIG. 13 shows an example of a carrier having a swivel tip in
an open position to allow an extension to be inserted.
[0031] FIG. 14 shows the example of FIG. 13 with the swivel tip in
a closed position to provide a tunneling function.
[0032] FIG. 15 shows an example of a tunneling tip having a slot
for receiving an extension connector.
[0033] FIG. 16 shows an example of a carrier with a reduced
structure.
[0034] FIG. 17 shows an example of a carrier that is tethered and
attached to the tunneling tool during tunneling.
[0035] FIG. 18 shows the carrier of FIG. 17 after being detached
from the tunneling tool and attached to an extension connector
while remaining tethered to the tunneling tool.
[0036] FIG. 19 shows an example of a carrier that is attached to
the tunneling tool and pivotably connected to the tunneling tool
during tunneling.
[0037] FIG. 20 shows the carrier of FIG. 19 after being detached
from the tunneling tool and being pivoted while being attached to
an extension connector.
[0038] FIG. 21 shows an exemplary cross-sectional view of a
catheter extension body with the tip including the pin and barb
inserted into the catheter extension body.
DETAILED DESCRIPTION
[0039] Embodiments provide tips for tunneling tools to aid in the
implantation of implantable medical lead extensions. A tip that
includes a pin and a barb allows the connector body to be engaged
for the pull-through procedure by inserting the pin and barb into
the connector body. A tip that includes a carrier with a cavity has
a body positioned within the cavity during tunneling which is
easily removed after tunneling to allow the connector body to then
be installed into the cavity for the pull-through procedure.
[0040] FIG. 1 shows a first stage of an implantation procedure
within a typical operating environment for the various embodiments.
Here, there are two surgical incisions 102, 104 made in the patient
100. Incision 102 is in proximity to the proximal end of the
implantable lead, which may have already been routed within the
patient 100 to the internal stimulation site. Incision 104 is in
proximity to the intended mounting location of the external
stimulator. Incision 104 is used as the externalizing exit site of
a lead extension. The lead extension is externalized to connect to
the external stimulator. Tunneling away from incision 102 reduces
the chance of infection at the incision 102 during the trialing
period.
[0041] A tunneling tool tip 108 is installed onto an end of a
tunneling tool shaft 106 that is coupled to a handle 110 of a
tunneling tool 112 being manipulated by the surgeon. The handle and
the shaft may be of a unitary construction as shown. The tunneling
tool tip 108 may attach to the end of the tunneling tool shaft 106
in various ways, such as by having an end that is threaded onto
matching threads present on an end of the tunneling tip 108. The
tunneling tool tip 108 may be of various forms such as a removable
trocar tip. As an alternative, the tunneling tool tip may be a
carrier for receiving the connector body of the lead extension
where the carrier has a cavity that includes a body temporarily
filling the cavity during tunneling. This body may provide the
tunneling tip that creates the tunnel in the tissue. Examples of
such a tunneling tip 108 are discussed in more detail below with
reference to FIGS. 7-12.
[0042] As shown in FIG. 1, the tunneling tip 108 is then inserted
through the incision 102 and is forced subcutaneously by the
tunneling rod 106 and by skillful manipulation from the surgeon
until exiting through the incision 104. This effectively creates a
tunnel through fatty tissue between the incision 102 and the
incision 104.
[0043] As shown in FIG. 2, in some embodiments the tunneling tool
tip 108 is removed while a separate pull-through tip 114 is
installed on the end of the tunneling tool shaft 106. The
pull-through tip 114 may be of various forms such as a pin that is
inserted into the lead bore of the connector body 116 of the lead
extension 118. Alternatively, the connector body 116 may provide a
bore that is dedicated to the tunneling procedure such that the
pull-through tip 114 in the form of a pin is inserted into the
dedicated bore. Examples of the pin are discussed below in more
detail with reference to FIGS. 4-6.
[0044] At this stage of the implantation procedure shown in FIG. 2,
the surgeon pulls the tunneling tool 112 via the handle 110 back
through the tunnel between the incisions 102 and 104. Because the
connector body 116 is coupled to the tip 114 of the tool 112, the
connector body 116 and the lead extension 118 are also pulled
through the incision 104 and the tunnel. Once the connector body
116 and lead extension 118 have exited the incision 102, the
connector body 116 is then freed from the tip 114.
[0045] A subsequent stage of the implantation procedure is shown in
FIG. 3. Here, the incisions 102', 104' are closed with the
implantable lead extension 118 exiting the closed incision 104'.
The connector body 116 has been connected to the proximal end of
the implanted lead (not shown) and is stored subcutaneously beneath
the closed incision 102'. A proximal connector 120 of the
implantable lead extension is available for connection to an
external extension in some embodiments or directly to an external
stimulator 120 in other embodiments.
[0046] FIG. 4 shows an example of a tunneling tool tip that is a
pin 114 such as the pin 114 discussed above in relation to FIG. 2.
The pin 114 is attached to the shaft 106 on one end 124 such as by
a threaded engagement and engages the connector body 116 on the
opposite end. FIG. 6 shows the pin 114 of FIG. 4 once inserted into
the connector body 116, which is shown in cross-section.
[0047] This pin 114 has a barb 130 that is present between the two
ends. The barb 130 of this example has a tapered side 134 and a
blunt side 132 forming a shoulder. This configuration of the barb
130 allows the barb to more easily enter into an opening in the
compliant region 146 of the connector 116 by having the tapered
side 134 allows the compliant region 146 to gradually slide onto
and over the barb 130. This compliant region 146 may be constructed
of a compliant material such as liquid silicone rubber which may
serve as an overmold to the underlying structures of the connector
body 116 such as a connector carrier 150 and bore components 156
such as seals and electrical connectors. Once within the compliant
region 146, the blunt side 132 of the barb 130 creates a snug
interference fit that allows the pin 114 to be pulled through the
subcutaneous tunnel while maintaining the coupling to the connector
body 116. This coupling results in the connector body 116 and lead
extension 118 also being pulled through the tunnel without
requiring any further efforts by the surgeon to secure the pin 114
to the connector body 116. This saves the surgeon from spending
time and effort to tighten a set screw or other manual fixation
mechanism.
[0048] The embodiment of a pin 144 as shown in FIG. 5 also has the
barb 130 with the tapered side 134 and the blunt side 132 forming a
shoulder. Thus, the barb 130 of the pin 144 enters the opening of
the compliant region 146 and then creates a snug interference fit
with the compliant region 146 in the same manner as the embodiment
shown in FIG. 4.
[0049] The pin embodiments of FIGS. 4 and 5 also have a first
section 136, 136' with a first diameter on the tapered side of the
barb 130 and have an end 142 with the same diameter as the first
section 136, 136'. However, the pin 114 has a second section 138
between the first section 136 and the end 142 which has a second
diameter that is less than the first diameter, which results in a
shoulder 140. This section 138 provides an area where a set screw
154 of a set screw block 152 may be tightened against while a
shoulder 140 is engages the set screw 154 if the pin 114 is being
pulled outward from the connector body 116 to prevent the escape of
the pin 114. Thus, this section 138 may be included to provide
surgeons with the option of creating an even more secure engagement
of the pin 114 to the connector body 116 if they choose not to rely
solely on the engagement by the barb 130. While the pin 144 of FIG.
5 does not include the reduced diameter section 138, a surgeon may
also opt to tighten a set screw against the section 136' if so
desired to provide additional security of the engagement.
[0050] The first section 136, 136' and the end 142 enters a lead
bore 158 within the connector body 116 and resides there during the
pull-through stage of implantation. Thus, the pin 114, 144 is
stabilized to prevent to lateral movements that might tend to
dislodge the barb 130. Rather than the lead bore 158, the connector
body 116 may provide a separate bore dedicated to the tunneling
procedure and the pin 114, 144 may instead be inserted in to the
dedicated bore where a compliant portion of the dedicated bore
engages the barb 130 to thereby apply the pulling force to the
connector body.
[0051] The pin 114, 144 also includes a third section 122 having a
third diameter and a fourth section 128 having a fourth diameter
that is smaller than the third diameter. This allows the opening of
the compliant region 146 to close upon the fourth section while
abutting the blunt end 126 of the third section 122. In this
manner, the shoulder created by the blunt end 126 serves as a stop
during insertion of the pin 114, 144 into the connector body 116
and provides confirmation that the pin 114, 144 has been inserted
the proper distance. In this particular embodiment, the third
diameter of the third section 122 is approximately equal to the
diameter of the barb 130, while the fourth diameter of the fourth
section 128 is larger than the first diameter of the first section
136, 136', although these diameters may vary for various
embodiments.
[0052] In these examples, the pin 114, 144 may be made of various
biocompatible materials such as metals or rigid plastics. Examples
of such materials include Stainless Steel, Polyether ether ketone
(PEEK), and Titanium.
[0053] Once the pull-through stage of the implantation is complete,
the pin 114, 144 is then removed by simply pulling with an amount
of force that is capable of overcoming the interference fit cause
by the blunt side 132 against the compliant region 146. This amount
of force is greater than the amount of drag created on the
connector body 116 by the tissue surrounding the tunnel but is
still small enough to be easily achieved manually by a surgeon. If
a set screw 154 was tightened against the pin 114, 144, then the
set screw 154 is released prior to pulling the pin 114, 144 free
from the connector body 116.
[0054] FIG. 7 shows an alternative tip for the tunneling tool 112.
This tip is in the form of a carrier 200 which as an end 210 that
attaches to the end of the shaft 106 of the tool 112 such as by a
threaded engagement. The carrier 200 includes a portion 201 that
forms a hollow, tapered cylinder. Another portion 204 is formed by
walls that form only a partial cylinder which exposes a cavity 204
within the carrier. The cavity 204 is shaped and sized roughly the
same as the outer dimensions of the connector body 116. A section
206 also forms a hollow, tapered partial cylinder and defines a
passageway 208 that accommodates the lead extension 118 extending
away from the connector body 116 once the connector body 116 is
positioned within the cavity 204.
[0055] Prior to positioning the connector body 116 within the
cavity, the carrier 200 may be installed on the end of the shaft
106 of the tool 112 during the tunneling stage of the implantation
procedure. This eliminates the surgeon from having to attach the
carrier 200 to the shaft 106 after tunneling, but the cavity 204
must be isolated from the tissue during the tunneling. Also, there
must be a structure for creating the tunnel ahead of the carrier
200.
[0056] FIGS. 8 and 9 show a body 212 that fulfills those needs. The
body 212 includes a portion 214, a portion 216, and a portion 218
that are a close match in size and shape to the connector body 116.
Thus, these portions 212, 214, and 216 of the body 212 achieve an
interference fit within the cavity 204.
[0057] In this embodiment, the body 212 also includes a tip portion
220 that provides a tunneling function. Thus, during tunneling with
the tool 112, the carrier 200 is present with the body 212 residing
in the cavity 204 to prevent tissue from snagging on and collecting
within the cavity 204 while the tip portion 220 tunnels through the
tissue to create the tunnel that the carrier 200 is passing
through.
[0058] FIG. 10 shows the carrier 200 with the body 212 present
within the cavity 204 and with the tip portion 220 present ahead of
the carrier 200. As can be seen, both the portion 206 and the
portion 206 of the carrier 200 aid in retaining the body 212 within
the cavity 204 via the interference fit. This fit allows the
surgeon to then press laterally on the tip portion 220 to remove
the body 212 from the cavity 204 once tunneling is complete.
[0059] FIG. 11 shows another example of a body 222 that addresses
the issues presented by the carrier 200 during tunneling. The body
222 includes a portion 224, a portion 226, and a portion 228 that
are a close match in size and shape to the connector body 116.
Thus, these portions 222, 224, and 226 of the body 222 also achieve
an interference fit within the cavity 204.
[0060] In this embodiment, the body 222 also includes a tip portion
230 that provides a tunneling function. Thus, during tunneling with
the tool 112, the carrier 200 is present with the body 222 residing
in the cavity 204 to prevent tissue from snagging on and collecting
within the cavity 204 while the tip portion 230 tunnels through the
tissue to create the tunnel that the carrier 200 is passing
through.
[0061] FIG. 12 shows the carrier 200 with the body 222 present
within the cavity 204 and with the tip portion 230 present ahead of
the carrier 200. As can be seen, both the portion 206 and the
portion 206 of the carrier 200 aid in retaining the body 222 within
the cavity 204 via the interference fit. This fit allows the
surgeon to then press laterally on the tip portion 230 to remove
the body 222 from the cavity 204 once tunneling is complete.
Because the tip portion 230 is smaller in diameter at its broadest
point than the carrier 200, this embodiment relies on the tapered
portion 206 of the carrier 200 to also push away tissue that the
tip portion 230 is penetrating during the tunneling.
[0062] Accordingly, the combination of the carrier 200 and body 212
or carrier 200 and body 222 may serve as the tip 108 as shown in
FIG. 1. Thereafter, the body 212 or 222 is removed. Furthermore,
the carrier 200 may serve as a tip that engages the connector body
116 for pulling the connector body into the incision 104 and
through the tunnel as shown in FIG. 2.
[0063] In these examples, the carrier 200 may be made of various
biocompatible materials such as metals or rigid plastics. Examples
of such materials include Stainless Steel, Delrin.RTM., PEEK,
Titanium. Similarly, the body 212, 222 may also be made of various
biocompatible materials such as metals or rigid plastics. Examples
of such materials also include Stainless Steel, Delrin.RTM., PEEK,
Titanium.
[0064] FIG. 13 shows an example of a tip in the form of a carrier
300 that is attached to the shaft 106. The carrier 300 includes a
body 302 defining a cavity 304 with a portion 301 on one end and a
portion 306 on the opposite end for holding the connector within
the cavity 304. The portion 306 includes a longitudinal slot 308
for allowing the elongated portion of the extension lead to pass
through. A conical cover 310 is positioned about the portion 306
where an end of the conical cover 310 is seated within a lateral
groove 312 about the circumference of portion 306. This allows the
cover 310 to swivel from an open position to expose the slot 308 as
in FIG. 13 to a closed position to cover the slot 308 as in FIG.
14.
[0065] Closing the cover 310 over the slot 308 allows the cover 310
to provide a tunneling function such that the carrier 300 remains
installed during tunneling. Once tunneled, the cover 310 may then
be swiveled to the open position to expose the slot 308 and to
allow the connector of the lead extension to be loaded into the
cavity 304 with the elongated portion passing through the slot 308
in preparation for the pull-through procedure.
[0066] FIG. 15 shows an example of a tunneling tip 400 with a stem
portion 406 attached to the shaft 106. The tunneling tip includes a
blunt point 402 and a body 404 with a conical shape for tunneling.
A longitudinal slot 408 is present within the tip 400 so that the
connector 116 may be positioned into a rear portion 410 of the slot
408, behind the large diameter area 412 of the tip 400. The slot
portion 410 retains the connector 116 during the pull-through
procedure.
[0067] FIG. 16 shows an example of a tip in the form of a carrier
500 attached to the shaft 106. The carrier 500 includes a first
portion 502 at the shaft 106 and a second portion 504 on the
opposite end. Both the first portion 502 and the second portion 504
define receptacles that receive the lead extension connector 116. A
strip 506 is present to couple the first portion 502 to the second
portion 504. The strip 506 may be flexible to aid in positioning
the connector 116 within the receptacles of portions 502, 504.
[0068] FIG. 17 shows an example of a tip in the form of a
combination tunneling tip 701 and carrier 700. The carrier 700
includes a body portion 702 that has a slot 706 that allows the
body portion 702 to snap onto and off of the shaft 106. The body
portion 702 is tethered to the shaft 706 via a tether strip 704.
During tunneling, the body 702 remains attached to the shaft 106.
For the pull-through procedure, the body 702 is removed from the
shaft 106 and is attached onto the connector 116, as shown in FIG.
18.
[0069] FIG. 19 shows an example of a tip in the form of a
combination tunneling tip 801 and carrier 800. The carrier 800
includes a body portion 802 that has a slot 806 that allows the
body portion 802 to snap onto and off of the shaft 106. The body
portion 802 is also pivotably attached to the shaft 106 via arm
804. A similar arm may also be present on the backside of the shaft
106. The arm 804 has a pivot point 808. During tunneling, the body
802 remains attached to the shaft 106. For the pull-through
procedure, the body 802 is removed from the shaft 106, is pivoted
180 degrees and is attached onto the connector 116, as shown in
FIG. 18.
[0070] FIG. 21 shows an additional use for a structure such as the
pin 144 of FIG. 5. Here, a catheter extension body 900 is being
pulled through a subcutaneous tunnel. The end 142 of the pin 144 is
inserted into the bore of the catheter extension body 900. The barb
130 engages a compliant distal portion 902 of the catheter
extension body 900. Thus, the pin 144 can apply a pulling force
while relying on the engagement of the barb 130 to the distal
portion 902 to pull the catheter extension body 900 through the
tunnel.
[0071] While embodiments have been particularly shown and
described, it will be understood by those skilled in the art that
various other changes in the form and details may be made therein
without departing from the spirit and scope of the invention.
* * * * *