U.S. patent application number 14/165236 was filed with the patent office on 2014-09-25 for modular medical injection system.
The applicant listed for this patent is Medtronic, Inc.. Invention is credited to Michael Collinson, Kenneth C. Gardeski, Michael A. Neidert, David F. Quinn, Russell J. Redmond, Claude A. Vidal.
Application Number | 20140288501 14/165236 |
Document ID | / |
Family ID | 35461448 |
Filed Date | 2014-09-25 |
United States Patent
Application |
20140288501 |
Kind Code |
A1 |
Neidert; Michael A. ; et
al. |
September 25, 2014 |
MODULAR MEDICAL INJECTION SYSTEM
Abstract
A medical injection system includes an elongate injection
apparatus and an actuator apparatus. The actuator apparatus
includes a fitting for coupling the actuator apparatus to a
delivery catheter and a reversible gripping means to grip the
injection apparatus; the gripping means is included in a plunger
that is slideably engaged with the fitting and directs the
injection apparatus through a fitting lumen and through a catheter
lumen, when the fitting is coupled to the catheter.
Inventors: |
Neidert; Michael A.;
(Minneapolis, MN) ; Gardeski; Kenneth C.;
(Plymouth, MN) ; Quinn; David F.; (Galway, IE)
; Redmond; Russell J.; (Goleta, CA) ; Collinson;
Michael; (Goleta, CA) ; Vidal; Claude A.;
(Santa Barbara, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Medtronic, Inc. |
Minneapolis |
MN |
US |
|
|
Family ID: |
35461448 |
Appl. No.: |
14/165236 |
Filed: |
January 27, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10867059 |
Jun 14, 2004 |
8636694 |
|
|
14165236 |
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Current U.S.
Class: |
604/164.09 |
Current CPC
Class: |
A61M 25/0662 20130101;
A61M 2025/0073 20130101; A61M 25/0068 20130101; A61M 25/0606
20130101; A61M 2025/0004 20130101; A61M 25/0102 20130101; A61M
25/0097 20130101 |
Class at
Publication: |
604/164.09 |
International
Class: |
A61M 25/00 20060101
A61M025/00; A61M 25/06 20060101 A61M025/06; A61M 25/01 20060101
A61M025/01 |
Claims
1-76. (canceled)
77. A medical delivery system, comprising: an elongate delivery
apparatus comprising: an elongate shaft including a shaft lumen
extending from a proximal end of the shaft to a distal end of the
shaft, a proximal portion extending distally from the proximal end,
and a distal spiral cut portion extending distally from the
proximal portion to the distal end of the shaft, the distal spiral
cut portion comprising a first segment extending distally from the
proximal portion, a second segment extending distally from the
first segment, and a spiral cut extending along the first segment
and second segment, the spiral cut having a pitch that decreases at
a first rate within the first segment and a pitch that decreases at
a second rate within the second segment, wherein the first and
second rates are different; and a needle tip coupled to the shaft
and extending distal to the distal end of the shaft, the needle tip
including a needle lumen extending therethrough and approximately
aligned with the shaft lumen; and an actuator apparatus comprising:
a fitting for coupling the actuator apparatus to a proximal portion
of a catheter, the fitting including a fitting lumen configured to
receive the needle tip and the elongate shaft of the delivery
apparatus and to direct the needle tip and the elongate shaft of
the delivery apparatus through a catheter lumen of the catheter;
and a plunger slidably engaged with the fitting, the plunger
including a plunger lumen configured to slidably receive the needle
tip and the elongate shaft of the delivery apparatus and to direct
the needle tip and elongate shaft through the fitting lumen;
wherein the plunger is configured to reversibly grip the elongate
shaft of the delivery apparatus such that moving the plunger
distally and proximally moves the needle tip and elongate shaft of
the delivery apparatus distally and proximally relative to the
catheter lumen when the actuator apparatus is coupled to the
catheter and the elongate shaft is gripped by the plunger.
78. The system of claim 77, wherein the first rate at which the
pitch decreases within the first segment is a generally
exponentially decreasing rate.
79. The system of claim 77, wherein the second rate at which the
pitch decreases within the second segment is a generally linearly
decreasing rate.
80. The system of claim 77, wherein the first rate at which the
pitch decreases within the first segment is a generally
exponentially decreasing rate, and wherein the second rate at which
the pitch decreases within the second segment is a generally
linearly decreasing rate.
81. The system of claim 77, wherein the plunger comprises a valve
configured to reversibly grip the elongate shaft of the delivery
apparatus.
82. The system of claim 77, wherein the actuator apparatus further
comprises an elastomeric plug positioned between the plunger and
the catheter lumen, wherein the elastomeric plug seals the plunger
from the catheter lumen while allowing passage of the elongate
shaft of the delivery apparatus.
83. The system of claim 77, wherein the actuator apparatus fitting
further includes a Luer thread configured to couple with the
catheter.
84. The system of claim 77, wherein the actuator apparatus further
comprises a spring member mounted between the plunger and the
fitting to hold the plunger in a retracted position until a force
is applied to slide the plunger distally with respect to the
fitting.
85. The system of claim 77, further comprising an introducer
configured to pass through the fitting lumen and the plunger lumen
of the actuator apparatus, the introducer including an introducer
lumen extending therethrough that is configured to receive the
needle tip and the elongate shaft of the delivery apparatus.
86. The system of claim 77, wherein the distal spiral cut portion
of the elongate shaft further includes at third segment extending
distally between the first segment and the second segment, the
spiral cut having a generally constant pitch along the third
segment.
87. The system of claim 77, wherein the elongate shaft further
comprises an outer layer extending over the distal spiral cut
portion.
88. The system of claim 87, wherein the outer layer has a wall
thickness less than or equal to approximately 0.05 mm.
89. The system of claim 87, wherein the outer layer comprises a
polymer.
90. The system of claim 86, wherein the distal spiral cut portion
of the elongate shaft has a length between approximately 50 mm and
500 mm.
91. The system of claim 77, wherein the delivery apparatus further
comprises a grip tube positioned about the elongate shaft, wherein
the grip tube is closer to the proximal end than the distal end of
the elongate shaft.
92. A medical delivery system comprising: an elongate delivery
apparatus comprising: an elongate shaft including a shaft lumen
extending distally from a proximal end of the shaft to a distal end
of the shall, a proximal portion extending from the proximal end,
and a distal spiral cut portion extending distally from the
proximal portion to the distal end of the shaft, the distal spiral
cut portion comprising a first segment extending distally from the
proximal portion, a second segment extending distally from the
first segment, and a spiral cut extending along the first segment
and second segment, the spiral cut having a first pitch within the
first segment and a second pitch within the second segment, wherein
the first pitch is different than the second pitch; and a needle
tip coupled to the shaft and extending distal to the distal end of
the shaft, the needle tip including a needle lumen extending
therethrough and approximately aligned with the shaft lumen; and an
actuator apparatus comprising: a fitting for coupling the actuator
apparatus to a proximal portion of a catheter, the fitting
including a fitting lumen configured to receive the needle tip and
the elongate shaft of the delivery apparatus and to direct the
needle tip and the elongate shaft of the delivery apparatus through
a catheter lumen of the catheter; and a plunger slidably engaged
with the fitting, the plunger including a plunger lumen configured
to slidably receive the needle tip and the elongate shaft of the
delivery apparatus and to direct the needle tip and elongate shaft
through the fitting lumen; wherein the plunger is configured to
reversibly grip the elongate shaft of the delivery apparatus such
that moving the plunger distally and proximally moves the needle
tip and elongate shaft of the delivery apparatus distally and
proximally relative to the catheter lumen when the actuator
apparatus is coupled to the catheter and the elongate shaft is
gripped by the plunger.
93. The system of claim 92, wherein the first pitch within the
first segment is a generally constant pitch.
94. The system of claim 92, wherein the second pitch within the
second segment is a generally linearly decreasing pitch.
95. The system of claim 92, wherein the first pitch within the
first segment is a generally constant pitch, and wherein the second
pitch within the second segment is a generally linearly decreasing
pitch.
96. The system of claim 92, wherein the plunger comprises a valve
configured to reversibly grip the elongate shaft of the delivery
apparatus.
97. The system of claim 92, wherein the actuator apparatus further
comprises an elastomeric plug positioned between the plunger and
the catheter lumen, wherein the elastomeric plug seals the plunger
from the catheter lumen while allowing passage of the delivery
apparatus.
98. The system of claim 92, wherein the actuator apparatus further
comprises a spring member mounted between the plunger and the
fitting to hold the plunger in a retracted position until a force
is applied to slide the plunger distally with respect to the
fitting.
99. The system of claim 92, further comprising an introducer
configured to pass through the fitting lumen and the plunger lumen,
the introducer including an introducer lumen extending therethrough
that is configured to slidably receive the needle tip and the
elongate shaft of the delivery apparatus.
100. The system of claim 92, wherein the distal spiral cut portion
of the elongate shaft of the delivery apparatus further includes a
third segment extending distally between the proximal portion and
the first segment, the spiral cut having a generally exponentially
decreasing pitch along the third segment.
101. The system of claim 92, wherein the delivery apparatus further
comprises an outer layer extending over the distal spiral cut
portion.
102. The system of claim 101, wherein the outer layer comprises a
polymer.
103. The system of claim 92, wherein the length of the distal
spiral cut portion is between approximately 50 mm and approximately
500 mm long.
104. The system of claim 92, wherein the delivery apparatus further
comprises a grip tube positioned about the elongate shaft, wherein
the grip tube is closer to the proximal end than the distal end of
the elongate shaft.
105. A medical actuator apparatus comprising: a fitting for
coupling the apparatus to a proximal portion of a catheter, the
fitting including a fitting lumen configured to slidably receive an
elongate member and to direct the elongate member through a
catheter lumen of the catheter; a plunger slidably engaged with the
fitting, the plunger including a plunger lumen configured to
slidably receive the elongate member and to direct the elongate
member through the fitting lumen; wherein the plunger is configured
to reversibly grip the elongate member such that moving the plunger
distally with respect to the fitting advances the elongate member
within the catheter lumen when the apparatus is coupled to the
catheter and the elongate shaft is gripped by the plunger; and an
introducer configured to be inserted through the fitting lumen and
the plunger lumen, the introducer including an introducer lumen
configured to slidably receive the elongate member, and wherein the
elongate member may be loaded into the fitting lumen and the
plunger lumen of the apparatus by the introducer, and further
wherein the introducer is configured to be removed from the
apparatus following loading of the elongate member into the fitting
lumen and the plunger lumen of the apparatus.
106. The system of claim 105, wherein the plunger comprises a valve
configured to reversibly grip the elongate shaft of the delivery
apparatus.
107. The system of claim 105, wherein the actuator apparatus
further comprises a spring member mounted between the plunger and
the fitting to hold the plunger in a retracted position until a
force is applied to slide the plunger distally with respect to the
fitting.
Description
RELATED APPLICATION
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/867,059, filed Jun. 14, 2004 entitled
"MODULAR MEDICAL INJECTION SYSTEM", herein incorporated by
reference in its entirety.
TECHNICAL FIELD
[0002] The present invention relates generally to medical systems
for delivering therapeutic agents and more particularly to elements
of a modular injection system.
BACKGROUND
[0003] Because a therapeutic agent, for example pharmacological,
genetic, or biological, may be ineffective or even toxic when
delivered systemically, tools and methods for delivering
therapeutic agents locally, that is, to a targeted tissue site,
have been developed.
[0004] Many state-of-the art steerable catheters have lumens
through which agents may be delivered. Rather than modifying
state-of-the-art steerable catheter designs to integrally
incorporate specific delivery mechanisms, such as means to inject
agents into a tissue site, it is desirable to provide modular
apparatuses, which can be coupled to any of such state-of-the-art
steerable catheters and which include desired specific delivery
mechanisms.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] The following drawings are illustrative of particular
embodiments of the invention and therefore do not limit its scope,
but are presented to assist in providing a proper understanding of
the invention. The drawings are not to scale (unless so stated) and
are intended for use in conjunction with the explanations in the
following detailed description. The present invention will
hereinafter be described in conjunction with the appended drawings,
wherein like numerals denote like elements, and:
[0006] FIG. 1 is a plan view of a modular medical injection system
according to one embodiment of the present invention;
[0007] FIG. 2 is a perspective sectional view of an actuator
apparatus and injection apparatus of the system shown in FIG.
1;
[0008] FIG. 3 is a section view of another member of a modular
injection system according to one embodiment of the present
invention;
[0009] FIG. 4 is a plan view of the injection apparatus shown in
FIG. 1 according to one embodiment of the present invention;
[0010] FIG. 5 is an enlarged detailed view of a portion of the
injection apparatus shown in FIG. 4 according to some embodiments
of the present invention; and
[0011] FIGS. 6A-D are partial section views of distal portions of
injection apparatuses according to alternate embodiments of the
present invention.
DETAILED DESCRIPTION
[0012] The following detailed description is exemplary in nature
and is not intended to limit the scope, applicability, or
configuration of the invention in any way. Rather, the following
description provides a practical illustration for implementing
exemplary embodiments of the invention.
[0013] FIG. 1 is a plan view of a modular medical injection system
according to one embodiment of the present invention. FIG. 1
illustrates the system including a delivery catheter 120 to which
an actuator 100 is joined by means of a coupling or connector 12
terminating a distal end of an actuator fitting 104; a lumen (not
shown), which extends through a shaft 123 and a handle 122 of
catheter 120 and through actuator 100, slideably engages an
injection apparatus 110 whose needle tip 114 is shown extending out
from a catheter distal end 125. FIG. 1 further illustrates
injection apparatus 110 including an elongate shaft 112 and a
fitting 3 terminating a proximal end of shaft 112, fitting 3 being
adapted to couple injection apparatus 110 to a source, for example
a syringe, for injection of therapeutic agents from the source
through a lumen 113 (FIG. 4) of injection apparatus 110. According
to the illustrated embodiment, actuator 100 further includes a
plunger 105 slideably engaged with fitting 104; plunger 105
includes a valve 11, for reversibly gripping shaft 112 of injection
apparatus 110 so that when an operator forces plunger 105 toward
fitting 104 per arrow A, shaft 112, being gripped by valve 11, is
forced distally through catheter 120 so that needle tip 114 moves
out from catheter distal end 125 to pierce a target tissue site in
proximity to distal end 125. FIG. 1 further illustrates plunger 105
and fitting 104 each including radially extending surfaces 5 and 4,
respectively, to facilitate operator handling to perform this
operation.
[0014] According to embodiments of the present invention, catheter
120 may be any delivery catheter, known to those skilled in the
art, that includes a compatible coupling for connector 12, for
example a luer coupling; but catheter 120 is preferably selected
from a group of steerable catheters known to those skilled in the
art, for example those that would include manipulator means
incorporated into a handle, i.e. handle 122 illustrated in FIG. 1,
the manipulator means causing deflection of catheter shaft 123 to
facilitate positioning of catheter distal end 125 at the target
tissue site.
[0015] FIG. 2 is a perspective sectional view of one embodiment of
actuator apparatus 100 and injection apparatus 110 of the system
shown in FIG. 1. FIG. 2 illustrates injection apparatus 110 having
been positioned within actuator apparatus 100 by passing needle tip
114 (FIG. 1) into opened valve 11, through lumens of plunger 105
and fitting 104, and then out through connector 12. According to an
exemplary embodiment, molded rigid plastics, examples of which
include polycarbonate, polyethylene and polypropylene, form plunger
105 and fitting 104.
[0016] FIG. 2 further illustrates fitting 104 including a spring
member 10, which is mounted at an interface between plunger 105 and
fitting 104, a side port 14, which is terminated by a stop cock 13
and in fluid communication with the lumen of fitting 104, for
flushing a lumen of a catheter to which fitting will be coupled,
and a septum 7, which is held in place by a septum cap 6, for
sealing plunger 105 from the catheter lumen, while allowing passage
of injection apparatus 110 therethrough. According to the
illustrated embodiment, spring member 10 holds plunger 9 in a
retracted position until a force is applied to slide plunger 105
distally with respect to fitting 104. When this force is applied,
valve 11, which is illustrated here as a Touhy-Borst type, will
have been tightened, according to means known to those skilled in
the art, such that internal walls of a compressible member 1
protrude into the lumen of plunger 105 to grip injection apparatus
110 so that injection apparatus 110 is advanced distally along with
plunger 105. It should be noted that the scope of the present
invention covers other means for reversibly gripping injection
apparatus 110 known to those skilled in the art, examples of which
include, but are not limited to, 3-jaw chucks and set screws. FIG.
2 further illustrates injection apparatus 110 including a grip tube
9 positioned around shaft 112 (further illustrated in FIG. 4),
which enlarges an outer diameter of shaft 112 to facilitate
gripping of injection apparatus 110 by valve 11; grip tube 9 may
further enhance gripping by means of a corrugated or soft and/or
tacky outer surface.
[0017] According to one embodiment of the present invention, an
introducer 30 as illustrated in section view in FIG. 3 is used to
facilitate insertion of injection apparatus 110 through actuator
apparatus 100. FIG. 3 illustrates introducer 30 including an
introducer shaft 34 coupled to an introducer handle 32 and a lumen
36 extending through an entire length of introducer 30; according
to one embodiment, a length of shaft 34 is sufficient to extend
within actuator apparatus 100 from connector 12 through valve 11
(FIG. 2) so that lumen 36 may provide a smooth passage for
injection apparatus 110 through an entire length of actuator 100.
According to one method, a first end 366 of introducer 30 would be
inserted into actuator 100 at connector 12 and passed through
actuator 100 until first end 366 extends out from valve 11; then
needle tip 114 (FIG. 1) would be inserted into lumen 36 at first
end 366 and passed through until tip 114 protrudes from a second
end 362 of introducer 30; finally introducer 30 would be removed
from actuator 100 and fitting 104 may then be coupled to a
catheter.
[0018] Returning now to FIG. 1, a method for advancing injection
apparatus 110 through catheter 123, according to one embodiment of
the present invention, will be described. Upon coupling actuator
100 to catheter 120, an operator may advance injection apparatus
110 through catheter until needle tip 114 is approximately flush
with catheter distal end 125, at which time valve 11 is closed to
grip injection apparatus 110; thus, injection apparatus 110 is held
in place within catheter 120 while the operator advances catheter
120 to a target tissue site. Once the operator has positioned
catheter distal tip 125 in close proximity to the target site, the
operator causes plunger 105 to advance distally, thereby pushing
needle tip 114 of injection apparatus 110 into the site; either in
conjunction with or following plunger action, a therapeutic agent
is injected through injection apparatus 110 from a source of
therapeutic agent which is coupled to injection apparatus 110, via
fitting 3. According to the embodiment illustrated in FIG. 2,
actuator apparatus 100 includes a stop in the form of a pin 8
extending into fitting 104 and interfacing with a depression 18
formed on plunger 105; the stop is designed to limit the plunger
travel according to a prescribed injection depth. Finally, after
injection of the therapeutic agent is completed, the operator
allows plunger 105 to retract by means of the spring force
previously described.
[0019] FIG. 4 is a plan view of injection apparatus 110 according
to one embodiment of the present invention. FIG. 4 illustrates
injection apparatus 110 including a modified distal portion 40 of
shaft 112; distal portion 40 extends from an end 44 of a proximal
portion of shaft 112 to a distal end 42 of shaft 112 and is
modified for increased flexibility relative to the proximal portion
of shaft 112. FIG. 4 further illustrates needle tip 114 extending
from shaft distal end 42; according to some embodiments needle tip
114 is an independent member, which has been fixedly coupled to
shaft 112 in proximity to distal end 42. Examples of appropriate
needle tips include, but are not limited to, 20-25 gauge stainless
steel tips.
[0020] Dashed lines in FIG. 4 indicate lumen 113 of shaft 112
extending from injection apparatus fitting 3 to needle tip 114 and
approximately aligned with a lumen 115 of needle tip; lumens 113,
115 are adapted to deliver therapeutic agents out through needle
tip 114 when tip 114 has been inserted into a target tissue site.
Shaft may be formed from any appropriate biocompatible material
known to those skilled in the art, which has sufficient strength
and rigidity to accommodate lumen 113 and to push needle tip 114
into a target tissue site; one such material is stainless steel,
for example 304 or 316L stainless steel. Because a pathway to a
target tissue site may include a number of bends, which can be more
acute closer to the target site, modified distal portion 40
decreases the inherent rigidity of shaft 112 over the length of
distal portion 40 to improve tracking of injection apparatus 110
through catheter 120 to the target site.
[0021] FIG. 5 is an enlarged detailed view of distal portion 40 of
injection apparatus 110 according to some embodiments of the
present invention. FIG. 5 illustrates distal portion 40 including a
spiral cut extending along segments A, B and C; according to the
illustrated embodiment a pitch of spiral cut varies along portion
40 from a maximum or most proximal pitch PP to a minimum pitch P1.
FIG. 5 further illustrates segment C having an exponentially
decreasing pitch from end 44 distally, segment B having a constant
pitch, segment A having a linearly decreasing pitch from P2 to P1,
and a non-cut segment D terminating segment A. According to
embodiments of the present invention, the spiral cut is formed
through an entire wall thickness of shaft distal portion 40.
Appropriate methods for making the spiral cut are known to those
skilled in the art, one example of which is laser cutting, and,
according to preferred embodiments, a kerf width is between
approximately 0.015 mm and approximately 0.035 mm.
[0022] Examples of modified distal portion 40, included among
embodiments of the present invention, are described in the
following table:
TABLE-US-00001 Segment C Wherein pitch is Segment A blended
exponen- Segment B Wherein pitch tially decreasing Wherein pitch
decreases linearly from ~4.9 mm is ~ from ~0.75 mm to ~0.8 mm.
constant. to ~0.5 mm Example 1 Length .apprxeq. 75 mm Length
.apprxeq. 40 mm Length .apprxeq. 3.75 mm Example 2 Length .apprxeq.
100 mm Length .apprxeq. 100 mm Length .apprxeq. 3.75 mm Example 3
Length .apprxeq. 200 mm Length .apprxeq. 100 mm Length .apprxeq.
3.75 mm Example 4 Length .apprxeq. 300 mm Length .apprxeq. 100 mm
Length .apprxeq. 3.75 mm
[0023] According to the exemplary embodiments, an overall length of
injection apparatus 110 is approximately 150 cm and an outer
diameter is between approximately 0.6 mm and approximately 0.7
mm.
[0024] FIGS. 6A-D are partial section views of distal portions of
injection apparatuses according to alternate embodiments of the
present invention. FIG. 6A illustrates a needle tip 64 inserted
into distal end 42 of shaft 112 such that a proximal end 641 is in
proximity to distal end 42, while FIGS. 6B-C illustrate needle tips
640 and 604 that extend into shaft 112 beneath an entire length of
distal portion 40 such that tip proximal ends 642 and 602,
respectively, are positioned proximal to end 44. Needle tips 64,
640 and 604 may be formed of stainless steel, Nitinol, or any other
appropriate needle material known to those skilled in the art.
[0025] According to the embodiment illustrated in FIG. 6A, needle
tip 64 is fixedly coupled to shaft 112 by means of a joint 61,
which may be formed by adhesive bonding, laser welding, mechanical
crimping or any other suitable means known to those skilled in the
art. FIG. 6A further illustrates an outer layer 60 formed about
distal portion 40; according to the spiral cut embodiments, layer
60 prevents leakage of therapeutic agents out through the cuts.
Outer layer 60 may be extruded over distal portion 40 or, in the
form of a previously extruded tube, fitted over portion 40 and
bonded in place, for example with an adhesive or by laser energy;
examples of suitable materials for such outer layers include but
are not limited to polyether block amides (PEBAX), polyurethanes,
polyethylenes and silicones. According to alternate embodiments,
outer layer 60 is a tube, which has been fitted over distal portion
40 and heat shrunk into relatively tight conformance with an outer
surface of portion 40; examples of suitable materials for a
shrink-fit outer layer include, but are not limited to, polyesters
and fluoropolymers. One such exemplary embodiment incorporates a
polyester shrink tube, available from Advanced Polymers of New
Hampshire, having an inner diameter of approximately 0.029 inch and
a wall thickness of approximately 0.00025 inch. FIG. 6B illustrates
an alternate embodiment in which outer layer 60 is not included;
rather a seal 65, for example made from silicone rubber, is
positioned about an outer surface of needle tip 640, proximal to
end 44, and engages an inner surface of shaft 112 to prevent
passage of agents out through the spiral cuts of portion 40. FIG.
6B further illustrates needle tip 640 fixedly coupled to shaft by
both joint 61 and a second joint 62.
[0026] FIG. 6C illustrates needle tip 604 tapering from proximal
end 602 to distal end 601 wherein proximal end 602 is wedged within
shaft 112. FIG. 6C further illustrates outer layer 60 formed about
portion 40 and a joint 67 formed between needle tip 604 and shaft
distal end 42. According to one embodiment, joint 67 solely fixedly
couples tip 604 to shaft 112 and, according to another embodiment,
joint 67 not only couples but further provides sealing between tip
604 and shaft distal end 42 (as illustrated by dashed lines), if
proximal end 602 is not sealed within shaft. An adhesive backfill,
a laser weld, or a mechanical crimp may form joint 67.
[0027] FIG. 6D illustrates an outer layer 605 extending over distal
portion 40 and over a portion of needle tip 640 just distal to
shaft distal end 42; layer 605 may be formed in any manner similar
to those described for layer 60 and may be selected from the same
group of materials. FIG. 6D further illustrates a seal 650
positioned between needle tip 640 and outer layer 605. It should be
noted that shorter needle tip 64, illustrated in FIG. 6A could be
incorporated into this embodiment as well.
[0028] In the foregoing detailed description the invention has been
described with reference to specific embodiments. However, it may
be appreciated that various modifications and changes can be made
without departing from the scope of the invention as set forth in
the appended claims.
* * * * *