U.S. patent application number 11/280979 was filed with the patent office on 2006-06-15 for method and system for drug delivery.
Invention is credited to Russel M. Sampson.
Application Number | 20060129128 11/280979 |
Document ID | / |
Family ID | 35892565 |
Filed Date | 2006-06-15 |
United States Patent
Application |
20060129128 |
Kind Code |
A1 |
Sampson; Russel M. |
June 15, 2006 |
Method and system for drug delivery
Abstract
A medical device and procedure for delivering a drug into a
uterus are described. In one implementation, the medical device
includes a first elongate member, a second elongate member and a
stopper device. The first elongate member is configured for
transcervical insertion into the uterus and includes a lumen
extending therethrough. The second elongate member is positioned
within said lumen and also includes a lumen therethrough. The
second elongate member is positionable in a retracted or an
extended position. A distal end of the second elongate member is
configured to extend beyond a distal end of the first elongate
member and penetrate uterine tissue when in the extended position.
A proximal end of the second elongate member is configured to
receive a drug for delivery through the lumen of the second
elongate member. The stopper device controls movement of the second
elongate member within the first elongate member.
Inventors: |
Sampson; Russel M.; (Palo
Alto, CA) |
Correspondence
Address: |
FISH & RICHARDSON P.C.
PO BOX 1022
MINNEAPOLIS
MN
55440-1022
US
|
Family ID: |
35892565 |
Appl. No.: |
11/280979 |
Filed: |
November 15, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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60627684 |
Nov 15, 2004 |
|
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Current U.S.
Class: |
604/515 ;
600/160; 604/506 |
Current CPC
Class: |
A61B 17/42 20130101;
A61M 25/0606 20130101; A61M 5/46 20130101; A61B 17/3478 20130101;
A61M 25/0084 20130101; A61M 31/00 20130101; A61B 2017/4216
20130101; A61M 2025/0175 20130101 |
Class at
Publication: |
604/515 ;
600/160; 604/506 |
International
Class: |
A61M 31/00 20060101
A61M031/00 |
Claims
1. A medical device for drug delivery, comprising: a first elongate
member configured for transcervical insertion into a uterine
cavity, the first elongate member including a proximal end, a
distal end and a lumen extending therethrough; a second elongate
member positioned within the lumen of the first elongate member and
including a proximal end, a distal end and lumen therethrough,
where: the second elongate member is positionable in a retracted or
an extended position relative to the first elongate member; the
distal end is configured to extend beyond the distal end of the
first elongate member and penetrate uterine tissue when in the
extended position; the proximal end is configured to receive a drug
for delivery through the lumen of the second elongate member; and a
stopper device configured to control movement of the second
elongate member within the first elongate member thereby defining
the retracted and extended positions of the second elongate
member.
2. The medical device of claim 1, wherein the stopper device
includes a groove formed in the proximal end of the first elongate
member and a retainer clip connected to the proximal end of the
second elongate member, where the retainer clip is configured to
engage the groove when the second elongate member is in the
extended position.
3. The medical device of claim 1, wherein the stopper device
includes a first finger grip included at the proximal end of the
first elongate member and a second finger grip included at the
proximal end of the second elongate member, where the second finger
grip is configured to contact the first finger grip when the second
elongate member is in the extended position.
4. The medical device of claim 1, where the first elongate member
further includes: a second lumen extending therethrough, the second
lumen including light fibers; a third lumen extending therethrough,
the third lumen including a micro-endoscope; a light post coupler
coupled to the light fibers and configured to couple to a light
source; and a camera adapter coupled to the micro-endoscope and
configured to couple to a camera.
5. The medical device of claim 1, further comprising: a first
connector coupled to the proximal end of the second elongate member
and configured to couple to a drug source; and a second connector
coupled to the proximal end of the second elongate member and
configured to couple to a distension medium source.
6. The medical device of claim 1, wherein the drug is a local
anesthetic.
7. A system for drug delivery, comprising: a hysteroscope including
a working channel; and a medical device configured to position
within the working channel of the hysteroscope, the medical device
including: a first elongate member configured for transcervical
insertion into a uterine cavity, the first elongate member
including a proximal end, a distal end and a lumen extending
therethrough; a second elongate member positioned within the lumen
of the first elongate member and including a proximal end, a distal
end and lumen therethrough, where: the second elongate member is
positionable in a retracted or an extended position relative to the
first elongate member; the distal end is configured to extend
beyond the distal end of the first elongate member and pierce
uterine tissue when in the extended position; the proximal end is
configured to receive a drug for delivery through the lumen of the
second elongate member; and a stopper device configured to control
movement of the second elongate member within the first elongate
member thereby defining the retracted and extended positions of the
second elongate member.
8. The system of claim 7, further comprising: a drug source coupled
to the proximal end of the second elongate member.
9. The system of claim 8, further comprising: a distension medium
source coupled to the proximal end of the second elongate
member.
10. The system of claim 7, wherein the stopper device includes a
groove formed in the proximal end of the first elongate member and
a retainer clip connected to the proximal end of the second
elongate member, where the retainer clip is configured to engage
the groove when the second elongate member is in the extended
position.
11. The system of claim 7, wherein the stopper device includes a
first finger grip included at the proximal end of the first
elongate member and a second finger grip included at the proximal
end of the second elongate member, where the second finger grip is
configured to contact the first finger grip when the second
elongate member is in the extended position.
12. The system of claim 7, wherein the first elongate member
further includes: a second lumen extending therethrough, the second
lumen including light fibers; a third lumen extending therethrough,
the third lumen including a micro-endoscope; a light post coupler
coupled to the light fibers and configured to couple to a light
source; and a camera adapter coupled to the micro-endoscope and
configured to couple to a camera.
13. The system of claim 7, the medical device further comprising: a
first connector coupled to the proximal end of the second elongate
member and configured to couple to a drug source; and a second
connector coupled to the proximal end of the second elongate member
and configured to couple to a distension medium source.
14. The system of claim 7, wherein the drug is a local
anesthetic.
15. A method of delivering a drug to a uterus, the method
comprising: transcervically positioning a delivery device within a
uterine cavity until a distal end of the delivery device is near or
contacting the fundus, where the delivery device includes a second
elongate member included in a lumen of a first elongate member and
a stopper device configured to define a retracted position and an
extended position of the second elongate member relative to the
first elongate member; translating the second elongate member
within the lumen of the first elongate member toward the distal end
of the delivery device and from a retracted position to an extended
position; penetrating tissue at or near the fundus with a distal
tip of the second elongate member, the second elongate member
including a lumen filled with a drug; and purging at least some of
the drug from the lumen of the second elongate member into the
tissue at approximately the fundus.
16. The method of claim 15, further comprising: translating the
second elongate member within the lumen of the first elongate
member toward a proximal end of the delivery device and from the
extended position to the retracted position; and withdrawing the
delivery device from the uterine cavity.
17. The method of claim 15, further comprising: coupling the second
elongate member to a distension medium source; and delivering the
distension medium to the uterine cavity through the lumen and
distal tip of the second elongate member.
18. The method of claim 15, wherein translating the second elongate
member from a retracted position to an extended position includes
engaging a retainer clip included a proximal end of the second
elongate member with a locator included in a proximal end of the
first elongate member.
19. The method of claim 15, wherein translating the second elongate
member from a retracted position to an extended position includes
advancing a second finger grip included at a proximal end of the
second elongate member toward and into contact with a first finger
grip included at a proximal end of the first elongate member.
20. The method of claim 15, wherein transcervically positioning a
delivery device within a uterine cavity includes: transcervically
positioning a hysteroscope within a uterine cavity, where the
delivery device is included in a working channel of the
hysteroscope.
21. The method of claim 15, wherein the drug is a local
anesthetic.
22. A medical device for local anesthesia delivery, comprising: a
first elongate member configured for transcervical insertion into a
uterine cavity, the first elongate member including a proximal end,
a distal end and a lumen extending therethrough; a second elongate
member positioned within the lumen of the first elongate member and
including a proximal end, a distal end and lumen therethrough,
where: the second elongate member is positionable in a retracted or
an extended position relative to the first elongate member; the
distal end is configured to extend beyond the distal end of the
first elongate member and penetrate uterine tissue when in the
extended position; the proximal end is configured to receive a
local anesthesia for delivery through the lumen of the second
elongate member; and a stopper device configured to control
movement of the second elongate member within the first elongate
member thereby defining the retracted and extended positions of the
second elongate member.
23. The medical device of claim 22, wherein the stopper device
includes a groove formed in the proximal end of the first elongate
member and a retainer clip connected to the proximal end of the
second elongate member, where the retainer clip is configured to
engage the groove when the second elongate member is in the
extended position.
24. The medical device of claim 22, wherein the stopper device
includes a first finger grip included at the proximal end of the
first elongate member and a second finger grip included at the
proximal end of the second elongate member, where the second finger
grip is configured to contact the first finger grip when the second
elongate member is in the extended position.
25. The medical device of claim 22, where the first elongate member
further includes: a second lumen extending therethrough, the second
lumen including light fibers; a third lumen extending therethrough,
the third lumen including a micro-endoscope; a light post coupler
coupled to the light fibers and configured to couple to a light
source; and a camera adapter coupled to the micro-endoscope and
configured to couple to a camera.
26. The medical device of claim 22, further comprising: a first
connector coupled to the proximal end of the second elongate member
and configured to couple to a local anesthesia source; and a second
connector coupled to the proximal end of the second elongate member
and configured to couple to a distension medium source.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application claims priority to pending U.S. Provisional
Application Ser. No. 60/627,684, entitled "Method and Apparatus for
Local Anesthesia Delivery", filed on Nov. 15, 2004, the entire
contents of which are hereby incorporated by reference.
TECHNICAL FIELD
[0002] This invention relates to a medical device and
procedure.
BACKGROUND
[0003] Endometrial ablation and other transcervical procedures have
historically been performed in an ASC (Ambulatory Surgery Center)
or hospital operating room setting, where intravenous sedation or
general anesthesia is readily available. As medical procedures
migrate to the physician's office, these forms of sedation are less
desirable. A local anesthesia is most desirable, since no
anesthesiologist is needed. However, with respect to transcervical
procedures, a para-cervical block (PCB) or intra-cervical block
(ICB) can adequately anesthetize the cervix and most of the uterine
corpus, but typically does not reach the fundus of the uterus.
Various formulations of topical anesthetics have been instilled
into the uterine cavity, but their absorption, for example into the
endo-myometrial tissue, can be inadequate.
SUMMARY
[0004] This invention relates to a medical device and procedure. In
general, in one aspect, the invention features a medical device for
drug delivery. The medical device includes a first elongate member,
a second elongate member and a stopper device. The first elongate
member is configured for transcervical insertion into a uterine
cavity and includes a proximal end, a distal end and a lumen
extending therethrough. The second elongate member is positioned
within the lumen of the first elongate member and includes a
proximal end, a distal end and lumen therethrough. The second
elongate member is positionable in a retracted or an extended
position relative to the first elongate member. The distal end of
the second elongate member is configured to extend beyond the
distal end of the first elongate member and penetrate uterine
tissue when in the extended position. The proximal end of the
second elongate member is configured to receive a drug for delivery
through the lumen of the second elongate member. The stopper device
is configured to control movement of the second elongate member
within the first elongate member, thereby defining the retracted
and extended positions of the second elongate member.
[0005] Implementations of the invention may include one or more of
the following features. The stopper device can include a groove
formed in the proximal end of the first elongate member and a
retainer clip connected to the proximal end of the second elongate
member, where the retainer clip is configured to engage the groove
when the second elongate member is in the extended position. In
another implementation, the stopper device includes a first finger
grip included at the proximal end of the first elongate member and
a second finger grip included at the proximal end of the second
elongate member, where the second finger grip is configured to
contact the first finger grip when the second elongate member is in
the extended position.
[0006] The first elongate member can further include a second lumen
extending therethrough, the second lumen including light fibers,
and a third lumen extending therethrough, the third lumen including
a micro-endoscope. A light post coupler can be coupled to the light
fibers and configured to couple to a light source, and a camera
adapter can be coupled to the micro-endoscope and configured to
couple to a camera. A first connector can be coupled to the
proximal end of the second elongate member and configured to couple
to a drug source, and a second connector can be coupled to the
proximal end of the second elongate member and configured to couple
to a distension medium source. In one implementation, the drug
delivered through the medical device is a local anesthetic.
[0007] In general, in another aspect, the invention features a
system for drug delivery including a hysteroscope including a
working channel and a medical device configured to position within
the working channel of the hysteroscope. The medical device
includes a first elongate member, a second elongate member and a
stopper device. The first elongate member is configured for
transcervical insertion into a uterine cavity and includes a
proximal end, a distal end and a lumen extending therethrough. The
second elongate member is positioned within the lumen of the first
elongate member and includes a proximal end, a distal end and lumen
therethrough. The second elongate member is positionable in a
retracted or an extended position relative to the first elongate
member. The distal end of the second elongate member is configured
to extend beyond the distal end of the first elongate member and
penetrate uterine tissue when in the extended position. The
proximal end of the second elongate member is configured to receive
a drug for delivery through the lumen of the second elongate
member. The stopper device is configured to control movement of the
second elongate member within the first elongate member, thereby
defining the retracted and extended positions of the second
elongate member.
[0008] Implementations of the invention may include one or more of
the following features. The system may further include a drug
source coupled to the proximal end of the second elongate member
and/or a distension medium source coupled to the proximal end of
the second elongate member. The stopper device can include a groove
formed in the proximal end of the first elongate member and a
retainer clip connected to the proximal end of the second elongate
member, where the retainer clip is configured to engage the groove
when the second elongate member is in the extended position. In
another implementation, the stopper device can include a first
finger grip included at the proximal end of the first elongate
member and a second finger grip included at the proximal end of the
second elongate member, where the second finger grip is configured
to contact the first finger grip when the second elongate member is
in the extended position.
[0009] The first elongate member can further include a second lumen
extending therethrough, the second lumen including light fibers
and/or a third lumen extending therethrough, the third lumen
including a micro-endoscope. A light post coupler can be coupled to
the light fibers and configured to couple to a light source. A
camera adapter can be coupled to the micro-endoscope and configured
to couple to a camera. The medical device may further include a
first connector coupled to the proximal end of the second elongate
member and configured to couple to a drug source and/or a second
connector coupled to the proximal end of the second elongate member
and configured to couple to a distension medium source. In one
implementation, the drug delivered by the system is a local
anesthetic.
[0010] In general, in another aspect, the invention features a
method of delivering a drug to a uterus. The method includes
transcervically positioning a delivery device within a uterine
cavity until a distal end of the delivery device is near or
contacting the fundus. The delivery device includes a second
elongate member included in a lumen of a first elongate member and
a stopper device configured to define a retracted position and an
extended position of the second elongate member relative to the
first elongate member. The second elongate member is translated
within the lumen of the first elongate member toward the distal end
of the delivery device and from a retracted position to an extended
position. The tissue at or near the fundus is penetrated with a
distal tip of the second elongate member, the second elongate
member including a lumen filled with a drug. At least some of the
drug is purged from the lumen of the second elongate member into
the tissue at approximately the fundus.
[0011] Implementations of the invention can include one or more of
the following features. The method can further include translating
the second elongate member within the lumen of the first elongate
member toward a proximal end of the delivery device and from the
extended position to the retracted position, and withdrawing the
delivery device from the uterine cavity.
[0012] The second elongate member can be coupled to a distension
medium source, and the distension medium can be delivered to the
uterine cavity through the lumen and distal tip of the second
elongate member. Translating the second elongate member from a
retracted position to an extended position can include engaging a
retainer clip included a proximal end of the second elongate member
with a locator included in a proximal end of the first elongate
member. Translating the second elongate member from a retracted
position to an extended position can include advancing a second
finger grip included at a proximal end of the second elongate
member toward and into contact with a first finger grip included at
a proximal end of the first elongate member.
[0013] Transcervically positioning a delivery device within a
uterine cavity can include transcervically positioning a
hysteroscope within a uterine cavity, where the delivery device is
included in a working channel of the hysteroscope. In one
implementation, the drug delivered is a local anesthetic.
[0014] In general, in one aspect, the invention features a medical
device for local anesthesia delivery. The medical device includes a
first elongate member, a second elongate member and a stopper
device. The first elongate member is configured for transcervical
insertion into a uterine cavity and includes a proximal end, a
distal end and a lumen extending therethrough. The second elongate
member is positioned within the lumen of the first elongate member
and includes a proximal end, a distal end and lumen therethrough.
The second elongate member is positionable in a retracted or an
extended position relative to the first elongate member. The distal
end of the second elongate member is configured to extend beyond
the distal end of the first elongate member and penetrate uterine
tissue when in the extended position. The proximal end of the
second elongate member is configured to receive a local anesthesia
for delivery through the lumen of the second elongate member. The
stopper device is configured to control movement of the second
elongate member within the first elongate member, thereby defining
the retracted and extended positions of the second elongate
member.
[0015] Implementations of the invention may include one or more of
the following features. The stopper device can include a groove
formed in the proximal end of the first elongate member and a
retainer clip connected to the proximal end of the second elongate
member, where the retainer clip is configured to engage the groove
when the second elongate member is in the extended position. In
another implementation, the stopper device includes a first finger
grip included at the proximal end of the first elongate member and
a second finger grip included at the proximal end of the second
elongate member, where the second finger grip is configured to
contact the first finger grip when the second elongate member is in
the extended position.
[0016] The first elongate member can further include a second lumen
extending therethrough, the second lumen including light fibers,
and a third lumen extending therethrough, the third lumen including
a micro-endoscope. A light post coupler can be coupled to the light
fibers and configured to couple to a light source, and a camera
adapter can be coupled to the micro-endoscope and configured to
couple to a camera. A first connector can be coupled to the
proximal end of the second elongate member and configured to couple
to a drug source, and a second connector can be coupled to the
proximal end of the second elongate member and configured to couple
to a distension medium source.
[0017] Implementations of the invention can realize one or more of
the following advantages. A method or system for providing a
controlled amount of local anesthesia to a particular location in
uterine tissue is provided. Medical procedures that require
anesthesia, yet are able to be performed in a physician's office
using local anesthesia only, often can be performed without
requiring the presence of an anesthesiologist. Additionally, the
procedure can be performed without subjecting the patient to a
general anesthesia, thereby avoiding possible side effects or
complications associated therewith. A patient is able to recover
from the procedure and be released from the medical office or
hospital where the procedure was performed more quickly.
[0018] The details of one or more embodiments of the invention are
set forth in the accompanying drawings and the description below.
Other features, objects, and advantages of the invention will be
apparent from the description and drawings, and from the
claims.
DESCRIPTION OF DRAWINGS
[0019] FIG. 1 is a top view of a drug delivery device.
[0020] FIG. 2 is a side view of the drug delivery device of FIG.
1.
[0021] FIG. 3 is an enlarged, cross-sectional view of the distal
end of the drug delivery device of FIG. 1.
[0022] FIG. 4 is a side view of a portion of the proximal end of
the drug delivery device of FIG. 1.
[0023] FIG. 5 is a flowchart showing a process for intrauterine
delivery of a local anesthetic.
[0024] FIG. 6 is a top, partial cross-sectional view of an
alternative implementation of a drug delivery device.
[0025] FIG. 7 is an enlarged, cross-sectional view of a distal end
of the drug delivery device of FIG. 5.
[0026] FIG. 8 is a top, partial cross-sectional view of an
alternative implementation of a drug delivery device.
[0027] FIG. 9 is an end view of a distal end of the alternative
implementation of the drug delivery device of FIG. 8.
[0028] Like reference symbols in the various drawings indicate like
elements.
DETAILED DESCRIPTION
[0029] A medical device and technique for drug delivery to a uterus
is described. A drug delivery device includes a first elongate
member configured for transcervical insertion into a uterine
cavity. The first elongate member includes a proximal end, a distal
end and a lumen extending therethrough. A second elongate member is
positioned within the lumen of the first elongate member and
includes a proximal end, a distal end and lumen therethrough. The
second elongate member is positionable in a retracted or an
extended position. The distal end of the second elongate member is
configured to extend beyond the distal end of the first elongate
member and penetrate uterine tissue when in the extended position.
The proximal end of the second elongate member extends from the
proximal end of the first elongate member and is configured to
receive a drug for delivery through the lumen of the second
elongate member. The device further includes a stopper device
configured to control movement of the second elongate member within
the first elongate member thereby defining the retracted and
extended positions of the second elongate member.
[0030] In one implementation, the drug delivery device can be used
to deliver a local anesthesia. However, other drugs can be
delivered into the uterine tissue, and a local anesthesia is merely
one example. Any suitable drug, e.g., in a liquid or gel state, can
be delivered either into the uterine cavity or the uterine tissue
using the apparatus and processes described herein. For
illustrative purposes, the apparatus and processes are described in
reference to delivery of a local anesthetic, but it should be
understood that this selection of drug is exemplary and not
limiting.
[0031] Referring to FIG. 1, one implementation of a drug delivery
device 100 is shown. The delivery device 100 includes a first
elongate member, or outer shaft 102. The outer shaft 102 includes a
distal end 104 and a proximal end 106. A lumen 108 (see FIG. 3)
extends the length of the outer shaft 102. The outer shaft 102 can
be configured to be straight or curved. In the curved
implementation, the outer shaft 102 can be curved similarly to a
conventional uterine sound to approximate the curvature of the
uterine cavity. Near the proximal end 106 of the outer shaft 102 is
a position locator 110. The locator 110 can be configured in any
convenient manner, including, for example, a detent, groove or
slot. In one implementation, the distal end 104 of the outer shaft
102 can be configured to prevent damage to the uterine tissue
during tactile placement, for example, the distal end 104 can be
rounded.
[0032] A second elongate member, or needle 112, is positioned
coaxially within the lumen 108 of the outer shaft 102. The needle
112 includes a distal end 114 configured to penetrate uterine
tissue, e.g., tissue at the fundus of the uterus. The needle 112
further includes a proximal end 116 that protrudes from the
proximal end of the outer shaft 102. In this implementation, the
proximal end 116 includes a leur connector 118. The leur connector
118 can couple to a drug-filled syringe to fill the lumen of the
needle 112 with the drug, e.g., an anesthetic. Other connectors can
be used in place of the leur connector 118, which is one exemplary
configuration. Alternatively, the proximal end 116 of the needle
112 can include a drug source, e.g., can include an integrated
syringe.
[0033] A stopper device is included in the proximal region of the
needle 112. The stopper device in the implementation shown is a
retainer clip 120 that can engage with a slot-type locator 110
located on the proximal end 106 of the outer shaft 102. However,
other configurations of stopper device can be used, and the
configuration shown is exemplary. When the needle 112 is in the
retracted position, the retainer clip 120 is in a position A. When
the needle 112 is advanced through the lumen 108 of the outer shaft
102 into the extended position, the retainer clip 120 is in a
position B. Position B of the retainer clip 120 corresponds to the
retainer clip 120 engaging the locator 110, which prevents the
retainer clip, and therefore the needle 112, from any further
advancement. The distance the distal end 114 of the needle 112
translates into the fundus tissue can thereby be controlled. That
is, the difference in distance between position A (retracted
position; FIGS. 2 and 3) and position B (extended position; FIGS. 3
and 4), which is shown in FIGS. 2 and 3 as length 122, can be set
by a physician to control how far the distal end 114 of the needle
112 extends from the distal end 104 of the outer shaft 102. For
example, the distal end 114 may extend in the range of
approximately 1 to 10 mm, or approximately 5 mm, depending on the
application.
[0034] In one implementation, position A of the retainer clip 120
is adjustable by a user to adjust the travel distance of the
retainer clip 120 and therefore adjust the extended position of the
distal end of the needle 112. In another implementation, position A
of the retainer clip 120 is fixed, thereby providing a fixed
extended position of the distal end of the needle 112.
[0035] The delivery device 100 can be inserted into the uterine
cavity along the mid-plane of the uterus, or can be turned to
either side to come into contact with the regions of the cornua.
The distance the distal end 114 of the needle 112 protrudes from
the distal end of outer shaft 102 can be adjusted as a function of
the location of the desired injection. For example, the extension
distance for a drug injection at the midline of the fundus may be
set deeper, e.g., approximately 10 mm, than the extension distance
set for injection into the cornua, e.g., approximately 5 mm.
[0036] Referring to FIG. 5, a flowchart is shown illustrating a
process 200 for using a drug delivery device to deliver a local
anesthetic to the fundus tissue. For illustrative purposes the
process shall be described in reference to the implementation of
the delivery device 100 shown in FIG. 1. However, it should be
understood that other implementations of the delivery device can be
used to carry out the process, and that the steps of the process
can be carried out in a different sequence, while still achieving
the desired results.
[0037] The needle 112 is positioned within the lumen 108 of the
outer shaft 102 (step 202). The proximal end 116 of the needle is
fluidly coupled to a source of anesthetic (step 204). For example,
in the implementation being described, an anesthetic filled syringe
is connected to the leur connector 118. Any fluid or gas contained
within the needle 112 (e.g., air), is purged and the substantially
the entire lumen of the needle 112 is filled with the anesthetic
(step 206). The drug delivery device 100 is transcervically
inserted into the uterine cavity (step 208) and the fundus is
located with the distal end 104 of the outer shaft 102 (step 210).
A physician or other medical person using the device can detect the
outer shaft 102 has reached the fundus by tactile feedback. The
needle 112 is moved within the lumen 108 of the outer shaft 102
until the needle 112 can move no further, due to the stopper
device, e.g., the retaining clip 120, ceasing translation of the
needle. The distal end 114 of the needle--during the
movement--pierces and enters the tissue at the fundus of the uterus
(step 212). The desired amount of anesthetic is delivered into the
tissue, e.g., by pushing the plunger of the syringe attached to the
needle 112 (step 214). The distal end 114 of the needle is then
retracted and withdrawn from the tissue (step 216). The delivery
device 100 is then transcervically retracted and removed from the
uterine cavity and the patient's body (step 218). The above
procedure is described in the context of delivering a local
anesthetic to uterine tissue, however, as previously mentioned, a
local anesthetic is just one example of a drug that can be
delivered using the device and procedure described herein.
[0038] Other implementations of the delivery device are possible.
Referring to FIG. 6, an alternative implementation of a delivery
device 300 is shown. The delivery device 300 is configured as a
catheter with a diameter 302 sufficiently small so as to be
compatible with the working channel of a hysteroscope. The delivery
device 300 can be inserted into a uterine cavity either alone or
can be used in conjunction with a conventional hysteroscope for use
under direct visualization. The delivery device 300, having a
distal end 304 and a proximal end 306, includes an external sheath
308 extending between the distal and proximal ends, with a first
finger grip 310 located at the proximal end 306. The external
sheath 308 includes a lumen 310 extending the length of the
external sheath 308. A needle 312 is positioned within the lumen
310. The needle 312 includes a distal tip 314 configured to
penetrate tissue, and a proximal end 316 with a second finger grip
318 attached. The needle 312 includes a lumen 320 extending the
length of the needle 312, including extending through the second
finger grip 318. The lumen 320 is fluidly coupled to an anesthetic
source. In this implementation, tubing 322 and a standard leur
connector 324 included at the proximal end 316 of the needle 312
fluidly couple the lumen 320 to an anesthetic filled syringe that
can be connected to the leur connector 324.
[0039] The first finger grip 310 attached to the external sheath
308 and the second finger grip 318 at the proximal end of the
needle 312, together form a stopper device. In use, the delivery
device 300 can be inserted into the uterine cavity and the distal
end 304 of the external sheath 308 advanced to the fundus. A
distance 326 between the first finger grip 310 and the second
finger grip 318 corresponds to a controlled travel distance of the
needle 312. Referring to FIG. 7, an enlarged view of the distal
region of the needle 312 is shown. The distal tip 314 of the needle
312 travels the same distance 326 as the second finger grip 318
travels to come into contact with the first finger grip 310.
Therefore, the protrusion of the distal tip 314 from the distal end
304 of the external sheath 308 is controllable to a predetermined
distance. As such, the penetration of the distal tip 314 into the
uterine tissue is also controllable.
[0040] Referring now to FIG. 8, another implementation of a
delivery device 400 is shown. The delivery device 400 is similar to
the implementation shown in FIG. 6, but includes a triple lumen
sheath 402. This implementation is configured for direct
visualization during device and needle placement. FIG. 9 shows an
end view of the delivery device 400. The sheath 402 includes a
central lumen 404 and additional lumens 406 and 408. Lumen 406
includes light fibers and lumen 408 includes a micro-endoscope. A
light post coupler 410 is coupled to the light fibers within lumen
406 and is configured to connect to a light cable, providing a
light source to the fibers. A camera adapter 412 is coupled to the
micro-endoscope included in lumen 408 and is configured to connect
to a digital camera.
[0041] The delivery device 400 includes a needle 414 positioned
coaxially within the central lumen 404 and including a distal tip
416 configured to pierce uterine tissue. A first finger grip 418 is
included at the proximal end 420 of the triple lumen sheath 402. A
second finger grip 422 is included at the proximal end of the
needle 414. As explained above in reference to the implementation
shown in FIG. 6, the first and second finger grips 418, 422
together form a stopper device and can be used to control the
distance the distal tip 416 of the needle 414 extends from the
distal end of the triple lumen sheath 402. Other configurations of
stopper device can be used, including, for example, the
configuration shown in FIG. 1 (i e., a retainer clip and
locator).
[0042] A standard leur connector 424 is coupled to the proximal end
of the needle 414 and configured to connect to a drug source, e.g.,
a syringe. Other configurations of connector can be used. In the
implementation shown, a second standard leur connector 426 is also
included and coupled to the proximal end of the needle 414. The
second leur connector 426 can be fluidly coupled to a distension
medium, for example, a saline solution. Some uses of the delivery
device 400 may require the uterine cavity be distended prior to or
after delivery of the drug. A distension medium can be delivered
into the uterine cavity using the same needle 414 as used to
delivery the drug into the uterine tissue.
[0043] In another implementation, the second leur connector can be
included in a delivery device, such as that shown in FIG. 1 or 6,
including a single lumen in the external sheath. Other
configurations are possible, including different combinations of
configurations of stopper device, numbers of lumens, and numbers of
leur connectors and types of connectors. The implementations
described are exemplary.
[0044] In any of the implementations of the delivery device,
including the delivery devices 100, 300 and 400 discussed above,
the first elongate member (i.e., the outer shaft, external sheath
or triple lumen sheath) can be formed using any suitable material,
including for example, an extruded thermoplastic elastomer. The
second elongate member (i.e., the needle) can be formed from any
suitable material, including for example, a stainless steel tubing
hypotube.
[0045] A number of embodiments of the invention have been
described. Nevertheless, it will be understood that various
modifications may be made without departing from the spirit and
scope of the invention. For example, the steps shown in FIG. 5 can
be performed in a different order and still achieve desirous
results. Additionally, as noted above, the delivery device can be
used to deliver drugs other than an anesthetic to the uterine
cavity or uterine tissue, and the invention described herein is not
limited to delivery of a local anesthetic. Accordingly, other
embodiments are within the scope of the following claims.
* * * * *