U.S. patent application number 11/928987 was filed with the patent office on 2008-05-01 for removing tissue.
Invention is credited to Yem Chin.
Application Number | 20080103412 11/928987 |
Document ID | / |
Family ID | 39331188 |
Filed Date | 2008-05-01 |
United States Patent
Application |
20080103412 |
Kind Code |
A1 |
Chin; Yem |
May 1, 2008 |
Removing Tissue
Abstract
Tissue can be removed from a patient with a catheter or other
medical device having a cutting member. A source of suction can be
coupled to the device for suctioning removed tissue through a lumen
in the device and out of the patient's body.
Inventors: |
Chin; Yem; (Burlington,
MA) |
Correspondence
Address: |
COOLEY GODWARD KRONISH LLP;ATTN: Patent Group
Suite 1100
777 - 6th Street, NW
WASHINGTON
DC
20001
US
|
Family ID: |
39331188 |
Appl. No.: |
11/928987 |
Filed: |
October 30, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60856182 |
Nov 1, 2006 |
|
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Current U.S.
Class: |
600/566 ;
128/898; 606/15; 606/169; 606/46 |
Current CPC
Class: |
A61B 2090/309 20160201;
A61B 17/320783 20130101; A61B 17/320725 20130101; A61B 2017/320733
20130101; A61B 2090/306 20160201; A61B 10/0275 20130101; A61B
2017/32007 20170801; A61B 2017/00057 20130101; A61B 2017/00199
20130101; A61B 90/37 20160201; A61B 2017/320032 20130101; A61B
10/0096 20130101; A61B 2017/00287 20130101; A61B 10/0283 20130101;
A61B 2017/320064 20130101; A61B 2017/00274 20130101; A61B
2017/320024 20130101; A61B 17/320758 20130101; A61B 17/32002
20130101; A61B 17/320016 20130101 |
Class at
Publication: |
600/566 ;
128/898; 606/015; 606/169; 606/046 |
International
Class: |
A61B 10/04 20060101
A61B010/04; A61B 17/32 20060101 A61B017/32; A61B 18/14 20060101
A61B018/14 |
Claims
1. A medical device, comprising: a) an outer catheter including a
distal end and defining a lumen; and b) a tubular member defining a
lumen and an opening for cutting tissue within the body of a
patient, the lumen of the tubular member being couplable to a
suction source to provide suction through the opening, the tubular
member disposed movably within the lumen of the outer catheter such
that at least a portion of the tubular member is extendable beyond
the distal end of the outer catheter to engage tissue within the
opening, the tubular member being configured to cut the engaged
tissue when the tubular member is moved with respect to the outer
catheter, the cut tissue being transported through the lumen of the
tubular member when the suction source is coupled to lumen of the
tubular member.
2. The medical device of claim 1, wherein the opening is elongate
and is defined at least in part by two substantially parallel
edges.
3. The medical device of claim 2, wherein at least one of the edges
defines a cutting member for cutting the engaged tissue.
4. The medical device of claim 3, wherein the cutting member is
configured to cut the engaged tissue when the tubular member is
rotated about a longitudinal axis of the outer catheter.
5. The medical device of claim 3, wherein the cutting member is
configured to cut the engaged tissue when the tubular member is
moved along a longitudinal axis of the outer catheter.
6. The medical device of claim 3, further comprising an ultrasound
device operably coupled to the cutting member and being adapted to
facilitate cutting tissue.
7. The medical device of claim 3, wherein the cutting member
includes an active cord cautery device.
8. The medical device of claim 3, wherein the cutting member
includes a bipolar cautery device.
9. The medical device of claim 3, wherein the cutting member is a
monopolar cautery device.
10. The medical device of claim 1, further including a light source
configured to facilitate determining the location of the opening
while inside of a patient.
11. The medical device of claim 10, wherein the light source
includes a fiber optic element.
12. The medical device of claim 10, wherein the light source
includes a light emitting diode.
13. A system, comprising: a) a medical device, comprising an outer
catheter including a distal end and defining a lumen; and a tubular
member defining a lumen and an opening for cutting tissue within
the body of a patient, the lumen of the tubular member being
couplable to a suction source to provide suction through the
opening, the tubular member disposed movably within the lumen of
the outer catheter such that at least a portion of the tubular
member is extendable beyond the distal end of the outer catheter to
engage tissue within the opening, the tubular member being
configured to cut the engaged tissue when the tubular member is
moved with respect to the outer catheter, the cut tissue being
transported through the lumen of the tubular member when the
suction source is coupled to lumen of the tubular member; and b) a
computer interface coupled to the medical device and capable of
providing signals representative of a visual image of an internal
portion of the body of the patient.
14. The system of claim 13, further including a bag coupled to the
medical device for collecting a tissue sample.
15. A system, comprising: a) a medical device, comprising an outer
catheter including a distal end and defining a lumen; and a tubular
member defining a lumen and an opening for cutting tissue within
the body of a patient, the lumen of the tubular member being
couplable to a suction source to provide suction through the
opening, the tubular member disposed movably within the lumen of
the outer catheter such that at least a portion of the tubular
member is extendable beyond the distal end of the outer catheter to
engage tissue within the opening, the tubular member being
configured to cut the engaged tissue when the tubular member is
moved with respect to the outer catheter, the cut tissue being
transported through the lumen of the tubular member when the
suction source is coupled to lumen of the tubular member; and b) a
suction source adapted and configured to provide suction through
the lumen.
16. A medical device comprising: a main body portion including a
distal end, the main body portion defining a longitudinal axis; a
cutting member operably coupled to the distal end of the main body
portion, the cutting member being configured to rotate about an
axis transverse to the longitudinal axis from a first position to a
second position when performing a cutting operation.
17. The medical device of claim 16, wherein the main body portion
defines a lumen along at least a portion of its length, a distal
port at the distal end, and a proximal port proximal to the distal
end.
18. The medical device of claim 17, wherein the proximal port is in
fluid communication with a suction source for removing tissue cut
by the cutting member through the distal port and the lumen.
19. The medical device of claim 16, wherein the cutting member has
a substantially arcuate shape and circumscribes a volume when moved
from the first position to the second position.
20. The medical device of claim 19, further including an actuator
for moving the cutting member from the first position to the second
position.
21. The medical device of claim 20, wherein the actuator includes a
wire having a distal end, the distal end of the wire being operably
coupled to the cutting member and being configured to circumscribe
an arcuate path when the wire is moved along the longitudinal
axis.
22. The medical device of claim 21, wherein the main body portion
defines a lumen and the wire is disposed within the lumen.
23. The medical device of claim 21, wherein the wire is made from
spring steel.
24. The medical device of claim 21, wherein the wire is made from a
shape memory material.
25. The medical device of claim 24, wherein the wire is made from a
nickel-titanium alloy.
26. The medical device of claim 21, wherein the cutting member
moves from the first position to the second position when the wire
is advanced in a distal direction with respect to the main body
portion.
27. The medical device of claim 21, wherein the cutting member
moves from the first position to the second position when the wire
is advanced in a proximal direction with respect to the main body
portion.
28. The medical device of claim 20, wherein the actuator moves the
cutting member from the first position to the second position by
applying an electromagnetic force thereto.
29. The medical device of claim 28, wherein the actuator and the
cutting member are configured to carry electrical currents in
opposing paths.
30. The medical device of claim 29, further including a switching
mechanism, a power supply and a controller operably associated with
the switching mechanism and power supply, the controller adapted to
operate the switching mechanism to alternate electrical current
flowing through the actuator and cutting member to cause the
cutting member to oscillate between the first position and the
second position.
31. A medical device comprising: a main body portion defining a
lumen therethrough and including a distal end; a shaft rotatably
disposed in the lumen of the main body portion, the shaft including
a proximal end and a distal end, the shaft being capable of
rotation with respect to the main body portion about a longitudinal
axis; a rotational drive source operably coupled to the proximal
end of the shaft; a substantially arcuate cutting member attached
to the distal end of the shaft, the cutting member configured to
circumscribe a volume about the longitudinal axis when the shaft is
rotated; and a compartment affixed to the distal end of the main
body portion, the compartment configured to house the cutting
member.
32. The medical device of claim 31, wherein the main body portion
defines a second lumen therethrough, the second lumen having a
distal port proximate the cutting member and a proximal opening
proximal to the distal end of the main body portion.
33. The medical device of claim 32, further comprising a suction
source operably coupled to the compartment by way of the second
lumen to facilitate removal of tissue from a patient.
34. A medical device comprising: a main body portion including a
distal end and defining a lumen therethrough; a rotatable cutting
member disposed in the lumen, the cutting member defined by at
least one helical cutting edge and defining at least one helical
channel therethrough, the cutting member being capable of being
disposed beyond the distal end of the main body portion.
35. The medical device of claim 34, wherein the cutting member can
be moved in a rotational direction with respect to the main body
portion.
36. The medical device of claim 34, wherein the cutting member can
be moved in a longitudinal direction with respect to the main body
portion.
37. The medical device of claim 34, wherein the cutting member can
be moved in a longitudinal direction and in a rotational direction
with respect to the main body portion.
38. A medical device comprising: a main body portion including a
distal end and defining a lumen therethrough; a shaft slidably
disposed through the lumen of the main body portion, the shaft
including a distal end and a cup shaped cutting member attached to
the distal end of the shaft, the cutting member including a cutting
edge disposed proximate to a rim of the cup shaped cutting member,
the cutting member configured to cut tissue when advanced in a
proximal direction with respect to the main body portion of the
medical device.
39. The medical device of claim 38, wherein the cutting member
protrudes from the distal end of the main body portion.
40. The medical device of claim 38, wherein the main body portion
includes a closed end and defines a tissue entry port through a
sidewall of the main body portion suitable to permit entry of
tissue to be removed from a patient.
41. A method of removing tissue from a patient, comprising;
providing a medical device including a main body portion and a
cutting member slidably coupled thereto; introducing the medical
device through the urethra of a patient; removing tissue from the
patient by advancing the cutting member in a proximal direction
with respect to the main body portion; and withdrawing the medical
device from the patient.
42. The method of claim 41, wherein the removing step comprises
removing tissue from the bladder of the patient.
43. The method of claim 42, wherein the removing step comprises
removing tissue from the prostate gland of the patient.
Description
[0001] This application claims priority to U.S. Provisional Patent
Application No. 60/856,182, filed Nov. 1, 2006, entitled "Removing
Tissue," the entire content of which is hereby incorporated by
reference.
TECHNICAL FIELD
[0002] The present invention relates to removing tissue from a
patient and to medical devices and procedures for removing
tissue.
BACKGROUND INFORMATION
[0003] Minimally invasive surgery generally reduces patient trauma
and speeds recovery time as opposed to more conventional surgical
procedures in which a large portion of the patient's body is
opened. Minimally invasive endoscopic surgery generally involves
incising through body walls for examining, viewing, and/or
operating on various bodily organs or structures, including the
ovaries, uterus, gall bladder, bowels, kidneys, appendix, etc. In
such endoscopic procedures, a trocar typically creates an incision
and trocar tubes or cannula devices are extended into and left in
place (in, for example, the abdominal wall) so that endoscopic
surgical tools may be inserted into the patient's body. A camera or
endoscope can be inserted to enable visual inspection and
magnification of a cavity in the body of the patient. The surgeon
then performs the desired procedure with the aid of specialized
instrumentation designed to fit through additional openings which
provide additional entries into the desired body cavity. Thus,
instead of a rather large incision (typically 12 inches or larger)
necessary to complete a more conventional fully invasive surgical
procedure, minimally invasive endoscopic surgery results in one or
several smaller incisions, usually between 5 and 15 millimeters in
size. In most instances, recovery is quicker and less painful than
conventional surgery. In addition, because the surgical field
typically is greatly magnified, surgeons are often better able to
dissect blood vessels and control blood loss. In addition, heat and
water loss are often reduced as a result of the smaller
incisions.
[0004] In some surgical procedures, it is necessary to remove
tissue or diseased organs. This can be challenging during
endoscopic surgery because the tissue or organ removal must be
achieved through the small openings through which the procedure is
performed. In these situations, it may be desirable to fragment,
morcellate, or otherwise reduce body tissue into smaller pieces
that can be readily removed through the small endoscopic
openings.
[0005] Morcellation involves fragmenting and removing diseased
tissue or organ parts from healthy tissue or organs. In endoscopic
morcellation, the fragmented pieces are typically removed from the
patient's body through a small incision or through a trocar cannula
device which extends through the abdominal wall. When the tissue or
organ part is diseased or infected, it is preferred that the
excised portions thereof be isolated from contact with surrounding
healthy tissue. Accordingly, it is often necessary to enclose the
fragmented organ during removal, thus preventing contamination of
healthy tissue and bodily organs. In some instances, the organ is
fragmented in a bag by a surgical device known as a morcellator,
until such a time as the entire specimen is small enough to be
removed while in the bag from the abdominal cavity through one of
the minimally invasive endoscopic openings.
SUMMARY OF THE INVENTION
[0006] The invention generally relates to removing tissue from a
patient in a minimally invasive manner. The patient can be a human
or other mammal, for example. A catheter or other medical device
for removing tissue in accordance with the invention can be
inexpensive and easy to manufacture.
[0007] In one aspect, the invention relates to a medical device for
removing tissue from a patient. The medical device comprises an
outer catheter including a distal end and defining a lumen and a
tubular member defining a lumen and an opening for cutting tissue
within the body of a patient. The lumen of the tubular member is
couplable to a suction source to provide suction through the
opening. The tubular member is disposed movably within the lumen of
the outer catheter such that at least a portion of the tubular
member is extendable beyond the distal end of the outer catheter to
engage tissue within the opening. The tubular member is configured
to cut the engaged tissue when the tubular member is moved with
respect to the outer catheter, the cut tissue being transported
through the lumen of the tubular member when the suction source is
coupled to lumen of the tubular member.
[0008] Embodiments according to this aspect of the invention can
include the following features. The opening can be elongate and be
defined at least in part by two substantially parallel edges. At
least one of the edges can define a cutting member for cutting the
engaged tissue. The cutting member can be configured to cut the
engaged tissue when the tubular member is rotated about a
longitudinal axis of the outer catheter. Additionally or
alternatively, the cutting member can be configured to cut the
engaged tissue when the tubular member is moved along a
longitudinal axis of the outer catheter. The medical device can
further comprise an ultrasound device operably coupled to the
cutting member and being adapted to facilitate cutting tissue.
Moreover, the cutting member can includes an active cord cautery
device, such as a monopolar or bipolar cautery device. The medical
device can further include a light source configured to facilitate
determining the location of the opening while inside of a patient.
The light source can include a fiber optic element and/or a light
emitting diode.
[0009] In another aspect, the invention involves a system
comprising a medical device as described above and a computer
interface coupled to the medical device and capable of providing
signals representative of a visual image of an internal portion of
the body of the patient. In certain embodiments, the system
includes a bag coupled to the medical device for collecting a
tissue sample and/or a suction source adapted and configured to
provide suction through the lumen.
[0010] In another aspect, the invention involves a medical device
comprising a main body portion including a distal end and a cutting
member operably coupled to the distal end of the main body portion.
The main body portion defines a longitudinal axis, and the cutting
member is configured to rotate about an axis transverse to the
longitudinal axis from a first position to a second position when
performing a cutting operation.
[0011] Embodiments according to this other aspect of the invention
can include the following features. The main body portion can
define a lumen along at least a portion of its length, a distal
port at the distal end, and a proximal port proximal to the distal
end. The proximal port can be in fluid communication with a suction
source for removing tissue cut by the cutting member through the
distal port and the lumen. The cutting member can have a
substantially arcuate shape and circumscribe a volume when moved
from the first position to the second position. The medical device
can further include an actuator for moving the cutting member from
the first position to the second position. The actuator can include
a wire having a distal end, the distal end of the wire being
operably coupled to the cutting member and being configured to
circumscribe an arcuate path when the wire is moved along the
longitudinal axis. The main body portion can define a lumen and the
wire can be disposed within the lumen. The wire can be made from
spring steel and/or a shape memory material, such as a
nickel-titanium alloy. The cutting member can be caused to move
from the first position to the second position when the wire is
advanced in a proximal or distal direction with respect to the main
body portion. The actuator can alternatively move the cutting
member from the first position to the second position by applying
an electromagnetic force thereto. The actuator and the cutting
member can accordingly be configured to carry electrical currents
in opposing paths. The medical device can further include a
switching mechanism, a power supply and a controller operably
associated with the switching mechanism and power supply, the
controller adapted to operate the switching mechanism to alternate
electrical current flowing through the actuator and cutting member
to cause the cutting member to oscillate between the first position
and the second position.
[0012] In yet another aspect, the invention features a medical
device comprising a main body portion defining a lumen therethrough
and including a distal end, and a shaft rotatably disposed in the
lumen of the main body portion. The shaft includes a proximal end
and a distal end, and the shaft is capable of rotation with respect
to the main body portion about a longitudinal axis. The device
further comprises a rotational drive source operably coupled to the
proximal end of the shaft and a substantially arcuate cutting
member attached to the distal end of the shaft. The cutting member
is configured to circumscribe a volume about the longitudinal axis
when the shaft is rotated. A compartment is affixed to the distal
end of the main body portion, and the compartment is configured to
house the cutting member.
[0013] Embodiments according to this aspect of the invention can
include the following features. The main body portion can define a
second lumen therethrough, the second lumen having a distal port
proximate the cutting member and a proximal opening proximal to the
distal end of the main body portion. A suction source can be
coupled to the compartment by way of the second lumen to facilitate
removal of tissue from a patient.
[0014] In still another aspect, the invention relates to a medical
device comprising a main body portion including a distal end and
defining a lumen therethrough. The medical device also comprises a
rotatable cutting member disposed in the lumen. The cutting member
is defined by at least one helical cutting edge and defines at
least one helical channel therethrough, and the cutting member is
capable of being disposed beyond the distal end of the main body
portion.
[0015] Embodiments according to this aspect of the invention can
include the following features. The cutting member can be moved in
a rotational and/or longitudinal direction with respect to the main
body portion. A suction source can be coupled to the medical device
to facilitate removal of tissue from a patient through the
lumen.
[0016] In a further aspect, the invention features a medical device
comprising a main body portion including a distal end and defining
a lumen therethrough. The device also comprises a shaft slidably
disposed through the lumen of the main body portion. The shaft
includes a distal end and a cup shaped cutting member attached to
the distal end of the shaft. The cutting member includes a cutting
edge disposed proximate to a rim of the cup shaped cutting member,
and the cutting member is configured to cut tissue when advanced in
a proximal direction with respect to the main body portion of the
medical device.
[0017] Embodiments according to this aspect of the invention can
include the following features. The cutting member can protrude
from the distal end of the main body portion. The main body portion
can include a closed end that defines a tissue entry port through a
sidewall of the main body portion suitable to permit entry of
tissue to be removed from a patient.
[0018] In still a further aspect, the invention features a method
of removing tissue from a patient. The method comprises providing a
medical device including a main body portion and a cutting member
slidably coupled thereto, introducing the medical device through
the urethra of a patient, removing tissue from the patient by
advancing the cutting member in a proximal direction with respect
to the main body portion, and withdrawing the medical device from
the patient. Tissue can be removed from, for example, the patient's
bladder or the prostate gland.
[0019] Both the foregoing and following descriptions are exemplary
and illustrative. The accompanying drawings, which are incorporated
in and constitute part of this specification, are included to
illustrate and provide a further understanding of the invention and
particular embodiments thereof. The drawings are not necessarily to
scale and generally serve to help illustrate the principles and/or
certain embodiments of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] FIG. 1(a) is a schematic representation of a first
representative embodiment of a medical device made in accordance
with the present invention.
[0021] FIGS. 1(b)-1(d) are partial views of a portion of the
medical device depicted in FIG. 1(a).
[0022] FIG. 2(a) is an isometric view of a second representative
embodiment of a medical device made in accordance with the present
invention.
[0023] FIGS. 2(b)-2(d) are isometric views of a portion of the
medical device depicted in FIG. 2(a).
[0024] FIG. 2(e) is a schematic representation of an alternate
embodiment of the medical device depicted in FIG. 2(a).
[0025] FIG. 3(a) is an isometric view of a third representative
embodiment of a medical device made in accordance with the present
invention.
[0026] FIGS. 3(b)-3(d) are isometric views of a portion of the
medical device depicted in FIG. 3(a).
[0027] FIG. 4 is an isometric view of a fourth representative
embodiment of a medical device made in accordance with the present
invention.
[0028] FIG. 5(a) is an isometric view of a fifth representative
embodiment of a medical device made in accordance with the present
invention.
[0029] FIGS. 5(b)-5(d) are partial cross-sectional views of an
alternate embodiment of the medical device depicted in FIG.
5(a).
DESCRIPTION
[0030] The devices and methods presented, described, and shown
herein may be used for resecting tissue from within the body of a
patient and removing the resected tissue from the patient's body,
for example. Medical devices and procedures according to the
invention are particularly well suited for resecting cancerous
growths from the bladder and/or the prostate gland of a
patient.
[0031] For purpose of explanation and illustration, and not
limitation, a partial view of an exemplary embodiment of the
medical device in accordance with the invention is shown in FIG.
1(a) and is designated generally by reference character 110. Other
embodiments of a system in accordance with the invention, or
aspects thereof, are provided in FIGS. 2-5, as will be
described.
[0032] In accordance with one aspect of the invention, an outer
catheter of a medical device includes a distal end and defines a
lumen.
[0033] For purposes of illustration and not limitation, as embodied
herein and as depicted in FIG. 1(a), a medical device 110 has an
outer catheter 120 which includes a proximal end 122, a distal end
124, and defines a lumen 126 therethrough. Lumen 126 includes a
proximal port 128 and a distal port 130. Outer catheter 120 can be
further coupled to a handle 136 proximate its proximal end 122 for
gripping by an operator such as a surgeon or other medical
professional. The handle can be attached to outer catheter 120 by,
for example, welding, use of an adhesive, or forming the handle
integrally with outer catheter 120. Other ways of attachment also
are possible.
[0034] Outer catheter 120 can be made from any one of a variety of
materials including metal, plastic, and composite materials.
Combinations of such materials also can be used to form the outer
catheter. For example, the outer catheter 120 can be made of a
fiber reinforced plastic. The outer catheter 120 can also be
constructed of a braided reinforcement layer over a lubricious
inner layer such as tetrafluoroethylene (Teflon or TFE). The braid
can be oversleeved or overextruded or coextruded with a
thermoplastic polymer such as Nylon or Pebax graded to provide the
appropriate rigidity. The braid material can be Liquid Crystal
Polymer, sold as Vectran, in mono or multifilament. The braid
material can also include metallic wire in one or more carriers.
These wires can be stainless steel or a more radiopaque metal such
as platinum. The polymer oversleeve can also be filled with a
material such as barium to enhance radiopacity. A hydrophilic
coating can be added to the outer catheter to improve lubricity. A
knitted configuration or a coil can also substitute for the
braid.
[0035] Other examples of materials from which the outer catheter
120 can be formed include silicone, nylons, urethanes and
thermoplastic materials such as TFE, high density polyethylene
(HDPE), law density polyethylene (LDPE), polypropylene (PP),
polyethylene (PE), and PEEK.TM. polymer. In general, any material
or combination of materials used to make the outer catheter 120
should result in the outer catheter 120 being biocompatible,
because at least a portion of the outer catheter 120 typically will
be inserted into the body of a mammal (such as a human patient)
when the medical device 110 is used for its intended purpose. Outer
catheter 120 can have a uniform stiffness along its length, or a
stiffness that increases or decreases along its distal length, as
desired for the particular application. Adjusting the stiffness can
be accomplished by varying the thickness of outer catheter 120, or
by adjusting the properties and/or composition of the outer
catheter. For example, a braided layer can be impregnated along a
polymeric outer catheter 120 along a part of its length, providing
an outer catheter 120 with a stiff proximal segment and a flexible
distal segment. If polymers are used, it is possible to adjust the
blend of polymers or method of curing the polymer along the length
of catheter 120 to achieve a desired stiffness profile. Other ways
of adjusting the stiffness and/or making the outer catheter more or
less flexible or inflexible also can be employed.
[0036] As indicated in FIG. 1(a), the medical device 110 further
includes a tubular member 140 including a proximal end 142, a
distal end 144, and a sidewall 145, and the tubular member 140 also
defines a lumen 146 therethrough. Lumen 146 includes a proximal
port 148 and defines an opening 150 for cutting tissue. Lumen 146
is couplable to a suction source 160 to provide suction through
opening 150 to facilitate removal of tissue from a patient, as
discussed in detail below. Tubular member 140 can be rotatably
and/or longitudinally movable within lumen 126 of outer catheter
120. Preferably, outer catheter 120 and tubular member 140 are
sealingly connected, such as by interposing one or more o-rings
(not shown) between these two components of the medical device 110.
Proximal end 142 of tubular member 140 can also be provided with a
handle 147 for gripping by an operator such as a surgeon or other
medical professional.
[0037] A variety of materials can be used to form tubular member
140. For example, tubular member 140 can be made of the same or
similar material(s) as the outer catheter 120. It is also possible
to configure tubular member 140 to have a desired constant or
varying flexibility or stiffness along its length, as it is with
outer catheter 120.
[0038] If made from plastic, outer catheter 120 and tubular member
140 can be manufactured from a single extrusion of material or from
a multiple extrusion, such as a trilayer extrusion described in
U.S. Pat. No. 6,165,166 to Samuelson et al. Other ways of making
these components of the medical device 110 are possible. For
example, outer catheter 120 and tubular member 140 can be formed by
shrinking polymeric tubing in layers over a mandrel or by dipping a
mandrel in molten plastic material to build up layers of plastic
material. Layers of reinforcement material such as various metallic
or fibrous braided material can be interposed between the layers of
plastic material.
[0039] As discussed above, proximal port 148 is preferably in fluid
communication with a suction source 160, described in detail below.
Additionally or alternatively, a Luer connector 134 can be provided
as depicted in FIG. 1(b), or proximal port 148 can be defined
through sidewall 145 of member 140 as depicted in FIG. 1(c). The
Luer connector 134 (FIG. 1(b)) can be used to couple the suction
source 160 to the medical device 110, yet still permit introduction
of other components and/or beneficial agents through lumen 146
during a surgical procedure. Saline solution is one example of what
can be introduced through the lumen 146.
[0040] As depicted in FIG. 1(d), an opening 150 has an elongate
shape and is defined in sidewall 145. The opening 150 is defined by
two elongate substantially parallel edges 152 and 154.
[0041] One or both of the edges 152, 154 can be sharpened to serve
as cutting members to facilitate removal of tissue from a patient.
Additionally or alternatively, proximal and distal portions 156 and
158 of opening can be sharpened to form cutting members. Opening
150 can be defined by the same material(s) that form(s) the tubular
member 140, or a separate insert can be disposed within the opening
150 to define its boundary and provide the cutting edge(s) of the
opening 150. For example, if tubular member 140 is formed of a
polymer, opening 150 can be defined by the same polymeric material,
or can be formed from a metallic insert about which tubular member
140 is formed, such as by injection molding.
[0042] Regardless which portions 152, 154, 156, 158 of opening 150
are formed into cutting members, tissue that is cut from within the
body of a patient can be removed from the patient's body by
applying suction through opening 150 from suction source 160 such
that the cut tissue is drawn through the medical device 110 and out
of the patient's body. To cut or resect tissue within the patient's
body, the distal end 144 of the tubular member (including at least
a portion of the opening 150) is moved to place it distal of the
distal end 124 of the outer catheter 120. Tissue can then be
engaged within the opening 150 by manipulating the medical device
110, and the engaged tissue is then cut from the patient's body by
moving the tubular member 140 in a longitudinal direction along
longitudinal axis X and/or in a rotational direction about axis X
with respect to the outer catheter 120. The cut or resected tissue
is then removed from within the patient's body by the use of
suction which draws it up through the lumen 146 and out of the
patient's body.
[0043] While a sharpened edge of opening 150 has been described as
acting as a cutting member for cutting tissue and thus allowing its
removal from a patient's body, other mechanisms for cutting tissue
within a patient's body are possible. For example, a cutting member
can be provided in the form of an active cord cautery device such
as a bipolar cautery device or a monopolar cautery device.
Moreover, an ultrasound device 170 (see FIG. 1(a)) can be operably
coupled to one or more edges 152, 154, 156, 158 of opening 150 to
facilitate tissue removal.
[0044] A suction source can be operably coupled to the medical
device to facilitate removal of tissue from a patient. As depicted
in FIG. 1(a), suction source 160 can take the form of a constant
vacuum that can be applied through the lumens 146 of the medical
device 110. The suction source 160 can be provided at a wall
connection in an operating room or other medical treatment area, or
it can be a portable source of suction provided by a movable vacuum
generator. The suction source 160 can be placed in fluid
communication with the medical device 110 by way of a controllable
valve 162 that can be opened or closed to apply a desired amount of
suction through the medical device 110. The surgeon operating the
medical device 110 or some other medical professional can operate
the valve 162.
[0045] A collector 164 can be provided to collect tissue that is
removed from a patient after it has been cut from the patient and
suctioned out of the patient's body. The collector 164 could be a
bag or some other type of container.
[0046] A light source can be provided to facilitate determination
of the location of the opening of the medical device while inside a
patient. For example, a light source 172 can be disposed on the
medical device 110 to aid the operator of the device 110, as
depicted in FIG. 1(a). The light source can include one or more
fiber optic elements 174 and/or light emitting diodes 176. By using
the light source 172, the positioning and/or location of the
portion of the medical device 110 inserted into the body of the
patient can be more easily and/or accurately determined, resulting
in a more efficient surgical procedure.
[0047] Other elements can be included with a medical device as
described herein to assist a surgeon or other medical professional
in performing a surgical procedure using the medical device. For
example, as depicted in FIG. 1(a), a computer interface 180 can be
used to provide a visual image of the surgical site to the surgeon.
As such, the computer interface can be operably coupled to one or
more optical elements (such as elements 174) in visual
communication with the surgical site.
[0048] In operation, a surgeon can introduce medical device 110
into a patient. Signals in the form of visual information are
received through fiber optic elements 174 and directed to computer
interface 180. Computer interface 180 is configured and adapted to
display a representative image of the surgical site on a graphical
user interface 182 as depicted in FIG. 1. Graphical user interface
182 can comprise a display panel configured to display a plurality
of data objects 184, such as a window for displaying an image of
the surgical site, touch screen menus and the like. A control panel
186 (such as a keyboard and pointing device, if desired) can also
be provided to navigate through images collected of the surgical
site.
[0049] Suitable fiber optic probes such as Spyglass.TM. fiber optic
probes commercially available from Boston Scientific of
Massachusetts can be used. Moreover, other types of imaging systems
can be used in combination with the medical device of the present
invention including, but not limited to, CT imaging, Magnetic
Resonance Imaging, fluoroscopic and ultrasound imaging. Data
obtained from each of these types of imaging systems can be routed
through leads into computer interface 180 to provide a real time
image of the surgical site. Moreover, it is possible and within the
scope of the invention to use other computer assisted visual tools
to perform a surgical procedure. For example, virtual imaging
software can be used to simulate the surgical site based on data
acquired through other means, such as position sensors.
[0050] A bag can be provided for collecting a tissue sample. For
example, as depicted in FIG. 1(a), a bag 190 is provided for
collecting a tissue sample. Bag 190 can be coupled to the distal
end 144 of tubular member 140 of medical device 110 as depicted in
FIG. 1(a), or can be introduced by means of a separate catheter
(not shown). Bag 190 can be used to collect a sample in lieu of or
in addition to suction from suction source 160.
[0051] Depicted in FIGS. 2(a)-5(d) are other embodiments of medical
devices according to the invention. These devices also can be used
to remove tissue from within the body of a patient, and these
devices can be used with or without suction.
[0052] As depicted in FIG. 2(a), a medical device 210 includes a
main body portion 220, and the main body portion 220 includes a
proximal end 222 and a distal end 224. Main body portion 220
extends along a longitudinal axis X. If desired, proximal end 222
of main body portion 220 can be affixed to and/or integrally formed
with a handle portion 236. Main body portion 220 can be made from a
variety materials as with portions 120, 140 of medical device 110.
A cutting member 250 is operably coupled to the distal end 224 of
the main body portion 220. As depicted in FIGS. 2(b)-2(d), cutting
member 250 is configured to rotate and/or pivot about an axis T
that is transverse to the longitudinal axis X from a first position
as depicted in FIG. 2(b) to a second position as depicted in FIG.
2(d) when performing a cutting operation.
[0053] Medical device 210 can take on a variety of forms. While
medical device 210 can be provided with a bag 290 for collecting
tissue removed from a patient, main body portion 220 can define a
lumen 226 along at least a portion of its length, the lumen having
a distal port 230 at the distal end 224 of the medical device 210
and a proximal port 228 proximal to the distal end 224 of the
medical device. The proximal port 228 can be in fluid communication
with a suction source similar to the embodiment of FIG. 1(a) for
removing tissue cut by the cutting member 250 through the lumen
226. The cutting member 250 can have an substantially arcuate shape
and circumscribe a volume when moved from the first position to the
second position that is substantially hemispherical.
[0054] Main body portion 220 can be made of a variety of materials
and by a variety of methods as with outer catheter 120 described
above. Also, main body portion 220 can have a uniform or increasing
or decreasing stiffness along its length to provide the surgeon
with the appropriate stiffness or flexibility required by the
application at hand.
[0055] The cutting member 250 can be made from surgical grade
steel. A variety of other materials could be used to form the
cutting member. The cutting member 250 can be manufactured by
stamping out an appropriately shaped piece of metal or by any of a
variety of other processes.
[0056] As depicted in FIGS. 2(b)-2(d), an actuator 260 is provided.
The actuator 260 can be a wire including a proximal end 262 and a
distal end 264, with the distal end 264 of the actuator operably
coupled to the cutting member 250. The distal end 264 of the
actuator 260 can be configured to circumscribe an arcuate path when
the proximal end of the wire 262 is moved along the longitudinal
axis X, as shown in FIGS. 2(b)-2(d). Optionally, the wire can be
received by a second lumen 266 traversing the length of the main
body portion 220 of medical device 210. The actuator 260 can be
made at least in part from spring steel with a distal end 264 that
is biased to form an arc as disposed in FIG. 2(d). When actuator
260 is withdrawn into lumen 266 it straightens out until it is once
again moved distally out of lumen 266. The cutting member 250 can
be caused to move from the first position to the second position
when the wire is advanced in a distal or proximal direction with
respect to the main body portion. By way of further example, if
desired, it is possible to form actuator 260 of a shape memory
material such as an alloy of nickel and titanium (e.g.,
Nitinol.TM.). Other materials can be used to form the actuator
260.
[0057] As depicted in FIG. 2(e), the medical device 210 includes
the cutting member 250 and the cutting member 250 is moved between
a first position and a second position by use of an electromagnetic
force applied to the cutting member 250. In this embodiment, the
actuator 260 and the cutting member 250 can be configured to carry
electrical currents in opposing paths to create attractive and
repulsive forces to cause a desired movement of the cutting member
250. For example, the cutting member 250 can be mounted on
insulated electrical leads 250a, 250b that are routed to a switched
power supply 258. Electrical loops 252 and 254 can be provided
embedded in the face 225 of distal end 224 of main body portion 220
of medical device 210 that are also connected to the power supply
258. Electrical power can be routed through each of the circuits
defined by loops 250a, 250b, 252 and 254, for example, by use of a
switching mechanism having pin diodes 256(a)-(f) that are
controlled by a controller 259. By sending electrical current
through the cutting member 250 and loop 252 in opposite directions,
a repulsive force can be achieved between the two conductors,
causing cutting member 250 to pivot away from loop 252. Similarly,
by operating a current in the same direction through loop 254 and
cutting member 250, an attractive force can be imposed between the
two conductors. Thus, for example, by ramping and switching the
direction of the current going through cutting member 250 and
maintaining the directions of the current going through loops 252
and 254 in opposite directions, it is possible to cause cutting
member 250 to oscillate between first and second positions. Other
ways of actuating and moving the cutting member 250 are
possible.
[0058] In operation, the medical device 210 of FIGS. 2(a)-2(e) can
be used as follows. The medical device 210 is introduced into a
patient and the cutting member 250 is positioned close to or in
contact with tissue to be removed from within the body of the
patient. For example, a medical device according to the invention
can be inserted through a urethra of a patient to remove tissue
from the patient's bladder or prostate. The actuator 260 can be
actuated to move the cutting member 250 between the first position
to the second position. As the cutting member 250 is moved from the
first position to the second position, scalloped shaped pieces of
tissue are removed from the patient. If a lumen of the medical
device 210 is operably coupled to a suction source (such as the
suction source 160 described above), substantially continuous
removal of tissue can be accomplished through the lumen as the
tissue is cut from within the patient's body by the cutting member
250.
[0059] In accordance with another aspect of the invention, a
medical device includes a main body portion, a shaft rotatably
disposed in a lumen of the main body portion, and a substantially
arcuate cutting member attached to the distal end of the shaft. As
depicted in FIGS. 3(a)-3(d), a medical device 310 is provided
including a main body portion 320 defining a lumen 326 through the
main body portion 320, the main body portion 320 having a proximal
end 322 and a distal end 324. A shaft 328 rotatable about a
longitudinal axis X with respect to main body portion 320 is also
provided, disposed in the lumen 326 of the main body portion 320.
Additionally, a substantially arcuate cutting member 350 and
compartment 360 are attached to the distal end 332 of the shaft. In
one embodiment, cutting member 350 and compartment 360 are smaller
than depicted in FIGS. 3(a)-3(d). Cutting member 350 and
compartment 360 can be at least small enough to fit through the
smallest cannula, incision or lumen that allows passage of the main
body portion 320 of device 310. For illustrative purposes, cutting
member 350 and compartment 360 are shown enlarged in FIGS.
3(a)-3(d) so that details of these elements can be seen more
easily. In another embodiment, to permit resection of larger
amounts of tissue, cutting member 350 and compartment 360 can be
made larger or at least as shown in FIGS. 3(a)-3(d), in which case
the main body portion 320 of device 310 can be introduced through a
larger incision, lumen or cannula. Other shapes are possible
instead of the substantially arcuate shape. The cutting member 350
is configured to circumscribe a volume about the longitudinal axis
X when the shaft is rotated as depicted in FIGS. 3(a)-3(d).
[0060] A compartment 360 can be disposed at the distal end 324 of
the main body portion 320 as depicted in FIG. 3(a)-3(d).
Compartment 360 houses cutting member 350 when it is not in use,
such as when medical device 310 is being introduced into or
withdrawn from a patient. Compartment 360 can thus protect cutting
member 350 from being damaged when not in use. Compartment 360 can
also be used to capture pieces of tissue cut from a target area
using cutting member 350. As depicted in FIGS. 3(a), 3(b) and 3(d),
compartment 360 is defined by a solid hemispherical wall 364 having
an interior surface 362.
[0061] Main body portion 320 and compartment 360 can be made of a
variety of materials and by a variety of methods as with outer
catheter 120 and main body portion 220 described above. Main body
portion 320 can be attached to compartment 360 by various
processes. For example, welding can be used to attached the main
body portion 320 to the compartment 360. Alternatively, the main
body portion 320 and the compartment 360 can be integrally formed
together as one piece. The main body portion 320 can have a uniform
or increasing or decreasing stiffness along its length.
[0062] The cutting member 350 can be made from a variety of
materials as described above for cutting member 250. The cutting
member 350 can also be manufactured in various ways, as with
cutting member 250. The cutting member 350 can be formed from the
same piece of material as shaft 328. If formed from the same piece
of material, shaft 328 and cutting member 350 can be formed in
tandem in a single manufacturing operation or in separate
operations. Alternatively, cutting member 350 can be formed
separately from shaft 328 and attached thereto, such as by welding
or any other means known in the art. It is also possible to form
both portions from the same piece of material. The cutting member
350 can be made from surgical grade steel, or another material can
be used.
[0063] A rotational drive source 355 can be coupled to the proximal
end 330 of the shaft 328. Drive source 355 can be a manual source,
such as a handle for manual rotation as depicted in FIG. 3(a).
Alternatively, drive source 355 can be a motor attached to shaft
328 by way of a rotational coupling.
[0064] By way of further example and as depicted in FIG. 3(a),
cutting member 350 can be disposed within a compartment 360 affixed
to the distal end 324 of the main body portion 320 as depicted in
FIG. 3(a)-3(d). In operation, medical device 310 is introduced into
a patient, and compartment 360 is placed proximate a target tissue
area to be removed. Shaft 328 is then rotated with respect to main
body portion 320, and cutting member 350 is rotated out of
compartment 360, and about longitudinal axis X. As cutting member
350 is rotated outside of compartment 360, it slices through target
tissue, separating the tissue from the patient. Once separated, the
tissue is collected in compartment 360, at which point the tissue
can be removed from the patent. To facilitate tissue removal, main
body portion 320 can define a second lumen 334 therethrough. Second
lumen 334 includes a distal port 338 proximate the cutting member
350 defined in the interior surface 362 of compartment 360 and a
proximal port 336 proximal to the distal end 324 of the main body
portion 320. To facilitate tissue removal, a suction source (such
as suction source 160 described above) can be placed in fluid
communication with proximal port 336 of lumen 334. Thus, as tissue
is cut by cutting member 350 and collected by container 360,
suction will draw morcellated tissue through distal port 338 and
through second lumen 334.
[0065] In accordance with still another aspect of the invention, a
medical device includes a main body portion including a proximal
end and a distal end, and the main body portion defines a lumen
therethrough. The medical device further includes a rotatable
cutting member disposed in the lumen. As depicted in FIG. 4, a
medical device 410 includes a main body portion 420. The main body
portion 420 includes a proximal end 422 and a distal end 424, and
the main body portion 420 defines a lumen 426 therethrough with a
proximal port 428 and a distal port 430. Medical device 410 further
includes a cutting member 450 in the form of an auger that is
disposed in the lumen 426. Cutting member 450 is rotatably and/or
longitudinally movable within main body portion 420. Cutting member
450 includes at least one helical cutting edge 452 and defines at
least one helical channel 454 therethrough that is in fluid
communication with lumen 426. The auger 450 can be extended out of
the lumen 426 and beyond the distal end 424 of the main body
portion 420 through distal port 430, with or without suction being
applied to proximal port 428 of lumen 426. It is possible to
provide the auger 450 with varying configurations including
different blade edge configurations and pitches.
[0066] Main body portion 420 can be made of a variety of materials
and by a variety of methods as with outer catheter 320 described
above. Likewise, main body portion 420 can have a varying or
uniform stiffness along the length of catheter. The auger 450 can
be made from any of a variety of materials such as surgical grade
steel, and the auger 450 can be manufactured using any of a variety
of processes such as forging, swaging, and machining.
[0067] In operation, the medical device 410 is introduced into a
patient (such as through the urethra) and the auger 450 is
positioned near or in contact with tissue to be removed from within
the body of the patient (such as from the bladder or prostate
gland). Distal end 456 of the auger 450 can be made to extend or
protrude from distal end 424 of main body portion 420. Whether or
not the auger 450 is extended out of the main body portion 420,
rotational movement of the auger 450 with respect to main body
portion 420 will grab tissue near or in contact with the auger 450.
While rotating, the helical cutting edge 452 of the auger 450
slices tissue and carries it up the channel 454. If the lumen 426
is operably coupled to a suction source (such as the suction source
160 described above), substantially continuous removal of tissue
can be accomplished through lumen as it is cut from the patient by
the auger 450. Even without suction, the rotating auger 450 causes
tissue to be drawn through the channel 454 and up into the lumen
426.
[0068] In accordance with another aspect of the invention, a
medical device includes a main body portion with a shaft slidably
disposed therein and a cup shaped cutting member attached to a
distal end of the shaft. As depicted in FIGS. 5(a)-5(d), a medical
device 510 includes a main body portion 520. The main body portion
520 includes a proximal end 522 and a distal end 524, and the main
body portion 520 defines a lumen 526 therethrough. A handle 528 can
be connected to the proximal end 522 of main body portion 520 for
gripping by the surgeon or other operator of the medical device
510. Medical device 510 further includes a shaft 540 slidably
disposed through the lumen 526 of the main body portion 520, and a
cup shaped cutting member 550 attached to the distal end 544 of the
shaft 540. Shaft 540 also can have a handle 548 attached to the
proximal end 542 thereof for gripping. Cutting member 550 can have
a cutting edge 552 disposed proximate to rim 554 of the cup shaped
cutting member 550. The cutting member 550 is preferably configured
to cut tissue when advanced in a proximal direction with respect to
the main body portion 520 of the medical device 510.
[0069] Main body portion 520 can be made of a variety of materials
and by a variety of methods as with main body portion 220 described
above. Likewise, main body portion 520 can have a uniform or
increasing or decreasing stiffness along the length thereof. The
cutting member 550 can be made from a variety of materials, and the
cutting member 550 can be manufactured using any of a variety of
processes. Also, the cutting member 550 can be affixed to the shaft
540 in various ways such as welding.
[0070] In operation, medical device 510 can be configured as
depicted in FIG. 5(a), wherein the cutting member 550 can protrude
beyond the distal end 520 of the main body portion 520. In
operation, main body portion 520 of medical device 510 can be held
stationary within the patient by gripping handle 528, and, by
gripping handle 548 shaft 540 carrying cutting member 550 can be
advanced distally with respect to main body portion into or
adjacent to a mass to be removed. Shaft 540 can then be withdrawn
proximally causing cutting edge 552 to slice through and remove
tissue and capture the removed tissue using cup shaped cutting
member 550. Cutting member 550 can then be withdrawn into main body
portion 520 of medical device 510 and flushed and cleaned by way or
irrigation and suction through lumen 526 if sufficiently large or a
second lumen, if needed, and then redeployed to collect more
tissue, if desired.
[0071] Alternatively, and as depicted in FIGS. 5(b)-5(d), main body
portion 520 can be provided with a closed distal end 524 and define
a tissue entry port 560 through a sidewall 525 of main body portion
520 suitable to permit entry of tissue to be removed from a
patient. In accordance with this embodiment suction can be applied
to lumen 526 to initiate a flow therethrough that draws tissue to
be removed into port 560. Cutting member 550 can then be drawn
proximally to cut the tissue from the patient, and the suction can
cause the resected tissue to be removed through lumen 526.
[0072] In accordance with another aspect of the invention, a method
of removing tissue from within the body of a patient includes the
steps of providing a medical device (such as one of the medical
devices described herein), introducing the medical device through
the urethra of a patient, removing tissue from the patient by
advancing a cutting member in a proximal direction with respect to
the main body portion, and withdrawing the medical device from the
patient. The method can be used to remove tissue from the bladder
and/or prostate gland of the patient, for example.
[0073] Particular embodiments according to the invention are
described and shown herein, but the invention is not limited to
these particular embodiments. Various modifications, additions, and
deletions can be made to the embodiments described and shown herein
without departing from the spirit or scope of the invention. Also,
the various features described and/or shown with respect to the
embodiments can be combined in various ways even if not
specifically described or shown in those combinations.
* * * * *