U.S. patent application number 10/374584 was filed with the patent office on 2003-10-30 for tissue separating and localizing catheter assembly.
This patent application is currently assigned to Artemis Medical, Inc.. Invention is credited to Buehlmann, Eric L., Laird, Robert J., Morrison, George A., Ventura, Christine P..
Application Number | 20030204188 10/374584 |
Document ID | / |
Family ID | 32926252 |
Filed Date | 2003-10-30 |
United States Patent
Application |
20030204188 |
Kind Code |
A1 |
Morrison, George A. ; et
al. |
October 30, 2003 |
Tissue separating and localizing catheter assembly
Abstract
A tissue-separating catheter assembly comprises a rotatable
shaft, having a distal shaft portion, and a tissue separator device
extending along the shaft. The tissue separator device has a distal
separator part at the distal shaft portion movable between a
retracted state, towards the distal shaft portion, and an outwardly
extending, operational state, away from the distal shaft portion. A
localization device is movable to a radially expanded state. An
expandable tubular element is movable so that its outer end is
generally axially aligned with the localization device so to
capture a separated tissue section therebetween to aid removal of
the separated tissue section from the patient.
Inventors: |
Morrison, George A.; (San
Mateo, CA) ; Laird, Robert J.; (Pinole, CA) ;
Buehlmann, Eric L.; (Redwood City, CA) ; Ventura,
Christine P.; (San Jose, CA) |
Correspondence
Address: |
HAYNES BEFFEL & WOLFELD LLP
P O BOX 366
HALF MOON BAY
CA
94019
US
|
Assignee: |
Artemis Medical, Inc.
655 Mariners Island Boulevard Suite 303
San Mateo
CA
94404
|
Family ID: |
32926252 |
Appl. No.: |
10/374584 |
Filed: |
February 25, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10374584 |
Feb 25, 2003 |
|
|
|
10045657 |
Nov 7, 2001 |
|
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Current U.S.
Class: |
606/45 ;
606/47 |
Current CPC
Class: |
A61B 2090/3908 20160201;
A61B 2018/00601 20130101; A61B 17/221 20130101; A61B 2018/1475
20130101; A61B 18/148 20130101 |
Class at
Publication: |
606/45 ;
606/47 |
International
Class: |
A61B 018/14 |
Claims
What is claimed is:
1. A tissue-separating catheter assembly comprising: a rotatable
shaft having a distal shaft portion; a tissue separator device
extending along the shaft and having a distal separator part at the
distal shaft portion movable between a retracted state, towards the
distal shaft portion, and an outwardly extending, operational
state, away from the distal shaft portion; a localization device at
the distal shaft portion movable from a first, radially-contracted
state to a second, radially-expanded state; and an expandable
tubular element, having an outer end, said tubular element being
movable between a first position, with the outer end proximal of
the tissue separator device, and a second position, with the outer
end generally axially aligned with the localization device; whereby
a tissue section separated from surrounding tissue by the tissue
separator device is capturable by the localization device in the
second state and the tubular element in the second position to aid
removal of the separated tissue section from a patient.
2. The assembly according to claim 1 wherein the expandable tubular
element comprises a radially-expandable tubular braided
element.
3. A method for separating and capturing a tissue section from
surrounding tissue of a patient comprising: directing a
localization device along a tissue track to a position distal of a
target site; changing the localization device from a first,
radially-contracted state to a second, radially-expanded state;
separating a tissue section at the target site from surrounding
tissue; and pushing an expandable tubular element, having an outer
end, over the separated tissue section until the outer end is
generally aligned with the localization device, thereby effectively
capturing the separated tissue section.
4. The method according to claim 3 wherein the pushing step is
carried out using a radially-expandable tubular braided element as
the expandable tubular element.
5. The method according to claim 3 further comprising removing the
separated tissue section, together with the localization device and
the tubular element, along the tissue track.
Description
CROSS REFERENCE TO OTHER APPLICATIONS
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 10/045,657 filed Nov. 7, 2001 and entitled
Tissue Separator Assembly And Method. This application is related
to the following two patent applications filed on the same date as
this application: Tissue Separating Catheter Assembly And Method,
attorney Docket No. ARTM 1016-1; Tissue Localizing And Separating
Assembly, attorney Docket No. 1019-1. See also: (1) U.S. Pat. No.
6,179,860 issued Jan. 30, 2001 and entitled Target Tissue
Localization Device And Method, (2) International Publication No.
WO 00/10471 published Mar. 2, 2000 and entitled Target Tissue
Localization Device And Method, (3) U.S. Pat. No. 6,221,006 issued
Apr. 24, 2001 and entitled Entrapping Apparatus And Method For Use,
(4) International Publication No. WO 99/39648 published Aug. 12,
1999 and entitled Entrapping Apparatus And Method For Use, (5) U.S.
patent application Ser. No. 09/588,278 filed Jun. 5, 2000 and
entitled Tissue Removal Methods And Apparatus, (6) International
Publication No. WO 00/74561 published Dec. 14, 2000 and entitled
Tissue Removal Methods And Apparatus; (7) U.S. patent application
Ser. No. 09/844,661 filed Apr. 27, 2001 and entitled Intraoperative
Tissue Treatment Methods.
BACKGROUND OF THE INVENTION
[0002] Cancer presently results in over one thousand five hundred
deaths every day in the United States (550,000 deaths every year).
Therapy modalities for cancer are plentiful and continued to be
researched with vigor. Still, the preferred treatment continues to
be physical removal of the cancer. When applicable, surgical
removal is preferred (breast, colon, brain, lung, kidney, etc.).
Open, excisional, surgical removal is often extremely invasive so
that efforts to remove cancerous tissue in less invasive ways
continue, but have not yet been perfected.
[0003] The only cure for cancer continues to be the early diagnosis
and subsequent early treatment. As cancer therapies continue at
earlier stages of diagnosis, the cancerous tissue being operated on
is also smaller. Early removal of the smaller cancers demand new
techniques for removal and obliteration of these less invasive
cancers.
[0004] There is a variety of techniques that attempt to accomplish
less invasive cancer therapy, but so far without sufficiently
improved results. For example, the ABBI system from U.S. Surgical
Corporation and the Site Select system from ImaGyn Corporation,
attempt to accomplish less invasive cancer therapy. However,
conventional techniques, in contrast with Minimally Invasive
Surgery (MIS) techniques, require a large core (that is more than
about 15 mm diameter) incision. Additionally, the Mammotome system
from Johnson and Johnson and MIBB system from U.S. Surgical
Corporation also require large core (over about 4 mm diameter)
access to accomplish biopsy.
[0005] A convention held by the American Society of Surgical
Oncologists on Mar. 13, 2000 reported that conventional
stereotactic core biopsy (SCB) procedures fall short in providing
definitive answers to detail precise surgical regimens after this
SCB type vacuum assisted biopsy, especially with ductile carcinoma
in situ (DCIS). Apparently these percutaneous systems damage
"normal" tissue cells so that it is difficult to determine if the
cells are "normal damaged" cells or early pre-cancerous (e.g.
Atypical Ductal Hyerplasia (ADH)) cells.
[0006] A study presented by Dr. Ollila et al. from the University
of North Carolina, Chapel Hill, demonstrated that histology and
pathology is compromised using these conventional techniques
because of the damage done to the removed tissue specimens. Hence,
for many reasons, including the fact that DCIS is becoming more
detectable and hence more prevalent in breast cancer diagnosis in
the U.S., there is a growing need to improve upon conventional
vacuum assisted core biopsy systems.
SUMMARY OF THE INVENTION
[0007] A first aspect of the invention is directed to a
tissue-separating catheter assembly comprising a rotatable shaft
having a distal shaft portion, a tissue separator device extending
along the shaft and having an expandable distal separator part at
the distal shaft portion, a radially-expandable localization device
at the distal shaft portion, and an expandable tubular element
movable so its outer end may be generally axially aligned with the
localization device. A tissue section separated from surrounding
tissue by the tissue separator device may be capturable by the
localization device and the tubular element to aid removal of the
separated tissue section from a patient.
[0008] A second aspect of the invention is directed to a method for
separating and capturing a tissue section from surrounding tissue
of a patient. A localization device is directed along a tissue
track to a position distal of a target site. The localization
device is changed from a first, radially-contracted state to a
second, radially-expanded state. A tissue section at the target
site is separated from surrounding tissue. An expandable tubular
element is pushed over the separated tissue section until its outer
end is generally aligned with the localization device, thereby
effectively capturing the separated tissue section.
[0009] Other features and advantages of the invention will appear
from the following description in which the preferred embodiments
have been set forth in detail in conjunction with the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 is a partially schematic overall view of a tissue
separator assembly made according to the invention with portions of
the handle removed for clarity;
[0011] FIG. 1A is a simplified cross-sectional view taken along
line 1A-1A of FIG. 1 showing the engagement of a pin within a slot
in the lead nut mounted to the lead screw;
[0012] FIG. 2 is schematic view of portions of the drive elements
of the assembly of FIG. 1;
[0013] FIG. 3 is a simplified cross-sectional view of the catheter
assembly taken along line 3-3 of FIG. 1;
[0014] FIG. 4 is an oblique view of the housing half of FIG. 1
together with the drive screw, drive nut and an L-shaped actuator
connected to and movable with the drive nut;
[0015] FIGS. 5 and 6 show the handle and catheter assembly of FIG.
1 after the actuator has moved from the position of FIG. 1 and the
actuator extension has pushed the separator wire pusher screw in a
distal direction causing the separator wire to move radially
outwardly;
[0016] FIG. 7 is a simplified the end view of the block and the
pusher screw just after the pusher screw has exited the slot in the
block showing the off-vertical orientation of the pusher screw;
[0017] FIG. 8 illustrates the proximal end of the lead screw, which
is visible from outside the housing, and a rotary position
indicator marked thereon corresponding to the position of the
separator wire in FIG. 10;
[0018] FIGS. 9 and 10 illustrate the structure of FIGS. 5 and 6
after the drive screw has moved the actuator distally causing the
lead nut to rotate the lead screw, catheter shaft and separator
wire therewith about 540 degrees to create a separated tissue
section;
[0019] FIGS. 11 and 12 illustrate the manual actuation of tissue
section holding elements;
[0020] FIG. 13 is a simplified view of certain of the components of
FIG. 12;
[0021] FIG. 14 is a cross-sectional view of the catheter taken
along line 14-14 of FIG. 13;
[0022] FIGS. 15 and 16 illustrate the manual actuation of a tubular
braided element to surround the separated tissue section;
[0023] FIG. 17 is a simplified view of certain of the components of
FIG. 16;
[0024] FIG. 18 is enlarged side view of the distal end of an
alternative embodiment of the catheter assembly of FIG. 1;
[0025] FIG. 19 is a side view of a modified embodiment of the
distal end of the catheter assembly of FIG. 18;
[0026] FIG. 20 is a schematic illustration showing the difference
in size between the separated tissue sections of the embodiments of
FIGS. 18 and 19;
[0027] FIG. 21 is an enlarged top view taken along line 21-21 of
FIG. 18;
[0028] FIG. 22 is an enlarged cross-sectional view taken along the
line 22-22 of FIG. 21;
[0029] FIG. 23 is a cross-sectional view taken along line 23-23 of
FIG. 18;
[0030] FIGS. 24A-24H are simplified side views of different
embodiments of the guide element/transition surface of FIG. 18;
[0031] FIG. 25 is an overall view of the distal end of the catheter
assembly of FIG. 18 illustrating a hook wire/tissue holding element
in a deployed condition;
[0032] FIG. 26 is a cross-sectional view of a portion of the shaft
of FIG. 25;
[0033] FIG. 27 is a somewhat simplified cross-sectional view of the
structure of FIG. 25 with the separator wire portion in a radially
retracted state;
[0034] FIG. 27A is a somewhat simplified cross-sectional view of
the structure of FIG. 25 with the separator wire portion in a
radially extended state;
[0035] FIG. 28 illustrates a further embodiment of the invention of
FIG. 18 including three separator wire portions, one of which is
shown in the operational state; and
[0036] FIG. 29A is a simplified end view of the structure of FIG.
28 suggesting three equally-spaced separator wire portions, each in
their retracted states;
[0037] FIG. 29B is a view similar to FIG. 29A but with one
separator wire portion in an operational state;
[0038] FIG. 30 is a simplified schematic illustration of a
tissue-penetrating assembly;
[0039] FIG. 31 is an overall view of a tissue localizing and
separating assembly made according to the invention including a
tissue separator assembly, a coupler and a tissue localization
assembly, the localization device of the tissue localization
assembly being in an expanded condition at a target site within a
patient;
[0040] FIG. 32 is an enlarged view of a portion of the assembly of
FIG. 31 illustrating a loop at the distal end of the coupler being
engaged with the proximal end of the tissue localization
assembly;
[0041] FIGS. 33 and 34 illustrate the distal end of the coupler and
the proximal end of the tissue localization assembly of FIG. 31
joined to one another;
[0042] FIG. 35 illustrates the distal movement of the tissue
separator assembly causing the joined ends of FIGS. 33 and 34 to be
moved into the catheter assembly thereby docking the tissue
localization assembly to the tissue separator assembly;
[0043] FIGS. 35A-35C are simplified drawings showing the movement
of an indicator tube, secured to the elongate coupler, through an
opening in the proximal end of the handle;
[0044] FIG. 36 is an enlarged view of the distal portion of the
assembly of FIG. 35 after the separator wire portion has been
radially expanded and rotated and after the hook wire has been
deployed to engage the separated tissue section;
[0045] FIG. 37 illustrates the assembly of FIG. 36 after the
catheter assembly sleeve has been moved proximally a short distance
to expose the distal end of the tubular braided element;
[0046] FIG. 38 is a somewhat idealized illustration of the movement
of the tubular braided element in a distal direction within a
patient with the tubular braided element initially generally
following the outline of the separated tissue section and its outer
end generally axially aligned with the localization device;
[0047] FIG. 39 illustrates the assembly of FIG. 38 after having
been removed from the patient with the outer end of the tubular
braided element returned to its relaxed state;
[0048] FIG. 40 illustrates the shape of a tubular braided material
after it has been stretched over a cylindrical mandrel having an
enlarged central portion;
[0049] FIG. 41 illustrates the structure of FIG. 40 after one end
of the mandrel and the tubular braided material has been dipped
into a silicone compound;
[0050] FIG. 42 illustrates the open mesh end of the dipped tubular
braided material, after the silicone has been cured and removed
from the mandrel, being pulled back into the dipped end to create a
tubular braided element;
[0051] FIG. 43 illustrates the resulting tubular braided element
being mounted to the distal end of the actuator tube;
[0052] FIG. 44 shows the proximal end of the tubular braided
element being secured to the distal end of the actuator tube by a
length of heat shrink tubing; and
[0053] FIG. 45 illustrates the tubular braided element secured to
the actuator tube.
DESCRIPTION OF THE SPECIFIC EMBODIMENTS
[0054] FIGS. 1 and 2 illustrate a tissue separator assembly 10 used
to separate target tissue from surrounding tissue, typically within
a patient's breast. The removal of target tissue may be for
diagnostic or therapeutic purposes. The assembly 10 includes a
catheter assembly 12 extending from a handle 14. Introduction of
catheter assembly 12 into the patient, typically through the skin,
is preferably aided by the use of, for example, a trocar or an RF
tip to provide a suitable path through the tissue. A stepper motor
16 is connected to handle 14 by a drive cable 18 and a drive cable
connector 20 mounted to the handle housing 22. Note that in the
Figs. only one-half of handle housing 22 is shown; the other
housing half is substantially similar. RF energy is supplied to
catheter assembly 12 from an RF source 24, along drive cable 18 and
to the interior of handle 14. A controller 26 controls the
operation of stepper motor 16 as well as RF source 24, such as
speed of operation and energy level. Controller 26 also receives
appropriate feedback signals from handle 14 and catheter assembly
12, such as tissue temperature, resistance force signals, tissue
impedance, rotary orientation, and so forth.
[0055] Drive cable 18 is connected to and rotates a drive screw 28
rotatably mounted within handle 14 at a fixed axial location by
drive screw supports 30, 32. A drive nut 34 is threadably mounted
to drive screw 28. An L-shaped actuator 36 is secured to drive nut
34. Actuator 36, see FIG. 4, includes a generally horizontal base
portion 38 and a generally vertical upright portion 40 sized and
configured to move within handle 14 parallel to the axis of drive
screw 28. Therefore, rotation of drive screw 28 by stepper motor 16
causes actuator 36 to slide within housing 22 from the initial
position of FIG. 1 to the position of FIG. 10. Reverse and
reciprocating movement is also possible.
[0056] Catheter assembly 12 includes in introducer sheath 42
mounted to and extending from housing 22. Catheter assembly 12 also
includes an actuator tube 43, discussed below with reference to
FIGS. 14-17, passing through sheath 42 and a shaft 44 passing
through tube 43. See FIG. 3. Shaft 44 has a distal portion 46
extending distally of the distal end 48 of sheath 42 and a proximal
portion 50 extending into the interior of handle 14. Proximal
portion 50 is secured to and rotates with a lead screw 52.
Accordingly, shaft 44 rotates with lead screw 52. Lead screw 52 is
mounted within housing 22 in a manner so that it can rotate but not
move axially within housing 22. A tissue separator device 54
extends along shaft 44 and has a separator wire portion 56 secured
to the distal end 58 of shaft 44. The separator wire 56 is
positioned externally of distal portion 46. The majority of tissue
separator device 54 is in the form of a wire and extends through an
axial bore 60 formed in shaft 44. The separator device 54 has a
radially extending pusher screw 62 at its proximal end. The
proximal end of shaft 44 has an axially extending slot 64, see FIG.
2, through which pusher screw 62 extends. Accordingly, pushing
pusher screw 62 distally, that is to the left in the Figs., causes
tissue separator wire 56 to move outwardly from its radially
contracted condition of FIG. 1 to its radially extended condition
of FIGS. 5 and 6. This radially outwardly movement is typically
accomplished at the target site within the patient, typically a
patient's breast. To aid movement of separator wire through the
tissue, wire 56 is supplied with RF energy from RF source 24. Other
applications of energy, such as mechanical reciprocation or
mechanical vibration, can also be used.
[0057] The axial movement of pusher screw 62 is caused by the axial
movement of actuator 36. Actuator 36 has an extension 66 extending
distally from upright portion 40. Extension 66 has a downwardly
formed distal end 68 aligned with pusher screw 62. The initial
axial movement of actuator 40, caused by the rotation of drive
screw 28 by stepper motor 16, closes a small gap 70 (see FIG. 2)
between distal end 68 and pusher screw 62. This small gap permits
the initiation of an electrosurgical arc prior to the outwardly
radial movement of separator wire 56. Continued distal movement of
actuator 36 moves pusher screw 62 distally causing separator wire
56 to bow outwardly to the position of FIGS. 5 and 6. FIGS. 5 and 6
(but not FIG. 1) show the use of a support block 72, which is a
part of housing 22, to support the distal end of lead screw 52 and
the proximal end of shaft 44. Support block 72 has an axially
extending slot 74, see FIGS. 5 and 7, which initially houses pusher
screw 62. At the time separator wire 56 is fully extended, pusher
screw 62 exits slot 74 and the distal end 68 of extension 66, which
has a chamfered face, causes pusher screw 62, along with shaft 44,
to begin rotating to the off-vertical position of FIG. 7. At the
same time upright portion 40 of actuator 36 closes gap 73 (see FIG.
2) and contacts a lead nut 75 threadably mounted on lead screw 52.
An anti-rotation pin 76 extends from upright portion 40 of actuator
36 and is housed within a U-shaped slot 78 formed in lead nut 74,
see FIG. 1A, to prevent lead nut 74 from rotating around lead screw
52 as lead nut 74 it is moved axially by actuator 36. Instead, the
axial movement of actuator 36 causes lead screw 52 to rotate thus
rotating shaft 44. Assembly 10 is configured so that shaft 44
rotates about 540 degrees to ensure a tissue section 80 is
completely separated from the surrounding tissue by the passage of
separator wire 56 through the tissue. The radial position of
separator wire 56 can be easily determined by looking at the
proximal end 82 of lead screw 52, which is exposed through housing
22. See FIG. 8. Proximal end 82 has a rotary position indicator 84
formed thereon corresponding to the rotary position of separator
wire 56.
[0058] The above-described sequence of events, according to this
disclosed embodiment, proceeds automatically once initiated by a
user. Of course operation of the device, including one or more of
extension of separator wire 56, rotation of shaft 44 and energizing
wire 56, can be terminated manually or automatically based on, for
example, an unexpected resistance to the rotation of shaft 44.
[0059] Assembly 10 also includes a T-pusher device 86 having a pair
of pusher tabs 88 extending laterally outwardly from slots formed
in housing 22. See FIGS. 11-13. After shaft 44 has completed its
rotation, the user begins pushing tabs 88 distally. This causes an
extension 90 of device 86 to rotate a flipper cam 92 about a pivot
pin 94; flipper cam 92 is connected to the proximal ends of a pair
of tissue section holding elements 96. Holding elements 96 are in
the form of wires passing through axial bores 98 formed in shaft 44
as shown in FIG. 3. The distal ends of holding elements 96 are
preformed hook wires 100, preferably made of a shape memory
material such as Nitinol, which pass through openings formed in
distal portion 46 of shaft 44 and engage separated tissue section
80 to help secure tissue section 80 to distal portion 46 of shaft
44.
[0060] Device 86 includes a distal end 102 connected to the
proximal end of actuator tube 43. Thus, the movement of device 86
causes tube 43 to move distally within introducer sheath 42. At
this point, that is with hook wires 100 deployed as an FIGS. 11-13,
a tubular braided element 104, see FIGS. 14-17, secured to the
distal end of actuator tube 43, is still fully housed within sheath
42. Further distal movement of device 86 causes tubular braided
element 104 to extend outwardly past distal end 48 of sheath 42 to
the position of FIGS. 15-17. The purpose of tubular braided element
104 is to surround separated tissue section 80 by passing along the
dissection plane between the separated tissue section and the
surrounding tissue. The open outer end 106 of element 104 naturally
expands radially as it is pushed axially through the tissue. To aid
the proper initial radial expansion of element 104, shaft 44 has an
outwardly tapered guide surface 108, formed on a guide element 110,
positioned adjacent to distal end 48 of introducer shaft 42. The
proper radial expansion of element 104 may also be aided by the
shape that element 104 takes when in its relaxed state. See, for
example, the discussion of tubular braided element 104 with regard
to FIGS. 40-45. Guide element 110 has a slot in its proximal
surface into which the proximal end of separator wire 56 passes
when in the radially expanded condition of FIG. 9; this helps to
keep separator wire 56 from folding over during rotation. If
desired, outer end 106 of tubular braided element 104 could include
a drawstring or other type of closure element. The separated tissue
section 80, now substantially enclosed within tubular braided
element 104 and secured to distal portion 46 of shaft 44 by hook
wires 100, may be removed from the patient.
[0061] With the present invention separated tissue section 80
retains most if not all of its physical integrity once removed from
the patient. Also, the use of tubular braided element 104,
especially when it is sealed or otherwise impermeable to the
passage of material, helps to reduce the possibility of seeding
diseased tissue along the tissue track during removal of separated
tissue section 80.
[0062] FIGS. 18-29B illustrate further embodiments of the invention
with like reference numerals referring to like elements. FIG. 18 is
an enlarged side view of the distal end 120 of alternative
embodiment of the catheter assembly 12 of FIG. 1. Referring now
also to FIGS. 21, 22 and 27, separator wire portion 56 is seen to
include a distal end 122. Distal end 122 terminates at a ball-type
element 124 (see FIG. 22) housed within a cavity 126 defined within
distal portion 46 of shaft 44 at the tip 136 of the distal portion
to form a pivot joint 128. The provision of pivot joint 128 permits
distal end 122 to effectively pivot freely as separator wire
portion 56 is moved between the operational and retracted states.
In addition to reducing stresses and improving the fatigue
characteristics of distal end 122 of separator wire portion 56, the
use of pivot joint 128 helps to increase the volume of the
separated tissue section removed from the patient for the same
distance of travel of tissue separator device 54. This increase in
volume may be appreciated by comparing the embodiments of FIGS. 18
and 19. In the FIG. 19 embodiment, the distal end 122 of separator
wire portion 56 is rigidly or otherwise non-pivotally secured to
distal portion 46 of shaft 44. FIG. 20 illustrates the increased
volume of separated tissue section 80A resulting from the
embodiment of FIG. 18 to the reduced volume, separated tissue
section 80B from the embodiment of FIG. 19. In this example the
volume of separated tissue section 80A has been calculated to be
about 50 percent greater than the volume of separated tissue
section 80B for the same distance of travel of tissue separator
device 54.
[0063] Distal portion 46 of shaft 44 includes guide element 110
which acts as a transition surface 110. Transition surface 110 is a
distally-facing surface extending radially outwardly and
proximally, that is longitudinally away from the tip 136 of distal
portion 46. A series of spaced-apart, first, proximal energizable
tissue separator elements 130 are positioned along transition
surface 110. FIG. 23 is a cross-sectional view taken along line
23-23 of FIG. 18 and illustrates the electrical connection of
elements 130 to metallic tube 132.
[0064] FIGS. 24A-24H illustrate alternative embodiments of first
elements 130. Elements 130A have extended longitudinal lengths, as
compared with the essentially circular elements 130 of FIGS. 18 and
23. It is believed that the extended lengths of element 130A may be
useful for reducing the penetration force needed for placement at
the target site. The FIG. 24A embodiment is the presently preferred
embodiment. Element 130B comprises a circumferentially continuous
or substantially circumferentially continuous element. The
circumferentially extending element 130B may also be useful for
reducing the required penetration force. Elements 130C are similar
to elements 130 but are located at peripheral region 140 of
transition surface 110. Elements 130D and 130E, shown in FIGS. 24D
and 24E, are generally V-shaped and serpentine-shaped variations.
Elements 130F and 130G, shown in FIGS. 24F and 24G, extend along
substantially the entire lengths of distal portion 46 in straight
and spiral configurations, respectively. FIG. 24H illustrates a
further embodiment of elements 130H with elements 130H extending
radially outwardly from distal portion 46; elements 130H may be
retractable and may have shapes other than the pointed, triangular
shape illustrated. While elements 130 are typically formed from
metal wires or similar structure, elements 130 may also be painted,
plated or otherwise deposited on the surface of distal portion 46.
A combination of two or more of the arrangements of element 130 may
be useful in appropriate circumstances. While presently all of
elements 130 are supplied with equal energy levels, different
energy levels may be supplied. Also, the energy levels supplied may
be varied over time or according to the resistance to the passage
of separator wire portion 56 through the tissue. Also, energy to
elements 130 may be turned on as needed at the discretion of the
user.
[0065] Distal portion 46 is hollow and contains an electrically
conductive, metallic tube 132 defining an opening 134 at the tip
136 of distal portion 46. The outer, annular edge of tube 132 acts
as a second, distal energizable tissue separator element 138. Both
first element 130 and second element 138 are selectively coupleable
to one or more appropriate energy sources to aid movement of distal
portion 46 through tissue to the target site.
[0066] FIGS. 25 and 26 illustrate the hook wires 100, which act as
tissue holding elements, extending through openings 142 formed
within distal portion 46 of shaft 44. Hook wires 100 are preferably
sized, positioned and shaped to engage separated tissue section 80
at about its center of mass. While two hook wires 100 are shown in
this embodiment, a greater or lesser number may also be used. Also,
hook wires 100 having different sizes and shapes may be used. Hook
wires 100 may also be located at different axial positions and may
be energizable to aid movement through tissue.
[0067] FIGS. 25, 27 and 27A illustrate the passage of separator
wire portion 56 through proximal and distal channels 146, 148
formed in distal shaft portion 46. Distal portion 46 defines a base
surface 150 extending along the bottoms of channels 146 and 148 and
extending between channels 146 and 148. Separator wire portion 56
lies against base surface 150 when in a retracted state. As shown
best in FIGS. 27 and 27A, the central portion 152 of base surface
150 is convex so that when separator wire portion 56 is in the
retracted state, a central portion of wire portion 56 lies along a
convex line, that is a line that bows slightly outwardly. Therefore
when tissue separator device 54 is moved distally, separator wire
portion 56 is predisposed to move radially outwardly in the desired
manner. The amount of force needed to be applied to device 54 may
also be reduced by the use of convex central portion 152.
[0068] FIG. 28 illustrates a further alternative embodiment to the
embodiment of FIG. 18 comprising three separator wire portions 56,
as opposed to one in FIG. 18, one wire portion 56 being shown in an
operational state and the other two wire portions 56 in retracted
states and adjacent base surfaces 150. This is suggested in FIG.
29B. Another difference from the embodiment of FIG. 18 is that the
function of first, proximal energizable tissue separator elements
130 has been replaced by energizing the three separator wire
portions 56 when the device is directed through tissue to a target
site with wire portions 56 in retracted states. This is suggested
in FIG. 29A. Once at the target site the physician may decide to
move one, two or all three of separator wire portions 56 from the
retracted state to the operational state depending on various
factors, such as the characteristics of the tissue and the number
of pieces tissue section 80 is to be divided into.
[0069] Distal portion 46, in the embodiment of FIGS. 18-29B,
comprises a proximal element 154, a body portion 156 and tip 136,
tip 136 acting as an end cap. FIG. 27 illustrates the
interengagement of elements 154, 156 and 136. Elements 154, 156 and
136 are configured to promote simple assembly. Assembly may take
place by simply stacking each element in order over central tube
132, the parts being held in place distally by the flared end 138
of the tube. Elements 154, 156 and 136 are preferably electrically
non-conductive. Elements 154 and 156 are typically made from the
medical grade ceramic material, such as Al.sub.2O.sub.3 or
zirconia, while tip 136 is typically made from a medical grade
polymer, such as PEEK or polyimide.
[0070] The amount of force required for the passage of a needle, or
other tissue-penetrating element, such as distal portion 46 of
shaft 44, through tissue often changes because the tissue
characteristics often changes between the point of entry and the
target site. If the tissue-penetrating element must pass through a
hard or otherwise difficult-to-penetrate tissue region, the amount
of force needed to penetrate the hard tissue region may be
sufficiently great to, for example, cause the tissue-penetrating
element to buckle. Even if the tissue-penetrating element has
sufficient columnar strength to resist buckling, the amount of
force required may be sufficient to cause the tissue to be deformed
making it difficult to position the tip of the tissue-penetrating
element at the target site. Also, once the tip has passed through
the difficult-to-penetrate tissue region, the amount of force
needed to do so may tend to cause the tip of the tissue-penetrating
element to be inserted much farther than desired causing unintended
tissue trauma and possibly injuring adjacent organs.
[0071] FIG. 30 illustrates, in schematic form, a tissue-penetrating
assembly 160 comprising broadly a tissue-penetrating subassembly
162 coupled to a tissue-energizing circuit 164 and a
force-sensitive switch 166 operably coupled to the
tissue-penetrating subassembly. The subassembly 162 comprises a
handle assembly 168, or other support assembly, including a handle
170, a handle extension 172 extending rigidly from handle 170, and
a needle clamp 172 mounted to handle 170 at a pivot 176.
Subassembly 162 also includes a needle 178, or other
tissue-penetrating device, secured to and extending from needle
clamp 174. Needle 178 includes a needle shaft 180 covered by
electrical installation 182 along most of its length. Electrical
installation 182 helps to concentrate the tissue-penetrating energy
at the tip 184 of needle 178, tip 184 having a tissue-separating
surface 185.
[0072] Force-sensitive switch 166 includes a compression spring 186
captured between needle clamp 174 and handle extension 172.
Assembly 160 also includes an arming switch 188 mounted to handle
170, switch 188 including an arm 190 mounted to handle 170 at a
pivot 192. Switch 188 also includes an arming compression spring
194 captured between arm 190 and handle extension 172. The use of
arming switch 188 helps to enhance the safety of assembly 160 by
helping to prevent the inadvertent connection of needle 178 to RF
generator 200. Circuit 164 includes a pair of leads 196, 198
electrically connected to needle clamp 174, and thus needle tip
184, and to arm 190 through pivots 176, 192, respectively. Circuit
164 also comprises an RF generator 200, from which leads 196, 198
extend, and a return cable 202 coupling generator 200 to a return
pad 204. An electrical conductor 206 is mounted to handle extension
172 and has electrical contact surfaces 208, 210 positioned
opposite the corresponding surfaces of needle shaft 180 and arm
190. An arming button 212 is mounted to arm 190 to permit the user
to arm assembly 116 by pressing on arming button 212 to cause arm
190 to contact surface 210. With the device now armed, needle 178
is directed into tissue, exemplified by three layers of tissue,
including soft tissue layers 214 and 218 and hard or otherwise
difficult-to-penetrate tissue layer 216. Upon encountering hard
tissue layer 216, the force needed to penetrate tissue layer 216 is
sufficient to compress spring 186 and cause needle shaft 180 to
contact electrical contact surface 208 thus completing the circuit
to RF generator 200. At this point RF generator 200 can supply
energy to surface 185 at tip 184 permitting needle 178 to pass
through hard tissue 216 without excessive force. Once tip 184 has
passed through hard tissue layer 216, the force on needle 178
decreases to permit spring 186 to separate needle shaft 180 from
contact surface 208 so to stop supplying RF energy to tissue
separator surface 185.
[0073] Tissue-penetrating assembly 160 can be used to aid the
insertion of a simple needle into tissue. However, the
tissue-penetrating invention also can be incorporated into other
devices including tissue-penetrating elements, such as the
embodiments discussed above including shaft 44 and a target tissue
localization device disclosed in U.S. Pat. No. 6,179,860.
[0074] FIGS. 31-39 illustrate further aspects of the invention in
which tissue separator assembly 10 is combined with an elongated
coupler 220 and a tissue localization assembly 222 to arrive at a
tissue localizing and separating assembly 224. Tissue localization
assembly 222 may be of the type disclosed in U.S. Pat. No.
6,179,860. Assembly 222 is shown deployed within a patient 226 with
localization device to 112 in a radially expanded, deployed
condition. Assembly 222 includes a sheath 228 (see FIG. 32) within
which a pull wire 230 is slidably housed. The relative axial
movement of sheath 228 and pull wire 230 causes localization device
112 to radially expand and radially contract. The proximal end 232
of pull wire 230 is a recurved end 232 (see FIGS. 32, 34) for
engagement by coupler 220 as discussed below.
[0075] Coupler 220 is a flexible wire having a coupler loop 234 at
its distal end and an enlarged proximal end 236. Coupler 220 passes
through shaft 44 (see FIGS. 2, 32) of catheter assembly 12. Coupler
loop 234 is used to join coupler 220 to the recurved end 232 of
pull wire 230; this is shown in FIGS. 31-34. After being so joined,
tissue separator assembly 10 is moved distally along coupler 220,
while the user grasps end 236 to maintain tension on the tissue
localization assembly 220, causing the joined ends 232, 234 to pass
into shaft 44 thus docking tissue localization assembly 222 to
tissue separator assembly 10. Continued distal movement of assembly
10 causes catheter assembly 12 to enter patient 226 and pass along
the tissue track created by tissue localization assembly 222 until
tip 136 of distal portion 46 of shaft 44 is properly positioned
relative to localization device 112. Proper positioning is visually
indicated to the user by a length of tube 233, typically colored
red and affixed to coupler 220, becoming exposed after exiting the
proximal end opening 235 of handle 14 as shown in FIGS. 35A-35C.
When properly positioned, see FIG. 35C, a locking spring clip 237,
located on handle 14 adjacent to proximal end opening 235, springs
back from its biased position of FIG. 35B to its unbiased position
of FIGS. 35A and 35C to prevent tube 237 from inadvertently
reentering handle 14. When so positioned, tissue localization
assembly 222 becomes at least temporarily locked or fixed to tissue
separator assembly 10 to prevent the inadvertent relative axial
movement between localization device 112 and assembly 10. Of course
other locking mechanisms, such as a spring finger carried by
assembly 220 and engageable with handle 14, can also be used to
lock assemblies 10, 222 to one another.
[0076] FIG. 36 is an enlarged view of the distal portion of
assembly 224 of FIG. 35 after separator wire portion 56 has been
radially expanded and rotated, to create a separated tissue section
80, and after hook wire 100 has been deployed to engage the
separated tissue section 80. It has been found to be desirable to
leave a space, indicated generally as distance 238, between
localization device 112 and separated tissue section 80. FIG. 37
illustrates the assembly of FIG. 36 after introducer sheath 42 has
been moved proximally a short distance to expose outer end 106 of
tubular braided element 104. FIG. 38 is a somewhat generalized
illustration of the movement of tubular braided element 104 in a
distal direction within patient 226 with the tubular braided
element initially generally following the outline of separated
tissue section 80 and outer end 106 generally axially aligned with
localization device 112. It should be noted that the movement of
outer end 106 of tubular braided element 104 will generally
following the path indicated until it reaches position 240.
Following position 240, the path outer end 106 takes will largely
depend on the physical characteristics of the tissue through which
is passing. However, the path illustrated is typical. Separated
tissue section 80 is then removed from patient 226 by
simultaneously pulling the entire assembly shown in FIG. 38,
including separated tissue section 80 captured by tubular braided
element 104 and localization device 112, secured by coupler 220,
back along the tissue track. During this movement tubular braided
element 104 has a tendency to elongate axially to a reduced
diameter, more cylindrical form thus reducing potential tissue
trauma along the tissue track and through the access opening at the
beginning of the tissue track.
[0077] FIG. 39 illustrates the assembly of FIG. 38 after having
been removed from patient 226 with outer end 106 of tubular braided
element 104 returned to its relaxed state and tissue specimen 80
retained by tubular braided element 104 and localization device
112. As suggested in FIG. 39, tubular braided element 104, when in
a relaxed state, has a generally trumpet shape with outer end 106
flaring outwardly. It has been found that this trumpet shape helps
to guide tubular braided element 104 around separated tissue
section 80, especially during its initial movement from introducer
sheath 42.
[0078] FIGS. 40-45 illustrate a preferred method of making tubular
braided element 104. Tubular braided element 104 is sized according
to the size of the tissue specimen being removed so that the number
of elements, sizes and other specifications discussed below may be
varied according to a particular circumstance. FIG. 40 illustrates
the shape of a length of tubular braided material 244 after it has
been stretched over a cylindrical mandrel (not shown) having an
enlarged (20.5 mm diameter by 50 mm long) central portion in this
embodiment. Material 244, prior to being stretched over the
mandrel, is supplied in a continuous length and cut to size for the
mandrel and a starting diameter of {fraction (5/16)}" or .about.8
mm. Material 244 is made of monofilament polyester fibers having a
diameter of 0.10 inch (0.25 mm) The braid consists of 56
monofilaments and is made on 56 carrier braider. The braid, when
formed in continuous lengths, maintains an approximate {fraction
(5/16)}" (8 mm) internal diameter. The braid angle is held fixed
during the braiding operation, and was chosen for this application
because a small shortening in axial length results in a rapid
change in diameter. The enlarged central portion of the mandrel
corresponds to the shape of tubular braided material 244, that is
it is cylindrical with generally hemispherical ends. FIG. 41
illustrates the structure of FIG. 40 after one end of the mandrel
and tubular braided material 244 has been dipped into a silicone
compound. The dipped structure is then cured, typically in an oven,
to create a silicone film or web 246 covering one end of tubular
braided material 244. After curing, the dipped, cured structure 248
is removed from the mandrel by being pulled over the mandrel from
left to right in FIG. 41. FIG. 42 illustrates the open mesh end 250
of the dipped, cured structure 248 being pulled back into the
dipped end to create the dual-wall tubular braided element 104
shown in FIG. 43. FIG. 43 illustrates tubular braided element 104
being mounted to the distal end of actuator tube 43. FIGS. 44 and
45 show the proximal end of tubular braided element 104 being
secured to the distal end of actuator tube 43 by a length of heat
shrink tubing 252 and an adhesive to create a tissue-surrounding
assembly 254. Dual-wall tubular braided element 104 has an outer
wall 256 substantially completely covered with silicone web 246,
and inner wall 258 at least substantially free of the silicone web
material, an an open outer end 106 covered with silicone web
246.
[0079] Silicone web 246 serves at least two functions. It helps
maintain the trumpet shape of tubular braided element 104 in its
relaxed state while permitting the tubular braided element to
radially expand and radially contract from the trumpet shape. It
also helps to prevent passage of tissue through tubular braided
element 104 during removal of separated tissue section 80. This
helps to prevent contamination along the tissue track during tissue
removal procedures. While tubular braided element 104 could be made
as a single layer, that is without open mesh end 250 being pulled
back into the structure, it has been found that doing so helps to
maintain a softer leading edge at outer end 106 of tubular braided
element 104. The general trumpet shape shown in FIGS. 43-45 occurs
as a natural result of the forming process illustrated and
described.
[0080] The following discussion of the development of the current
embodiment of braided element 104 may be useful in appreciating its
various features and advantages. The presently preferred embodiment
of braided element 104 comprises a tubular sleeve of braided
polyester (PET--polyethylene terephthalate) monofilament folded
over itself to form a smooth end. The open weave construction
allows it to enlarge to several times its original diameter. The
outer braided layer is coated with silicone.
[0081] Early braided element prototypes consisted of Nitinol
braided tubing. The wire diameter, braid angle and number of wires
that comprise the braid were explored. These properties affect the
strength of the braided element. The braided element must have
enough stiffness and columnar strength to overcome the forces
acting against it as it is deployed in the tissue. However, if it
is too rigid, it may push the separated tissue section further into
the cut cavity. Non-braided forms were also considered, such as
Nitinol wire placed axially along the lengths of the axis,
supported by coating or other rigid members. The combination of
wire diameter, braid angle, and number of wires also affects the
retracted properties of the braided element. In its undeployed
state, the braided element was designed to fit inside a 6 mm
sheath. Some of the Nitinol prototypes that were fabricated seemed
to have adequate strength and stiffness, and fit within a 6 mm
sheath. However, because of other factors discussed below, a PET
braid presently preferred over a Nitinol braid.
[0082] There are several factors that interact to effect columnar
strength. Braid angle, number of filaments, and filament material
stiffness and diameter are the main determinants. Axial
orientation, greater number and stiffer filaments all combine for
greater columnar strength. The presently preferred material for
braided element 104 is 0.010" (0.25 mm) diameter monofilament. The
number of monofilaments in the braid was chosen to optimize the
mechanical properties of braided element 104. Increasing the number
of filaments will create the opposite effect--the columnar strength
will be reduced thus increasing the chance of buckling. Fewer
filaments creates an increase in spacing between the filaments as
the braided element expands from retracted to deployed. If the
spacing becomes too large, the coating may tear. Also, a braided
element constructed with a more axially oriented braid angle will
take up much more length in the retracted state and therefore
require a greater amount of travel to deploy. The number of
filaments was chosen to optimize braided element strength, spacing
between filaments, and amount of deployment travel.
[0083] It is presently preferred that the distal end of the braided
element, that is the end that first comes into contact with the
tissue, be smooth. It was discovered at a braided element with
jagged or sharp edge may get caught in the tissue and fail to slide
into the cut tissue interface around the separated tissue section.
For the Nitinol braid, various methods of terminating the lose
wires were explored, such as soldering, brazing, or bonding balls
at the wire ends, or folding each single wire over. These methods
were not very successful. For the balls to be atraumatic, they need
to be of considerable size. The balls or folded-over ends increase
the diameter of the retracted braided element, making it difficult
to fit inside a sheath. This led to concepts of `roll-over` and
`double layer` braided elements. For both concepts, the tubular
braid is folded over itself to form a two-layered braided element
with folded-over, smooth ends. For a `double layer` braided
element, the two layers are bonded together at the proximal end.
The two-layered Nitinol braided elements that were prototyped
showed promising characteristics. However the folded-over ends
provided too much bulge and made it difficult or impossible to
retract into a 6 mm diameter sheath. The PET braid, on the other
hand, forms a nice crease when the braid is folded over, and is
easily retracted into the sheath. For deployment, the outer layer
is pushed forward and allowed to slide over the inner layer. This
embodiment has potential but is not the presently preferred
embodiment.
[0084] The shape of the braided element also affects its
functionality. Braided element prototypes of many different shapes
were tested, such as "bullet", "cone", and "bell" or "trumpet"
profiles of varying diameters. A desirable characteristic of
braided element 104 is that the braided element flares open as it
is initially deployed, so that it is predisposed to expand around
the biopsy sample rather than push the sample further into the
cavity. The shape of braided element 104 has been optimized to
maximize the amount that it flares open during deployment.
[0085] The braided element is currently coated with a two-component
silicone elastomer. Some polyurethane coatings were investigated
also, but did not perform as well as silicone coatings during
preliminary testing. The silicone coating was chosen because of its
high tear strength and elasticity. From the retracted state to the
fully deployed state, the diameter of braided element 104 may
expand as much as 300%. The braided element may have a snare at the
distal end to aid in capturing the sample.
[0086] Modification and variation can be made to the disclosed
embodiments without departing from the subject of the invention as
defined in the following claims. For example, lead screw 52 could
be hollow to permit actuator shaft 114, or other medical devices,
to pass therethrough and into a lumen within shaft 44. While base
surface 150 is shown to have a smoothly curving shape, surface 150
may have other shapes, such as a discontinuous surface shape, a
flat surface shape with one or more projections providing the
desired bow in the separator wire portion 56, or a combination
thereof. Braided element 104 may be made of other materials and by
other processes than those disclosed.
[0087] Any and all patents, patent applications and printed
publications referred to above are hereby incorporated by
reference.
* * * * *