U.S. patent application number 09/850021 was filed with the patent office on 2001-08-23 for vessel cutting devices.
This patent application is currently assigned to St. Jude Medical Cardiovascular Group, Inc.. Invention is credited to Berg, Todd A., Prigge, Christopher M..
Application Number | 20010016752 09/850021 |
Document ID | / |
Family ID | 21767554 |
Filed Date | 2001-08-23 |
United States Patent
Application |
20010016752 |
Kind Code |
A1 |
Berg, Todd A. ; et
al. |
August 23, 2001 |
Vessel cutting devices
Abstract
A catheter-based system for accessing specific body cavities
percutaneously and minimizing patient trauma is provided. In the
preferred embodiment, in order to create an aperture at an access
site in a patient's existing tubular body organ structure, a
delivery sheath is passed axially along the interior of a portion
of the existing tubular body organ structure to place a distal end
of the delivery sheath near the access site. A centering wire is
passed axially along the interior of the delivery sheath, piercing
through from inside to outside of the patient's existing tubular
body organ structure at the access site by causing an end portion
of the centering wire to emerge from the distal end of the delivery
sheath. A cutting catheter is passed substantially coaxially over
the centering wire and axially along the interior of the delivery
sheath. The aperture is formed by advancing a distal end of the
cutting catheter through from inside to outside of the patient's
existing tubular body organ structure at the access site and
advancing the distal end of the delivery sheath through from inside
to outside of the patient's existing tubular body organ structure
at the access site.
Inventors: |
Berg, Todd A.; (Plymouth,
MN) ; Prigge, Christopher M.; (New Hope, MN) |
Correspondence
Address: |
FISH & NEAVE
1251 AVENUE OF THE AMERICAS
50TH FLOOR
NEW YORK
NY
10020-1105
US
|
Assignee: |
St. Jude Medical Cardiovascular
Group, Inc.
|
Family ID: |
21767554 |
Appl. No.: |
09/850021 |
Filed: |
May 7, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
09850021 |
May 7, 2001 |
|
|
|
09014759 |
Jan 28, 1998 |
|
|
|
Current U.S.
Class: |
606/180 |
Current CPC
Class: |
A61B 17/32053 20130101;
A61B 2017/1107 20130101; A61B 2017/00252 20130101; A61B 17/32002
20130101; A61B 17/11 20130101; A61B 2017/00557 20130101; A61B
2017/00243 20130101 |
Class at
Publication: |
606/180 |
International
Class: |
A61B 017/32 |
Claims
What is claimed is:
1. Apparatus for cutting an aperture in a side wall of a patient's
blood vessel comprising: a tissue-piercing structure having a
longitudinal axis and being configured to pierce the side wall by
passing through the side wall substantially parallel to the
longitudinal axis; a plurality of resilient structures mounted on
the tissue-piercing structure so that they do not substantially
increase dimensions of the tissue-piercing structure transverse to
the longitudinal axis as the tissue-piercing structure and the
resilient structures pass through the side wall, the resilient
structures being resiliently biased to spring radially outwardly
from the tissue-piercing structure after the tissue-piercing
structure and the resilient structures have passed through the side
wall; and a hollow annular tissue-cutter structure disposed
annularly around the tissue-piercing structure and configured for
movement substantially parallel to the longitudinal axis to produce
an annular cut through the side wall and to thereby sever from the
side wall a disc of tissue that was previously pierced by and that
remains impaled on the tissue-piercing structure, the outwardly
sprung resilient structures serving to at least help hold the disc
on the tissue-piercing structure.
2. The apparatus defined in claim 1 wherein the resilient
structures are mounted on the tissue-piercing structure in an array
which is annular about the longitudinal axis.
3. The apparatus defined in claim 1 wherein each resilient
structure is mounted on the tissue-piercing structure so that the
resilient structure is resiliently deflectable substantially
parallel to the longitudinal axis.
4. The apparatus defined in claim 1 wherein each resilient
structure has a distal portion and a proximal portion, the distal
portion being closer to an end of the tissue-piercing structure
that is first to pass through the side wall, the resilient
structure being secured to the tissue-piercing structure adjacent
the distal portion, and the proximal portion being resiliently
biased to spring radially outwardly from the tissue-piercing
structure.
5. The apparatus defined in claim 1 wherein the tissue-cutter
structure is mounted for movement relative to the tissue-piercing
structure substantially parallel to the longitudinal axis.
6. The apparatus defined in claim 1 wherein the tissue-cutter
structure is rotatable about the longitudinal axis.
7. The apparatus defined in claim 1 wherein the tissue-cutter
structure is rotatable relative to the tissue-piercing structure
about the longitudinal axis.
8. The apparatus defined in claim 1 wherein the tissue-cutter
structure has a serrated tissue cutting edge.
9. The apparatus defined in claim 1 wherein a distal portion of the
tissue-piercing structure is configured to deflect transversely to
the longitudinal axis after passing through the side wall.
10. The apparatus defined in claim 1 wherein the tissue-cutter
structure is configured to cut through the side wall in the same
direction that the tissue-piercing structure is configured to
pierce through the side wall.
11. The apparatus defined in claim 1 wherein the tissue-cutter
structure is configured to receive the disc in its hollow.
12. The apparatus defined in claim 1 wherein the tissue-cutter
structure has a substantially circular tissue cutting edge.
Description
[0001] This is a continuation of application Ser. No. 09/014,759,
filed Jan. 28, 1998, which is hereby incorporated by reference
herein in its entirety.
BACKGROUND OF THE INVENTION
[0002] This invention relates to vessel cutting devices for use in
the repair, replacement or supplement of a medical patient's
natural body organ structures or tissues. More particularly, this
invention relates to vessel cutting devices for use in vascular
anastomosis (the surgical connection of vessels).
[0003] An example of the possible uses of the invention is a
minimally invasive cardiac bypass procedure. This and other
examples are considered in detail in Goldsteen et al. U.S. Pat. No.
5,976,178, which is hereby incorporated by reference herein in its
entirety.
[0004] Vascular anastomosis is a delicate and time-consuming
procedure in which fast and accurate vessel cutting plays a
particularly important role.
[0005] In view of the foregoing, it would be desirable to provide a
catheter-based system for accessing specific body cavities
percutaneously, thereby minimizing patient trauma.
[0006] It would also be desirable to provide fast and accurate
vessel cutting devices.
SUMMARY OF THE INVENTION
[0007] It is an object of the present invention to provide a
catheter-based system for accessing specific body cavities
percutaneously, thereby minimizing patient trauma. It is also an
object to provide fast and accurate vessel cutting devices.
[0008] These and other objects are accomplished by providing a
method and apparatus for creating an aperture at an access site in
a patient's existing tubular body organ structure by passing a
delivery sheath axially along the interior of a portion of the
existing tubular body organ structure to place a distal end of the
delivery sheath near the access site, passing a centering wire
axially along the interior of the delivery sheath, piercing through
from inside to outside of the patient's existing tubular body organ
structure at the access site by causing an end portion of the
centering wire to emerge from the distal end of the delivery
sheath, passing a cutting catheter substantially coaxially over the
centering wire and axially along the interior of the delivery
sheath, forming the aperture by advancing a distal end of the
cutting catheter through from inside to outside of the patient's
existing tubular body organ structure at the access site and
advancing the distal end of the delivery sheath through from inside
to outside of the patient's existing tubular body organ structure
at the access site.
[0009] In one embodiment, the distal end of the cutting catheter is
rotated to cut through the patient's existing tubular body organ
structure at the access site. In another embodiment, a cutting
catheter with a conical (preferably star-shaped) cutting edge is
pushed through the patient's existing tubular body organ structure
at the access site.
[0010] The present invention can also be used to create an aperture
in the patient's existing tubular body organ structure by advancing
a distal end of the cutting catheter through from outside to inside
of the patient's existing tubular body organ structure at the
access site.
[0011] In the most preferred embodiment, all or substantially all
necessary apparatus is inserted into the patient via the patient's
existing body organ vessel. In addition, all or substantially all
apparatus functions are controlled by the physician (a term used
herein to also include supporting technicians) from outside the
patient's body.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] The above and other objects and advantages of the invention
will be apparent upon consideration of the following detailed
description, taken in conjunction with the accompanying drawings,
in which like reference characters refer to like parts throughout,
and in which:
[0013] FIG. 1a is a simplified sectional view showing the distal
end of a delivery sheath in the interior of a portion of the
existing tubular body organ structure with a centering wire
piercing through from inside to outside of the patient's existing
tubular body organ structure at the access site;
[0014] FIG. 1b is a view similar to portions of FIG. 1a showing a
centering wire piercing through from inside to outside of the
patient's existing tubular body organ structure at the access site,
wherein the end portion of the centering wire includes a
selectively enlargeable structure;
[0015] FIG. 1c is another view similar to portions of FIG. 1a
showing a centering wire piercing through from inside to outside of
the patient's existing tubular body organ structure at the access
site, wherein the end portion of the centering wire includes
fasteners;
[0016] FIG. 2 is yet another view similar to FIG. 1a showing a
cutting catheter positioned for cutting at the distal end of a
delivery sheath at the access site;
[0017] FIG. 3 is still another view similar to FIG. 1a showing
forming the aperture by advancing a distal end of the cutting
catheter through from inside to outside of the patient's existing
tubular body organ structure at the access site;
[0018] FIG. 4 is yet another view similar to FIG. 1a showing
advancing the distal end of the delivery sheath through from inside
to outside of the patient's existing tubular body organ structure
at the access site;
[0019] FIG. 5 is a simplified elevational view, partly in section,
showing the distal end of the cutting catheter advancing through
from outside to inside to create an aperture in the patient's
existing tubular body organ structure;
[0020] FIG. 6 is a side view of the patient's existing tubular body
organ structure of FIG. 5, showing the aperture created;
[0021] FIG. 7a is still another view similar to FIG. 1a showing the
distal end of a delivery sheath in the interior of a portion of the
existing tubular body organ structure with a centering wire
piercing through from inside to outside of the patient's existing
tubular body organ structure at the access site, wherein the
cutting catheter includes a dilator;
[0022] FIG. 7b is yet another view similar to FIG. 1a forming the
aperture by advancing a distal end of the cutting catheter through
from inside to outside of the patient's existing tubular body organ
structure at the access site, wherein the cutting catheter includes
a dilator;
[0023] FIG. 7c is still another view similar to FIG. 1a showing
advancing the delivery sheath through the aperture at the access
site; and
[0024] FIG. 8 is yet another view similar to FIG. 1a showing a
delivery sheath which includes distal and proximal selectively
enlargeable structures.
DETAILED DESCRIPTION OF THE INVENTION
[0025] As a preliminary step in creating an aperture at an access
site 10 in a patient's existing tubular body organ structure 1, a
delivery sheath 20 is passed axially along the interior of a
portion of tubular body organ structure 1 to place a distal end of
delivery sheath 20 near access site 10. When the distal end of
delivery sheath 20 is adjacent to access site 10, a centering wire
30 is passed axially along the interior of the sheath until the end
portion of centering wire 30 emerges from the distal end of the
sheath and pokes through from inside to outside of tubular body
organ structure 1. Centering wire 30 provides a pilot track for
cutting catheter 40 to follow. FIG. 1a shows the distal end of
delivery sheath 20 in the interior of a portion of tubular body
organ structure 1 with a centering wire 30 piercing through from
inside to outside of the organ structure at access site 10.
[0026] The distal end of centering wire 30 is preferably deformable
to facilitate deployment and removal, but resumes its operational
(preferably hooked) shape once deployed. Centering wire 30 is kept
relatively straight when it is inside sheath 20. But, when
centering wire 30 is pushed axially out the distal end of sheath
20, it curves to one side, as shown in FIGS. 1a, 1b and 1c. FIGS.
1b and 1c show alternative structures for centering wire 30. In
FIG. 1b, the end portion of centering wire 30 includes a
selectively enlargeable structure (such as a balloon 50 which
extends annularly around the exterior of the centering wire and
projects radially outwardly from the centering wire in all radially
outward directions when inflated). In FIG. 1c, the end portion of
centering wire 30 includes struts 55 spaced circumferentially
around centering wire 30 and which are resiliently biased to
project from the centering wire after the end portion of the
centering wire pierces through body organ structure 1 at access
site 10. By providing a selectively enlargeable structure disposed
on the exterior of the centering wire at a predetermined distance
proximally from the distal end of the centering wire and enlarging
that structure after the centering wire has pierced organ structure
1, it is possible to prevent the portion of centering wire 30 which
is distal of the enlargeable structure from passing back into the
organ structure. In addition to the retaining function, the
enlargeable structure serves to seal the aperture and displace
tissue from around the outside of organ structure 1 near access
site 10, thereby creating a space. Such a space helps to prevent
cutting head 45 from cutting other tissues after exiting organ
structure 1 at access site 10.
[0027] After piercing through organ structure 1 at access site 10
with centering wire 30, cutting catheter 40 is passed substantially
coaxially over the centering wire and axially along the interior of
sheath 20. FIG. 2 shows cutting head 45 of cutting catheter 40
positioned for cutting at the distal end of delivery sheath 20 at
access site 10.
[0028] Centering wire 30 holds cutting catheter 40 and delivery
sheath 20 against organ structure 1 at access site 10, thereby
preventing undue bleeding during and after the creation of the
aperture that could occur if the cutting catheter and the delivery
sheath were to move away from the access site. FIG. 3 shows how the
aperture is formed by advancing the distal end of cutting catheter
40 (i.e., cutting head 45) through from inside to outside of organ
structure 1 at access site 10 by rotating and/or pushing the distal
end of the cutting catheter.
[0029] As shown in FIGS. 2, 3, and 4, the distal end of cutting
catheter 40 has a circular cutting edge. Cutting catheter 40, which
when advanced by rotation, cuts through tissue and removes tissue
plug 60. The preferred embodiment of cutting head 45 also includes
a serrated cutting edge and an axially aligned recess for accepting
tissue plug 60. By removing plug 60 of tissue (rather than merely
displacing tissue, as in FIGS. 5 and 6), the elastic recoil of
organ structure 1 at access site 10 is reduced, which may be a
desirable condition for optimal graft attachment.
[0030] FIG. 4 shows advancing the distal end of delivery sheath 20
through from inside to outside of organ structure 1 at access site
10 and removing centering wire 30 and cutting catheter 40 along
with tissue plug 60 contained within cutting head 45.
[0031] As shown in FIG. 5, non-rotating cutting catheter 40 can be
used to create specific geometric aperture shapes (e.g., oblong
aperture 70 for coronary anastomosis). FIG. 5 also shows the use of
the present invention in creating an aperture in organ structure 1
by advancing a distal end of cutting catheter 40 through from
outside to inside of the organ structure at access site 10.
Centering wire 30 is tracked through cutting catheter 40 and is
shown piercing organ structure 1 at access site 10. Following such
an outside-to-inside aperture, delivery sheath 20 can be passed
axially along the interior of a portion of organ structure 1 to
place a distal end of delivery sheath 20 near second access site 10
where an inside-to-outside aperture can be created. (Note that
organ structure 1 is shown smaller in scale relative to sheath 20
and cutting catheter 40.) FIG. 6 is a side view of organ structure
1, showing aperture 70 created using non-rotating cutting catheter
40 of FIG. 5.
[0032] Cutting catheter 40 shown in FIG. 7a is a rotating catheter.
Cutting head 45 could be a saw-tooth or a razor-edge type, for
example. The distal end of delivery sheath 20 is shown in the
interior of a portion of organ structure 1 with centering wire 30
piercing through from inside to outside of the organ structure at
access site 10, wherein cutting catheter 40 includes dilator 80.
Dilator 80 facilitates advancing sheath 20 through the aperture (as
is shown by the succession of steps illustrated by FIGS. 7b and
7c).
[0033] The outer diameter of dilator 80 is close to the inner
diameter of sheath 20 and is typically larger than the diameter of
cutting head 45. As shown in FIG. 7b, as dilator 80 advances
through the aperture at access site 10, the aperture is
simultaneously sealed against bleeding.
[0034] FIG. 8 shows delivery sheath 20 which includes proximal and
distal selectively enlargeable structures 90, 100. Preferably, both
selectively enlargeable structures 90, 100 are balloons which
extend annularly around the exterior of delivery sheath 20 and
project radially outward when inflated. Although the embodiment
shown in FIG. 8 includes both proximal and distal selectively
enlargeable structures, either one or both may be included. When
enlarged, proximal selectively enlargeable structure 90 prevents
more than the portion of delivery sheath 20 which is distal of the
enlargeable structure from passing out of the tubular structure via
the aperture. Similarly, when enlarged, distal selectively
enlargeable structure 100 prevents the portion of delivery sheath
20 which is distal of the enlargeable structure from passing back
in to the tubular structure via the aperture.
[0035] As an illustrative example of the application of the present
invention, consider the following. Delivery sheath 20 (preferably
about 4.0 mm in diameter) including cutting catheter 40 is
introduced into organ structure 1 percutaneously through the
femoral artery near the thigh. Cutting catheter 40 includes cutting
head 45 (preferably about 3.5 mm in diameter). Delivery sheath 20
is positioned at access site 10, here the ascending aorta.
Centering wire 30 is tracked through cutting catheter 40 and is
caused to pierce the aortic artery at access site 10. Cutting
catheter 40 is then tracked over centering wire 30 by either
pushing or rotating (or a combination of both pushing and rotating)
and caused to advance through the aortic wall. An approximately 3.5
mm aperture is created with tissue plug 60 retained in cutting head
45 and removed along with the cutting catheter 40. Delivery sheath
20 can now be advanced through the approximately 3.5 mm aperture
created by the cutting catheter 40, causing organ structure 1 to
stretch slightly (i.e., about 0.5 mm). This stretching is desirable
because it provides a blood seal around delivery sheath 20 to
prevent bleeding into the chest cavity. Delivery sheath 20 can now
be used to introduce other catheters (including cameras, for
example) from the femoral artery into the chest cavity for the
purpose of diagnosis or intervention (e.g., grafts or TMR laser
surgery).
[0036] To minimize patient trauma, delivery sheath 20, cutting
catheter 40 and centering wire 30 are all preferably coupled to and
controlled by a controller located on the outside of the
patient.
[0037] Various methods and apparatus for delivering and installing
plugs in walls of organ structures, as well as methods and
apparatus for promoting the closing and healing of apertures in
walls of organ structures, are available (e.g., of the type shown
in Goldsteen et al. U.S. Pat. No. 5,976,178; Goldsteen et al.
published PCT patent application WO 98/47430; and Sullivan et al.
published PCT patent application WO 98/55027, all of which are
hereby incorporated by reference herein).
[0038] Thus, it is seen that a method and apparatus for creating an
aperture at an access site in a patient's existing tubular body
organ structure and making it possible to access specific body
cavities percutaneously, thereby minimizing patient trauma, is
provided. One skilled in the art will appreciate that the present
invention can be practiced by other than the described embodiments,
which are presented for purposes of illustration and not of
limitation, and the present invention is limited only by the claims
which follow.
* * * * *