U.S. patent application number 13/038676 was filed with the patent office on 2011-09-01 for minimally invasive valve repair procedure and apparatus.
This patent application is currently assigned to Medtronic, Inc.. Invention is credited to Art Hill, John D. Nguyen, Laurent Schaller.
Application Number | 20110213387 13/038676 |
Document ID | / |
Family ID | 24754517 |
Filed Date | 2011-09-01 |
United States Patent
Application |
20110213387 |
Kind Code |
A1 |
Nguyen; John D. ; et
al. |
September 1, 2011 |
Minimally Invasive Valve Repair Procedure and Apparatus
Abstract
An apparatus for minimally invasive valve repair includes first
and second needles, first and second flexible members, a clip, and
first and second release mechanisms. The needles are each
releasably connected to one of the opposing end points of the clip
through a corresponding one of the flexible members via a
corresponding one of the release mechanisms.
Inventors: |
Nguyen; John D.; (San Jose,
CA) ; Schaller; Laurent; (Los Altos, CA) ;
Hill; Art; (San Francisco, CA) |
Assignee: |
Medtronic, Inc.
Minneapolis
MN
|
Family ID: |
24754517 |
Appl. No.: |
13/038676 |
Filed: |
March 2, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11007825 |
Dec 7, 2004 |
7914544 |
|
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13038676 |
|
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|
|
09686004 |
Oct 10, 2000 |
6926730 |
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11007825 |
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Current U.S.
Class: |
606/151 |
Current CPC
Class: |
A61B 2017/0472 20130101;
A61B 2017/06057 20130101; A61B 17/0469 20130101; A61B 17/064
20130101; A61B 2017/06009 20130101; A61F 2/2442 20130101; A61B
17/06 20130101; A61B 2017/081 20130101 |
Class at
Publication: |
606/151 |
International
Class: |
A61B 17/00 20060101
A61B017/00 |
Claims
1-23. (canceled)
24. Apparatus for minimally invasive valve repair, the apparatus
comprising: a first and second needle; a first and second flexible
member; a clip having an open configuration and a closed
configuration, the clip having a first and second end point, the
first needle being connected through the first flexible member to
the first end point and the second needle being connected through
the second flexible member to the second end point; and a first and
second release mechanism, wherein the first release mechanism
releasably connects the first flexible member to the first end
point and the second release mechanism releasably connects the
second flexible member to the second end point.
25. The apparatus of claim 24 wherein the clip is generally
U-shaped when in the open configuration.
26. The apparatus of claim 24 wherein the clip comprises a wire
made of shape memory material.
27. The apparatus of claim 24 wherein the clip in the closed
configuration is looped by more than 360 degrees.
28-42. (canceled)
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of co-pending U.S. patent
application Ser. No. 11/007,825, filed Dec. 7, 2004, now U.S. Pat.
No. 7,914,544, issued Mar. 29, 2011, which is a continuation of
U.S. patent application Ser. No. 09/686,004, filed Oct. 10, 2000,
now U.S. Pat. No. 6,926,730, issued Aug. 9, 2005, the entire
contents of which are incorporated by reference herein.
BACKGROUND OF THE INVENTION
[0002] This invention relates to methods and apparatus for
minimally invasive valve repair and more particularly to minimally
invasive methods and apparatus for reducing the valve orifice.
[0003] Valve repair is currently done in open surgical procedures
as described, for example, by F. Maisano, et al. in their article
entitled "The double-orifice technique as a standardized approach
to treat mitral regurgitation due to severe myxomatous disease"
which appeared in European Journal of Cardio-thoracic Surgery, Vol.
17 (2000) 201-205. Cumbersome suture management, knot tying, pain
and long recovery time are inherent to such open surgical
procedures. It now goes without saying that minimally invasive
surgery is the preferred procedure, having allowed surgeons to
perform procedures with less pain and disability than open surgical
procedures. Tissue-connector apparatus and methods usable in such
minimally invasive surgery procedures have recently been disclosed
in U.S. patent applications Ser. Nos. 09/089,884 and 09/090,305
both filed Jun. 3, 1998 and Ser. Nos. 09/259,705 and 09/260,623
both filed Mar. 1, 2000.
[0004] It is therefore a general object of this invention to
provide improved minimally invasive methods and apparatus for
coaptation of leaflets in the case of regurgitation to reduce the
annular orifice.
[0005] It is a more specific object of this invention to provide
such improved minimally invasive methods and apparatus using a
tissue-connector apparatus disclosed in aforementioned U.S. patent
applications.
SUMMARY OF THE INVENTION
[0006] Methods and apparatus embodying this invention with which
the above and other objects can be accomplished are characterized
as using a clip of a self-closing type as a tissue connector to
capture leaflets and secure them together. Such a clip is typically
U-shaped, having two end points, when it is constrained to be in an
open configuration but is made of a wire of a shape memory material
such that it tends to coil up to assume its natural closed
configuration. Thus, if such a clip is placed between a pair of
valve leaflets to be repaired, having each of its end points
penetrating and completely passing through a different one of the
leaflets while being constrained to be in its open configuration,
and if the constraint which has been keeping the clip in its open
configuration is then removed, it naturally tends to coil up,
although it will not come to assume its natural closed
configuration because it is hooked to the leaflets, tending
nevertheless to reduce the distance of separation between its two
end points. This has the effect of holding the leaflets
together.
[0007] Such a clip may be deployed in the form of a clip assembly,
having at least one of the end points of the clip connected to a
tissue-piecing needle through a flexible member such as a suture
and a release mechanism by which the clip can be easily released.
The needle is attached to the front end of a needle-holder and
passed through a cannula inserted through an incision towards the
valve leaflets to be repaired. The needle-holder, according to a
preferred embodiment of the invention, is formed with an outer tube
and an inner member which is slidable inside the outer tube and is
designed such that as the inner member is pushed forward against
the biasing force of a spring contained in the outer tube, a slit
which is provided at the front end becomes wider for accepting the
needle therein but as the inner member is allowed to move to a
backward position, the slit becomes narrower and grips the needle
tightly.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The accompanying drawings, which are incorporated in and
form a part of this specification, illustrate embodiments of the
invention and, together with the description, serve to explain the
principles of the invention. In the drawings:
[0009] FIG. 1 is a schematic view of a tissue-connector apparatus
embodying this invention when it is about to be used, its
double-arm clip assembly being shown as a diagonal view and its
needle holder being shown as a sectional side view;
[0010] FIG. 2 is an enlarged external view of the double-arm clip
assembly of FIG. 1;
[0011] FIG. 3 is an enlarged sectional view of a portion of the
needle holder near its front end;
[0012] FIG. 4A is a schematic diagonal view of the clip assembly of
FIGS. 1 and 2 being used in a valve repair procedure embodying this
invention, and FIG. 4B is another schematic diagonal view of the
clip of FIG. 4A after it has been released;
[0013] FIG. 5 is an external view of a single-arm clip assembly
which may be used in a method of minimally invasive valve repair
embodying this invention;
[0014] FIG. 6 is a schematic sectional view for showing a method of
valve repair embodying this invention by using the single-arm clip
assembly of FIG. 5;
[0015] FIG. 7 is another clip assembly embodying this invention;
and
[0016] FIG. 8A is a schematic sectional view of leaflets repaired
by a clip assembly of FIG. 7, FIG. 8B is a top view of the leaflets
of FIG. 8A, and FIG. 8C is a top view of leaflets repaired in an
alternative manner.
[0017] Throughout herein like components are indicated by the same
numerals even where they are components of different assemblies and
may not necessarily described repetitiously.
[0018] The schematic drawings are intended to be indeed schematic
and only to show the basic concepts of the invention, not
necessarily representing realistic views, for example, with
realistic relative sizes of body components and apparatus
components.
DETAILED DESCRIPTION OF THE INVENTION
[0019] The invention is described next by way of examples. FIG. 1
shows schematically a tissue-connector apparatus 10 embodying this
invention for a minimally invasive procedure. Described briefly,
the apparatus 10 consists of a clip assembly 20 and a needle holder
30, which will be described next sequentially in detail.
[0020] The clip assembly 20 according to this embodiment may be
referred to as the double-arm clip assembly, characterized as
having a clip 22 of a self-closing type with two end points each
connected through a flexible member 24 such as a suture to a tissue
penetrating needle 25 (as disclosed, for example, in aforementioned
U.S. patent applications Ser. Nos. 09/259,705 and 09/260,623 both
filed Mar. 1, 2000, both of which are herein incorporated by
reference). Each of the needles 25 has a tissue-piercing sharp
point and is connected to a corresponding one of the flexible
members 24. As shown more clearly in FIG. 2, the two end points of
the clip 22 are each provided with and directly connected to a
release mechanism 23 such that it can be released easily from the
flexible members 24 and from being constrained to remain in its
generally U-shaped open configuration.
[0021] The clip 22, or a surgical fastener, of the so-called
self-closing type may be one disclosed in aforementioned U.S.
patent applications Ser. Nos. 09/089,884 and 09/090,305 both filed
Jun. 3, 1998 (herein also incorporated by reference), as well as in
aforementioned U.S. patent applications Ser. Nos. 09/259,705 and
09/260,623, characterized as having two end points, being generally
U-shaped when in an open configuration (as shown in FIGS. 1 and 2),
being naturally in a closed configuration (state or condition) and
being elastic (or pseudoelastic, but herein broadly characterized
as being "elastic") so as to tend to return to the closed
configuration by reducing the separation distance between its end
points when forced into an open configuration. As disclosed in
aforementioned U.S. patent applications Ser. Nos. 09/089,884 and
09/090,305, such a clip 22 may comprise a deformable wire made of a
shape memory alloy such as a nickel titanium based alloy (nitinol).
It is also known that the alloy may include additional elements,
depending on the desired yield strength of the material or the
temperature at which particular pseudoelastic or shape
transformation characteristics occur. When the clip 22 is in its
closed configuration (not shown) with no external restraining force
thereupon, it may be in a completely closed loop with its end
points in a side-by-side or overlapping orientation, the wire being
looped by more than 360.degree.. The diameter of the wire for the
clip 22 and the diameter of the loop when it is in the closed
configuration may be selected, depending on the application, and do
not limit the scope of the invention.
[0022] The needle holder 30 consists essentially of a hollow outer
tube 32, an inner member 34 and a spring 38, as shown in FIG. 1.
The outer tube 32 is elongated, defining a longitudinal direction.
The inner member 34 is also longitudinally elongated and is adapted
to slide longitudinally inside the outer tube 32 and to releasably
grab the needles 25, one at a time. According to the embodiment
shown in FIG. 1, the inner member 34 is comprised of a knob 341 at
its proximal end, a conjunction tube 342 in the middle and a
needle-holding tube 343 in front. The conjunction tube 342 and the
needle holding tube 343 are laser-welded together. A threaded
adapter is laser-welded to the proximal end of the conjunction tube
342 for allowing the knob 341 to be screwed thereonto after the
spring 38 is inserted inside the outer tube 32 such that, once the
needle holder 30 is thus assembled, the knob 341, the conjunction
tube 342 and the needle-holding tube 343 will move together as a
single unit. The front end of the needle-holding tube 343 is
provided with a longitudinally elongated slit 35 for holding the
needle 25, and the outer tube 32 has a front opening 33, as shown
more clearly in FIG. 3. The needle-holding tube 343 with the slit
35 and the front opening 33 of the outer tube 32 are so designed
that the slit 35 will open and become sufficiently wide in front as
the inner member 34 is pushed forward through the outer tube 32 for
accepting a needle 25 (shown by broken lines in FIG. 3) therein and
that the opening of the slit 35 tends to become smaller as the
inner member 34 is moved backwards through the outer tube 32 so as
to retract the needle-holding tube 343 through the front opening 33
of the outer tube 32, causing the needle-holding tube 343 to
securely grab the needle 25 once accepted. The spring 38 is
disposed inside the outer tube 32 so as to provide a backward
biasing force on the inner member 34. In other words, the inner
member 34 is normally in a backward position inside the outer tube
32 under the influence of the backward biasing force of the spring
38 thereon. As the user pushes the inner member 34 forward by
operating the knob 341 against aforementioned backward biasing
force of the spring, the front part of the needle-holding tube 343
protrudes farther outward from the front opening 33 of the outer
tube 32 and the slit 35 opens wider, its front opening becoming
wide enough to accept the back part of a needle (away from its
tissue-piercing sharp point). If the user then releases the force
being applied to the knob 341 after the back part of the needle 25
has been accepted inside the slit 35, the backward biasing force by
the spring pushes the inner member 34 backward, reducing the length
of the needle-holding tube 343 outside the front opening 33 of the
outer tube 32. This has the effect of reducing the opening of the
slit 35 and hence of having the needle 25 firmly gripped by the
needle holder 30. In summary, the user pushes the knob 341 forward
to accept the needle 25 and releases the force on the knob 341 to
firmly grab it. When a needle is already being held by the needle
holder 30, the user has only to push the knob 341 to release
it.
[0023] A valve repair procedure embodying this invention, such as
for reducing the valve orifice by using the apparatus described
above, will be described next.
[0024] To access a mitral valve, a small incision is made on the
appendage of the left atrium. One of the needles 25 of the clip
assembly 20 is grabbed by the needle holder 30, as shown in FIG. 1,
by pushing the knob 341 forward to accept the needle 25 and then
releasing it to firmly attach the needle 25 to the needle holder
30, as described above. A cannula is inserted into the incision.
FIG. 1 shows the cannula schematically at 40 but the patient's body
part are omitted from FIG. 1. With an aid of an ultrasound machine
(not shown), the needle holder 30 is passed through the cannula 40
towards the leaflets, and the needle 25 held by the needle holder
30 is caused to penetrate and be completely pulled through one of
the leaflets. Thereafter, the knob 341 is pushed forward to release
the needle 25. The knob 341 is pushed forward again to grab the
same needle 25 from the other side of the leaflet to secure the
needle 25 on the leaflet. Thereafter, the needle 25 is released,
the needle holder 30 is pulled out of the cannula 40 and the other
of the needles 25 of the double-arm clip assembly 20 is similarly
grabbed by its needle holder 30. The same procedure as described
above is repeated to cause the second needle 25 of the clip
assembly 20 to penetrate and be completely pulled through and be
secured to the other of the leaflets. The needles 25 are pulled,
together with the flexible members 24 attached thereto, until the
clip 22 comes to span the leaflets, as shown in FIG. 4A.
Thereafter, the release mechanisms 23 are squeezed by an instrument
such as the needle holder 30 itself to release the clip 22 from the
flexible members 24. Free of constraints, the clip 22 now tends to
return to its natural closed configuration, reducing the distance
separating its two end points. This has the effect of tightly
bringing the leaflets together, as shown in FIG. 4B, thereby
reducing the valve orifice.
[0025] The invention was described above by way of only one example
but this example is not intended to limit the scope of the
invention. Many modifications and variations are possible within
the scope of the invention. For example, although the use of a clip
assembly having two needles each connected to a corresponding one
of the two end points of a generally U-shaped clip was disclosed,
use may be made under certain circumstances of a simpler single-arm
clip assembly 20' shown in FIG. 5 and described, for example, in
aforementioned U.S. patent applications Ser. Nos. 09/089,884 and
09/090,305, having only one needle 25 attached through a flexible
member 24 and a release mechanism 23 to one of the two end points
of a clip 22'. Such a single-arm clip assembly 20' may be used
similarly, as described above in connection with the double-arm
clip assembly 20 shown in FIGS. 1 and 2, except that the clip 22'
is provided with a stopper 26 at the other of its two end points
not connected to the flexible member 24 for keeping the clip 22' in
its generally U-shaped open configuration. After the needle 25 is
caused to penetrate both leaflets, as shown in FIG. 6, the clip 22'
can be caused to pull the two leaflets together as the flexible
member 24 is pulled, the stopper 26 serving to locate the clip 22'
across the leaflets.
[0026] FIG. 7 shows still another clip assembly 20'' embodying this
invention, indicating like components by the same numerals as used
in FIGS. 2 and 5. This clip assembly 20'' is characterized as
having not only two tissue penetrating needles 25 each connected to
a flexible member 24 but also two self-closing clips 22' as shown
in and explained with reference to FIG. 5, each having a stopper 26
at one end point for keeping the clip 22' in a generally U-shaped
open configuration and the other end point being connected to a
corresponding one of the flexible members 24 through a release
mechanism 23 for separating the clip 22' from the flexible member
24 and thereby releasing the clip 22' from remaining in its open
configuration. These two clips 22' are connected through their
stoppers 26 by another flexible member 29 which may be a suture or
a metal wire.
[0027] A clip assembly 22' thus structured may be used in a valve
repair procedure, for example, by penetrating a leaflet tissue with
one of the needles 25, causing it to come up and out at another
position in a manner of ordinary stitching, pulling the associated
flexible member 24 until the clip 22' connected thereto penetrates
the leaflet tissue partially such that the end point of this clip
22' on the side of the release mechanism 23 penetrates the tissue
and reappears on the surface while the other end point on the side
of the stopped 26 does not penetrate the tissue, and doing the same
with the other needle 25 on the leaflet on the opposite side of the
valve opening. After the release mechanisms 23 on both clips 22'
are pressed, as described above, to release the clips 22' from the
needles 25, each clip 22' tends to coil up, getting firmly attached
to the respective leaflet, the flexible member 29 therebetween
holding the leaflets together, as shown in FIGS. 8A and 8B. In
other words, it is the flexible member 29 between the two clips 22'
that holds the leaflets together. As an alternative procedure, the
needles 25 may be operated such that the connecting flexible member
29 makes a loop between the leaflets, as shown in FIG. 8C.
[0028] Although the clips 22 and 22', when constrained to an open
configuration before they are released from the flexible member 24,
are described as being generally U-shaped, this description is
intended to be interpreted broadly. As should be clear from the
intended function of the clips 22 and 22', their open configuration
may look more like a C or a J than a U. The release mechanisms 23,
described above as serving to release the connection between the
clip 22 or 22' and the flexible members 24 and to release the clip
22 or 22' from its forced open configuration, may be structured as
disclosed in aforementioned U.S. patent application Ser. No.
09/260,623 but their structure is not intended to limit the scope
of the invention.
[0029] In summary, the disclosure is intended to be interpreted
broadly. Although the invention has been described as being
addressed to a method and an apparatus for valve repair, a person
skilled in the art will immediately realize that the method and
apparatus of this invention as described above can be used for
holding two tissue parts close together, not being limited to valve
leaflets. The scope of this invention, therefore, is to be
understood as including methods of and apparatus for holding two
tissue parts close together.
* * * * *