WO2000067661A2 - Heart valve and apparatus for replacement thereof, blood vessel leak detector and temporary pacemaker lead - Google Patents

Heart valve and apparatus for replacement thereof, blood vessel leak detector and temporary pacemaker lead Download PDF

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Publication number
WO2000067661A2
WO2000067661A2 PCT/US2000/013129 US0013129W WO0067661A2 WO 2000067661 A2 WO2000067661 A2 WO 2000067661A2 US 0013129 W US0013129 W US 0013129W WO 0067661 A2 WO0067661 A2 WO 0067661A2
Authority
WO
WIPO (PCT)
Prior art keywords
heart valve
vessel
commisures
replacement heart
commisure
Prior art date
Application number
PCT/US2000/013129
Other languages
French (fr)
Other versions
WO2000067661A3 (en
Inventor
Paul A. Spence
Mark Ortiz
Original Assignee
Spence Paul A
Mark Ortiz
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US09/310,891 external-priority patent/US6309417B1/en
Priority claimed from US09/312,785 external-priority patent/US6256543B1/en
Application filed by Spence Paul A, Mark Ortiz filed Critical Spence Paul A
Priority to AU47132/00A priority Critical patent/AU4713200A/en
Publication of WO2000067661A2 publication Critical patent/WO2000067661A2/en
Publication of WO2000067661A3 publication Critical patent/WO2000067661A3/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445Annuloplasty rings in direct contact with the valve annulus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0073Quadric-shaped
    • A61F2230/0078Quadric-shaped hyperboloidal

Definitions

  • a popular option for aortic valve replacement is to retain the
  • aorta is therefore collapsed and unpressurized leaving a pressurized section
  • the unpressurized section of aorta is
  • aorta may or may not need to be affixed to the aorta as discussed below.
  • the first general type of valve is a mechanical prosthesis which
  • commisures that are self-supporting and do not need to be affixed
  • Mechanical prostheses are generally formed entirely of
  • artificial material such as carbon fiber, titanium, dacron and teflon.
  • blood clots can form on the valve and subsequently cause
  • the second major type of prosthetic or replacement heart valve is the second major type of prosthetic or replacement heart valve
  • This category includes valves harvested from human
  • cadavers i.e., allografts or homografts, or animal tissue generally harvested
  • biologic prostheses generally do
  • a stented valve includes a permanent, rigid frame for supporting the valve,
  • the frames can be any suitable material that can be used to treat the commisures, during and after implantation.
  • the frames can be any suitable material that can be used to treat the commisures, during and after implantation.
  • valves are not generally available with permanent frames or stents.
  • the frames or stents can take up valuable space inside the aorta
  • the frame includes artificial materials which can increase
  • valve do not support themselves in the proper orientation for implantation.
  • an L-shaped retractor is
  • the aorta is not a straight tube at the surgical site, but
  • valve commisures are attached to the aorta and proper orientation and
  • vessels are large enough, such as several millimeters in diameter, relatively
  • the vessel can slide off the cannula and, therefore, an assistant
  • vessels are very small, such as in the range of 1 to 2
  • Temporary pacing wires are placed at almost every cardiac
  • Leads in reality a bare segment of an insulated wire
  • the needle through the heart with a partial thickness bight. The needle is then cut off the wire. Exposed wire is left in contact with the heart. The wire is
  • the wire often has a series of bends or a
  • the suture method requires that the surgeon place a
  • heart 51 4 will be torn as the suture snaps or that the suture does not snap
  • suture 520 is passed through the heart 51 4 is quicker.
  • Flared stop portion 524 is designed to
  • the present invention generally provides apparatus directed at
  • the invention provides a
  • the replacement heart valve will generally have an annular
  • the valve may be formed of animal tissue,
  • valves harvested from pigs, cows or human donors such as valves harvested from pigs, cows or human donors.
  • valve may be formed from synthetic, biologically compatible material.
  • each commisure includes a proximal end connected
  • commisure stabilizers are connected to the commisures in a removable
  • the commisure stabilizers are preferably removed to avert the vessel
  • commisure stabilizers are connected together at spaced apart distal
  • stabilizer preferably comprises at least one elongate member attachable in a
  • the replacement heart valve can include respective receiving
  • elements for the commisure stabilizers may comprise pockets, loops
  • commisure stabilizers may also be removably affixed to
  • Each commisure stabilizer may further comprise at least two
  • One or more of these members may curve or flare outwardly in a
  • stabilizing device may be formed in a collapsible manner allowing insertion
  • the positioning and stabilizing device is configured to control the valve within the vessel.
  • the positioning and stabilizing device is configured to control the valve within the vessel.
  • This material may also be secured to the internal wall of the
  • accordance with the invention includes inserting the replacement heart
  • commisure stabilizers to orient the commisures
  • a cannula is
  • a hub of the cannula contains a friction lock so
  • suture which holds the vessel on the cannula may be retained by
  • the friction lock may be substituted with other retaining members for the
  • the vessel engaging portions of the jaws may be covered with a soft material
  • the jaws may be moved
  • the cannula is inserted in the vessel
  • the device would be inexpensive and simple to
  • the invention further contemplates a temporary pacing wire
  • An electrode is permanently attached to the heart.
  • electrode can be a very tiny piece of metal, such as a clip.
  • the electrode does not cause bleeding on
  • the electrode is not removed from the heart, so
  • the electrode could be sutured to the heart. More simply and
  • Clips can be
  • the clip could take the form
  • attachment could include an extension attached to a hemoclip which
  • Another variation could include a clip that looks like a
  • the attachment of the wire to the clip can be accomplished in
  • the clip could have a small loop through which a loop
  • the clip could have two parallel rabbit ear ⁇
  • the pacing wire is attached reversibly to the electrode clip so
  • the product is easy to manufacture, package and distribute as
  • Figure 1 is a partially fragmented perspective view of an aorta
  • Figure 2 is a view similar to Fig. 1 , but showing the initial
  • Figure 3 is a perspective view similar to Fig. 2, but showing
  • Figure 4 is a perspective view similar to Fig. 3, but showing
  • Figure 4A is a cross sectional view taken along line 4A-4A of
  • Figure 5 is a perspective view showing an alternative
  • Figure 6 is a perspective view of another alternative
  • Figure 6A is a cross sectional view taken along line 6A-6A of
  • Figure 7 is a perspective view of another alternative
  • Figures 8A and 8B are perspective views of another alternative
  • Figure 9 is a perspective view of an alternative replacement
  • Figure 9A is a perspective view of the apparatus shown in Fig.
  • Figure 9B is a fragmented and enlarged view of the positioning
  • Figure 1 0 is a perspective view of another alternative
  • Figure 1 1 is a perspective view of an aortic expansion device
  • Figure 1 2 is a perspective view of an alternative aortic
  • Figure 1 3A is a top view of the expansion device illustrated in
  • Figure 1 3B is a top view of the expansion device shown in
  • FIG. 1 2 in an expanded condition.
  • Figure 1 4 is a fragmented, partial cross sectional view of a
  • Figure 1 5 is a fragmented, partial cross sectional view of a
  • Figure 1 5A is an enlarged view of encircled portion 1 5A of
  • Figure 1 6 is a fragmented, partial cross sectional view of a
  • Figure 1 7 is a fragmented, elevational view of the device
  • Figure 1 8 is an elevational view of an alternative embodiment
  • Figure 1 9 is a cross sectional view taken along line 1 9-1 9 of
  • Figure 20 is an elevational view showing a prior art method of
  • Figure 21 is an elevational view similar to Figure 20, but
  • Figure 22 is a perspective view of a temporary pacemaker lead
  • Figure 23 is a perspective view showing the temporary
  • pacemaker lead of Figure 22 attached to the heart of a patient
  • Figure 24 is a perspective view of one alternative embodiment
  • Figure 25 is a side elevational view of the embodiment shown
  • Figure 26 is a perspective view of another alternative
  • Figure 1 illustrates an aorta 1 0 which a surgeon has incised to
  • One or more retractors 1 4 may be used by assistants to gain
  • Aorta 1 0 may be partially incised as shown or it
  • the patient's heart 1 6, disposed below the surgical site, is normally in an
  • An unstented replacement valve 20 is further shown within
  • covering 22 is stitched on the outside of the biologic tissue 24, which may
  • Replacement valve may be human or other animal tissue or synthetic material.
  • 20 comprises typically three commisures 26, 28, 30 extending from an
  • annular base 32 is disposed at the annulus 34 of aorta 1 0.
  • Replacement valve 20 must be disposed within aorta 1 0 so as not to
  • replacement valve includes three cusps 42, 44, 46, respectively connected
  • each commisure should preferably extend in a
  • Figures 2 and 3 illustrate one embodiment of a positioning
  • positioning and stabilizing device 60 may be used in a temporary
  • Positioning and stabilizing device 60 in this embodiment, includes an annular portion 62 connected with a plurality of stabilizers 64, 66, 68, each
  • flared region 70 of the aortic root As one of many possible temporary
  • each stabilizer 64, 66, 68 is slipped between fabric
  • stabilizers 64, 66 may be used to attach stabilizers 64, 66,
  • valve 20 is inserted within aorta 1 0.
  • assembly of a positioning and stabilizing device and
  • annulus 34 suturing of commisures 26, 28, 30 can begin. This may be
  • 1 0 may be used in accordance with the invention and, for example, include
  • the distal ends 26a, 28a 30a may be any suitable covering 22 and biologic tissue 24, the distal ends 26a, 28a 30a.
  • Figure 5 illustrates one alternative embodiment of a
  • Replacement valve 20 includes pockets 80 on the outside of each
  • stabilizing device 90 Like the first embodiment, positioning and stabilizing
  • the device 90 can include an annular portion 92 and a plurality of three
  • each stabilizer further comprises
  • each stabilizer 94, 96, 98 comprises
  • stabilizer 94, 96, 98 bows outwardly, as in the first embodiment, to
  • Stabilizers 94, 96, 98 are
  • Positioning and stabilizing device 90 may be formed from various materials and in various configurations for this purpose. These may include metals,
  • FIGS 6 and 6A illustrate another alternative positioning
  • annular portion 1 02 is removable from a plurality of
  • stabilizing device 1 00 may be used as described above with respect to
  • annular portion 1 02 may be removed for
  • stabilizer 1 04 may be received with a slight interference fit against a
  • the other stabilizers 1 06, 1 08 may have a similar
  • Figure 7 illustrates another alternative positioning
  • stabilizing device 1 20 having a generally similar construction and function
  • Device 1 20 may be formed from a single
  • length of wire for example, and includes portions 1 22, 1 24, 1 26
  • a connector 1 28 may be provided to connect opposite ends of the wire.
  • 1 32, 1 34 are formed with three sections each for purposes previously
  • FIGS 8A and 8B illustrate another alternative positioning
  • stabilizing device 1 40 constructed from a shape memory material such as
  • device 1 40 may be collapsed in each a
  • a replacement heart valve for insertion within the patient's aorta as a
  • the aorta, device 1 40 expands to the position shown in Figure 8B and may
  • one illustrative example of this device also includes an annular portion 1 42
  • FIGS 9 and 9A illustrate another heart valve replacement
  • a replacement heart valve 1 62 may include a flexible material
  • valve 1 62 optionally part of the fabric covering 1 66 of valve 1 62, which secures
  • commisures 168, 170, 172 may be stitched to the interior aortic wall in conjunction with commisures 168, 170, 172.
  • material 164 will prevent distal ends 168a, 170a,
  • embodiment of a positioning and stabilizing device 180 includes an annular
  • portion 182 constructed from separate sections 182a, 182b, 182c, and a
  • stabilizers 184, 186, 188 are retained within
  • loops 190 which may be suture loops sewn into fabric 166. It will be
  • connectable end portions 192, 194 formed respectively as male and
  • female portions may be used to make various connections and
  • stabilizers 184, 186, 188 may be connected at a junction 196 as shown in
  • connecting elements 198 This may be accomplished through the use of connecting elements 198
  • connecting portions 192 It will be understood that many alternative connectors and structures may be substituted for those shown while
  • Figure 1 0 illustrates a heart valve replacement apparatus 200
  • a replacement heart valve 202 which may be formed from
  • Heart valve biological tissue or synthetic biologically compatible material.
  • a positioning and stabilizing device 21 0 is
  • valve 202 fastened to the outside of valve 202, for example, by suture loops 21 1 .
  • embodiment positioning and stabilizing device 21 0 is formed in three
  • sections 21 2, 21 4, 21 6 may be removed individually from heart valve 202
  • 21 4, 21 6 are preferably formed of a highly flexible plastic or metal which is
  • commisures 204, 206, 208 while suturing or otherwise securing
  • commisures 204, 206, 208 to the aortic wall. It will be appreciated that other configurations and numbers of legs and sections may be utilized by
  • Figure 1 1 illustrates an expansion device 240 useful for
  • expansion device may be formed as a
  • collapsible and expandable structure such as by being formed of shape
  • device 240 may have three extensions 242, 244, 246 of a desired length
  • Device 240 need not be attached to heart valve commisures, but
  • This device overcomes the drawbacks of typical retractors which tend to
  • Device 240 may be
  • FIGS 1 2, 1 3A and 1 3B illustrate an alternative collapsible
  • This device may be formed from a
  • An upper end 256 is formed with
  • FIG. 1 5 illustrates another embodiment of the invention.
  • a cannulating device 320 is connected to a vessel 322 by
  • a suture 328 is tied around the outside of vessel 322, as
  • Friction lock 332 may take many different forms,
  • FIGS 1 6-1 9 illustrate two additional and similar
  • cannulating device 340 is again shown as used on a vessel 342.
  • tube 344 of device 340 is inserted into vessel 342 and includes a lumen
  • a clamp 348 is secured to a hub 350 of device
  • clamp 350 generally comprises a pair of jaws 352, 354.
  • a rubber ligature 356 may be
  • 356 may be retained in respective recesses 358, 360 when jaws 352, 354
  • Each jaw 352, 354 includes a respective semi-
  • cylindrical jaw portion 362, 364 for partially encircling vessel 342 as best
  • devices 340 and 340' may
  • handles 366, 368 which may form part of jaws 352, 354 and which are
  • biased mechanisms may be used to retain jaws 352, 354 in the closed position.
  • one or more torsion springs may be used to retain jaws 352, 354 in the closed position.
  • one or more torsion springs may be used to retain jaws 352, 354 in the closed position.
  • jaws 352, 354 are biased into a normally closed position as shown in solid
  • handles 366, 368 may be squeezed in this manner while initially attaching
  • jaws 352, 354 may be moved to a rearward position to hold jaws 352, 354 in an open
  • ligature 356 may be moved into recesses 358,
  • 358, 360 and 359, 361 may provide different degrees of clamping force.
  • recesses 359, 361 will provide greater clamping
  • FIGS 22 and 23 show another embodiment of the invention.
  • the electrode comprises a clip 430 which can be pinched onto the heart
  • 430 is attached to a wire 434 in a releasable manner. This may be
  • FIGs 24 and 25 show an alternate attachment of the wire
  • Figure 26 shows another way to attach an electrode to the

Abstract

Apparatus and methods for replacing a heart valve within a vessel (10). The apparatus includes a replacement heart valve (20) and a plurality of commisure stabilizers (64, 66, 68) temporarily connected to the commisures of the heart valve (20) in a removable manner. A cannulating device (320) which, in a first embodiment, includes a cannula (324), a hub portion, and a retaining member (332) extending from the hub portion. In a second embodiment, a clamp (348) is coupled with the hub portion (350) and may be moved between open and closed positions to retain the vessel (342) in a sealed condition on the cannula. A temporary pacemaker lead including a wire (434) having an electrically conductive portion, a first connector portion (438) on the wire, and an electrode (430) having a second connector portion (436).

Description

HEART VALVE AND APPARATUS FOR REPLACEMENT THEREOF, BLOOD VESSEL LEAK DETECTOR AND TEMPORARY PACEMAKER LEAD
Background of the Invention
A popular option for aortic valve replacement is to retain the
native aortic root and the normal coronary artery attachments and secure
the replacement prosthesis inside the patient's own aorta. With this
procedure, only the valve is replaced and not the entire root. It is
unnecessary to re-attach the coronary arteries and, should repeat surgery be
necessary, a surgeon must only replace the valve and not an entire section
of the aorta. When a surgeon replaces the aortic valve in this manner, the
patient is first placed on a heart-lung machine and the section of the aorta
having the aortic valve is clamped off to allow access. That section of the
aorta is therefore collapsed and unpressurized leaving a pressurized section
connected to the heart-lung machine. The unpressurized section of aorta is
then opened and the diseased valve is removed in its entirety, including
careful removal of calcium deposits within the aorta and annulus. The aorta
and sinotubular junction are then sized and the surgeon prepares the
appropriate replacement valve. The surgeon then sutures the inflow or
annular end of the replacement valve into the inside of the aorta. When
these sutures are drawn tight, the valve is pulled inside the aorta when
approximately 20 sutures are then applied around the annular end. The commisures of the replacement valve, which extend from the annular end,
may or may not need to be affixed to the aorta as discussed below.
Two major types of prosthetic or replacement heart valves
exist. The first general type of valve is a mechanical prosthesis which
includes commisures that are self-supporting and do not need to be affixed
to the aortic wall. Mechanical prostheses are generally formed entirely of
artificial material, such as carbon fiber, titanium, dacron and teflon. While
these mechanical prostheses are durable, relatively quick to implant and
generally easy to manipulate during surgery, they also have certain
disadvantages. For example, due to the artificial materials used in their
construction, blood clots can form on the valve and subsequently cause
valve failure. If the clot dislodges from the valve, the clot can lodge in a
downstream vessel and cause stroke or organ ischemia. For these reasons,
patients with mechanical heart valves must take anticoagulants for the rest
of their lives. Anticoagulants bring about their own complications in some
patients, including internal bleeding or other side effects.
The second major type of prosthetic or replacement heart valve
is a biologic valve. This category includes valves harvested from human
cadavers, i.e., allografts or homografts, or animal tissue generally harvested
from cows and pigs. More recently, there has been increasing effort to
develop synthetic biologically compatible materials to substitute for these
natural tissues. Among their advantages, biologic prostheses generally do
not require lifelong anticoagulation as they do not often lead to clot
formation. These valves are provided in stented or unstented forms. A stented valve includes a permanent, rigid frame for supporting the valve,
including the commisures, during and after implantation. The frames can
take the form of a wire or other metal framework or a plastic frame encased
within a flexible fabric covering. Unstented valves do not have built-in
commisure support so surgeons must use their skill and best judgement to
determine the optimal site of implantation inside the patient's native aorta
to maintain valve competence. When securing the valve commisures,
obstruction of the patient's native coronary arteries must be avoided or
myocardial infarction may result.
There are many limitations to procedures utilizing permanently
stented biologic replacement valves. First, allografts (human cadaver donor
valves) are not generally available with permanent frames or stents.
Second, the frames or stents can take up valuable space inside the aorta
such that there is a narrowing at the site of valve implantation. This
narrowing leads to pressure gradients and increased loads on the left
ventricle and, therefore, increased incidence of hypertrophy and reduced
patient survival. The frame includes artificial materials which can increase
the risk of new infection or perpetuate an existing infection. It is also very
important to realize that although the permanent frames or stents guarantee
alignment of the commisures, they cause very high stresses on the
commisures when the valve cusps move between open and closed
positions. A patient's natural commisures are not placed under significant
strain during opening and closing of the valve due to the natural resilience
of the aorta. On the other hand, artificially mounted valves place the commisures under strain during operation of the valve due to the rigid
materials of the frame. Over time, the valve cusps tend to decay under this
strain and manifest calcification and tears which can lead to valve failure.
In many situations, biologic replacement heart valves are
preferred in the unstented form due to the drawbacks mentioned above.
Such valves are more resistant to infection when implanted free of any
foreign material attachments, such as stents or frames. Also, the heart
valve is more efficient when used without a stent. Efficiency refers to the
pressure gradient across the valve during use. Natural human valves have
almost no pressure gradient. When a natural heart valve is replaced by a
biologic heart valve with a low pressure gradient, complications such as
hypertrophy arise less often and result in improved patient survival.
Despite the known advantages of using biologic prosthetic
heart valves without artificial supporting devices such as permanent stents
or frames, relatively few surgeons employ this surgical technique due to its
high level of difficulty. When unsupported or unstented by artificial
devices, such as permanent stents, biologic replacement heart valves have
a flimsy, soft and flexible nature. That is, the commisures of the heart
valve do not support themselves in the proper orientation for implantation.
For these reasons, it is very difficult to secure the commisures properly into
place. In this regard, the surgeon must generally suture the individual
commisures of the heart valve in exactly the proper orientation to allow the
valve to fully and properly function. During valve replacement surgery, an L-shaped retractor is
placed inside the aorta to pull it open for access purposes. While this
provides exposure, it distorts the aorta and may give the surgeon an
incorrect impression of the correct valve position. Next, and especially with
regard to unstented biologic valve procedures, the surgeon must guarantee
that the commisures pass straight up the aorta at roughly right angles to
the plane of the annulus. There is very little technology to help the surgeon
correctly place the stentless replacement valve. To help confirm that the
leaflets are correctly spaced at 1 20° apart, surgeons may use a disc having
markings 1 20° apart. The surgeon can use this to roughly estimate the
spacing by placing it near the distal ends of the commisures. However, this
provides only a rough guide. For example, it is possible to equally space the
commisures at the upper end and still have a valve placed in a skewed
position. Finally, the aorta is not a straight tube at the surgical site, but
instead flares outward at the surgical site. The valve must conform to the
flare of the aorta at this location. Once the surgeon has completed an
inspection for these three elements, i.e., correct spacing at approximately
1 20° between the commisures, correct perpendicular position of the
commisures relative to the annulus plane, and appropriate conformation to
the flare of the aorta, the surgeon must suture the commisures to the wall
of the aorta. As this is done, it is necessary to make sure there is no
encroachment on the ostia or origins of the coronary arteries. After the
valve commisures are attached to the aorta and proper orientation and
positioning is confirmed, the surgeon closes the aorta. Following surgery, there is a risk that the aorta will dilate at
the sinotubular junction months or years later and draw the valve
commisures and attached cusps apart from each other. This will cause
insufficiency and failure due to leakage through the valve. There is a further
need for methods to ensure that late enlargement of the sinotubular junction
does not necessitate reoperation for late valve insufficiency and failure.
In general, there is an increasing need for devices which
improve the efficiency and reliability of implanting replacement heart valves.
In conjunction with this, there is a need to improve these procedures so
that all surgeons, not just those with the highest skill levels, can implant
heart valves with superior results.
Blood vessels must frequently be cannulated with fine tubes,
i.e., cannulas, to allow injection of fluids into the vessels. When the
vessels are large enough, such as several millimeters in diameter, relatively
large and rigid cannulas may be placed inside the vessel. A tie is then
typically secured around the vessel and the inserted cannula to prevent to
vessel from sliding off. These larger, more rigid cannulas have a
circumferential ridge behind which the tie is formed to help prevent the
vessel from sliding off the cannula. This process is somewhat cumbersome
as it requires cannulation, stabilizing of the cannula within the vessel, and
finally tying of a suture around the vessel and cannula. As the suture is
being tied, the vessel can slide off the cannula and, therefore, an assistant
must be used to hold the vessel and cannula stable. When vessels are very small, such as in the range of 1 to 2
millimeters, very small cannulas 1 0 must be inserted into the vessel 1 2
(Figure 1 4) . The walls of these small cannulas are very thin so that there is
space for an infusion lumen 1 4. Also, there is no increased diameter
portion or ridge on the cannula 1 0. For this reason, it is more difficult to
hold the vessel 1 2 in place with a suture 1 6. The suture 1 6 must be tied
quite tightly to hold the vessel 1 2 on the cannula 1 0. As the cannula 1 0 is
thin, this frequently occludes the lumen 1 4 by crushing the cannula 1 0, as
shown in Figure 1 , and thereby prevents fluid flow. If the suture is tied too
loosely, the vessel frequently slides off the cannula.
In view of these and other problems in this area, it would be
desirable to provide a device that simplifies the attachment of a cannula to
a vessel. Additional advantages would be obtained by eliminating the need
for suture tying, increasing the speed of the procedure, and reducing the
problems related to cannulating small vessels.
Temporary pacing wires are placed at almost every cardiac
operation, but there have been no advances for many years. There are a
number of current temporary pacemaker leads available for pacing after
cardiac surgery. Leads (in reality a bare segment of an insulated wire) can
be attached to the heart by a suture which holds the exposed wire in
contact with the surface of the heart. When the lead is removed it is
simply pulled out, breaking the stitch. The other way to attach the
temporary lead is to attach a needle to the end of it and then pass the
needle through the heart with a partial thickness bight. The needle is then cut off the wire. Exposed wire is left in contact with the heart. The wire is
removed by simply pulling it out. The wire often has a series of bends or a
small amount of attached plastic material to increase the friction to keep it
from coming out.
There are a number of problems with these two options.
Referring to Figure 20, the suture method requires that the surgeon place a
stitch in the form of a loop 51 0 and then feed the wire 51 2 through the
loop 51 0 and tie it. This is somewhat tedious, especially on a beating heart
51 4. The wire 51 2 under the suture loop to is often easily removed by
even a minimum of pull on the wire and it frequently has to be replaced.
When a secure wire 51 2 is removed, there is the risk that the surface of the
heart 51 4 will be torn as the suture snaps or that the suture does not snap
and a small divot 51 6 of myocardium is pulled off as also shown in Figure
20. This can lead to bleeding which can be fatal.
The second system is shown in Figure 21 whereby a wire
suture 520 is passed through the heart 51 4 is quicker. The wire suture
520 must be passed and the wire cut off as shown at cut 522 located
above a flared stop portion 524. Flared stop portion 524 is designed to
prevent the wire from being pulled back through heart 51 4. However,
during insertion the wire 520 frequently causes bleeding and the bleeders
must be sutured. When the wire 520 is removed, there is a risk that the
friction of the wire removal combined with the drag of the flared portion
524 will result in a piece of myocardium being torn, again resulting in bleeding. Also, the wire 520 frequently becomes dislodged before the
chest is closed and it has to be replaced.
The prior art does not demonstrate the concept of leaving a
small permanent electrode in place and separating this from the wire. This
concept is very important because on removal the risk of bleeding comes
when the wire is pulled through the heart muscle or when the suture must
snap.
In short, current methods are somewhat tedious, can result in
bleeding at insertion and removal and the leads frequently become dislodged
requiring complete reinsertion. It would be very useful to ease the insertion,
permit reattachment should the wire become dislodged and reduce the risk
of bleeding when the wire is removed.
Summary of the Invention
The present invention generally provides apparatus directed at
solving problems, such as those described above, with regard to replacing a
heart valve within a vessel. In one general aspect, the invention provides a
replacement heart valve and a plurality of temporary commisure stabilizers.
More particularly, the replacement heart valve will generally have an annular
base and a plurality of spaced apart commisures extending from the annular
base at spaced apart positions. The valve may be formed of animal tissue,
such as valves harvested from pigs, cows or human donors. Optionally, the
valve may be formed from synthetic, biologically compatible material. With
the typical aortic valve replacement, there will be three commisures spaced roughly 1 20° apart. Each commisure includes a proximal end connected
with the annular base and an opposite distal end. The plurality of
commisure stabilizers are connected to the commisures in a removable
manner. These commisure stabilizers position and stabilize the commisures
of the replacement heart valve as a surgeon secures the replacement heart
valve in place within the vessel. The commisure stabilizers, in the instance
of an aortic valve replacement, positively orient the commisures at the 1 20°
spaced apart positions and generally perpendicular to a plane which
contains the annular base of the heart valve.
Following securement of the replacement heart valve within
the vessel, the commisure stabilizers are preferably removed to avert the
various disadvantages of permanent stents or frames. However, there may
be situations in which a particular surgeon desires to leave one or more of
the commisure stabilizers in place and the invention advantageously
provides for this option as well. In the preferred embodiment, the
commisure stabilizers are connected together at spaced apart distal
positions, for example, by a generally annular member. Each commisure
stabilizer preferably comprises at least one elongate member attachable in a
manner allowing removal from the distal end of the respective commisure
following implantation of the heart valve.
The replacement heart valve can include respective receiving
elements for the commisure stabilizers. These may comprise pockets, loops
or other structure adapted to receive the stabilizers in a manner allowing
removal by a surgeon at the distal end of the commisures after implantation. The commisure stabilizers may also be removably affixed to
other supporting structure, such as the generally annular member described
above. This, for example, will allow the surgeon to remove the annular
member or other supporting structure for easier suturing access, while at
least temporarily leaving the commisure stabilizers in place for positioning
purposes. After suturing and/or other securement of the valve, the
commisure stabilizers would be removable to achieve the full advantages of
this invention.
Each commisure stabilizer may further comprise at least two
spaced apart elongate members or, more preferably, three elongate
members. One or more of these members may curve or flare outwardly in a
lengthwise direction to urge the commisures of the replacement heart valve
against the flared interior wall of the vessel. The outer elongate members
may also angle or curve away from the central elongate member to extend
along opposite edge portions of the respective commisures.
In another aspect of the invention, the positioning and
stabilizing device may be formed in a collapsible manner allowing insertion
into the vessel in a collapsed state and subsequent expansion for
positioning and stabilizing the valve commisures during securement of the
valve within the vessel. For example, the positioning and stabilizing device
may be at least partially formed of a shape memory material allowing the
positioning device to be collapsed and expanded as necessary. This aspect
of the invention may also be practiced in other manners, such as through
the use of hinged or otherwise collapsible and expandible structures. ln accordance with another aspect of the invention, a flexible
material may connect the distal ends of the three commisures. This will
prevent the commisures from moving radially apart due to late sinotubular
enlargement. This material may also be secured to the internal wall of the
vessel to help prevent the need for reoperation due to the complications of
late enlargement of the sinotubular junction as described above.
A method of implanting a replacement heart valve in
accordance with the invention includes inserting the replacement heart
valve into a patient, connecting at least one commisure stabilizer to each of
the commisures of the replacement heart valve either before or after
inserting the replacement heart valve, securing the replacement heart valve
within the patient using the commisure stabilizers to orient the commisures
of the replacement heart valve, and removing one or more of the commisure
stabilizers from the patient leaving the secured replacement heart valve in
place. Other methods of utilizing apparatus as described herein are also
within the scope of this invention as will be apparent.
According to another aspect of the invention, a cannula is
placed in a vessel and tied with a suture tight enough to prevent leaking
between the vessel and the cannula, but loose enough to prevent occluding
the lumen of the cannula. A hub of the cannula contains a friction lock so
that the suture which holds the vessel on the cannula may be retained by
the friction lock thereby preventing the vessel from sliding off the cannula.
The friction lock may be substituted with other retaining members for the
suture. ln another embodiment, tying a suture to the vessel is
eliminated, for example, through the use of a clamp having movable jaws.
The vessel engaging portions of the jaws may be covered with a soft
material, such as foam, for protecting the vessel. The jaws may be moved
between opened and closed positions. The cannula is inserted in the vessel
and the jaws are moved over the vessel containing the cannula. The jaws
are then moved from the open position to the closed position. This seals
the vessel to the cannula and prevents the vessel from sliding off the
cannula. This embodiment is presently preferred because it is quicker and
applies to small or large vessels. There is also no need for a ridge or area of
increased diameter on the cannula. Also, fine cannulas would not be
crushed and no assistant is necessary as one hand may hold the cannula
and vessel together, while the other hand may be used to open and close
the jaws. Finally, the device would be inexpensive and simple to
manufacture.
The invention further contemplates a temporary pacing wire
system which eliminates the risk of bleeding from the heart when the lead
is attached. It is another object of this invention to demonstrate a
temporary pacing lead which can be removed from the heart without the
risk of bleeding from the heart. It is another object of this invention to
demonstrate a temporary pacing lead which can be re-attached should it be
inadvertently removed from the heart before the incision is closed. It is a
further object of this invention to describe a temporary pacing system lead
that can be quickly attached to the heart without need for suture. An electrode is permanently attached to the heart. The
electrode can be a very tiny piece of metal, such as a clip. Releasably
attached to the electrode is a wire which can be removed from the
electrode and reattached to it. The electrode does not cause bleeding on
attachment to the heart. The electrode is not removed from the heart, so
that when the wire is pulled there is no ripping of the heart tissue but only
separation of the electrode from the wire. Should the wire be inadvertently
removed from the electrode after it is attached it is possible to quickly
reattach it.
The electrode could be sutured to the heart. More simply and
more efficient would be a mechanically applied electrode clip. Clips can be
applied in seconds and do not require suture. The clip could take the form
of a current vessel ligation clip. Alternatively, specially modified clips for
attachment could include an extension attached to a hemoclip which
impales the heart. Another variation could include a clip that looks like a
scorpion's pincer.
The attachment of the wire to the clip can be accomplished in
a number of ways. The clip could have a small loop through which a loop
of preformed pacing wire is attached. The loop on the pacing wire could
open to ensure easy removal. The clip could have two parallel rabbit ear¬
like attachments for holding the wire in place. Many other attachments
would be possible to configure.
There are multiple advantages to the invention. For example,
no suturing is required with a clip-on electrode. The clip is attached by simply squeezing the handle of a small tool. The wire is preattached to the
clip so that there is an instantly functioning pacemaker with no additional
steps.
The pacing wire is attached reversibly to the electrode clip so
that it can be easily pulled out without the risk of tearing myocardium. This
is due to the fact that the clip is permanently attached to the heart and the
wire slips away from or disengages the clip. There would be no direct
dislodgement from the heart.
Should the wire become accidently dislodged during surgery, it
can be easily reattached.
The product is easy to manufacture, package and distribute as
it may take the form of existing hemoclip products.
These and other objects, advantages, and features of the
invention will become more readily apparent to those of ordinary skill in the
art upon review of the following detailed description of the preferred
embodiments, taken in conjunction with the accompanying drawings and as
more generally set forth in the appended claims.
Brief Description of the Drawings
Figure 1 is a partially fragmented perspective view of an aorta
undergoing a valve replacement operation with an unstented biologic
replacement valve in the process of insertion;
Figure 2 is a view similar to Fig. 1 , but showing the initial
removable attachment of a positioning and stabilizing device having commisure stabilizers constructed in accordance with one embodiment of
the invention;
Figure 3 is a perspective view similar to Fig. 2, but showing
the positioning and stabilizing device fully inserted and the properly
positioned and stabilized commisures being sutured in place;
Figure 4 is a perspective view similar to Fig. 3, but showing
the fully implanted heart valve;
Figure 4A is a cross sectional view taken along line 4A-4A of
Fig. 4;
Figure 5 is a perspective view showing an alternative
embodiment of a positioning and stabilizing device being removed from a
replacement heart valve following implantation;
Figure 6 is a perspective view of another alternative
positioning and stabilizing device constructed in accordance with the
invention;
Figure 6A is a cross sectional view taken along line 6A-6A of
Fig. 6;
Figure 7 is a perspective view of another alternative
embodiment of a positioning and stabilizing device;
Figures 8A and 8B are perspective views of another alternative
positioning and stabilizing device respectively shown in collapsed and
expanded conditions; Figure 9 is a perspective view of an alternative replacement
heart valve and removable positioning and stabilizing device constructed in
accordance with the invention;
Figure 9A is a perspective view of the apparatus shown in Fig.
9 with the positioning and stabilizing device removed;
Figure 9B is a fragmented and enlarged view of the positioning
and stabilizing device of Figs. 9 and 9A showing the separable parts
thereof;
Figure 1 0 is a perspective view of another alternative
replacement heart valve and removable positioning and stabilizing device
constructed in accordance with the invention;
Figure 1 1 is a perspective view of an aortic expansion device
constructed in accordance with the invention;
Figure 1 2 is a perspective view of an alternative aortic
expansion device;
Figure 1 3A is a top view of the expansion device illustrated in
Figure 1 2, but shown in a collapsed condition; and
Figure 1 3B is a top view of the expansion device shown in
Figure 1 2 in an expanded condition.
Figure 1 4 is a fragmented, partial cross sectional view of a
prior art cannulating device.
Figure 1 5 is a fragmented, partial cross sectional view of a
cannulating device constructed according to one embodiment of the
invention. Figure 1 5A is an enlarged view of encircled portion 1 5A of
Figure 1 5.
Figure 1 6 is a fragmented, partial cross sectional view of a
cannulating device constructed in accordance with another embodiment of
the invention.
Figure 1 7 is a fragmented, elevational view of the device
shown in Figure 1 6, but showing an elastic ligature forcing a pair of
clamping jaws into a closed position.
Figure 1 8 is an elevational view of an alternative embodiment
similar to Figure 1 7, but showing the ligature in a disengaged position
holding the jaws in an open position.
Figure 1 9 is a cross sectional view taken along line 1 9-1 9 of
Figure 1 7.
Figure 20 is an elevational view showing a prior art method of
attaching and removing a temporary pacing wire to the heart of a patient;
Figure 21 is an elevational view similar to Figure 20, but
showing an alternative prior art method of attaching a temporary pacing
wire to the heart;
Figure 22 is a perspective view of a temporary pacemaker lead
constructed in accordance with one embodiment of the invention;
Figure 23 is a perspective view showing the temporary
pacemaker lead of Figure 22 attached to the heart of a patient;
Figure 24 is a perspective view of one alternative embodiment
of the invention; Figure 25 is a side elevational view of the embodiment shown
in Figure 24; and
Figure 26 is a perspective view of another alternative
embodiment of the invention.
Detailed Description of the Preferred Embodiments
Figure 1 illustrates an aorta 1 0 which a surgeon has incised to
create an opening 1 2 after a patient has been placed on a heart-lung
machine. One or more retractors 1 4 may be used by assistants to gain
access to opening 1 2. Aorta 1 0 may be partially incised as shown or it
may be fully incised across its transverse dimension. During this procedure,
the patient's heart 1 6, disposed below the surgical site, is normally in an
arrested state due to the use of the heart-lung bypass machine and
cardioplegia.
An unstented replacement valve 20 is further shown within
aorta 1 0 in an initial flimsy, unsupported condition. In this case, a fabric
covering 22 is stitched on the outside of the biologic tissue 24, which may
be human or other animal tissue or synthetic material. Replacement valve
20 comprises typically three commisures 26, 28, 30 extending from an
annular base 32. Replacement valve 20 has been inserted within aorta 1 0
such that annular base 32 is disposed at the annulus 34 of aorta 1 0.
Conventional sutures 36 may be used as shown to pull replacement valve
20 within aorta 1 0 until it resides on annulus 34 in a known manner. As further shown in Figure 4A, a plurality of sutures 54 are
typically placed around the annular base 32 and into annulus 34.
Replacement valve 20 must be disposed within aorta 1 0 so as not to
occlude orifices 38, 40 communicating with the left and right coronary
arteries (Figure 2) . As additionally shown in Figure 4A, the typical aortic
replacement valve includes three cusps 42, 44, 46, respectively connected
with the three commisures 26, 28, 30 for movement between open and
closed positions as the heart beats to pump blood into the aorta. Sealing
lines of contact 48, 50, 52 are formed between the respective cusps 42,
44, 46. To maintain an effective seal along lines 48, 50, 52, commisures
26, 28, 30 must be positioned and secured within aorta 1 0 in a precise
manner. In this regard, each commisure should preferably extend in a
relatively perpendicular, non-skewed manner along the interior aortic wall
1 0a, and in a manner that is essentially perpendicular to annular base 32.
If this is not done, strain will be placed on commisures 26, 28, 30 and an
effective seal between cusps 42, 44, 46 may eventually be lost. Undue
strain on commisures 26, 28, 30 can cause decay and calcification and
eventually lead to valve failure and either death or a second surgical
operation.
Figures 2 and 3 illustrate one embodiment of a positioning and
stabilizing device 60 constructed in accordance with the invention.
Generally, positioning and stabilizing device 60 may be used in a temporary
manner while securing commisures 26, 28, 30 to aortic wall 1 0a.
Positioning and stabilizing device 60, in this embodiment, includes an annular portion 62 connected with a plurality of stabilizers 64, 66, 68, each
taking the form of a single elongate member. Each stabilizer 64, 66, 68
preferably bows outwardly along its length so as to generally conform to a
flared region 70 of the aortic root. As one of many possible temporary
securement methods, each stabilizer 64, 66, 68 is slipped between fabric
covering 22 and biologic tissue 24 of replacement valve 20. In the case of
a valve which does not have a fabric covering, other securing structure
such as suture loops, hooks, etc., may be used to attach stabilizers 64, 66,
68. This temporary connection may be made before replacement valve 20
is inserted into aorta 1 0 or after valve 20 is inserted within aorta 1 0. In the
preferred embodiments, assembly of a positioning and stabilizing device and
replacement valve, such as device 60 and valve 20, is felt to be best
accomplished prior to surgery to allow for insertion as a unit. As shown in
Figure 3, once replacement valve 20 and positioning and stabilizing device
60 have been secured within aorta 1 0, with stitches 54 already placed at
annulus 34, suturing of commisures 26, 28, 30 can begin. This may be
accomplished using a typical needle 72 and suturing thread 74 manipulated
by a gripping implement 76. The surgeon places sutures 78 in this manner
along the entire periphery of each commisure 26, 28, 30. It will be
appreciated that other manners of securing replacement valve 20 to aorta
1 0 may be used in accordance with the invention and, for example, include
gluing, stapling or other mechanical fasteners. Figure 4 illustrates the
completely secured replacement valve 20 implanted within aorta 10. It will
be appreciated that, in this embodiment, once positioning and stabilizing device 60 has been removed from the pockets formed between fabric
covering 22 and biologic tissue 24, the distal ends 26a, 28a 30a may be
stitched to the aortic wall 10a.
Figure 5 illustrates one alternative embodiment of a
replacement valve 20' useful in accordance with the invention.
Replacement valve 20 includes pockets 80 on the outside of each
commisure 26, 28, 30 for receipt of an alternative positioning and
stabilizing device 90. Like the first embodiment, positioning and stabilizing
device 90 can include an annular portion 92 and a plurality of three
stabilizers 94, 96, 98. In this embodiment, each stabilizer further
comprises multiple elongate members adapted to be removably inserted
within pockets 80. More specifically, each stabilizer 94, 96, 98 comprises
respective elongate members 94a-c, 96a-c and 98a-c. As will be
appreciated from stabilizer 96, outer elongate members 96a, 96c curve
outwardly from the middle elongate member 96b. In this manner, outer
members 96a, 96c extend within respective pockets 80 along the outer
curved edges 28b, 28c of commisure 28. The remaining stabilizers 94, 98
function in a similar manner. It will be further appreciated that each
stabilizer 94, 96, 98 bows outwardly, as in the first embodiment, to
conform to the flare 70 at the aortic root. Stabilizers 94, 96, 98 are
flexible enough to be withdrawn, as shown in Figure 5, from pockets 80
after suturing of each commisure 26, 28, 30 as previously described.
Positioning and stabilizing device 90 may be formed from various materials and in various configurations for this purpose. These may include metals,
super elastic alloys, or plastics.
Figures 6 and 6A illustrate another alternative positioning and
stabilizing device 1 00 constructed in accordance with the invention. In this
embodiment, an annular portion 1 02 is removable from a plurality of
commisure stabilizers 1 04, 1 06, 1 08. In this manner, positioning and
stabilizing device 1 00 may be used as described above with respect to
devices 60 and 90, except that annular portion 1 02 may be removed for
easier suturing access or other securement access when securing
commisures 26, 28, 30 (Figure 4) to aortic wall 1 0a. One of many
possibilities for facilitating this function is shown in Figure 6 and Figure 6A
in the form of connectors 1 1 0, 1 1 2, 1 14. Each of these connectors may
receive a stabilizer 1 04, 1 06, 1 08 in a removable fashion with a slight
interference fit. As best shown in Figure 6A, an end portion 1 04a of
stabilizer 1 04 may be received with a slight interference fit against a
resilient tab 1 1 6. The other stabilizers 1 06, 1 08 may have a similar
structure, as exemplified by end 1 08a shown in Figure 6. Many other
fastening structures are possible other than this schematically illustrated
example.
Figure 7 illustrates another alternative positioning and
stabilizing device 1 20 having a generally similar construction and function
to device 90 shown in Figure 5. Device 1 20 may be formed from a single
length of wire, for example, and includes portions 1 22, 1 24, 1 26
analogous to the previously described annular portions. A connector 1 28 may be provided to connect opposite ends of the wire. Stabilizers 1 30,
1 32, 1 34 are formed with three sections each for purposes previously
described in connection with Figure 5. These sections 1 30a-c, 1 32a-c,
1 34a-c serve similar functions to position and stabilize the commisures of a
replacement heart valve, and device 1 20 may be removed from the heart
valve in previously described manners.
Figures 8A and 8B illustrate another alternative positioning and
stabilizing device 1 40 constructed from a shape memory material such as
Nitenol. As shown in Figure 8A, device 1 40 may be collapsed in each a
detached form with respect to a heart valve, as shown, or while connected
to a replacement heart valve for insertion within the patient's aorta as a
unit. Upon the application of heat or electric current once inserted within
the aorta, device 1 40 expands to the position shown in Figure 8B and may
then be used as previously described to position and stabilize the heart
valve commisures during implantation. As shown in Figures 8A and 8B,
one illustrative example of this device also includes an annular portion 1 42
and respective three-legged commisure stabilizers 1 44, 1 46, 1 48.
Figures 9 and 9A illustrate another heart valve replacement
apparatus 1 60 constructed in accordance with the invention. In this
embodiment, a replacement heart valve 1 62 may include a flexible material
1 64, optionally part of the fabric covering 1 66 of valve 1 62, which secures
the three commisures 1 68, 1 70, 1 72 together at their respective distal
ends 1 68a, 1 70a, 1 72a. It will be appreciated that flexible material 1 64
may be stitched to the interior aortic wall in conjunction with commisures 168, 170, 172. Thus, material 164 will prevent distal ends 168a, 170a,
172a from expanding away from one another as occurs during late
sinotubular enlargement of the aorta. Therefore, this prevents valve failure
as a result.
As further shown in Figures 9, 9A and 9B, an alternative
embodiment of a positioning and stabilizing device 180 includes an annular
portion 182 constructed from separate sections 182a, 182b, 182c, and a
plurality of three stabilizers 184, 186, 188. Stabilizer 184, 186, 188 again
are shown as three-legged structures for purposes previously described. In
this embodiment, however, stabilizers 184, 186, 188 are retained within
loops 190, which may be suture loops sewn into fabric 166. It will be
appreciated that other types of retaining structure may be used to at least
temporarily retain stabilizers 184, 186, 188. In this embodiment,
connectable end portions 192, 194, formed respectively as male and
female portions, may be used to make various connections and
disconnections on device 180. For example, lower ends of adjacent
stabilizers 184, 186, 188 may be connected at a junction 196 as shown in
Figure 9. This may provide more consistent support along the edges of
commisures 168, 170, 172. As further shown in Figure 9B, stabilizers
184, 186, 188 may be completely disconnectable from annular portion 182
while also allowing selective disconnection of sections 182a, 182b, 182c.
This may be accomplished through the use of connecting elements 198
having respective female connecting portions 198a for engaging male
connecting portions 192. It will be understood that many alternative connectors and structures may be substituted for those shown while
retaining the basic function and general concepts expressed herein.
Figure 1 0 illustrates a heart valve replacement apparatus 200
comprised a replacement heart valve 202, which may be formed from
biological tissue or synthetic biologically compatible material. Heart valve
202 is again illustrated with three commisures 204, 206, 208, as is typical
for replacement aortic valves. A positioning and stabilizing device 21 0 is
fastened to the outside of valve 202, for example, by suture loops 21 1 .
This embodiment of the invention does not have any connection between
the distal ends 204a, 206a, 208a of commisures 204, 206, 208 or at the
distal end of positioning and stabilizing device 21 0. Also, in this
embodiment positioning and stabilizing device 21 0 is formed in three
sections 21 2, 21 4, 21 6 removably connected together at junctions 21 8,
220, 222. These connections may be similar to those shown in Figure 9B.
Other types of connections may be used as well. Use of this embodiment
of the invention will be similar to the previous embodiments, except that
sections 21 2, 21 4, 21 6 may be removed individually from heart valve 202
following completion of its securement within the aorta. Sections 21 2,
21 4, 21 6 are preferably formed of a highly flexible plastic or metal which is
biocompatible. This embodiment provides certain advantages, such as
allowing one or more of the sections 21 2, 21 4, 21 6 to remain in place
following surgery and providing additional room for a surgeon to access
commisures 204, 206, 208 while suturing or otherwise securing
commisures 204, 206, 208 to the aortic wall. It will be appreciated that other configurations and numbers of legs and sections may be utilized by
those of ordinary skill.
Figure 1 1 illustrates an expansion device 240 useful for
expanding a vessel, such as the aorta, during valve replacement
procedures. In this embodiment, expansion device may be formed as a
collapsible and expandable structure, such as by being formed of shape
memory material as described with respect to Figures 8A and 8B. It will be
appreciated that Figure 1 1 shows the expanded condition only. Expansion
device 240 may have three extensions 242, 244, 246 of a desired length
for disposition between the respective commisures of an aortic replacement
valve. Device 240 need not be attached to heart valve commisures, but
may be used to expand the collapsed aorta to the proper flared shape
thereby assisting the surgeon during a heart valve replacement procedure.
This device overcomes the drawbacks of typical retractors which tend to
distort the shape of the collapsed aorta and mislead the surgeon as to the
correct position and orientation of the heart valve. Device 240 may be
formed in various manners to be collapsible and selectively expandable,
such as through the use of mechanically expandable portions or, preferably,
expandable shape memory portions.
Figures 1 2, 1 3A and 1 3B illustrate an alternative collapsible
and expandable retraction device 250. This device may be formed from a
mesh or screen material and includes edge portions 252, 254 which allow
expanding and contracting of the device. An upper end 256 is formed with
a greater diameter than a lower end 258 in the expanded, operative position shown in Figures 1 2 and 1 3B. This allows a surgeon to have
greater access into and through the device to manipulate and, for example,
suture a replacement heart valve in place below device 250 within the
aorta. In use, and referring back to Figure 1 , a surgeon will insert the
device 250 in the collapsed form shown in Figure 1 3A through opening 1 2
such that lower end 258 is situated within aorta 1 0 and upper end 256 is
exposed. The surgeon will then allow device 250 to expand through its
own resilience or through a shape memory property to the position shown
in Figure 1 3B. Alternatively, other activation structure or means may be
provided for attaining the expanded condition. Once expanded, aorta 10
generally assumes a natural, pressurized shape allowing placement and
implantation of replacement valve 20 in a more efficient and accurate
manner. It will be understood that the expansion devices shown in Figures
1 1 through 1 3B are illustrated in the simplest currently contemplated
forms. It is further contemplated that additional handles or other support
and actuation structure may be added while achieving the same general
advantages of these embodiments.
Figure 1 5 illustrates another embodiment of the invention.
Specifically, a cannulating device 320 is connected to a vessel 322 by
inserting a tube 324 containing a lumen 326 for introducing fluids into
vessel 322. A suture 328 is tied around the outside of vessel 322, as
shown, and has at least one end secured to a friction lock 332, as best
shown in Figure 1 5A. Friction lock 332 may take many different forms,
however, one simple form is the tab, as shown, with a knurled or roughened undersurface 334 for retaining suture 328 in place and keeping
vessel 322 from sliding off tube 324.
Figures 1 6-1 9 illustrate two additional and similar
embodiments of a cannulating device 340, 340' . Like reference numerals
refer to like structure in these embodiments. As shown in Figure 1 6, a
cannulating device 340 is again shown as used on a vessel 342. A cannula
or tube 344 of device 340 is inserted into vessel 342 and includes a lumen
346 for introducing fluids. A clamp 348 is secured to a hub 350 of device
340 and may take many different forms. In the embodiments shown,
clamp 350 generally comprises a pair of jaws 352, 354. In the
embodiment shown in Figures 1 7 and 1 8, a rubber ligature 356 may be
used and moved from the position shown in Figure 1 8 to the position
shown in Figure 1 7 to clamp jaws 352, 354 against vessel 342. Ligature
356 may be retained in respective recesses 358, 360 when jaws 352, 354
are in the closed position. Each jaw 352, 354 includes a respective semi-
cylindrical jaw portion 362, 364 for partially encircling vessel 342 as best
shown in Figure 1 9.
As further shown in Figures 1 6-1 8, devices 340 and 340' may
be easily manipulated between open and closed positions by way of
handles 366, 368, which may form part of jaws 352, 354 and which are
secured to hub 350 by way of pivot connections 370, 372. It will be
appreciated that various other retaining members and clamps may be used
and, as more specifically related to the embodiments shown, other spring-
biased mechanisms may be used to retain jaws 352, 354 in the closed position. For example, one or more torsion springs (not shown) may be
incorporated into the device 340 shown in Figure 1 6 to normally bias jaws
52, 54 into a closed position.
Additional aspects of the invention are apparent from Figures
1 7 and 1 8. Specifically, with ligature 356 engaged as shown in Figure 1 7,
jaws 352, 354 are biased into a normally closed position as shown in solid
lines. However, the user may squeeze handles 366, 368 together, as
shown in phantom lines. This allows repositioning of device 340' or
handles 366, 368 may be squeezed in this manner while initially attaching
device 340' to vessel 342. As further shown in Figure 1 8, ligature 356
may be moved to a rearward position to hold jaws 352, 354 in an open
position. This holds handles 366, 368 against hub 350. This may be used
as an alternative manner of initially inserting tube 344 (Figure 1 6) into
vessel 342. Once inserted, ligature 356 may be moved into recesses 358,
360 or 359, 361 . As further shown in Figure 1 8, multiple sets of recesses
358, 360 and 359, 361 may provide different degrees of clamping force.
In this illustrative example, recesses 359, 361 will provide greater clamping
force as they are a greater distance apart.
Figures 22 and 23 show another embodiment of the invention.
The electrode comprises a clip 430 which can be pinched onto the heart
432 (Figure 23) for quick attachment with a clip applier. There will be no
bleeding since there is no hole and tissue is merely pinched. The electrode
430 is attached to a wire 434 in a releasable manner. This may be
accomplished with engageable and disengageable loops 436, 438 as shown. When the wire 434 is removed, the electrode stays on the heart
and so there is no ripping of tissue.
Figures 24 and 25 show an alternate attachment of the wire
434 and an alternative electrode 440. This provides even less friction on
removal. It is also easy to see that if the wire 434 comes free accidently
during surgery, it would be very easy to reattach. This is because of the
frictional engagement members 442, 444. Figures 24 and 25 also show an
electrode variation as mentioned above. In this embodiment, there is a
spike 446 that impales the heart which is then squeezed on with a clip
applier as with the first embodiment. This assures better contact with the
heart muscle.
Figure 26 shows another way to attach an electrode to the
heart with a scorpion-type pincer 450 that is pinched with a clip applier.
The sharp ends are squeezed together by the clip applier. Another
alternative releasable electrode/wire link is shown. This again includes
engageable and disengageable members 452, 454.
While the present invention has been illustrated by a
description of a preferred embodiment and while this embodiment has been
described in some detail, it is not the intention of the Applicants to restrict
or in any way limit the scope of the appended claims to such detail.
Additional advantages and modifications will readily appear to those skilled
in the art. The various features and concepts of the invention may be used
alone or in numerous combinations depending on the needs and preferences
of the user. This has been a description of the present invention, along with the preferred methods of practicing the present invention as currently
known. However, the invention itself should only be defined by the
appended claims, wherein we claim:

Claims

1 . Apparatus for replacing a heart valve within a vessel, the
apparatus comprising:
a replacement heart valve having an annular base and a
plurality of commisures extending from the annular base at spaced apart
positions, each commisure having a proximal end connected with the
annular base and an opposite distal end, and
a plurality of commisure stabilizers connected to the
replacement heart valve in a removable manner, wherein the commisure
stabilizers position and stabilize the commisures of the replacement heart
valve as the replacement heart valve is secured within a vessel but are
removable from the replacement heart valve following securement thereof
within the vessel.
2. The apparatus of claim 1 , wherein the commisure stabilizers
are connected together at the spaced apart distal positions by a generally
annular member and each commisure stabilizer further comprises at least
one elongate member.
3. The apparatus of claim 2, wherein the three elongate members
each curve outwardly in a lengthwise direction to urge the commisures of
the replacement heart valve against an interior wall of the vessel.
4. The apparatus of claim 2, wherein the replacement heart valve
includes respective receiving elements to removably receive the respective
commisure stabilizers.
5. The apparatus of claim 4, wherein the receiving elements
further comprise pockets.
6. The apparatus of claim 4, wherein the receiving elements
further comprise loops affixed to said commisures.
7. The apparatus of claim 2, wherein the commisure stabilizers
are removably affixed to the generally annular member.
8. The apparatus of claim 2, wherein each commisure stabilizer
further comprises at least two spaced apart elongate members.
9. The apparatus of claim 1 , wherein each commisure stabilizer
further comprises an elongate central member and a pair of elongate side
members angled away from the elongate central member and extending
along opposite edge portions of the respective commisure.
10. The apparatus of claim 1 , wherein the positioning and
stabilizing device is formed in a collapsible manner allowing insertion into
the vessel in a collapsed state and subsequent expansion for positioning
and stabilizing the valve commisures during securement of the valve within
the vessel.
1 1 . The apparatus of claim 1 1 , wherein the positioning and
stabilizing device is at least partially formed of a shape memory material
allowing the positioning device to be selectively collapsed and expanded.
1 2. The apparatus of claim 1 further comprising a flexible material
connecting the distal ends of the three commisures.
1 3. The apparatus of claim 1 , wherein said replacement heart
valve is formed from animal or human tissue.
1 4. The apparatus of claim 1 , wherein said replacement heart
valve is formed from a synthetic biologically compatible material.
1 5. The apparatus of claim 1 , wherein said commisure stabilizers
are connected to the commisures of said replacement heart valve in a
removable manner.
1 6. A replacement heart valve for implantation within a vessel, the
replacement heart valve comprising:
an annular base,
a plurality of commisures extending from the annular base at
spaced apart positions, said commisures having proximal ends connected
with said annular base and opposite distal ends, and
a flexible fabric material connecting the distal ends of said
commisures and adapted to be secured to said vessel during implantation.
1 7. An expandable and collapsible vessel retraction device
comprising:
a body movable between expanded and collapsed conditions
such that, in the collapsed condition the body may be inserted into an open
vessel and actuated into the expanded condition whereby said vessel
expands into a shape substantially corresponding to the natural pressurized
shape of the vessel.
1 8. The vessel retraction device of claim 1 7, wherein the body is
generally tubular.
1 9. The vessel retraction device of claim 1 7, wherein the body is
at least partially formed of a shape memory material.
20. A method of implanting a replacement heart valve including an
annular base and a plurality of commisures extending from spaced apart
positions of the annular base, the method comprising:
inserting said replacement heart valve into a patient,
connecting at least one commisure stabilizer to each of said
commisures of said replacement heart valve either before or after inserting
said replacement heart valve,
securing said replacement heart valve within the patient using
said commisure stabilizers to orient the commisures of the replacement
heart valve, and
removing said commisure stabilizers from the patient leaving
the secured replacement heart valve in place.
21 . A method of implanting a replacement heart valve including an
annular base and a plurality of commisures extending from spaced apart
positions of the annular base, the method comprising:
connecting three commisure stabilizers of a positioning and
stabilizing device to the respective three commisures of said replacement
heart valve,
inserting said replacement heart valve into a patient,
securing said replacement heart valve within the patient using
said commisure stabilizers to orient the three commisures of said
replacement heart valve, and removing said positioning and stabilizing device from the
patient leaving the secured replacement heart valve in place.
22. A cannulating device comprising:
a hub portion;
a cannula extending from said hub portion and adapted to be
inserted into a blood vessel; and
a retaining member extending from the hub portion and
adapted to retain a suture tied around the blood vessel to prevent the blood
vessel from slipping off the cannula.
23. The cannulating device of claim 22, wherein the retaining
member is a frictional engagement member.
24 The cannulating device of claim 23, wherein the frictional
engagement member includes a roughened surface for engaging the suture.
25. The cannulating device of claim 22, wherein a space is formed
between the hub and the retaining member for receiving and retaining the
suture.
26. A cannulating device comprising:
a hub portion;
a cannula extending from said hub portion and adapted to be
inserted into a blood vessel; and
a clamp coupled with the hub portion and adapted to retain the
blood vessel in a sealed condition on the cannula.
27. The cannulating device of claim 26 further including a biasing
mechanism operative to bias the clamp into at least one of an open position
and a closed position with respect to the vessel.
28. The cannulating device of claim 27, wherein the biasing
mechanism is an elastic ligature.
29. The cannulating device of claim 28, wherein the elastic
ligature is adjustable to provide different degrees of clamping force.
30. The cannulating device of claim 26, wherein the clamp
includes jaws with semi-cylindrical portions for receiving the vessel.
31 . The cannulating device of claim 26, wherein the clamp
includes soft jaw portions for engaging the vessel.
32. A temporary pacemaker lead for connection with heart tissue
of a patient, the temporary pacemaker lead comprising:
a wire having an electrically conductive portion;
a first connector portion on the wire;
an electrode having a second connector portion releasably
engaged with said first connector portion so as to establish electrical
conduction between the electrode and the electrically conductive portion of
the wire, whereby said electrode may be affixed to the heart tissue and
said wire may be releasably secured to the electrode by way of the first and
second connector portions.
33. The temporary pacemaker lead of claim 32, wherein said first
and second connector portions comprise engageable and disengageable
loops.
34. The temporary pacemaker lead of claim 32, wherein the
connector portions each comprise frictionally engaging connector portions.
35. The temporary pacemaker lead of claim 34, wherein the
second connector portion further comprises a pair of frictional engagement
elements.
36. The temporary pacemaker lead of claim 32, wherein the
electrode further includes a spike portion for insertion into the heart tissue.
37. The temporary pacemaker lead of claim 32, wherein the
electrode further comprises a pair of spike portions adapted to be moved
together into the heart tissue.
38. A temporary pacemaker lead for connection with heart tissue
of a patient, the temporary pacemaker lead comprising:
a wire having an electrically conductive portion;
a first connector portion on the wire;
an electrode clip having a second connector portion releasably
engaged with said first connector portion so as to establish electrical
conduction between the electrode clip and the electrically conductive
portion of the wire, said electrode clip having at least one movable portion
allowing fixation of the clip to the heart tissue and wherein said wire may
be releasably secured to the electrode clip by way of the first and second
connector portions.
PCT/US2000/013129 1999-05-12 2000-05-12 Heart valve and apparatus for replacement thereof, blood vessel leak detector and temporary pacemaker lead WO2000067661A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU47132/00A AU4713200A (en) 1999-05-12 2000-05-12 Heart valve and apparatus for replacement thereof, blood vessel leak detector and temporary pacemaker lead

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US09/310,891 US6309417B1 (en) 1999-05-12 1999-05-12 Heart valve and apparatus for replacement thereof
US09/310,891 1999-05-12
US09/312,785 US6256543B1 (en) 1999-05-17 1999-05-17 Temporary pacemaker lead
US09/312,785 1999-05-17
US33049899A 1999-06-11 1999-06-11
US09/330,498 1999-06-11

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Publication Number Publication Date
WO2000067661A2 true WO2000067661A2 (en) 2000-11-16
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