Source: http://www.allindianpatents.com/patents/252002-actuator-for-a-heart-assist-device
Timestamp: 2018-05-23 06:44:24
Document Index: 776715907

Matched Legal Cases: ['art 32', 'art 38', 'art 40', 'art 40', 'art 16', 'art 16', 'art 16', 'art 16']

Indian Patents. 252002:ACTUATOR FOR A HEART ASSIST DEVICE
US Patent No. 4630597 and International PCT Patent Application No. PCT/US00/22992 (WO 01/13974) both disclose heart assist devices that utilise an inflatable balloon that is positioned within an arterial vessel of a patient. The balloons replace a resected portion of the vessel and are cyclically inflated and deflated to expand into the vessel and thus assist in blood displacement during diastole and retract from within the vessel during systole.
The Applicant's International PCT Patent Application No's. PCT/AU00/00654, PCT/AUOl/01187, and PCT/AU02/00974 all disclose actuators that were found to fail due to fatigue in the balloon interfacing with the aorta.
Preferably, during inward displacement, at least part of thelnner surface of the balloon second body portion is able to be drawn against at least part of the inner surface of the balloon first body portion.
In a second aspect, the present invention provides an actuator for a heart assist
device, the actuator including: i a bushing adapted for connection to a hydraulic or pneumatic power source; and
In its preferred form* the heart assist device is configured for extra-aortic counter-pulsation. In this form, the balloon is positioned on the exterior of an arterial vessel.
The balloon is preferably formed from silicone, polyurethane or a polyurethane-polysiloxane block co-polymer. The balloon is preferably formed "by mandrel dipping. The balloon is preferably formed by dipping a suitably shaped mandrel into the polymer and allowing a thin coating of the polymer to cure on the mandrel. The balloon is preferably made of 2 to 4 coatings, with a total thickness of 150-300 microns. The balloon can then be removed from the mandrel.
The balloon is advantageously formed as a single piece. This avoids the presence of a seam line as is disclosed in US Patent specification 4,630,597 or International patent specification WO 01/13974. Such seam lines have been found by the present inventors to raise stress levels in the balloon and reduce the operational life of the balloon.
The balloon preferably also includes a bushing adapted for connection to a hydrauhc or pneumatic power source. The bushing also acts to prevent inward collapse of the balloon neck portion during deflation. If desired the bushing can be formed with internal restrictions such as flutes, ribs or secondary lumens to prevent the balloon being sucked into the bushing during deflation of the balloon. The neck portion of the balloon is preferably adapted for sealing connection with the bushing. The bushing preferably has a taper adapting the relatively large diameter of the neck of the balloon to the relatively small diameter of a hydraulic or pneumatic fluid line connecting the balloon to a power source. This taper is preferably elongated to enhance the flexibility of the bushing along its central axis.
Fig. 2 is an assembled, partial cut away, perspective view of the actuator shown in Fig, 1;
Fig. 10 is a perspective view of the actuator shown in Fig. 9; and Fig. 11 is a front view of the actuator shown in Fig. 9.
Fig.l shows an exploded perspective view of an actuator 10 according to a first embodiment of the present invention, which is sized for paediatric use. The actuator 10 has a flexible, inflatable balloon 12, an inelastic shroud 14, and a relatively rigid bushing 16.
When viewed in plan, the first and second body portions are generally elliptical in shape and have a maximum width and length of about 20-3 5mm and 50-90mm respectively for adult sized balloons. The balloon neck portion has a diameter of approximately 10-14mm at its distal end 18a and, at its proximal end 18b, it is elliptical in shape with dimensions of approximately 30-50mm in the long axis and 15-30mm in the short axis of the balloon 12, and with a converging taper therebetween. Paediatric balloons are also considered in this same application, but scaled downward appropriately.
The shroud 14 is formed, by mandrel dipping, from a material substantially equivalent to the material used for the balloon, such as a Polyurethane or a Polyurethane-Polysiloxane block co-polymer. The shroud 14 has a narrower neck portion 28 which is joined to a wider body portion 30 by a flared part 32. The shroud body portion 30 is also generally elliptical in shape when viewed in plan and has a larger peripheral extent (ie extends further in all directions) than the balloon body portions 22 and 26 and flexure region 24. More particularly, the shroud body portion 30 has a length (along the long axis of the balloon 12) of 60-100mm and a minimum width of (across the short axis of the balloon 12) of 20 mm. The shroud neck portion 28 is sized to be a snug sealing fit over the exterior of the balloon neck portion 18.
The bushing 16 is formed, by injection moulding, from a flexible plastic such as Polyurethane or a similar material. The bushing 16 has a hollow bore 36 which is adapted
for sealing connection with a fluid line from a motive power source such as a fluid pump (not shown). Suitable pumps are disclosed in the Applicant's International PCT Patent Application No. PCT/AU02/00974 entitled "A fluid pressure generating means", the contents of which are hereby incorporated by cross reference. The bushing 16 also has a relatively more tapered distal part 38 and a relatively less tapered proximal part 40. The proximal part 40 is sized to be a snug sealing fit within the interior of the balloon neck portion 18.
The operation of the device 10 will now be described by with reference to Figs. 3 and 4. Fig. 3 is a cross-sectional (anteror) view along the longitudinal direction of the aorta. Fig. 4 is a partial cross-sectional view orientated at 90 degrees from that of Fig. 3.
For extra-aortic heart assistance, the device 10 is placed with the balloon second portion 26 adjacent the exterior of an: arterial vessel, most preferably the outer part of the ascending aorta (not shown). A flexible, relatively inelastic wrap is placed over the shroud 30 and around the aorta in order to retain the device 10 in place. Wraps are well known in the art and thus will not be described in further detail. The wrap can also be used in place of the shroud.
In use, fluid is cyclically driven to and from the balloon 12, via the bushing bore 36, to cyclically inflate and deflate 1he balloon 12. The inflated balloon 12 is shown in solid line in Fig. 3. The inflated balbon 12 compresses the aorta and thus assists in blood displacement during diastole. When the balloon 12 is deflated it retracts to the position shown in phantom line, which allows the aorta to return to its natural shape during systole.
As Figs. 3 and 4 show, when the balloon 12 is inflated the shroud 14 restrains the balloon first portion 22, up to and including the part adjacent the flexure region 24, against outward displacement past a predetermined limit. That limit being defined by the shape of the shroud body portion 30. However, the shroud 14 does not restrain the
inward displacement of the balloon first portion 22, particularly that part at or near the flexure region 24, during deflation. This allows the balloon 12 to always retain a relatively large radius of curvature (e.g. 1.0mm) adjacent the flexure region 24, which is the part of the balloon 12 that undergoes the most deformation. This advantageously minimises stress and strain concentration in the flexure region 24, which results in a much more reliable and longer lasting balloon 18.
This is in contrast to the balloons shown in the two prior art documents mentioned previously which are restrained at a region equivalent to the flexure region for both inward and outward displacement. These balloons undergo a movement akin to pivoting or bending at their free edge;. This results in high levels of stress concentration, and associated higher risk of failure, :n those balloons.
Further, cycle testing of a group of actuators configured for use with sheep (and corresponding to the actuator 10 described above) were terminated after the equivalent of two years cycling without any failixes. In addition, cycle testing of similar actuators configured for use with humans has achieved the equivalent of 18 months use without any failures.
The actuator 10 is also simpler, and thus cheaper, to assemble and manixfacture than the prior art devices as the bushing 16 only engages with the balloon 12 in the region of their respective neck portions 40, 18, as opposed to positioning the bushing (or shell) more fully within the body portions of the balloon.
It should also be noted that the inward concavity of the balloon (when deflated) is designed to fit the arcuate ascending aorta particularly, to allow a conformal wrapping of the assembled actuator around the ascending aorta. With balloon inflation, the aortic wall is displaced in a "thumbprintimg" manner, which has been shown by finite element analysis to cause minimal strain concentration in the aortic wall and also to provide maximal blood volume displacement
In a more preferred embodiment, the balloon has in its longitudinal plane, a gentle arc of the order of radius of 150-300mm, to accommodate the slight spiral nature of the ascending aorta, to allow further conformal fitting of the assembled device.
Figs. 7 and 8 show a balloon 60 for a third embodiment of actuator according to the invention. The balloon 60 is sized for adult use is but is otherwise similar to the first embodiment and like reference numerals are used to indicate like features. When viewed in plan, the first and second body po: lions 24 and 26 are generally elliptical in shape and have a maximum width and length cf 35mm and 80mm respectively. The balloon neck portion has a diameter of approximately 10mm at its distal end 18a and approximately 26-44mm (oval in cross-section) at its proximal end 18b and a conical converging taper therebetween.
central cylindrical part 16a attached
Figs. 8 to 10 show a fourth embodiment of actuator 70 according to the invention. Like features to earlier embodiments are indicated with like reference numerals. The actuator 70 utilises the balloon 60 shown in Figs. 7 and 8. The bushing 16 of the actuator 70 differs from earlier embodiments in that it is substantially hollow with a
It will be appreciated by the and/or modifications can be made to
at one end to an outer flared conical part 16b. A series of radial webs 16c are provided between the central cylindrical part 16a and the flared conical part 16b. A flexible;, relatively inelastic wrap 72 is provided over the balloon 60, which has an opening 72a through which the bushing 16 protrudes.
persons skilled in the art that numerous variations the invention as shown in the specific embodiment without departing from the spirit or scope of the invention as broadly defined. For example, the blood displacing devices are described above in relation to extra-aortic counter-pulsation but also suitable for intra aortic counter-pulsation. In the latter the second portion of the balloon replaces a resected portion of arterial vessel, with the opening made in the resected arterial vessel being sealingly connected to the balloon adjacent the flexure region.
1.	An actuator for a heart assist device, the actuator including:
an inflatable balloon having; a first body portion, a second body portion and a flexure region joining the first and second body portions; and
displacement towards the shroud
wherein the balloon and the shroud or wrap are shaped such that the shroud or wrap restrains a part of the balloon first body portion at or near the flexure region against
or wrap past a predetermined limit but allows unrestrained displacement away from the shroud or wrap.
2.	The actuator as clamed in claim 1, wherein the balloon and the shroud are shaped such that the shroud restrains said part of the balloon first body portion at or near the flexure region against outward displacement during inflation of the balloon but allows unrestrained inward displacement during deflation.
3.	The actuator as clamed in claim 1 or 2, wherein, during inward displacement, at least part of the inner surface of the balloon second body portion is able to be drawn against at least part of the inner surface of the balloon first body portion,
4.	The actuator as claimed in claim 1,2 or 3, wherein the shroud is generally inwardly concave.
5.	The actuator as claimed in claim 4, wherein the shroud is elongated and elliptical.
Led in any one of the preceding claims, wherein the first body portion, second body portion and flexure region are integrally formed.
7.	The actuator as claimed in claim 6, wherein the first body portion, second body portion and flexure region are integrally formed by dip moulding.
8.	The actuator as claimed in any one of the preceding claims, wherein the actuator also includes a bushing adapted for connection to a motive power source.
9.	The actuator as claimed in claim 8, wherein the balloon also includes a neck portion joined to the first portion, the neck portion being adapted for sealing connection with the bushing.
10.	The actuator as claimed in claim 9, wherein the shroud also includes a neck portion adapted for sealing connection with the balloon neck portion.
11.	An actuator for a h eart assist device, the actuator including:
first end adjacent the neck portion and being generally inwardly concave, the
an inflatable balloon having a narrower neck portion adapted for sealing connection with the bushing exterior, wider first and second body portions and an arcuate flexure region joining the first and second body portions, the first body portion having a
a second end adjacent the second body portion and second body portion being inwardly concave when the balloon is inflated and generally oiitwardly concave when the balloon is deflated.
12.	The actuator as claimed in claim 11, wherein the device also includes a shroud or wrap having a body portion with a peripheral extent at least equal to the peripheral extent of the balloon first and second body portions.
13.	The actuator as claimed in claim 12, wherein the balloon and the shroud or wrap are shaped such that a part of the balloon first body portion at or near the flexure
region is restrained against outward
displacement past a predetermined limit by the
shroud or wrap but unrestrained against inward displacement.
14.	The actuator as claimed in claim 13, wherein during inward
displacement, at least part of the inner surface of the balloon second body portion is able
to be drawn directly against at least part of the inner surface of the balloon first body
15.	A heart assist device including:
connection with the bushing exterior,
a bushing adapted for operative connection to the motive power source; an inflatable balloon having a narrower neck portion adapted for sealing
wider first and second body portions and a flexure region joining the first and second body portions, the first body portion having a first end adjacent the neck portion and a second end adjacent the second body portion and being generally inwardly concave, the second body portion being generally inwardly concave when the balloon is inflated and generally outwardly concave when the balloon is deflated; and
a shroud or wrap having a bbdy portion with a peripheral extent at least equal to the peripheral extent of the balloon first and second body portions,
wherein the balloon and the shroud are shaped such that a part of the balloon first body portion at or near the flexure region is restrained against outward displacement by
the shroud past a predetermined limit
but unrestrained against inward displacement.
16. The device as claimed in claim 15, wherein, during inward
displacement, at least part of the inner surface of the balloon second body portion is able to be drawn against at least part of the inner surface of the balloon first body portion.
17.	The device as claimed in claim 15 or 16, wherein the balloon and shroud are shaped such that substantially all of the balloon first body portion is restrained against outward displacement by the shroud and unrestrained against inward displacement.
18.	The device as clainied in claim 15,16 or 17, wherein the heart assist device is configured for extra-aortic counter-pulsation and the balloon is positioned on the exterior of an arterial vessel.
19.	The device as clainied in claim 15,16 or 17, wherein the heart assist device is configured for use as an interposition graft in which the device replaces a completely resected section of the aoita.
20.	The device as clainied in claim 15,16 or 17, wherein the heart assist device is configured for use as an aortic patch in which an aperture is formed in the aorta which is filled with the heart assist device.
balloon is inflated, the flexure region
The device as clainied in any one of claims 15 to 20, wherein, when the
has a radius of curvature of at least 0.1 mm.
22.	The device as claimed in claim 21, wherein, when the balloon is inflated, the flexure region has a radius of curvature of approximately 1.0 mm.
23.	The device as claimed in claim 22, wherein, when the balloon is inflated, the flexure region has a radius of curvature of approximately 3.0 mm.
24.	The device as clairied in any one of claims 15 to 23, wherein the ratio of the diameter of the balloon neck portion to the balloon flexure region is no more than approximately 4:1.
25.	The device as claimed in any one of claims 15 to 23, wherein the ratio of the diameter of the balloon neck portion to the balloon flexure region is approximately 3:1
26.	The device as claimed in any one of claims 15 to 23, wherein the ratio of the diameter of the balloon neck portion to the balloon flexure region is approximately 2:1
27.	The device as claimed in any one of claims 15 to 26, wherein the bushing has an inlet/outlet bore,
28.	The device as claimed in claim 27, wherein the bore also includes one or more internal restrictions adapted to prevent suction of the balloon into the bore.
29.	The device as claimed in anyone of claims 15 to 28, wherein the balloon is formed from silicone, polyfurethane or a polyurethane-polysiloxane block co-polymer.
30.	The device as claimed in any one of claims 15 to 29, wherein the balloon is formed by mandrel dipping.
31.	The device as claimed in any one of claims 15 to 30, wherein the balloon is formed by dipping a suitably shaped mandrel into the polymer and allowing a thin coating of the polymer to cure on the mandrel.
32.	The device as claimed in claim 31, wherein the balloon is made of 2 to 4 coatings of the polymer.
33.	The device as claimed in claim 32, wherein the balloon a total thickness of 150-300 microns.
34.	The device as claimed in any one of claims 15 to 33, wherein the balloon neck portion is a snug sealing fit over the bushing exterior.
35.	The device as claimed in claim 34, wherein the shroud or wrap has a neck portion that is a snug sealing fit over the balloon neck portion.
36.	The device as claimed in claim 35, wherein the bushing has a slightly tapered neck portion adapted for engagement with the balloon neck portion,
37.	The device as claimed in claim 36, wherein the bushing neck portion has a converging taper in the direction of the balloon.
38.	The device as claimedin any one of claims 15 to 37, wherein the balloon is held in place on the aorta by a flexible wrap which extends about the aorta and bears against the first body portion of the balloon or a shroud mounted thereon.
39.	The device as claimed in claim 38, wherein the flexible wrap is shaped to fit the second body portion of the balloon.
40.	The device as claimed in claim 39, wherein the flexible wrap is also shaped to fit the neck portion.
41.	The device as claimed in claim 38,39 or 40, wherein the flexible wrap . is inelastic or slightly elastic so that its stretch and flexibility characteristics substantially match those of the native aorta.
42.	A flexible inflatable balloon for a blood displacing heart assist device, the balloon including:
the outer peripheries of the :irst and second body portions are connected along an annular inwardly concavely curved flexure portion adapted to maintain a radius of curvature during movement of the second body portion between inwardly concave and outwardly concave during deflation and inflation of the balloon respectively.
43.	The balloon as claimed in claim 42, wherein the balloon is formed as a single piece.
44.	The balloon as claimed in claim 42 or 43, and further including a shroud adapted to overlie and abut the annular first body portion of the balloon.
45.	The balloon as claimed in claim 44, wherein the shroud is shaped such that the shroud restrains said portion of the balloon at or near the flexure region against outward displacement during inflation of the balloon but allows unrestrained inward displacement during deflation.
46.	The balloon as claimed in claim 44 or 45, wherein the shroud is
generally inwardly concave
The balloon as claimed in claim 46, wherein the shroud is elongated, and elliptical.
47.	The balloon as claimed in any one of claims 44 to 46, wherein the shroud also includes a neck portionadapted for sealing connection with the balloon neck portion.
48.	The balloon as clained in claim 48, wherein the shroud is adapted to facilitate bonding of a wrap to the first body portion of the balloon.
49.	The balloon as clained in any one of claims 42 to 49, and further including a bushing adapted for connection to a hydraulic or pneumatic power source.
50.	The balloon as claimed in claim 50, wherein the bushing is formed with internal restrictions such as flutes, ribs, or secondary lumens to prevent the balloon being sucked into the bushing during deflation of the balloon.
51.	The balloon as claimed in claim 50or 51, wherein the neck portion of the balloon is adapted for sealing connection with the bushing.
52.	The balloon as claitned in claim 50, 51 or 52, wherein the bushing has a taper adapting the relatively large diameter of the neck of the balloon to the relatively
small diameter of a hydraulic or pneimatic fluid line connecting the balloon to a power source.
54.	The balloon as claimed in claim 53, wherein this taper is elongated to
enhance the flexibility of the bushing along its central axis.
55.	The balloon as claimed in any one of claims 42 to 54, wherein the
balloon has in its longitudinal plane, a gentle arc of the order of radius of 15O-300mm.
56.	An actuator for a heart assist device, the actuator including:
wherein, during deflation, this second side of the bulbous body portion is able to be drawn against the first side of the bulbous body portion.
57.	The actuator as claimed in claim 56, wherein the shroud or wrap
supports the first side of the balloon bulbous portion against substantial movement whilst
the second side of the balloon bulbous portion is free to move during inflation and
58.	A method of providing extra-aortic heart assistance using the actuator
claimed in any one of claims 1 to 13, 11 to 14 or 56 or 57, or the heart assist device
claimed in any one of claims 15 to 41, or the balloon claimed in any one of claims 40 to
51, the method including mounting the balloon second body portion adjacent the exterior
of an arterial vessel.
59.	A method of providing intra-aortic heart assistance using the actuator
claimed in any one of claims 1 to 10, 11 to 14 or 56 or 57, or the heart assist device
claimed in any one of claims 15 to 41, the method including resecting a portion of an
arterial vessel and mounting the balloon with the balloon second body portion sealingly
replacing the resected arterial portion.
2063-CHENP-2006 CORRESPONDENCE OTHERS 24-06-2011.pdf
2063-CHENP-2006 AMENDED PAGES OF SPECIFICATION 27-03-2012.pdf
2063-CHENP-2006 AMENDED CLAIMS 27-03-2012.pdf
2063-CHENP-2006 CORRESPONDENCE PO.pdf
2063-CHENP-2006 EXAMINATION REPORT REPLY RECEIVED 27-03-2012.pdf
2063-CHENP-2006 FORM-18.pdf
2063-CHENP-2006 FORM-3 27-03-2012.pdf
2063-CHENP-2006 OTHER PATENT DOCUMENT 27-03-2012.pdf
2063-CHENP-2006 POWER OF ATTORNEY 27-03-2012.pdf
2063-chenp-2006-abstract.pdf
2063-chenp-2006-claims.pdf
2063-chenp-2006-correspondnece-others.pdf
2063-chenp-2006-description(complete).pdf
2063-chenp-2006-drawings.pdf
2063-chenp-2006-form 1.pdf
2063-chenp-2006-form 3.pdf
2063-chenp-2006-form 5.pdf
2063-chenp-2006-pct.pdf
2063/CHENP/2006
2A River Street, Birchgrove, NSW 2041
1 MILLER, Scott, Hugh 35/10 Darley Road, Manly, NSW 2095
PCT/AU2004/001487
1 2003906212 2003-11-11 Australia