WO2016038587A1 - Aortoplastie adventitielle superficielle - Google Patents

Aortoplastie adventitielle superficielle Download PDF

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Publication number
WO2016038587A1
WO2016038587A1 PCT/IB2015/057006 IB2015057006W WO2016038587A1 WO 2016038587 A1 WO2016038587 A1 WO 2016038587A1 IB 2015057006 W IB2015057006 W IB 2015057006W WO 2016038587 A1 WO2016038587 A1 WO 2016038587A1
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WO
WIPO (PCT)
Prior art keywords
medical implant
layer
outer fabric
absorbable
resilient material
Prior art date
Application number
PCT/IB2015/057006
Other languages
English (en)
Inventor
Aditya KUMAR SINGH
Original Assignee
Kumar Singh Aditya
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
Application filed by Kumar Singh Aditya filed Critical Kumar Singh Aditya
Publication of WO2016038587A1 publication Critical patent/WO2016038587A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes

Definitions

  • Embodiments of the present invention generally relate to the field of medical implants, and, more particularly, to medical implants for surgical use.
  • the aorta is the largest artery in the body and is elastic in nature. Aorta by itself is quite distensible, stretching and expanding when blood is forced into it from the left ventricle. This stretching creates the potential energy that aids in retaining blood pressure during diastole. Subsequently, the aorta contracts passively when the heart relaxes after contraction. A thoracic aortic aneurysm (TAA) is caused due to weakness in the aorta's wall, which results in widening and bulging of whole or a part of the wall of the aorta. The pressure of blood from the pumping of the heart causes the weakened portion of the aorta to slowly stretch and bulge and expand like a balloon, leading to the formation of an aneurysm.
  • TAA thoracic aortic aneurysm
  • aortic aneurysms Approximately 25 percent of aortic aneurysms occur in the chest, and the rest involve the abdominal aorta. Thoracic aortic aneurysms are serious health risks to the patients because they can enlarge, dissect, burst or rupture. Even though, aortic aneurysms are slow to grow but they can be fatal if there is any complication. A ruptured aneurysm can cause severe internal bleeding, which can rapidly lead to life-threatening hemorrhage or death of the patient. Some patients may have aortic aneurysm extending to the abdominal aorta or may have aneurysms in other arteries of the body.
  • aortic aneurysms and dissections are repaired by a surgical procedure which generally requires a surgeon to open the chest cavity, clamp off the aorta, and repair the aneurysm or dissection, such as by sewing a fabric tube, called a graft, to the site.
  • repair of extensive ascending aortic dissection requires cooling the patient to profound hypothermic level, 16-20 degrees centigrade, in order to allow shutting the blood circulation down; a process called hypothermic circulatory arrest. This enables the surgeon to repair the aortic dissection when it extends into the distal ascending aorta or transverse arch.
  • heart failure is also a chronic condition associated with increased morbidity and mortality and poor quality of life.
  • impaired closure of the aortic valve causes retrograde blood flow from the aorta into the left ventricle during diastole, resulting in increased diastolic intra-ventricular pressure, ventricular volume overload and left ventricle (LV) dilatation and eventually congestive heart failure.
  • LV left ventricle
  • aortic stenosis the aortic valve opening is reduced in area so that increasing pressure gradient is needed to push the blood across the aortic valve orifice. This increase in pressure gradient across the valve can lead to left ventricular hypertrophy, post stenotic aortic dilatation, ischemic changes in the ventricular wall and heart failure.
  • Aortic valve replacement is a cardiac surgery procedure in which a patient's aortic valve is replaced by an artificial valve. Even though aortic valve replacement is usually very successful, the results may be less than ideal in long- term scenario because in some cases ascending aorta can continue to dilate even after AVR and can have all the complications associated with ascending aortic aneurysm. Particularly, ascending aortic dilatation is a late feature after AVR. It can develop in up to 15-20% of patients after AVR. However, depending upon the duration of observation this is likely to increase further.
  • ascending aortic dilatation occurs more frequently and at a younger age in patients with bicuspid aortic valves (BAV) than it does in patients with normal trileaflet aortic valves (TAV).
  • BAV bicuspid aortic valves
  • TAV normal trileaflet aortic valves
  • Ascending aortic dilatation with BAV warrants frequent monitoring, with possible early prophylactic surgical intervention to prevent dissection or rupture.
  • the basis of ascending aortic dilatation may not be entirely related to AVR nonetheless normal degenerative changes with advancing age can also be a likely contributing cause.
  • ascending aortic dilation can also develop after non-related cardiac surgery like mitral valve replacement (MVRs) or atrial septal defect (ASD) as degenerative changes sets in after few decades.
  • MVRs mitral valve replacement
  • ASD atrial septal defect
  • aneurysm is treated by surgical intervention techniques, where the affected portion of the blood vessel is removed or bypassed so that the vessel lumen is replaced by a synthetic graft.
  • this treatment regimen is highly invasive, typically requiring several days of stay after operation in the hospital, and several months of recuperative time.
  • Prophylactic methods for preventing the formation of aneurysms tend to rely on reducing blood pressure in an effort to reduce mechanical stress on the blood vessels.
  • these methods may not be always successful and involve use of drugs that can have undesirable side effects, e.g., kidney or liver damage, especially over long- term use.
  • ascending aorta replacement is performed on borderline dilated aorta along with AVR then many patients are exposed to surgery and risks associated which they didn't need to encounter or would have required in future.
  • External aortic aortoplasty techniques for example aortic wrap can be performed during AVR.
  • External aortic wrapping is technically feasible, safe and effective procedure when done concomitantly with AVR. Results and safety of combined procedure are better than AVR alone and can prevent late dilatation of ascending aorta but has few drawbacks.
  • the overall combined procedure of AVR and aortic wrap is costly and time consuming.
  • the aorta needs to be transected or the graft needs to be cut along the length and than secured together with a snug fit with multiple sutures otherwise aortic erosion can be a major complication.
  • Technically the procedure is time consuming.
  • external aortic wrapping of the aorta can be performed by a synthetic tube, or graft, usually fabricated of either DACRON®, TEFLON®, or other suitable material.
  • Prolene mesh used in hernia surgery and other gastrointestinal surgery may be used in external aortic aortoplasty though not commonly used, as Dacron graft is a better aortoplasty substitute.
  • intravascular stent grafts can be placed inside the dilated ascending aorta later once aortic dilatation reaches sufficient size but not all cases are suitable candidates for intravascular stenting. Isolated ascending aortic stenting is difficult and potential to occlude the coronary arteries or brachiocephalic trunk. Intravascular stenting is better treatment option for descending thoracic aorta. However, the effectiveness of the graft, mesh or any other intravascular devices, such as stent grafts depends upon the device being effectively anchored into the surrounding tissue to provide either structural support or to facilitate healing.
  • the effective attachment of the device or mesh to the tissue is not achieved because the mesh or the implantable medical devices generally are composed of materials that are highly biocompatible and designed to reduce the host tissue response. Therefore, imperfect attachment between the mesh and the patient tissue can have a tendency to migrate within the vessel or tissue in which they are implanted.
  • medical device may be anchored mechanically to the biological tissue, for example, by physical or mechanical means.
  • mechanical fasteners can damage the tissue or vessel wall when the device is deployed.
  • performing external aortic wrapping of the aorta can have its own complication like erosion of the aortic wall by repeated friction between the graft and the aortic wall.
  • the graft has to be sutured and fixed at multiple places for proper results which is time consuming and costly.
  • PARS personalized external aortic root support
  • a medical implant for surgical use includes a central graft body.
  • the central graft body includes a tubular body.
  • the tubular body has a circumference, a proximal end, a distal end, and, one or more layers.
  • the medical implant further includes, an outer fabric stratifying the circumference of the tubular body for providing strength and adhesiveness to the medical implant, and, a resilient material for securely binding the outer fabric on the tubular body.
  • the resilient material traverses through the one or more layers of the tubular body and the outer fabric thereby forming a reticular framework.
  • FIG. 1 illustrates an isometric view of a medical implant, according to an embodiment of the invention
  • FIG. 2 illustrates an isometric view of a straight open graft showing entire length of the medical implant, according to an embodiment of the invention
  • FIG. 3 illustrates an isometric view of the medical implant in folded position, according to an embodiment of the invention
  • FIG. 4A illustrates an isometric view of multiple layers of the medical implant, according to an embodiment of the invention
  • FIG. 4B illustrates a sectional view of the medical implant, according to an embodiment of the invention
  • FIG. 5 illustrates a sectional view of multiple layers of the medical implant, according to an embodiment of the invention.
  • FIG. 6A and FIG. 6B illustrate usage of the medical implant on diseased heart, according to an alternate embodiment of the invention
  • FIG. 7A and FIG. 7B illustrate usage of the medical implant on diseased heart, according to another alternate embodiment of the invention.
  • FIG. 7C and FIG. 7D illustrate usage of the medical implant on diseased heart, according to an alternate embodiment of the invention.
  • FIG. 1 illustrates an isometric view of a medical implant 100, according to an embodiment of the invention.
  • a medical implant 100 for surgical use includes, a central graft body 105 including a tubular body 1 10.
  • the tubular body 1 10 includes a circumference 1 15, a proximal end 120, a distal end 125, and, one or more layers.
  • FIG. 2 illustrates an isometric view of a straight open graft showing entire length of the medical implant, according to an embodiment of the invention.
  • one means to achieve the desirable strength of the plain sheet form 300 of the implant is with overlapping fabric in multiple layers over the bodily tissue till a desired level is achieved.
  • FIG. 3 illustrates an isometric view of the medical implant 100 in folded position, according to an embodiment of the invention.
  • the medical implant 100 further includes, an outer fabric 130 stratifying the circumference 1 15 of the tubular body 1 10 for providing strength and adhesiveness to the medical implant 100, and, a resilient material 135 for securely binding the outer fabric 130 on the tubular body 1 10.
  • the resilient material 135 traverses through the one or more layers of the tubular body 1 10 and the outer fabric 130 thereby forming a reticular framework 140.
  • FIG. 4A illustrates an isometric view of multiple layers of the medical implant
  • FIG. 4B and FIG.5 illustrates a sectional view of multiple layers of the medical implant, according to an embodiment of the invention.
  • the layers of the tubular body 1 10 include a first layer 1 12 and a second layer 1 14.
  • the first layer 1 12 includes a non-absorbable resilient material.
  • the second layer 1 14 includes a non-woven and a non-absorbable meshwork.
  • the mesh work is formed from one or more materials selected from a group consisting of cotton, linen, silk, knitted silkworm silk, insect silk, a polyamide, a polyester, a fluoropolymer, a polyolefin, polyethylene, polypropylene, polydioxone, polycolic acid, polyglactic acid and a blend of any of the foregoing polymers.
  • the outer fabric 130 is a bio-absorbable, adhesive and collagenous polymeric material.
  • the bio-absorbable and collagenous polymeric material is selected from a group including one or more of cellulose, starch, gelatin, fibrin, collagen or other available bioactive bioabsorable material.
  • the tubular graft 1 10 is in an open configuration.
  • the tubular graft 1 10 is tapered slightly from the proximal end 120 to the distal end 125.
  • the tubular graft 1 10 is in an open configuration for entire length of the tubular graft 1 10, as illustrated in FIG. 2.
  • the resilient material 135 is formed from multiple and variable thickness fibres of desirable strength.
  • the medical implant 100 can be coated with one or more therapeutic agents.
  • the therapeutic agent is a bactericidal agent and is selected from silver, rifampicin, vancomycin, minocyclin and the like.
  • a medical implant for surgical use having a self adhesive property includes, a central graft body 105 including one or more layers, an outer fabric 130 stratifying a circumference 1 15 of the central graft body 105 for providing strength and adhesiveness to the medical implant 100, and, a resilient material 135 for securely binding the outer fabric 130 on the central graft body 105.
  • the resilient material 135 traverses through the one or more layers of the central graft body 105 and the outer fabric 130 thereby forming a reticular framework 140.
  • the self-adhesive properties of the medical implant helps to secure the implant in place without any suturing or means of attachment.
  • the central graft body 105 is a tubular tape body 200 as illustrated in FIG. 6A and FIG. 6B of the present invention.
  • the central graft body 105 is a plain sheet form 300 as illustrated in FIG. 7A, FIG. 7B and FIG. 7D of the present invention.
  • the one or more layers of the central graft body 105 include a first layer 1 12 and a second layer 1 14.
  • the first layer 1 12 includes a non-absorbable resilient material
  • the second layer 1 14 includes a non-woven and a non-absorbable meshwork.
  • the outer fabric 130 is a bio-absorbable and collagenous polymeric material.
  • the bio- absorbable and collagenous polymeric material is selected from a group including one or more of cellulose, starch, gelatin, fibrin, thrombin, collagen or other available bioactive bioabsorable material.
  • the mesh work is formed from one or more materials selected from a group consisting of cotton, linen, silk, knitted silkworm silk, insect silk, a polyamide, a polyester, a fluoropolymer, a polyolefin, polyethylene, polypropylene, polydioxone, polycolic acid, polyglactic acid and a blend of any of the foregoing polymers.
  • the meshwork provides the implant more density because of employing strength fibers of polyprolylene, polyamide, silk, and polyester.
  • FIG. 6A and FIG. 6B illustrate usage of the medical implant on diseased heart, according to an alternate embodiment of the invention.
  • the central graft body 105 includes a tubular tape body 200.
  • FIG.7A - FIG.7D illustrates usage of the medical implant 100 on diseased heart, according to an alternate embodiment of the invention.
  • the central graft body 105 includes a plain sheet form 300.
  • the plain sheet form 300 of the medical implant can be cut and made into smaller desirable pieces and parts. Specifically, when the plain sheet form 300 is implanted inside the body with overlapping of edges, the plain sheet form 300 functions as a single implant material fabric in long term as illustrated in
  • FIG. 7D of the present invention Therefore, the present medical implant effectively functions as a single graft fabric even when applied in smaller pieces in continuity.
  • various embodiments of the present invention provide several advantages, such as, for example, but not limited to, a medical implant having a significant post implant strength to resist dilatation or expansions according to desirable strength needed for different bodily tissue using the plain sheet form of the implant.
  • the implant can mold and modify in shape, according to the any surfaces of body tissue or organ. This is due to non-woven interlacing meshwork of polyester, silk, polypropylene and like in one of the layers of the implant.
  • the medical implant has a significant self-adhesive property so it can be secured in place without any suturing or means of attachment.
  • the plain sheet form of the medical implant effectively functions as a single graft fabric even when applied in smaller pieces in continuity.
  • the present medical implant do not have any significant post implant shape memory in immediate post implant time period but yet have restrictive and shape retaining property after the implant is adhered to the surface and undergoes fibrosis and then together with fabric strength and fibrosis, resists delayed dilatation of the aorta or underlying tissue in long time duration.
  • the present medical implant can be utilised over small aneurysmal myocardial areas like apical aneursyms and akinetic and dyskinetic wall of left ventricle, which are not usually treated surgically during cabg surgery but left as such but which have the potential to increase in size, long after index surgery leading to compromised left ventricular function and decreased long term survival.
  • the implant is useful for circumferential area around the mitral annulus during cabg to prevent late dilatation of annular area which can lead to mitral valve regurgitation and delayed complications.

Abstract

L'invention concerne un implant médical, à usage chirurgical, qui comprend un corps de greffe central à configuration ouverte. En particulier, le corps de greffe central comprend un corps tubulaire. L'implant médical comprend, en outre, un tissu externe stratifiant la circonférence du corps tubulaire et un matériau élastique pour fixer fermement le tissu externe sur le corps tubulaire. En utilisation, le matériau élastique passe par une ou par plusieurs couches du corps tubulaire et du tissu externe, formant ainsi une structure réticulaire. L'invention concerne également un tel implant médical auto-adhésif pour empêcher la dilatation tardive de structures chirurgicales.
PCT/IB2015/057006 2014-09-13 2015-09-12 Aortoplastie adventitielle superficielle WO2016038587A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2641/DEL/2014 2014-09-13
IN2641DE2014 IN2014DE02641A (fr) 2014-09-13 2014-09-13

Publications (1)

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WO2016038587A1 true WO2016038587A1 (fr) 2016-03-17

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011082295A2 (fr) * 2009-12-31 2011-07-07 Neograft Technologies, Inc. Dispositifs de greffe et procédés de fabrication
EP2764845A1 (fr) * 2013-02-06 2014-08-13 Xiros Limited Réparation du tissu conjonctif

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011082295A2 (fr) * 2009-12-31 2011-07-07 Neograft Technologies, Inc. Dispositifs de greffe et procédés de fabrication
EP2764845A1 (fr) * 2013-02-06 2014-08-13 Xiros Limited Réparation du tissu conjonctif

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