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The Experience of a Patient with Thyroid Cancer

Posted in Best evidence, Clinical Diagnostics, Curation, Developmental biology, Disease Biology, Small Molecules in Development of Therapeutic Drugs, Electrophysiology, Endocrine Diseases, Experimental validation, Explanatory, Historical relevance, Immunodiagnostics, Inferential analysis, Innovation in Immunology Diagnostics, Interventional Oncology: Radiofrequency Ablation, Transarterial Chemoembolization, Microwave Ablation and Irreversible Electroporation (IRE), Medical Imaging Technology, Image Processing/Computing, MRI, CT, Nuclear Medicine, Ultra Sound, Nutrition, Patient Experience: Personal Memories of Invasive Medical Intervantion, Personalized and Precision Medicine & Genomic Research, Proteomics, Sensors & Analytics, Signaling, Technology Advance Assessment of, Translational Effectiveness, Translational Science, tagged Graves' disease, thyroid cancer, thyroid eye disease, TSH on July 14, 2014| Leave a Comment »

The Experience of a Patient with Thyroid Cancer

Interviewer and Curator: Larry H Bernstein, MD, FCAP

 

Thyroid cancer is usually a fairly innocuous disease, but it can present in different ways. There are are perhaps two main types – medullary, and follicular.  But an anaplastic type is also a third uncommon type.  It is speculative for me to suggest that the anaplastic type is a progression of either of the two main types.  A RAS genotype coexists with the aggressive anaplastic carcinoma.  Thyroid cancers are BRAF positive in genotype.  The histological feature that is used to identify this neoplasm is the presence of “sammoma bodies”.  It is more common in women, and less common in the elderly, and the incidence appears to have increased regionally in recent years.  A recent paper suggests a common specific feature with breast cancer, which is unconfirmed.

When we consider thyroid disease, we start with euthyroid status, hypothyroid and hyperthyroid, all of which are related to the synthetic activity of the gland, that has a right and left lobe joined by a isthmus.  In the midwestern US there is a deficiency of iodine, which leads to nodular thyroid goiter.  The Mayo brothers pioneered in thyroid surgery at their clinic in Rochester, MN.  This led to the insertion of iodine in table salt (Morton’s salt- “when it rains, it pours).  Hyperthyroid status is over production of the hormone by an overactive gland. It is usually primary disease, called Grave’s Disease, after the physician who described it. I am not aware of the occurrence secondary to hyperactivity of the pituitary gland, which would result in both an increased thyroid stimulating hormone (TSH), thyrotropin, and elevated thyroid hormone, except by a primary neoplasm of thyrotropin secreting cells.  The two hormones are under feedback control.  This feedback is a valuable diagnostic indicator because the TSH is suppressed with Grave’s disease.  The TSH assay is very accurate, and as the TSH falls, the TH increases, but the TH assay has never been as accurate as the TSH. The TH is transported in serum by three proteins: thyroxin-binding globulin (TBG), albumin, and trans-thy-retin (TTR), a quadruplex peptide with one subunit binding to retinol-binding protein (RPB), which transports retinol, vitamin A).  The importance of TTR is not a subject for discussion here, but it has extremely important ties to metabolic disease that includes hyperhomocysteinemia and Alzheimer’s disease, as this protein is produced by both the liver and the choroid plexus, but the CP production declines in the elderly.  The TTR metabolism is closely linked to total body sulfur, measured by K+ isotope measurement of lean body mass (fat free mass), and is a more accurate measure than use of urinary creatinine loss, which only measure the structural body mass, but not the visceral component.

There is another twist to the story in that thyroid hormone may be depressed over time secondary to an autoantibody to thyroid “peroxidase”, leading to destruction of the gland.  The thyroid antibody that occurs has been recently reported to be a “peroxidase” antibody in common with the mammary gland.  The disorder is denominated – Hashimoto’s thyroiditis. The presence of thyroid antibody may occur with Grave’s disease, with an occular protrusion with inflammation of the adductor muscles of eye movement.  This is termed “exophthalmus”.  However, thyroid eye disease is known to occur with hypo-, hyper-, and euthyroid status.

I here describe the long and difficult search to identify a confusing case.

 

Family history: Mother had thyroid cancer, surgically cured at Mayo Clinic. Sister had Hashimoto’s thyroiditis. Father had severe rheumatoid arthritis.

History of Illness.  The patient is a male over 65 years age who attended a discussion group for several years and participated in supervised fitness exercises and did daily walks for 2-3 years prior to the discovery of the problem when he recalls, his voice was weak in making presentations to the discussion group (age 86 and over).

At the end of summer, 2013, he experienced shortness of breath and dizziness on walking.  His physician had been concerned about the change of voice prior to this.  He had a history of sleep apnea, and he was actively trying to lose weight.  Cardiac and vascular examination of carotid and of peripheral circulation were unexpectedly excellent.  Pulmonary studies were good.

A visit to an ENT physician did not explain the voice impairment.  An unexpected low TSH result came back < 0.01, compared to a normal result 9 months earlier. This was the first indication of an active cyst or Grave’s disease. The patient was referred for ultrasound exam, and a thyroid panel was ordered.  The result of the ultrasound was an enlarged right lobe with two large degenerate cysts, and a central small calcified cyst.  The cyst was biopsied and it was malignant. It was BRAF pos and RAS negative.

He was referred to the nearest world-class academic center for further endocrine evaluation.  The endocrinologist palpated a thyroid enlargement, and a biopsy was performed of the lymph nodes under a full scan of the neck.  Surgery was scheduled and a surgeon skilled in endocrine surgery and cancer removed the thyroid, and noted that the right lobe compressed the recurrent laryngeal nerve.  This was consistent with en ENT examination of the larynx that showed paralysis of the right larynx.  The good news was that the prediction was that the nerve innovation was good, and would return.

There were a few involved lymph nodes in the removed specimen. The patient was put on synthroid. The next step was to schedule I131 radioiodine treatment by oral tablets.  This required a preparatory diet of no salt or iodine intake prior to treatment.  There was also a 5 day isolation for beta ray emission (which kills residual thyroid cells).  The neck was scanned with a gamma scanned prior to induction of treatment, which required a dose of synthetic TSH and a low dose of I131.   The patiemt is recovered for 14 days post treatment and has regained much energy.

There is a residual burden of the thyroid eye disease that requires special optical care because of loss of distance perception with diplopia.  This is stable, but any surgical repair would have to wait for a year.

 

Notes from PathologyOutlines.com, Nathan Pernick, Editor-in-Chief

Thyroid gland

Reviewer: Zubair W. Baloch, M.D., Shahidul Islam, M.D., Ph.D., Ricardo R. Lastra, M.D., Michelle R. Pramick, M.D., Phillip A. Williams, M.D., MSC (see Reviewers page)

Revised: 11 July 2014, last major update IN PROGRESS
Copyright: (c) 2001-2014, PathologyOutlines.com, Inc.

Endocrine abnormalities and thyroid gland
Hyperthyroidism

Reviewer: Shahidul Islam, M.D., Ph.D.

General
=======================================================

• Accelerated thyroid hormone biosynthesis and secretion by thyroid gland
• Early symptoms: anxiety, palpitations, rapid pulse, fatigue, muscle weakness, tremor, weight loss, diarrhea, heat intolerance, warm skin, excessive perspiration, menstrual changes, hand tremor
• Ocular changes: wide staring gaze and lid lag due to sympathetic overstimulation of levator palpebrae superioris

Thyrotoxicosis: hypermetabolic clinical syndrome due to elevated serum T3 or T4

Types
=======================================================

• Primary hyperthyroidism: intrinsic thyroid abnormality
  • Low TSH, high free T4, normal TRH stimulation test
• Secondary hyperthyroidism: high TSH, abnormal TRH stimulation test
• Subclinical hyperthyroidism: low TSH (< 0.1 µIU/ml), normal T3 and T4 (Eur J Endocrinol 2005;152:1), no clinical hyperthyroidism
  • May be due to exogenous thyroid hormone (Hormones (Athens) 2006;5:119)
  • Patients have increased risk of coronary heart disease (Int J Cardiol 2008;125:41)
• T3 hyperthyroidism: 1-4%ofhyperthyroid patients
  • Low TSH, high free T3, normal free T4
  • Associated with early treatment of hyperthyroidism with antithyroid drugs
• T4 hyperthyroidism:highT4, normal T3
  • Due to primary hyperthyroidism causes, also iodine, amiodarone (Arch Pathol Lab Med 2003;127:e275), pregnancy (2%)

Graves’ disease (85%)

Micro images
=======================================================

Diffuse hyperplasia of thyroid gland

Additional references
=======================================================

• Med J Aust 2004;180:186, eMedicine #1, #2, Wikipedia

Hashimoto’s thyroiditis

General
=======================================================

• Autoimmune disease with goiter, elevated circulating anti-thyroid peroxidase and anti-thyroglobulin antibodies
• First described by Hakaru Hashimoto in 1912 (World J Surg 2008;32:688)

Epidemiology
=======================================================

• 90-95% in women, usually 45-65 years old; clusters in families
• More common in Whites than Blacks or Japanese (Am J Clin Pathol 1994;101:698)
• Most common cause of sporadic goiter in children in iodine sufficient areas (J Pediatr Endocrinol Metab 2007;20:1199)

Clinical features

Clinical features
=======================================================

• Adults present with painless, gradual thyroid failure due to autoimmune destruction, may initially have transient hyperthyroidism
• Children have variable hypothyroidism and reversion to euthyroidism so must monitor thyroid function (Clin Endocrinol (Oxf) 2009;71:451)

• Associated with HLA-DR5 (goitrous form), HLA-DR3 (atrophic form)
• May coexist with SLE, rheumatoid arthritis, Sjögren’s syndrome, pernicious anemia, type 2 diabetes, Graves’ disease, chronic active hepatitis, adrenal insufficiency, MALT lymphoma of gastrointestinal tract (80:1 relative risk), other B cell lymphomas
• Associated with well differentiated thyroid cancer (J Am Coll Surg 2007;204:764)
• May evolve into thyroid lymphoma (J Clin Pathol 2008;61:438)

 

Laboratory
=======================================================

• Autoantibodies include:
  • Anti-TSH (specific for Hashimoto’s and Graves’ disease)
  • Anti-thyroglobulin (less sensitive but similar specificity as anti-thyroid peroxidase, Clin Chem Lab Med 2006;44:837)
  • Anti-thyroid peroxidase (previously called antimicrosomal antibody, sensitive but not specific as 20% of adult women without disease have these antibodies); anti-iodine transporter (rare)
  • Note: anti-TSH antibodies block the TSH receptor in Hashimoto’s disease but stimulate the TSH receptor in Graves’ disease

Papillary carcinoma

• 75-80% of thyroid carcinomas
• Occult tumors in 6% at autopsy (1 to 10 mm), 46% multicentric, 14% with nodal metastases (Am J Clin Pathol 1988;90:72)
• Occult tumors in up to 24% with other thyroid disease, but with male predominance (Mod Pathol 1996;9:816)

Epidemiology
=======================================================

• Usually women (70%) of reproductive age

Clinical features
=======================================================

• Usually presents as painless nodule or mass in neck or cervical node; usually cold on scan
• Usually diagnosed by FNA
• At presentation, 67% in thyroid only, 13% in thyroid and cervical nodes, 20% in nodes only
• Parathyroid gland invasion often occurs early (Arch Pathol Lab Med 2002;126:1511)
• Nodal involvement is often not clinically apparent due to small size and similar consistency; nodal metastases may undergo cystic change and resemble branchial cleft cysts (The Internet Journal of Nuclear Medicine 2007;4:2)
• Proteomic analysis of serum may be useful in future for screening or followup (Arch Otolaryngol Head Neck Surg 2008;134:198)
• Lymph nodes:
  • Measurement of thyroglobulin in FNA from lymph nodes in patients with history of papillary thyroid carcinoma is useful in detecting recurrent disease, especially if specimen is or likely will be inadequate for evaluation (Cytojournal 2008;5:1)
• Risk factors:
  • Ionizing radiation before age 20 (for acne – Surgery 1991;110:691, tonsillitis, tinea capitis, enlarged thymus)
  • Post-Chernobyl (particularly children, Endocr Pathol 2006;17:307) or after exposure to nuclear explosions at Marshall Islands (J Epidemiol 2003;13:99)
  • Hashimoto’s thyroiditis (possibly, Cancer 1995;76:2312)
  • Familial adenomatous polyposis (World J Surg 1998;22:738)
  • Is familial in 4.5%, similar prognosis as sporadic disease (Surgery 2009;145:100)

Prognostic factors
=======================================================

• 10 year survival is 98%, similar to general population (versus 92% for follicular carcinoma); 100% if under age 20, even with nodal metastases
• Cervical nodal involvement does NOT affect prognosis
• 5-20% have local recurrences, 10-15% have distant metastases (lung, bones, CNS)
• Poorer prognosis:
  • Age 40+ or elderly, male (possibly), local invasion (associated with higher incidence of nodal metastases, Arch Pathol Lab Med 1998;122:166), distant metastases (other sites worse than lung, Surgery 2008;143:35), large tumor size, multicentricity, tall cell, columnar or diffuse sclerosing variants
  • Poorly differentiated, anaplastic or squamous foci

added July 14, 2014

Summary – Intraoperative laryngeal nerve monitoring
Objectives: The aim of this study was to stimulate the recurrent laryngeal nerve during thyroidectomy or parathyroidectomy and to record the muscle responses in an attempt to predict postoperative vocal fold mobility.
Patients and methods: Intraoperative recurrent laryngeal nerve monitoring during general anaesthesia was performed by using an electrode-bearing endotracheal tube (nerve integrity monitor EMG endotracheal tube [Medtronic Xomed, Jacksonville, Flo, USA]). Two hundred and fifteen recurrent laryngeal nerves from 141 patients undergoing total thyroidectomy (n = 74),
hemithyroidectomy (n = 63), or parathyroidectomy (n = 4) were prospectively monitored. In each case, the muscle potential was recorded after stimulation of the recurrent laryngeal nerve by a monopolar probe.
Results: The nerve stimulation threshold before and after dissection that induced a muscle response of at least 100 V ranged from 0.1 to 0.85 mA (mean 0.4 mA). The supramaximal stimulation intensity was defined as 1 mA. The amplitude of muscle response varied considerably from one patient to another, but the similarity of the muscle response at supramaximal intensity between pre- and postdissection and between postdissection at the proximal and distal exposed
portions of the nerve was correlated with normal postoperative vocal fold function. Inversely, alteration of the muscle response indicated a considerable risk of recurrent laryngeal nerve palsy, but was not predictive of whether or not this lesion would be permanent.  http://dx.doi.org:/10.1016/j.anorl.2011.09.003

Summary – Prognostic impact of tumour multifocality in thyroid papillary microcarcinoma
European Annals of Otorhinolaryngology, Head and Neck diseases (2012) 129, 175—178

Objective: The objective of this study was to evaluate the prognostic impact of tumour multifocality in papillary thyroid microcarcinoma (PTMC).
Methods: All patients who underwent total thyroidectomy and central neck dissection for PTMC in our institution between 1990 and 2007 were included in this retrospective study. Statistical correlations between tumour multifocality and various clinical or pathological prognostic parameters were assessed by univariate and multivariate analyses.
Results: A total of 160 patients (133 women and 27 men; mean age: 47.8 ± 13.7 years) were included in this study. Tumour multifocality was demonstrated in 59 (37%) patients. Central neck metastatic lymph node involvement was identified in 46 (28%) patients. No statistical correlation was demonstrated between tumour multifocality and the following factors: age, gender, tumour size, extension beyond the thyroid, metastatic central neck lymph node involvement and risk of recurrence. A tumour diameter greater than 5 mm was associated with a higher risk of recurrence (P = 0.008).
Conclusion: Tumour multifocality does not appear to have a prognostic impact in PTMC.   http://dx.doi.org:/10.1016/j.anorl.2011.11.003

Positron emission tomography thyroid carcinoma
European Annals of Otorhinolaryngology, Head and Neck diseases (2012) 129, 251—256

Objectives: Recurrence is observed in 15—20% of patients under surveillance following treatment of differentiated thyroid cancer (DTC). However, due to cell dedifferentiation, the recurrence may be iodine-negative, thereby compromising detection. For this reason, new methods of exploration are indispensable to enable localization of such recurrences. The purpose of this work is to review the contribution of positron emission tomography—computed tomography (PET-CT) in the exploration of iodine-negative recurrent DTC.
Method: A comprehensive review and discussion of the medical literature was carried out.
Results: Depending on the report, the sensitivity of PET-CT ranged from 70% to 85%, with up to 90% specificity. However, the large number of false negatives, which can reach 40%, is the
disadvantage of this examination. PET-CT results lead to change in the therapeutic strategy in approximately 50% of patients with isolated raised serum thyroglobulin levels, and surgical exploration of a precise anatomical area in the neck.
Conclusion: As post-treatment recurrence of a DTC can affect patient survival, a thorough diagnostic work-up is required in these cases. Where thyroglobulin levels are elevated with no uptake on 131-iodine scans, PET-CT can be a useful complementary exploration, especially for localizing the site of recurrence.
http://dx.doi.org:/10.1016/j.anorl.2012.01.003
French ENT Society (SFORL) practice guidelines for lymph-node management in adult differentiated thyroid carcinoma
European Annals of Otorhinolaryngology, Head and Neck diseases (2012) 129, 197—206

Cervical and mediastinal lymph-node management differentiated thyroid carcinoma of the follicular epithelium (DTC) remains controversial. Depending on the situation, pre-operative staging and indications for and extent of lymph-node dissection are still matters of debate, even in case of palpable nodes found on primary surgery. Procedural indications for adenectomy, selective neck dissection, and anatomic regional extension of dissection are not clearly defined.

Questions raised:

• what is lymph-node involvement in DTC?
• what is the prognostic value of lymph-node invasion: for
recurrence, and for survival?

• what baseline assessment is required ahead of treatment
of papillary thyroid carcinoma to assess possible lymphnode
involvement?

• what are the principles of lymph-node surgery?
Central and lateral dissection, and dissection extended to the mediastinum;
• what is the iatrogenesis in cN0 and cN+ neck?
• what is the impact of central and lateral neck dissection on recurrence, survival, secondary treatment and surveillance in cN0 and cN+ ?
• in cN0 patients, when neck dissection is considered, what lymph-node regions should be indicated?
http://www.orlfrance.org/ download.php?id=159.

Molecular Diagnosis for Indeterminate Thyroid Nodules on Fine Needle Aspiration
Expert Rev Mol Diagn. 2013;13(6):613-62

Somatic mutation testing, mRNA gene expression platforms, protein immunocytochemistry and miRNA panels have improved the diagnostic accuracy of indeterminate thyroid nodules, and although no test is perfectly accurate, in the authors’ opinion, these methods will most certainly become an important part of the diagnostic tools for clinicians and cytopathologists in the future.

Several point mutations and gene rearrangements have been identified in thyroid cancer. The most common somatic mutation in differentiated thyroid cancer  has been studied as a potential tool to enhance the diagnostic accuracy of indeterminate FNA lesions – BRAF. This mutation occurs in papillary, poorly differentiated and anaplastic thyroid cancer and causes a V600E substitution in the BRAF protein, which results in neoplastic progression by aberrant activation of the MAPK pathway. The BRAF V600E mutation, along with RET/PTC rearrangements, are a hallmark of thyroid cancer and a vast majority of indeterminate thyroid nodules harboring either one of these two mutations are malignant on final pathology.

The RAS proto-oncogene encodes three different membrane associated GTP proteins: HRAS, KRAS and NRAS. Mutation of these domains causes increased signal transduction through both the MAPK and the PI3K/AKT pathways. These mutations are highly prevalent in FTC and in the follicular variant of papillary thyroid cancer (40–50%) and seldom detected in the classic variant papillary thyroid cancer (10%). RAS mutations have also been identified in benign FA; however, it is unclear whether RAS-positive FA have a higher chance of progression to cancer.

Recurrence detection in differentiated thyroid cancer patients..
Clinical endocrinology, Vol. 72, No. 4. (10 September 2009), pp. 558-563, doi:10.1111/j.1365-2265.2009.03693.x

There was a correlation between TgAb level and recurrence (p = 0.032).
). Recurrence was found in 37.5% of 24 TgAb+/Tg- patients who showed a gradually increasing tendency in serial measurements of TgAb. Sixteen cervical foci (21.1%) missed on neck USG and 17 lesions (22.4%) located outside the neck were additionally detected with PET/CT in TgAb+ patients.

Solving the mystery of iodine uptake
Science 20 June 2014: Vol. 344 no. 6190 p. 1355    http://dx.doi.org:/10.1126/science.344.6190.1355-a

The cell membrane protein NIS (sodium/iodine symporter) transports iodine into thyroid cells, but because iodine concentrations outside of the cell are so low, how it does so is a mystery. The key? Moving two sodium ions along with the iodine ion, Nicola et al found. NIS also does not bind sodium very tightly, but the high concentrations of sodium outside the cell allow one sodium ion to bind. This binding increases the affinity of NIS for a second sodium ion and also for iodine. With the three ions bound, NIS changes its conformation so that it opens to the inside of the cell, where the sodium concentration is low enough for NIS to release its sodium ions. When the sodium goes away, so does NIS’s affinity for iodine, leading NIS to release it.

 

 

 

 

 

 

 

 

 

 

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Device to Support Mitral Valve rather than Replace it: Boston Scientific gave $15 million Loan to Israeli Heart Valve Maker Mvalve in deal for a $200 million Buyout Option

Posted in Cardiac and Cardiovascular Surgical Procedures, Medical Devices R&D Investment, Mitral Valve: Repair and Replacement on July 13, 2014| Leave a Comment »

Device to Support Mitral Valve rather than Replace it: Boston Scientific gave $15 million Loan to Israeli Heart Valve Maker Mvalve in deal for a $200 million Buyout Option

Reporter: Aviva Lev-Ari, PhD, RN

See MValve Three Patent Claims, below 

Israeli heart valve maker Mvalve reportedly pulls in a $15 million investment from Boston Scientific in a deal that includes a $200 million buyout option.

Boston Scientific (NYSE:BSX) reportedly put down a $15 million investment in Israeli heart valve developer Mvalve Technologies that includes a $200 million buyout option.

Mvalve is developing technology to treat mitral valve regurgitation, according to its LinkedIn profile. Co-founder & CEO Assif Stoffman is an executive vice president with Israeli venture capital fund XT Hitech, which is the sole investor in Mvalve, according to Globes. 

SOURCE

http://www.biospace.com/News/stealthy-mvalve-raises-15-million-from-boston/339068

Stealthy Mvalve raises $15M from Boston Scientific

SOURCE

http://www.massdevice.com/news/report-stealthy-mvalve-raises-15m-boston-scientific?page=show

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July 7, 2014 by Brad Perriello

Israeli heart valve maker Mvalve reportedly pulls in a $15 million investment from Boston Scientific in a deal that includes a $200 million buyout option.

Boston Scientific (NYSE:BSX) reportedly put down a $15 million investment in Israeli heart valve developer Mvalve Technologies that includes a $200 million buyout option.

Mvalve is developing technology to treat mitral valve regurgitation, according to its LinkedIn profile. Co-founder & CEO Assif Stoffman is an executive vice president with Israeli venture capital fund XT Hitech, which is the sole investor in Mvalve, according to Globes.

The Boston Scientific investment is a $15 million convertible debt offering, according to the newspaper, which cited unnamed sources.

Mvalve has filed 3 patent applications, 2 covering “Cardiac Valve Support Structure” and another covering “Cardiac Valve Modification Device,” according to PatentBuddy.

SOURCE

http://www.massdevice.com/news/report-stealthy-mvalve-raises-15m-boston-scientific?page=show

MValve:  Three Patents and their Claims

Recent Publications

PUBLICATION #TITLEFILING DATEPUB DATEINTL CLASS

2014/0005,778 CARDIAC VALVE SUPPORT STRUCTUREMar 08, 13Jan 02, 14[A61F]

US Family Size

International Coverage

Abstract

See full text

Cardiac valve supports and their methods of use.

Abstract Image is not Available

First Claim

See full text

1. A cardiac valve support adapted for endovascular delivery to a cardiac valve, comprising:first and second support elements each having a collapsed delivery configuration and a deployed configuration;and wherein at least two bridging members extend from the first support element to the second support element, said bridging members having a delivery configuration and a deployed configuration, wherein said bridging members extend radially inward from the first and second support elements in the deployed configuration.

2. A cardiac valve support adapted for endovascular delivery to a cardiac valve, comprising: first and second support elements each having a collapsed delivery configuration and a deployed configuration; and wherein at least two bridging members extend from the first support element to the second support element, said bridging members having a delivery configuration and a deployed configuration, wherein said bridging members extend longitudinally, and without any appreciable radial curvature, between first and second support elements in the deployed configuration.

3. The cardiac valve support of claim 1 or claim 2, wherein the first and second bridging members extend from the first and second support elements about 180 degrees from one another.

4. The cardiac valve support of claim 1 or claim 2, wherein at least one of the first and second support elements has an annular shape.

5. The cardiac valve support of claim 1 or claim 2, wherein at least one of the first and second support elements has an outer perimeter that is entirely rigid.

6. The cardiac valve support of claim 1 or claim 2, wherein at least one portion of the inner perimeter of at least one of the support elements is elastically deformable in a radial direction.

7. The cardiac valve support of claim 1 or claim 2, wherein at least one of the support elements in its deployed configuration has the form of a flat annular ring, and wherein the difference (Rd) between the outer radius and the inner radius of said annular ring is in the range of 1-14 mm.

8. The cardiac valve support of claim 7, wherein the ratio between Rd and the thickness of the flat annular ring is between 10:1 and 20:1.

9. The cardiac valve support of claim 7, wherein the inner diameter of the flat annular ring is in the range of 23-29 mm and the outer diameter thereof is in the range of 30-50 mm.

10. The cardiac valve support of claim 7, wherein the thickness of the flat annular ring is in the range of 0.25-0.6 mm.

11. The cardiac valve support of claim 1 or claim 2, wherein said support device further comprises one or more extensions, attached to the bridging members or to one or both support elements, such that portion(s) of said one or more such extensions form a guidance element that is capable of centering a wire that is passed through the center of said support device.

12. The cardiac valve support of claim 1 or claim 2, wherein the bridging members and/or the support elements are fitted with heart tissue anchoring means adapted to securely anchor said support elements to the heart wall.

13. The cardiac valve support of claim 1 or claim 2, further comprising one or more intra-ventricular and/or intra-atrial stabilizing elements.

14. The cardiac valve support according to claim 13, wherein the stabilizing elements are selected from the group consisting of complete ring structures, partial rings, curved arms or wings, and elongate arms or wings.

15. The cardiac valve support of claim 1 or claim 2, comprising only two bridging members.

16. A system adapted for endovascular delivery or transapical delivery to replace a mitral valve, comprising: a cardiac valve support according to any one of the previous claims; and a replacement heart valve comprising an expandable anchor and a plurality of leaflets adapted to be secured to the cardiac valve support.

17. The system of claim 16, wherein the replacement heart valve is a prosthetic aortic valve.

18. A method of replacing a patient’s mitral valve, comprising the steps of: (a) delivering a valve support to a location near a subject’s mitral valve, the valve support comprising a first support element, a second support element, and at least two bridging members extending from the first and second support elements; (b) allowing the first support element to unfold from a collapsed configuration to a deployed configuration secured against cardiac tissue in the area of the mitral valve annulus; (c) allowing the bridge members to unfold from their delivery configuration to their deployed configuration positioned in general alignment with the coaptation points of the native mitral valve leaflets; and (d) allowing the second support element to unfold from a collapsed configuration to a deployed configuration secured against cardiac tissue in the area of the mitral valve annulus.

19. The method of claim 18, wherein native cardiac valve leaflet function is maintained throughout the procedure.

20. The method of claim 18, wherein the valve support is delivered either endovascularly or by the transapical route.

21. The method of claim 18, further comprising the step of causing anchoring and/or stabilizing means fitted to the support elements and/or bridging members to come into contact with cardiac tissue.

22. The method of claim 18 further comprising securing a prosthetic cardiac valve to the valve support.

23. The method of claim 22 wherein securing the prosthetic valve to the valve support comprises expanding said valve with a balloon.

24. The method of claim 22 wherein securing the prosthetic valve to the valve support comprises allowing said valve to self-expand.

25. The method of claim 22, wherein the prosthetic valve is delivered by the same route as the valve support.

26. The method of claim 22, wherein the prosthetic valve and the valve support are delivered by different routes.

27. The method of claim 22, wherein the prosthetic cardiac valve is a prosthetic aortic valve.

 SOURCE

http://www.patentbuddy.com/Patent/20140005778

– See more at: http://www.patentbuddy.com/Patent/20140005778#sthash.ZTTVCo0G.dpuf

2013/0304,197 CARDIAC VALVE MODIFICATION DEVICEFeb 27, 13Nov 14, 13[A61F]

SUMMARY OF THE INVENTION

One aspect of the disclosure is a valve-modification and support device, suitable for modifying a prosthetic aortic valve in order that it may be implanted and used as a replacement (prosthetic) mitral valve, such that after attachment of the modification device to the aortic replacement valve, said valve is readily implantable via endovascular delivery in a mitral position, said modification device comprising first and second support elements, wherein said first and second support elements each have a collapsed delivery configuration and a deployed configuration, and wherein at least two bridging members extend from the first support element to the second support element, said bridging members having a delivery configuration and a deployed configuration, wherein said bridging members either extend radially inward from the first and second support elements in the deployed configuration or are entirely straight and devoid of any visible curvature when in said deployed configuration.

In some embodiments the bridging members extend from discrete locations around adjacent support elements, and can be arranged symmetrically around the circumference of said support elements. Thus, in one embodiment, the first and second bridging members can extend from the adjacent support elements at points separated by about 180 degrees along the circumference of said support elements.

In certain other embodiments, the valve modification device may optionally further comprise secondary bridging members that mutually interconnect two or more main bridging members. In other embodiments, secondary bridging members are used to connect one or more of the main bridging members with the support elements. The term ‘secondary bridging members’ is used in this context to distinguish said optional, additional bridges from the main bridging members that connect the first and second support elements, as disclosed hereinabove.

In another aspect, the prosthetic valve modification device comprises a single support element, wherein said support element has a collapsed delivery configuration and a deployed configuration. In one embodiment, the single support element is provided in the form of a flat annular ring, preferably constructed from a material having superelastic and/or shape memory properties. One example of such a suitable material is Nitinol, which possesses both of the aforementioned physical properties. These properties may be utilized in order to permit said device, following its delivery in a collapsed conformation, to return to an expanded memory configuration after being heated above its transition temperature. This embodiment of the modification device is also referred to herein as the ‘single-ring’ valve modification device, while the embodiment having two support elements connected by bridging members disclosed hereinabove, is also sometimes referred to as the ‘two-ring’ modification device.

In some embodiments at least one of the support elements (or the single support element in the case of the one-ring device) has an annular shape.

In some embodiments the bridging members and/or support elements are fitted with replacement valve engagement means adapted to securely engage a replacement heart valve. In some embodiment, the engagements means can have anchoring and/or locking elements adapted to securely lock with a portion of a replacement heart valve. In other embodiments, the replacement valve engagement means are formed from a soft biocompatible material (such as a biocompatible fabric, silicon, PET etc.) which are fitted to the external surface of portions of the support elements and/or bridging members. In these embodiments, the soft, compressible nature of the biocompatible material permits certain portions thereof to be compressed by the struts or other structural elements of the replacement valve, upon expansion within the lumen of the valve support. Other portions of the soft biocompatible material which are not compressed by the expanded replacement valve protrude into the internal space of said valve between the struts and/or other structural elements. The protrusions formed in this way engage and grip the replacement valve thereby preventing its movement in relation to the valve support. In other embodiments, the replacement valve engagement means comprise rigid anchors of a size and shape such that they are capable of entering the internal space of the replacement valve between its struts and/or other structural elements, upon expansion of said valve within the internal space of the valve support.

In some embodiments, the support elements and/or bridging members are fitted with heart tissue anchoring means adapted to securely anchor said support elements to the heart wall. Non-limiting examples of such anchoring means include hooks and spirals.

In some embodiments, the valve-modification device further comprises one or more stabilizing elements, the function of which is to provide additional stabilization of said support within the ventricle and/or atrium. Thus, in some embodiments, the valve-modification device comprises one or more intra-ventricular stabilizing elements, one or more intra-atrial stabilizing elements. In other embodiments, the cardiac valve support will be fitted with at least one intra-ventricular stabilizing element and at least one intra-atrial stabilizing element.

In some embodiments the support element(s) are adapted to preferentially bend at at least one location.

In some embodiments the support element(s) have a curved portion in their deployed configurations, wherein the curved portions are adapted to assume a tighter curved configuration in the collapsed delivery configurations.

In some embodiments of the two-ring modification device the first and second bridging members are generally C-shaped in their deployed configurations.

In some embodiments the support element has at least one coupling element adapted to reversibly couple to a delivery system. The at least one coupling element can be a threaded bore.

In some embodiments of the two-ring prosthetic valve modification device, the second support element has a dimension in the deployed configuration that is larger than a dimension of the first support element in the deployed configuration with or without one or more fixation elements attached and radially engaging in cardiac tissue when needed.

In some embodiments of the two-ring prosthetic valve modification device, the first and second support elements are connected by only two bridging members.

One aspect of the disclosure is a system adapted for endovascular or transapical delivery to replace a mitral valve, comprising: either a two-ring prosthetic valve modification device or a single-ring prosthetic valve modification device as disclosed hereinabove and a replacement heart valve comprising an expandable anchor and a plurality of leaflets adapted to be secured to the cardiac valve support. For the sake of clarity of description, the above disclosure of a delivery system comprising a two-ring prosthetic valve modification device relates to an embodiment of said device in which the two support elements are connected by two bridging members. However, it is to be recognized that the endovascular delivery system of the present invention may be used to deliver cardiac valve supports in which more than two bridging members mutually connect the two support elements.

In some embodiments the bridging members and/or support elements are adapted to securingly engage the replacement heart valve. In one such embodiment, the bridging members are formed such that at least one portion thereof comprises a series of folds or pleats (e.g. z-shaped pleats), the purpose of which is to increase the surface area of the bridging members that are available for interacting with the prosthetic replacement valve. An additional benefit of this embodiment is that the pleated region also assists in the transition between the delivery (closed) conformation of the valve modification device and the deployed (open) conformation thereof. In other embodiments, the replacement valve securing means comprise attachment means, such as hooks or other mechanical anchors that are connected, at one of their ends, to the support elements and/or bridging members, and have a free end for attachment to the replacement valve.

In some embodiments of the invention, the system disclosed hereinabove further comprises pressure measuring elements. These elements may be situated anywhere in the system—including on the surface of the valve modification device, attached to the replacement valve, as well as within the guide catheter. In another embodiment, the system of the invention further comprises connection terminals that permit the connection of pacemaker leads to various parts of said system.

One aspect of the disclosure is a method of replacing a patient’s mitral valve, comprising: attaching a valve-modification device to an aortic replacement valve (either at the product manufacture or assembly site—e.g. in the factory—or in the hospital or other clinical setting prior to the procedure), the valve-modification device comprising a first support element a second support element, and at least two bridging members extending from the first and second support elements; Implanting the interconnected replacement valve and valve-modification device in the mitral valve annulus.

Similarly, the invention is also directed to a method of replacing a patient’s mitral valve, comprising: the ex vivo attachment of a valve-modification device to an aortic replacement valve (either at the product manufacture or assembly site—e.g. in the factory—or in the hospital or other clinical treatment room prior to the procedure), the valve-modification device comprising a single support element; Implanting the interconnected replacement valve and valve-modification device in the mitral valve annulus.

In one embodiment, the above-defined methods may be employed to deliver the prosthetic valve and modifying device by an endovascular route. In another embodiment, the methods may be used to deliver the valve and modifying device by a transapical route.

The valve-modification device may be self expanding, or may be balloon expandable.

In a preferred embodiment the modifying device is self expandable and is constructed from biocompatible metals such as Nitinol, Cobalt based metal, Stainless steel.

In other embodiments, the above-defined method further comprises the step of causing intra-ventricular stabilizing elements and/or intra-atrial stabilizing elements to engage, respectively, the inner ventricular wall and/or inner atrial wall.

For the sake of clarity of description, the above disclosure of a method for replacing a patient’s mitral valve using a two-ring prosthetic valve modification device relates to a method that uses a cardiac valve-modification device in which the two support elements are mutually connected by two bridging members. However, it is to be recognized that the endovascular delivery system of the present invention may be used to deliver cardiac valve supports containing more than two support elements and more than two bridging members.

SOURCE

http://www.patentbuddy.com/Patent/20130304197

– See more at: http://www.patentbuddy.com/Patent/20130304197#sthash.bkkEnilX.dpuf

2012/0059,458 Cardiac Valve Support StructureSep 01, 11Mar 08, 12[A61F]

Claims

---

1. A cardiac valve support adapted for endovascular delivery to a cardiac valve, comprising:a first support element with a collapsed delivery configuration and a deployed configuration;a second support element with a collapsed delivery configuration and a deployed configuration;a first bridging member extending from the first support element to the second support element, wherein the first bridging member has a delivery configuration and a deployed configuration; anda second bridging member extending from the first support element to the second support element, wherein the first bridging member has a delivery configuration and a deployed configuration;wherein the first and second bridging members extend radially inward from the first and second support elements in the deployed configurations.

2. The cardiac valve support of claim 1 wherein the first and second bridging members extend from first and second discrete locations around the first and second support elements.

3. The cardiac valve support of claim 2 wherein the first and second bridging members symmetrically extend from the first and second support elements.

4. The cardiac valve support of claim 2 wherein the first and second bridging members extend from the first and second support elements about 180 degrees from one another.

5. The cardiac valve support of claim 1 wherein at least one of the first and second support elements has an annular shape.

6. The cardiac valve support of claim 1 wherein the first and second bridging members each have a replacement valve engagement portion adapted to securely engage a replacement heart valve.

7. The cardiac valve support of claim 6 wherein the engagements portions each have a locking element adapted to securely lock with a portion of a replacement heart valve.

8. The cardiac valve support of claim 1 wherein the first and second support elements are adapted to preferentially bend at least one location.

9. The cardiac valve support of claim 1 wherein the first and second support elements each have a curved portion in their deployed configurations, wherein the curved portions are adapted to assume a tighter curved configuration in the collapsed delivery configurations.

10. The cardiac valve support of claim 1 wherein the first and second bridging members are generally C-shaped in their deployed configurations.

11. The cardiac valve support of claim 1 wherein the first support element has at least one coupling element adapted to reversibly couple to a delivery system.

12. The cardiac valve support of claim 10 wherein the at least one coupling element is a threaded bore.

13. The cardiac valve support of claim 1 wherein the second support element has a dimension in the deployed configuration that is larger than a dimension of the first support element in the deployed configuration.

14. A system adapted for endovascular delivery to replace a mitral valve, comprising: a cardiac valve support comprising a first support element with a collapsed delivery configuration and a deployed configuration; a second support element with a collapsed delivery configuration and a deployed configuration; a first bridging member extending from the first support element to the second support element, wherein the first bridging member has a delivery configuration and a deployed configuration; and a second bridging member extending from the first support element to the second support element, wherein the first bridging member has a delivery configuration and a deployed configuration; wherein the first and second bridging members extend radially inward from the first and second support elements in the deployed configurations; and a replacement heart valve comprising an expandable anchor and a plurality of leaflets adapted to be secured to the cardiac valve support.

15. The system of claim 14 wherein the bridging members are adapted to securingly engage the replacement heart valve.

16. A method of replacing a patient’s mitral valve, comprising: endovascularly delivering a valve support to a location near a subject’s mitral valve, the valve support comprising a first support element, a second support element, and first and second bridging members extending from the first and second support elements; expanding the first support element from a collapsed configuration to a deployed configuration secured against cardiac tissue below the plane of the mitral valve annulus; expanding the bridge members from delivery configurations to deployed configurations positioned in general alignment with the coaptation points of the native mitral valve leaflets; and expanding the second support element from a collapsed configuration to a deployed configuration secured against left atrial tissue above the plane of the mitral valve annulus.

17. The method of claim 16 wherein expanding the first support element comprises allowing the first support element to self-expand against cardiac tissue.

18. The method of claim 16 wherein expanding each of the bridge members comprises allowing the bridge members to assume a deployed configuration in which they extend radially inward from the first and second support elements.

19. The method of claim 16 wherein expanding the second support element against left atrial tissue comprises allowing the second support element to self-expand.

20. The method of claim 16 wherein expanding the first support element comprises expanding the first support element towards a generally annularly shaped deployed configuration.

21. The method of claim 16 wherein expanding the first support element comprises expanding the first support element secured against papillary tendons.

22. The method of claim 21 wherein expanding the first support element comprises expanding the first support element secured against papillary tendons without displacing them.

23. The method of claim 16 wherein native leaflets function after expanding the second support element.

24. The method of claim 16 wherein expanding the first support element occurs before expanding the second support element.

25. The method of claim 16 wherein expanding the bridge members comprises allowing the bridge members to symmetrically extend from the first support element to the second support element.

26. The method of claim 16 wherein expanding the bridge members comprises allowing the bridge members to extend from the first and second support elements about 180 degrees from one another.

27. The method of claim 16 wherein expanding the second support element comprises expanding the second support element to the deployed configuration in which the second support element has a dimension larger than a dimension of the first support element in the deployed configuration.

28. The method of claim 16 further comprising securing a replacement mitral valve to the valve support.

29. The method of claim 28 wherein securing the replacement mitral valve to the valve support comprises expanding the replacement mitral valve from a collapsed delivery configuration to an expanded configuration.

30. The method of claim 29 wherein expanding the replacement mitral valve comprises expanding the replacement mitral valve with a balloon.

31. The method of claim 29 wherein expanding the replacement mitral valve comprises allowing the replacement mitral valve to self-expand.

32. The method of claim 28 wherein securing a replacement mitral valve to the valve support comprises securing the replacement mitral valve radially within the valve support.

33. The method of claim 28 wherein securing a replacement mitral valve to the valve support comprises locking a replacement mitral valve element with a valve support element to lock the replacement mitral valve to the valve support.

34. The method of claim 33 wherein the bridge members each comprise a bridge lock element and the replacement mitral valve comprises a plurality of lock elements, and the locking step comprises locking one of the plurality of lock elements with one of the bridge lock elements and locking a second of the plurality of lock elements with the other of the bridge lock elements.

SOURCE

http://www.patentbuddy.com/Patent/20120059458

– See more at: http://www.patentbuddy.com/Patent/20120059458#sthash.4348GcVl.dpuf

– See more at: http://www.patentbuddy.com/Company/Profile/MVALVE-TECHNOLOGIES-LTD./5066825#sthash.PrSC4bIS.dpuf

 

SIMILAR ENTRIES

• MassDevice.com +3 | The top 3 medtech stories for July 7, 2014
• BSX invests $15M in Mvalve Technologies | Medtech funding for the week of July 7, 2014

 

Stealthy Mvalve has a single-page website listing only its name, an owner login and the slogan “A paradigm shift in the treatment of mitral regurgitation.” Its device is designed to support the mitral valve rather than replace it, according to Globes.[link broken]

 

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