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[287 U.S. 367, 368] Mr. Basil O'Connor, of New York City, for petitioner.
Mr. George Whitefield Betts, Jr., of New York City, for respondent.
Santiago, a seaman, shipped on the respondent's vessel for a voyage from the harbor of New York to Boca Grande, Fla., and return. On the home voyage, he fell ill of pneumonia, and died in a hospital after reaching the home port. His administrator, the petitioner, sued to recover damages for his death, which was charged to have been caused by the failure of the master of the ship to give him proper care. In the District Court there was a judgment for the petitioner, which was reversed upon appeal. The reversal was on the ground that the seaman's right of action for negligent care or cure was ended by his death, and did not accrue to the administrator for the use of next of kin. (C.C.A.) 52 F.(2d) 22. The case is here on certiorari. 285 U.S. 535 , 52 S.Ct. 458.
By the general maritime law, a seaman is without a remedy against the ship or her owners for injuries to his person, suffered in the line of service, with two exceptions [287 U.S. 367, 371] only. A remedy is his if the injury has been suffered as a consequence of the unseaworthiness of the ship or a defect in her equipment. The Osceola, 189 U.S. 158 , 23 S.Ct. 483; Chelentis v. Luckenbach S.S. Co., 247 U.S. 372 , 38 S.Ct. 501; Pacific S.S. Co. v. Peterson, 278 U.S. 130, 134 , 49 S.Ct. 75. A remedy is his also if the injury has been suffered through breach of the duty to provide him with 'maintenance and cure.' The duty to make such provision is imposed by the law itself as one annexed to the employment. The Osceola, supra. Contractual it is in the sense that it has its source in a relation which is contractual in origin, but, given the relation, no agreement is competent to abrogate the incident. If the failure to give maintenance or cure has caused or aggravated an illness, the seaman has his right of action for the injury thus done to him; the recovery in such circumstances including not only necessary expenses, but also compensation for the hurt. The Iroquois, 194 U.S. 240 , 24 S.Ct. 640. On the other hand, the remedy for the injury ends with his death in the absence of a statute continuing it or giving it to another for the use of wife or kin. Western Fuel Co. v. Garcia, 257 U.S. 233, 240 , 42 S.Ct. 89; Lindgren v. United States, 281 U.S. 38, 47 , 50 S.Ct. 207. Death is a composer of strife by the general law of the sea as it was for many centuries by the common law of the land.
The question then is to what extent the ancient rule has been changed by modern statute. Section 33 of the Merchant Marine Act of 1920, commonly known as the Jones Act1 (41 Stat. 1007, 33, 46 U.S. Code, 688 (46 USCA 688)), [287 U.S. 367, 372] gives a cause of action to the seaman who has suffered personal injury through the negligence of his employer. For death resulting from such injury, it gives a cause of action to his personal representative. We are to determine whether death resulting from the negligent omission to furnish care or cure is death from personal injury within the meaning of the statute.
The argument is pressed upon us that the care owing to a seaman disabled while in service is an implied term of his contract, and that the statute cannot have had in view the breach of a duty contractual in origin for which he had already a sufficient remedy under existing rules of law.
We think the origin of the duty is consistent with a remedy in tort, since the wrong, if a violation of a contract, is also something more. The duty, as already pointed out, is one annexed by law to a relation, and annexed as an inseparable incident without heed to any expression of the will of the contracting parties. For breach of a duty thus imposed, the remedy upon the contract does not exclude an alternative remedy built upon the tort. The passenger in a public conveyance who has been injured by the negligence of the carrier, may sue for breach of contract if he will, but also at his election in trespass on the case. Jackson v. Old Colony Street Ry., 206 Mass. 477, 485, 92 N.E. 725, 30 L.R.A.(N.S.) 1046, 19 Ann.Cas. 615; Busch v. Interborough R.T. Co., 187 N.Y. 388, 391, 80 N.E. 197, 10 Ann.Cas. 460; Rich v. N.Y.C. & H. Rev. Railroad Co., 87 N.Y. 382, 390; Neil v. Flynn Lumber Co., 71 W.Va. 708, 77 S.E. [287 U.S. 367, 373] 324. Cf. the cases cited in Pollock on Torts (13th Ed.) p. 557 et seq. The employee of an interstate carrier, injured through the omission to furnish him with safe and suitable appliances, may have a remedy under the Federal Employers' Liability Act 1 (45 U.S. Code 51 (45 USCA 51)), or at times under the Safety Appliance Act 1 to 6 (45 U.S. Code, 1 to 6 ( 45 USCA 1 to 6)), though the omission would not be actionable in the absence of a contract creating the employment. So, in the case at hand, the proper subject of inquiry is not the quality of the relation that gives birth to the duty, but the quality of the duty that is born of the relation. If the wrong is of such a nature as to bring it by fair intendment within the category of a 'personal injury' that has been caused by the 'negligence' of the master, it is not put beyond the statute because it may appropriately be placed in another category also.
We are thus brought to the inquiry whether 'negligence' and 'personal injury' are terms fittingly applied to the acts charged to the respondent. The case is helped by illustrations. Let us suppose the case of a seaman who is starved during the voyage in disregard of the duty of maintenance, with the result that his health is permanently impaired. There is little doubt that in the common speech of men he would be said to have suffered a personal injury, just as much as a child in an orphan's home who had been wronged in the same way. Cf. Queen v. Instan, (1895) 1 Q.B. 450. Let us suppose the case of a seaman slightly wounded through his own fault, but suffering grievous hurt thereafter as a consequence of septic poisoning brought about by lack of treatment. The common speech of men would give a like description to the wrong that he had suffered. The failure to provide maintenance or cure may be a personal injury or something else according to the consequences. If the seaman has been able to procure his maintenance and cure out of his own or his friends' money, his remedy [287 U.S. 367, 374] is for the outlay, but personal injury there is none. If the default of the vessel and its officers has impaired his bodily or mental health, the damage to mind or body is none the less a personal injury because he may be free at his election to plead it in a different count. Cf. Pacific S.S. Co. v. Peterson, supra, pages 137, 138 of 278 U.S., 49 S.Ct. 75. Nor is liability escaped by appeal to the distinction between acts of omission on the one hand and those of commission on the other. Moch Co. v. Rensselaer Water Co., 247 N.Y. 160, 167, 168, 159 N.E. 896, 62 A.L.R. 1199. A division is sometimes drawn between the termination of a relation at a time when it is still executory or future, and its termination when performance has gone forward to such a point that abandonment of duty becomes an active agency of harm. Moch Co. v. Rensselaer Co., supra. The respondent is not helped though its treatment of the seaman be subjected to that test. Here performance was begun when the vessel started on her voyage with Santiago aboard and with care and cure cut off from him unless furnished by officers or crew. From that time forth withdrawal was impossible and abandonment a tort. Given a relation involving in its existence a duty of care irrespective of a contract, a tort may result as well from acts of omission as of commission in the fulfillment of the duty thus recognized by law. Moch Co. v. Rensselaer Water Co., supra, citing Pollock on Torts (13th Ed.) p. 567; Kelley v. Met. Ry. Co., (1895) 1 Q.B. 944.
We are told, however, that the personal injury from negligence covered by the statute must be given a narrow content, excluding starvation and malpractice, because for starvation and malpractice the seaman without an enabling act had a sufficient remedy before. The seaman may indeed have had such a remedy, but his personal representative had none if the wrong resulted in his death. While the seaman was still alive, his cause of action for personal injury created by the statute may have [287 U.S. 367, 375] overlapped his cause of action for breach of the maritime duty of maintenance and cure, just as it may have overlapped his cause of action for injury caused through an unseaworthy ship. Pacific S.S. Co. v. Peterson, supra, page 138 of 278 U.S., 49 S.Ct. 75; Baltimore S.S. Co. v. Phillips, 274 U.S. 316, 321 , 324 S., 47 S.Ct. 600. In such circumstances it was his privilege, in so far as the causes of action covered the same ground, to sue indifferently on any one of them. The overlapping is no reason for denying to the words of the statute the breadth of meaning and operation that would normally belong to them, at all events when a consequence of the denial is to withhold any remedy whatever from dependent next of kin. A double remedy during life is not without a rational office if the effect of the duplication is to carry the remedy forward for others after death. The argument for the respondent imputes to the lawmakers a subtlety of discrimination which they would probably disclaim. There was to be a remedy for the personal representative if the seaman was killed by the negligent omission to place a cover over a hatchway or to keep the rigging safe and sound. There was to be none, we are told, if he was killed for lack of food or medicine, though the one duty equally with the other was attached by law to the relation. This court was held that the act is to be liberally construed in aid of its beneficent purpose to give protection to the seaman and to those dependent on his earnings. Jamison v. Encarnacion, 281 U.S. 635 , 50 S.Ct. 440. An assault by one member of the crew upon another with a view to hurrying up the work has been brought within the category of 'negligence,' and hence in a suit against the owner becomes an actionable wrong. Jamison v. Encarnacion, supra; Alpha S.S. Co. v. Cain, 281 U.S. 642 , 50 S.Ct. 443. Approaching the decision of this case in a like spirit of liberality, we put aside many of the refinements of construction that a different spirit might approve. [287 U.S. 367, 376] The failure to furnish cure is a personal injury actionable at the suit of the seaman during life, and at the suit of his personal representative now that he is dead. Cf. U.S. Shipping Board Emergency Fleet Corp. v. Greenwald (C.C.A.) 16 F.(2d) 948, 949.
We are warned, however, that, in giving this content to the statute, we are omitting to give heed to its reference to the act regulating the remedies of railroad employees, and are ignoring the standards of duty thus carried over and adopted. The Employers' Liability Act for the protection of the employees of common carriers by railroad gives a remedy to such employees 'for ... injury or death resulting in whole or in part from the negligence of any of the officers, agents, or employees of such carrier,' or by reason of any negligent defect in its roadbed or equipment. 35 Stat. 65, 1, 45 U.S. Code, 51 (45 USCA 51). True indeed it is that a common carrier by land is not subject to a duty, except in special circumstances, to give maintenance or cure to sick or disabled employees. We say except in special circumstances, for it would be hazardous to assert that such a duty may not rest upon the representative of a railroad as well as upon the master of a ship when the servant, exposed by the conditions of the work to extraordinary risks, is helpless altogether unless relief is given on the spot. Ohio & Mississippi Ry. Co. v. Early, 141 Ind. 73, 81, 40 N.E. 257, 28 L.R.A. 546; Shaw v. Chicago, M. & St. P.R. R. Co., 103 Minn. 8, 114 N.W. 85; Raasch v. Elite Laundry Co., 98 Minn. 357, 108 N.W. 477, 7 L.R.A.(N.S.) 940; Hunicke v. Meramec Quarry Co., 262 Mo. 560, 581, 597, 172 S.W. 43, L.R.A. 1915C, 789, Ann. Cas. 1915D, 493.2 The result, however, will not be different though we assume that the servant of a railroad company, if he has been injured without fault, may never call for help as due to him of right, however pressing the emergency and im- [287 U.S. 367, 377] perative the need. We do not read the act for the relief of seamen as expressing the will of Congress that only the same defaults imposing liability upon carriers by rail shall impose liability upon carriers by water. The conditions at sea differ widely from those on land, and the diversity of conditions breeds diversity of duties. This court has said that 'the ancient characterization of seamen as 'wards of admiralty' is even more accurate now than it was formerly.' Robertson v. Baldwin, 165 U.S. 275, 287 , 17 S.Ct. 326, 331. Another court has said: 'The master's authority is quite despotic, and sometimes roughly exercised, and the conveniences of a ship out upon the ocean are necessarily narrow and limited.' Scarff v. Metcalf, 107 N.Y. 211, 215, 13 N.E. 796, 797, 1 Am.St. Rep. 807. Out of this relation of dependence and submission there emerges for the stronger party a corresponding standard or obligation of fostering protection. There is doubt, and that substantial, whether the administrator of a railroad engineer who by misadventure has fallen from his locomotive while the train is on a bridge has a cause of action under the Federal Employers' Liability Act (45 USCA 51-59) because of the failure of the crew of the train to come to the rescue of their comrade. Harris v. Penn. R.R. Co. (C.C.A.) 50 F.(2d) 866, 868.3 There is little doubt that rescue is a duty when a sailor falls into the sea, United States v. Knowles, 4 Sawy. 517, Fed. Cas. 15,540, and that a liability to respond in damages is cast upon the shipowners if he is abandoned to his fate. Harris v. Penn. R.R. Co., supra.
The act for the protection of railroad employees does not define negligence. It leaves that definition to be filled in by the general rules of law applicable to the conditions in which a casualty occurs. Cf. Murray v. Chicago & N.W. Ry. Co. (C.C.) 62 F. 24, 31; Ward v. Erie R.R. Co., 230 N.Y. 230, 234, 129 N.E. 886; Michigan v. Michigan Trust Co., 286 U.S. 334, 343 , 52 S.Ct. 512. Congress did not mean [287 U.S. 367, 378] that the standards of legal duty must be the same by land and sea. Congress meant no more than this, that the duty must be legal, i.e., imposed by law; that it shall have been imposed for the benefit of the seaman, and for to promotion of his health or safety; and that the negligent omission to fulfill it shall have resulted in damage to his person. When this concurrence of duty, of negligence and of personal injury is made out, the seaman's remedy is to be the same as if a like duty had been imposed by law upon carriers by rail.
The Court of Appeals in its reversal of the District Court assumed without deciding that the care of the seaman had been negligent and that there was a causal relation between the negligence and the death. The correctness of that assumption is challenged by counsel for the shipowner. These issues of fact being still open and undecided should be disposed of by the court below.
The judgment is reversed, and the cause remanded to the Court of Appeals for further proceedings in conformity with this opinion.
Compare the Act of March 30, 1920, c. 111, 1, 41 Stat. 537, 46 U.S. Code, 761 (46 USCA 761) 'Death on the High Seas by Wrongful Act,' which extends to persons other than seamen, but is limited to suits in admiralty.
[ Footnote 2 ] The authorities are brought together and carefully discriminated by Prof. Francis H. Bohlen, in an article (Moral Duty to Aid Others as Basis of Tort Liability,' in 56 University of Penn. Law Review 217, 316, reprinted in his 'Studies in the Law of Torts,' pp. 290, 315.
[ Footnote 3 ] Compare again the authorities collected by Bohlen in his 'Studies in the Law of Torts,' p. 312.

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The case concerned complaints related to the detention of the former Ukrainian Prime Minister Yuliya Tymoshenko.
The Court held in particular: that Ms Tymoshenko’s pre-trial detention had been arbitrary; that the lawfulness of her detention had not been properly reviewed; and, that she had no possibility to seek compensation for her unlawful deprivation of liberty.
The Court also found that, given that the judge had referred to her alleged hindering of the proceedings and contemptuous behaviour, her right to liberty had been restricted for other reasons than those permissible under Article 5.
Yuliya Tymoshenko, born in 1960, is the leader of Batkivshchyna, one of the strongest opposition parties in Ukraine, and of Yuliya Tymoshenko’s Bloc. She was the Prime Minister of Ukraine in 2005 and between December 2007 and March 2010. In April 2011, criminal proceedings were brought against her for allegedly making an illegal order for the signing of a contract concerning gas imports. On 11 October 2011, she was convicted as charged, including of exceeding authority or official powers, and sentenced to seven years’ imprisonment and a three-year ban on holding public office. On 29 August 2012, the conviction and sentence were upheld in a final judgment.
During the criminal proceedings, on 5 August 2011, the trial court ordered Ms Tymoshenko’s detention on remand. The judge, granting the prosecutor’s request for the detention order, held in particular that she had ignored the presiding judge’s orders, had shown contempt towards the participants in the hearing and had refused to give any information about her address. On the same day, she was placed in the pre-trial detention facility in Kyiv (SIZO no. 13), where she remained until 30 December 2011. The trial court dismissed all her requests for release with reference to its reasoning given in the ruling of 5 August 2011. On 30 December 2011, Ms Tymoshenko was transferred to the Kachanivska Correctional Colony in Kharkiv to serve her prison sentence.
Suffering from numerous health problems – in particular severe food allergies, chronic gastritis, sciatica and other severe back problems, and vascular problems with sudden subcutaneous haemorrhages - Ms Tymoshenko alleges that the detention conditions in both facilities were inadequate and that she did not receive appropriate medical treatment. She maintains in particular that in the pre-trial detention facility the cells were poorly ventilated, the possibilities for her to take outside walks were limited, there was an insufficient supply of drinking water, the quality of the food was poor, and that in one of the cells there was no heating. In the colony, she was unable to take outdoor walks. According to Ms Tymoshenko, the authorities underestimated the seriousness of her health problems and failed to provide her with prompt and adequate medical care. On several occasions she refused to be examined by doctors other than those of her own choice, stating that she did not trust the medical staff of the detention facilities. Between February and April 2012, she was examined on a number of occasions by a team of German doctors, who recommended her treatment in a specialised hospital.
Following an interim measure indicated by the European Court of Human Rights that her medical treatment in an appropriate institutionalised setting should be ensured (see below), Ms Tymoshenko was transferred to the Kharkiv hospital on 20 April 2012. She maintains that she objected to the transfer and that force was used, allegedly causing bruising to her stomach and arms. She refused medical treatment because of what she contended was the inappropriateness of that hospital for her needs, and she went on a hunger strike in protest against the prison guard’s violence and her forced transfer.
On 22 April 2012, Ms Tymoshenko was returned to prison and on the next day she filed a complaint with the Kharkiv Prosecutor Office about her forced transfer to the hospital. On 24 April 2012, she was examined by the colony medical officers. According to the examination report, she had a number of bruises, but their apparent age did not correspond with the time of the incident as indicated by her. According to the Government, a forensic medical expert was invited to examine Ms Tymoshenko, but she refused to allow such an examination. The prosecutor then decided not to open criminal proceedings for lack of evidence, but on 25 April 2012, following media reports about the incident, he quashed that decision and ordered further investigation. According to the Government, a number of potential witnesses were questioned - including colony staff and the ambulance driver who had taken her to the hospital - who stated that she had not complained of, and they had not seen any signs of, injuries on her. On the following day, Ms Tymoshenko was again asked to undergo a forensic medical examination, which she refused to do. A forensic expert evaluated her injuries on the basis of the examination report of 24 April 2012 and concluded that they could not have been inflicted on 20 April, as she alleged. Having familiarised himself with her previous medical records, he noted that recurrent haematomas could have resulted from a condition of her vascular system instead of having been caused by external blows. On 3 May 2012, the prosecutor once again decided not to open criminal proceedings.
On 9 May 2012, Ms Tymoshenko was again transferred to the Kharkiv hospital, where she started medical treatment under the supervision of a German neurologist and ended her hunger strike. She subsequently filed a criminal complaint concerning her permanent video surveillance in the hospital and the alleged publication of confidential medical information. The prosecutor decided not to open a criminal case. An administrative action, brought by Ms Tymoshenko on 8 June 2012, concerning the same complaints and, in particular, the alleged denial of her right to make phone calls, was dismissed on 30 October 2012.
The application was lodged with the European Court of Human Rights on 10 August 2011.
Ms Tymoshenko complained in particular: that her detention conditions in the pre-trial detention facility in Kyiv and in the Kachanivska Correctional Colony in Kharkiv had been inadequate, with no appropriate medical care provided for her numerous health problems; that on 20 April 2012 she had been transferred to the hospital in Kharkiv against her will, that she had sustained injuries during the transfer and that the incident had not been properly investigated; that she had been under round-the-clock surveillance in the hospital; that her detention pending trial had been arbitrary and had lacked legal grounds; that she had been unable to challenge the lawfulness of the pre-trial detention and that she did not have an enforceable right to compensation; and, that her detention had ulterior motives. She relies principally on Article 3 (prohibition of degrading treatment or punishment), Article 5 (right to liberty and security), Article 8 (right to private life) and Article 18 (limitation on use of restrictions on rights) of the European Convention on Human Rights.
The Court decided, on 14 December 2011, to give priority to the case in view of the serious and sensitive nature of the allegations raised. On 15 March 2012, it granted an interim measure (under Rule 39 of its Rules of Court) requested by Ms Tymoshenko, indicating to the Ukrainian Government that her medical treatment in an appropriate institutionalised setting should be ensured. Following a formal request from the Government and their submission indicating that Ms Tymoshenko was receiving adequate treatment in an appropriate institutionalised setting, the Court decided to lift the interim measure on 31 May 2012, finding that the Government had complied with it. On the same date, the Court rejected a second request by Ms Tymoshenko for an interim measure, demanding that her treatment in a hospital in Germany should be ensured. On 28 August 2012, a public hearing took place in Strasbourg.
Dean Spielmann (Luxembourg), President, Mark Villiger (Liechtenstein), Karel Jungwiert (Czech Republic), Ann Power-Forde (Ireland), Ganna Yudkivska (Ukraine), Angelika Nußberger (Germany), André Potocki (France), and also Stephen Phillips, Deputy Section Registrar.
As regards the scope of the case, the Court noted that after the case had been communicated to the Ukrainian Government, Ms Tymoshenko had raised several new complaints, relating to the criminal proceedings against her. The Court considered that those complaints were not an elaboration of her original complaints and that it was therefore not appropriate to add them to the case; they are the subject of an application currently pending before the Court (application no. 65656/12).
The Court declared inadmissible the complaints raised by Ms Tymoshenko under Article 3 concerning the conditions of her pre-trial detention and concerning the alleged lack of appropriate medical treatment during her detention. While the Court accepted that she might have experienced certain problems on account of the material conditions during part of the detention – in particular limited access to daylight, lack of hot water and lack of heating during limited periods – the situation had not been severe enough to be covered by the scope of Article 3. It was clear from the voluminous materials before the Court that Ms Tymoshenko’s health had received considerable attention from the Ukrainian authorities, which had invested efforts far beyond the normal health-care arrangements available for ordinary detainees in Ukraine. The European Committee for the Prevention of Torture (CPT) had visited the pre-trial detention facility where she was detained in November and December 2011 and had not raised any particular concern with regard to the appropriateness of the medical care provided to her.
The Court also declared inadmissible - for non-exhaustion of national remedies – Ms Tymoshenko’s complaints under Article 8 concerning her alleged round-the-clock surveillance in the hospital. While the Ukrainian courts had dismissed her administrative action, the first-instance judgment could be challenged on appeal, and it would have been open to Ms Tymoshenko to apply to the domestic courts for an interim measure.
As regards Ms Tymoshenko’s complaint regarding her alleged ill-treatment during her transfer to hospital on 20 April 2012, the Court noted that it was established that several bruises had appeared on her body during her detention in the colony. That alone called for an explanation by the State authorities as to their origin. According to the Government’s submissions, the video surveillance in the colony had operated, at least on 20 April 2012, without any recordings of the images being made. The Court was therefore unable to verify the Government’s assertion that the video surveillance had revealed nothing out of the ordinary.
The Court noted that the location of Ms Tymoshenko’s bruises – on her stomach and arms – was consistent with her account that she had been violently pulled from her bed and punched in the stomach on the day of her transfer to the hospital. Nevertheless, the Court could not ignore the medical evidence before it that the apparent age of the bruises had not corresponded with the time she had indicated and that there had been other possible origins of the bruising which did not involve external trauma. Those findings could only have been satisfactorily confirmed or refuted if Ms Tymoshenko had undergone a full forensic medical examination, which she had refused to allow on two occasions. Given the absence of such forensic evidence, resulting from her decision not to undergo the examination, the Court could not find it established to the necessary standard of proof that the bruising had resulted from treatment in breach of Article 3 during her transfer to hospital on 20 April 2012.
Since Ms Tymoshenko had made an arguable complaint of ill-treatment before the Ukrainian authorities, they had been under an obligation to carry out an effective investigation into those allegations. However, the finding that the effectiveness of the investigation had been hindered by Ms Tymoshenko’s refusals to undergo a forensic medical examination was sufficient to lead the Court to conclude that the investigation into her complaint had been “effective” for the purpose of the requirements of Article 3.
There had accordingly been no violation of Article 3 either on account of the alleged ill-treatment or on account of the alleged ineffectiveness of the investigation.
As regards Ms Tymoshenko’s complaint that her pre-trial detention had been unlawful and arbitrary, the Court noted that her detention pending trial had been ordered for an indefinite period of time, which in itself was contrary to the requirements of Article 5. The Court had found in other cases against Ukraine that this had been a recurrent issue resulting from legislative lacunae.
Furthermore, the detention order of 5 August 2011 had not indicated that Ms Tymoshenko had breached the obligation not to leave town, which had been applied to her as a preventive measure. Nor had the judge of the trial court asserted that she had been absent from any of the court hearings. Accordingly, no risk of absconding was discernible from the accusations which had been advanced among the reasons for her detention, which included namely the fact that she had refused to announce her address at a court hearing and that she had been a few minutes late for one of the hearings. The main justification for her detention indicated by the judge had been her alleged hindering of the proceedings and contemptuous behaviour. This reason was not included among those which would justify deprivation of liberty under Article 5 § 1. Moreover, it remained unclear how it was a more appropriate measure in the circumstances of Ms Tymoshenko’s alleged contemptuous behaviour to replace the obligation not to leave town with her placement in detention. Given that the reasons indicated for her pre-trial detention remained the same until her conviction, the Court considered that the detention had been arbitrary and unlawful during the entire period. There had accordingly been a violation of Article 5 § 1.
The lawfulness of Ms Tymoshenko’s detention had been reviewed by the Ukrainian courts on several occasions. However, the relevant court decisions did not satisfy the requirements of Article 5 § 4, as they had been confined to the mere statement that no appeal was possible against a ruling on change of a preventive measure ordered during the examination of a criminal case and had reiterated the initially applied reasoning, which the Court had found to be deficient. While Ms Tymoshenko had advanced specific arguments in her numerous applications for release – in particular her unfailing compliance with the obligation not to leave town and the fact that she had made no attempt to obstruct the investigation – the trial court had dismissed her requests without having given any consideration to those arguments. Furthermore, the Court had already found in other cases that Ukrainian law did not provide for a procedure to review the lawfulness of continued detention after the completion of a pre-trial investigation that would satisfy the requirements of Article 5 § 4. There had accordingly been a violation of Article 5 § 4.
The Court observed that under Ukrainian law the right to compensation arose when the unlawfulness had been established by a judicial decision. However, there was no procedure under Ukrainian law for seeking compensation for a deprivation of liberty found to be in breach of Article 5 by the European Court of Human Rights. The Court had already noted that lacuna in its case-law in other cases against Ukraine and the situation had not changed. There had accordingly been a violation of Article 5 § 5.
The Court noted that Ms Tymoshenko, who was the former Prime Minister and the leader of one of the strongest opposition party, had been accused of exceeding authority or official powers and had been prosecuted shortly after the change of Government. In that respect, the case was similar to the case of Lutsenko v. Ukraine (6492/11), which had concerned the detention of a former Minister. Ms Tymoshenko complained in particular that her detention had been used by the authorities to prevent her from political life and from running as a candidate in the elections of 28 October 2012.
The Court had already found that Ms Tymoshenko’s detention – although according to the Government it had been effected for the purposes provided under Article 5 – had mainly served to punish her for a lack of respect for the trial court. The Court therefore concluded that the restriction of her liberty had not been applied for the purpose of bringing her before a competent legal authority on reasonable suspicion of having committed an offence, but for other reasons. The Court considered this a sufficient basis for finding a violation of Article 18 in conjunction with Article 5.
Ms Tymoshenko did not submit any claims in respect of damage or costs and expenses.
Judges Jungwiert, Nussberger and Potocki expressed a joint concurring opinion. Judges Spielmann, Villiger and Nussberger expressed a joint dissenting opinion. These opinions are annexed to the judgment.
Time for a Tymoshenko-Lutsenko Bill?

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D.C. Law Library - § 47–2853.43. Certain representations prohibited.
↪ § 47–2853.43. Certain representations prohibited.
(a) Except as provided in § 47-2853.49 and as permitted by the Board pursuant to subsection (b) of this section, no person shall assume or use the title or designation “certified public accountant” or the abbreviation “CPA” or any other title, designation, words, letters, abbreviation, sign, card, or device tending to indicate that the person is a certified public accountant, unless the person has received a license as a certified public accountant under this subchapter . No firm shall assume or use the title or designation “certified public accountant” or the abbreviation “CPA” or any other title, designation, words, letters, abbreviation, sign, card, or device tending to indicate that the firm is composed of certified public accountants unless the firm is registered as a firm of certified public accountants , and all offices of such firm in the District for the practice of public accounting are maintained and registered as required by § 47-2853.44, or unless the firm is exempt from registration under § 47-2853.44(a)(4). No person shall assume or use the title or designation “public accountant” or any other title, designation, words, letters, abbreviation, sign, card or device tending to indicate that such person is a public accountant unless that person is licensed as a certified public accountant under this part.
(b) No firm shall assume or use the title or designation “public accountant” or any other title, designation, words, letters, abbreviation, sign, card, or device tending to indicate that the firm is composed of public accountants unless it is a firm of public accountants or a firm of certified public accountants , and all offices of the firm in the District for the practice of public accounting are maintained and registered as required under § 47-2853.44, or unless the firm is exempt from registration under § 47-2853.44(a)(4).
(d)(1) No person shall sign or affix his or her name or any trade or assumed name used by the person in his or her profession or business to any opinion or certificate attesting in any way to the reliability of any representation or estimate in regard to any person or organization embracing financial information or facts concerning compliance with conditions established by law or contract, including, but not limited to, statutes, ordinances, regulations, grants, loans, and appropriations, together with any wording accompanying or contained in the opinion or certificate which indicates that the person is either an accountant or an auditor or has expert knowledge in accounting or auditing, unless the person holds a valid license or registration issued by the Board, or unless the person holds a practice privilege pursuant to § 47-2853.49.
(2) The provisions of this subsection shall not prohibit any officer, employee, partner, or principal of any organization from affixing his or her signature to any statement or report in reference to the affairs of the organization with any wording designating the position, title, or office which he or she holds in the organization nor shall the provisions of this subsection prohibit any act of a public official or public employee in the performance of his or her official duties.
(e) No person shall sign or affix a firm name to any opinion or certificate attesting in any way to the reliability of any representation or estimate in regard to any person or organization embracing financial information or facts respecting compliance with conditions established by law or contract, including, but not limited to, statutes, ordinances, regulations, grants, loans, and appropriations, together with any wording accompanying or contained in the opinion or certificate which indicates that the firm is composed of or employs accountants, auditors, or other persons having expert knowledge in accounting or auditing, unless the firm holds a valid registration issued by the Board , or is a firm exempt from registration under § 47-2853.44(a)(4).
(f) No person shall assume or use the title or designation “certified public accountant” or “public accountant” in conjunction with names indicating or implying that there is a firm or in conjunction with the designation “and Company” or “and Co.” or a similar designation if there is in fact no bona fide firm registered under § 47-2853.44, or unless the firm is exempt from registration under § 47-2853.44(a)(4) provided, that a sole proprietor or partnership lawfully using such title or designation in conjunction with such names or designation under prior law may continue to do so.
(g) Notwithstanding any other provision of this section, it shall not be a violation of this section for a firm that does not hold a valid registration under § 47-2853.44 and that does not have an office in the District to provide its professional services in the District so long as it complies with the requirements of § 47-2853.44(a)(4).
D.C. Law 16-130 rewrote subsec. (a); and in subsec. (b) and par. (d)(1), substituted “s” for “§§ 47-2853.45 and”.
D.C. Law 19-43, in subsec. (a), substituted “Except as provided in § 47-2853.49 and as permitted by the Board” for “Except as permitted by the Board”, substituted “under this subchapter and holds” for “under this subchapter, holds”; substituted “public accountants in the District” for “public accountants in the District, and all of the person’s offices in the District for the practice of public accounting are maintained and registered as required under § 47-2853.45”; in subsec. (b), substituted “under § 47-2853.44, or unless the firm is exempt from registration under § 47-2853.44(a)(2) or (3)” for “under § 47-2853.46”; in subsec. (c), substituted “, or anyone who holds a practice privilege pursuant to § 47-2853.49,” for “and all of whose offices in the District for the practice of public accounting are maintained and registered as required by the special rules”; in subsec. (d)(1), substituted “, or unless the person holds a practice privilege pursuant to § 47-2853.49” for “and all of the person’s offices in the District for the practice of public accounting are maintained and registered as required by § 47-2853.46”; in subsecs. (e) and (f), substituted “§ 47-2853.44, or unless the firm is exempt from registration under § 47-2853.44(a)(2) or (3)” for “§§ 47-2853.44 and 47-2853.46”; and added (g).
For temporary (90 day) amendment of section, see § 2(e) of Non-Health Related Occupations and Professions Licensure Emergency Act of 2006 (D.C. Act 16-255, January 26, 2006, 53 DCR 763).
Section 2(e) of D.C. Law 16-101, in subsec. (a), deleted “and 47-2853.45” and “, 47-2853.45,” and substituted “licensed as a certified public accountant under this part.” for the colon at the end of the lead-in text; repealed subsecs. (a)(1) and (a)(2); in subsec. (b), substituted “§” for “§§ 47-2853.45 and”; and, in subsec. (d)(1), substituted “§” for “§§ 47-2853.45 and”.


text:
2006-04-06 Assigned to ETHICON, INC. reassignment ETHICON, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BECKETT, TREVOR, GALE, DAVID, JOHNSON, PAUL, SCOTT, VALERIE, FURNISH, GREG, MORRIS, BEN, SZABO, DAVID, TREZZA, II, MICHAEL J.
2008-06-16 Assigned to CORDIS CORPORATION reassignment CORDIS CORPORATION ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ETHICON, INC.
Vessel wound closure systems and method for sealing a puncture wound in a target vessel, such as those puncture wounds that occur from prior interventional procedures. A sealing member is deployed intravascularly into the target vessel, and an anchor member is deployed extravascularly of the target vessel. The sealing member and the anchor member are connected by a suture that may be drawn to tighten the sealing member and the anchor member relative to one another in order to effect the seal of the puncture wound. After tightening, the suture is secured to maintain the sealing member and the anchor member relative to one another in order to maintain the seal. Preferably, the anchor member, the suture and the sealing member are comprised of biocompatible, bioresorbable materials that are absorbed into the body after the sealing of the puncture wound has been achieved. The sealing member, suture and the anchor member are delivered by a delivery rod or other components over a guidewire or through an introducer already in place from the preceding interventional procedure.
The invention generally relates to vessel wound closure techniques. More particularly, the invention relates to systems and methods for sealing puncture wounds in a blood vessel such as those that result from certain interventional procedures.
A large number of therapeutic and diagnostic procedures involve the percutaneous introduction of instrumentation into a blood vessel, for example, percutaneous transluminal coronary angioplasty (PTCA). Such procedures most often involve accessing an intended site through the femoral artery. Ideally, closing and healing of the resultant vascular puncture wound successfully completes the procedure.
Traditionally, the application of external pressure to the skin at the entry site of the instrumentation into the patient has been employed to stem bleeding from the wound. A nurse or physician, for example, applies pressure to the wound site until clotting and tissue rebuilding has occurred sufficiently to seal the perforation. In some situations, the external pressure is maintained for an hour or more, during which time the patient is uncomfortably immobilized. Thus patient comfort and physician efficiency are impaired where such external pressure techniques are employed.
Additionally, the risk of hematoma exists while bleeding from the vessel occurs. Such hematoma risk continues until sufficient clotting of the wound site occurs. Moreover, external pressure devices, such as femoral compression systems, are often unsuitable for some patients, such as those with substantial amounts of subcutaneous adipose tissue, as the skin surface may be a considerable distance away from the vasculature puncture site. Inaccurate skin compression, and thus less effective wound healing, tends to occur as a result.
U.S. Pat. No. 5,383,896 to Gershony, et al. discloses a device that applies pressure to a puncture site internally for a limited period of time, after which the device is removed. The device in Gershony includes a shaft with an expandable balloon and a guidewire tip at its distal end. The distal end of the device is introduced into a blood vessel through an introducer sheath that is typically used in percutaneous interventional procedures. The balloon is then inflated and withdrawn until the balloon hemostatically engages the inner surface of the blood vessel, after which the introducer sheath is removed. A fixation collar on the shaft applies tension to the balloon for a medically sufficient time and thereafter the balloon is deflated and the entire device is removed from the body.
U.S. Pat. No. 5,645,566 to Brenneman, et al. discloses a device that applies pressure to the outside wall of a punctured blood vessel from a distance using a balloon, a sheet and a foam pad. The pressure applying device is located using a balloon in the vessel (similar to that of Gershony) and a radiopaque marker.
PCT Application WO 98/11830, published Mar. 26, 1998, S. Barak, Inventor, discloses various embodiments of an apparatus for hemostasis. Among them is a device that positions an anchor against an inner surface of an artery wall and a balloon outside the wall. The balloon is inflated to pinch the artery wall, after which the anchor is withdrawn. The balloon is maintained against the puncture until hemostasis is achieved. The anchor and balloon are removed after hemostasis is achieved.
Other arterial closure devices include bioabsorbable materials intended to remain in the body until they are absorbed as in related U.S. Pat. Nos. 5,282,827 and 5,441,517, which disclose an anchor inserted into a vessel and urged against an inner wall of the vessel as a collagen plug is deployed externally of the puncture site to expand and fill the tissue tract leading to the puncture site. A filament attaches the plug to the anchor and moves the plug and anchor relative to one another in pulley-like fashion to effect a seal at the puncture site. After emplacement, a tamping member may be used to urge the plug against the external puncture site to help seal the same.
U.S. Pat. No. 5,662,681 discloses an arterial closure device in which an anchor and plug are attached to one another via a filament. The anchor is inserted into the vessel and urged against the interior wall of the vessel as the plug is urged against the exterior wall of the vessel at a puncture site. A separate locking means moves the plug and anchor relative to one another to maintain the plug and anchor in sealing position at the puncture site.
U.S. Pat. No. 5,391,183 to Janzen, et al. describes a device that inserts hemostatic material through a tissue channel and against the outside wall of the vessel around the puncture site.
U.S. Pat. No. 5,690,674 to Diaz discloses a biodegradable plug that has two substantially parallel disks joined at their centers by a waist. The plug is positioned so that the distal disk is on the interior wall of the blood vessel, the proximal disk is on the exterior wall, and the waist is in the wound of the vessel wall.
Another known closure device includes U.S. Pat. No. 5,741,223 to Janzen, et al. This '223 patent discloses the placement of a plug to seal a puncture site.
U.S. Pat. No. 5,354,271 to Voda discloses suture threads with barbed ends, wherein the suture threads are deployed into a vessel and then the barbed ends penetrate through the vessel wall and expand to prevent retraction thereof back into the vessel. The suture threads are then tied or otherwise secured across the puncture site.
U.S. Pat. No. 5,324,306 discloses a mass of hemostatic material pushed against the outside wall of a vessel at a puncture site. Manual pressure is applied to ensure blood flow has stopped.
U.S. Pat. No. 5,868,778 discloses a balloon used in combination with a procoagulant injected at the puncture site in order to seal a puncture site of a vessel.
U.S. Pat. No. 5,792,152 discloses a flexible needle with suture attached thereto that is deployed across a puncture site of a vessel. The flexible needle and suture are introduced into the vessel via an entry lumen, proceed through a U-shaped return lumen, and exit the vessel through an exit lumen. Thereafter the suture is drawn further outward from the vessel and tied or otherwise secured across the puncture site.
U.S. Patent Publication No. 2004/0006352 discloses an arterial closure device comprising an assembly in which clasp arms, to which a suture is initially secured, are deployed within a vessel. Penetrating members including suture catches are then separately deployed to snag or capture the sutures associated with a respective clasp arm. The sutures are then pulled taught by pulling the penetrating member with suture catches out from the vessel, and then tied or otherwise secured to close the puncture site. Thereafter the assembly is withdrawn from the body.
The various embodiments described herein comprise vessel wound closure systems and methods for closing a puncture wound in a target vessel.
In some embodiments the system comprises an outer sheath, a delivery rod slidably disposed within the outer sheath, a guidewire slidably associated with the delivery rod, a sealing member deployably housed within the outer sheath, and a anchor member deployably housed within the delivery rod, and a connecting suture connecting the sealing member and the anchor member, whereby the outer sheath encircles the delivery rod and constrains the sealing member, the connecting suture and the anchor member from deploying until sufficient proximal movement of the outer sheath has occurred. Upon deployment, the sealing member is positioned intravascularly about the inside surface of the target vessel, the anchor member is positioned extravascularly about the outside surface of the target vessel, and the sealing member and the anchor member are moved closer to one another by drawing and securing the connecting suture in order to seal the vessel wound. A portion of the connecting suture extends proximal of the anchor member and is accessible to a medical practitioner beyond a proximal end of the delivery rod and the outer sheath to help tighten the sealing member and the anchor member relative to one another.
The delivery rod further comprises an exterior channel and a tapered distal section through which the guidewire slides for locating the system within the target vessel. The delivery rod further comprises a first recess in which the sealing member is oriented for deployment therefrom, a second recess in which the anchor member is oriented for deployment therefrom, and an open channel between the first recess and the second recess in which open channel the connecting suture extends between the sealing member and the anchor member for deployment therefrom.
The system may further comprise a tamping tool to help push or maintain the anchor member in place as the sealing member and the anchor member are tightened by drawing the connecting suture after deployment. Once sufficiently tightened and secured, a separate cutting element is provided through the delivery rod to cut excess suture material, after which the system is removed from the patient's body.
The sealing member and the anchor member are preferably further comprised of bioresorbable material, wherein the sealing member is generally larger than the anchor member in order to effect the seal of the vessel wound. The connecting suture may further comprise one way barbs associated therewith that help secure the sealing member and the anchor member in place relative to one another after sufficient tightening thereof has occurred to seal the vessel wound.
In practice, the delivery rod is inserted through the outer sheath and over the guidewire into the target vessel through the vessel wound. The sealing member is deployed in the target vessel by partially retracting the outer sheath. The sealing member is positioned against an interior wall of the vessel by partial withdrawal of the entire system until resistance is felt by the medical practitioner. The anchor member and the connecting suture are then deployed by further retraction of the outer sheath. The anchor member is then positioned against the exterior wall of the vessel, and the accessible portion of the connecting suture proximal of the delivery rod and outer sheath is manipulated by the medical practitioner to draw and tighten the sealing member and the anchor member relative to one another on either side of the vessel. Once tightened, the connecting suture is secured to effect the seal about vessel wound by the sealing member and the anchor member. A tamping tool may be used to help push or maintain the anchor member in place as tightening occurs. After tightening and securement has occurred, excess suture material is cut and the system removed from the patient's body.
In other embodiments, the vessel wound closure system comprises an introducer, an outer sheath slidably disposed through the introducer from a proximal first position, to a distal second position at, or beyond, a distal end of the introducer, and to a partially proximally withdrawn third position, an inner sheath slidably disposed through the outer sheath between a proximal first position and a distal second position at, or beyond, a distal end of the outer sheath in the third position, a handle associated with the outer sheath and the inner sheath, a plunger having a support rod associated therewith and extending through the handle and within the inner sheath for controlling disposition of an anchor member and a sealing member, the sealing member configured to deploy from the distal end of the outer sheath when in the third position, the anchor member configured to deploy from the distal end of the inner sheath, and a connecting suture connecting the sealing member and the anchor member. Deployment of the sealing member within the target vessel occurs when the outer sheath is in the third position, whereas deployment of the anchor member occurs by depression of the plunger when the inner sheath is in the second position. The support rod provided within the inner sheath includes a tamper at its distal end for helping to push or maintain the anchor member in place as the anchor and sealing members are being tightened and secured by manipulation of the suture. The support rod may further comprise a recessed portion and a cutting member for cutting excess suture material after tightening and securing of the sealing member and the anchor member has occurred.
The introducer may further comprise a flared end into which a hub of the outer sheath is received when disposing the outer sheath to its distal second position and into the target vessel. The handle may further comprise a removable pull-tab extending from the handle and precluding the inner sheath from movement to its distal second position until removal of the pull-tab has occurred. The distal end of the inner sheath may further comprise an angled exit port that helps orient the sealing member or anchor member to effect the sealing of the vessel wound upon deployment thereof.
A portion of the suture extends proximal of the anchor member and is accessible to a medical practitioner to help tighten the sealing member and the anchor member relative to one another after deployment thereof. Thereafter, the suture is secured to maintain the sealing member and the anchor member in position about the vessel wound, excess suture material is cut by a cutter provided within the inner sheath, and the unsecured components of the system are removed from the patient.
In practice, the outer sheath is inserted through the introducer and partially withdrawn to the third position in order to deploy the sealing member in the target vessel. The handle is then moved distally to locate the inner sheath at its second position at, or beyond, the distal end of the outer sheath, which helps ensure that the anchor member is successfully deployed in the target vessel. Thereafter, the assembly of the outer sheath, inner sheath, handle, plunger, and support rod is partially withdrawn until resistance is felt by the medical practitioner indicating the sealing member is oriented against an interior surface of the target vessel. The plunger is then depressed to expel the anchor member therefrom the inner sheath and to dispose the anchor member extravascularly along the outer surface of the target vessel. Thereafter, the accessible portion of the suture is manipulated by the medical practitioner to tighten and secure the sealing member and the anchor member relative to one another to effect the seal of the vessel wound. Excess suture material is then cut and unsecured portions of the system are removed from the patient.
The above and other features of the invention, including various novel details of construction and combinations of parts, will now be more particularly described with reference to the accompanying drawings and claims. It will be understood that the various exemplary embodiments of the invention described herein are shown by way of illustration only and not as a limitation thereof. The principles and features of this invention may be employed in various alternative embodiments without departing from the scope of the invention.
FIG. 1 schematically illustrates an embodiment of a vessel wound closure system according to the description herein.
FIG. 2 schematically illustrates a partial view of an embodiment of a delivery rod having a first recess, a second recess, and an open channel therebetween according to the description herein.
FIGS. 3A-3F illustrate various designs and shapes of the distal or anchor member according to the description herein.
FIGS. 4A-4G illustrate steps for deploying the vessel wound closure system of FIG. 1 according to the description herein.
FIG. 5 illustrates another embodiment of a vessel wound closure system according to the description herein.
FIG. 6 illustrates illustrates another view, including inset A, of the system of FIG. 5 according to the description herein.
FIGS. 6A and 6B illustrate various views of inset A of FIG. 6 according to the description herein.
FIG. 7 illustrates aspects of the system of FIG. 5 with the outer sheath and the inner sheath omitted for illustrative purposes according to the description herein.
FIGS. 8A and 8B illustrate various other anchor members according to the description herein.
FIG. 1 illustrates one embodiment of a vessel wound closure system, wherein the term proximal, or variants thereof, is understood as closest to a medical practitioner operator, and the term distal, or variants thereof, is understood as furthest from a medical practitioner operator.
As shown in FIG. 1, the system comprises an outer sheath 10, a delivery rod 20 slidably disposed within the outer sheath 10, a guidewire 30 slidably associated with the delivery rod 20, a sealing member 40 deployably housed within the delivery rod 20, a anchor member 50 deployably housed within the delivery rod 20, and a suture 60 having a connecting portion 61 connecting the sealing member and the anchor member and an accessible portion 62 extending beyond a proximal end of the delivery rod 20 and the outer sheath 10, whereby the outer sheath 10 and the delivery rod 20 are configured such that at a first position the outer sheath 10 prevents the sealing member 40, the suture 60, and the anchor member 50 from deploying (dashed lines), and at a second position, when the outer sheath 10 and delivery rod 20 have been moved relative to one another, the sealing member 40, the suture 60 and the anchor member 50 are deployable. Upon deployment, the sealing member 40 is positioned intravascularly about an inside surface of a target vessel V, the anchor member 50 is positioned extravascularly about an outside surface of the target vessel V, and the sealing member 40 and the anchor member 50 are moved closer to one another by drawing and securing the connecting suture 60 in order to seal the vessel wound. The accessible portion 62 of the connecting suture 60 extends proximal of the anchor member 50 and beyond a proximal end of the delivery rod and the outer sheath for the medical practitioner to manipulate to help tighten the sealing member 40 and the anchor member 50 relative to one another.
Referring to FIGS. 1 and 2, the delivery rod 20 further comprises an exterior channel 21 and a tapered distal section 22 through which the guidewire 30 slides for locating the system 1 within the target vessel V. The delivery rod 20 further comprises a first recess 23 in which the sealing member 40 is oriented for deployment therefrom, a second recess 24 in which the anchor member 50 is oriented for deployment therefrom, and an open channel 25 between the first recess 23 and the second recess 24 and in which open channel 25 the connecting portion 61 of the suture 60 extends for deployment therefrom.
The system 1 may further comprise a tamping tool 80 (FIG. 3G), at least a portion of which is disposed within the delivery rod 20, to help push or maintain the anchor member 50 in place as the sealing member 40 and the anchor member 50 are tightened by drawing the connecting suture 60 after deployment. Once sufficiently tightened and secured, a separate cutting element 70 (FIG. 1), at least a portion of which is provided through the delivery rod 20, may be used to cut excess suture material, afterwhich the various unsecured components of the system 1 are removed from the patient's body.
The sealing member 40 and the anchor member 50 are preferably further comprised of bioresorbable material, wherein the sealing member 40 is generally larger than the anchor member 50 in order to effect the seal of the vessel wound. The connecting portion 61 of the suture 60 may further comprise one way barbs 65, or other self-locking elements, associated therewith that help secure the sealing member 40 and the anchor member 50 in place relative to one another after sufficient tightening thereof has occurred to seal the vessel wound. In the case of one way barbs 65, the anchor member 50 is further comprised of at least one passageway 51 through which the barbs 65 may proceed as the suture 60 is drawn to tighten and secure the sealing member 40 and the anchor member 50 relative to one another to effect the seal of the vessel wound.
FIGS. 3A-3F illustrate various designs and shapes of the sealing member 40 wherein the elliptical shape of FIG. 3C and the cylindrical shape of FIG. 3D are the preferred designs or shapes for intravascular sealing of the vessel wound. Ideally, a width (w) or diameter (d) of the sealing member 40 is less than the inner diameter of the delivery rod 20 or outer sheath 10 from which the sealing member 40 is deployed. Ideally also, the length (l) or diameter (d) of the sealing member 40 is sufficient to create a good seal against the interior vessel wall while minimizing undesirable positioning of the sealing member 40 during deployment thereof. A length (l) of 10.2 mm and a width (w) of 2.65 mm is preferred when using an 8 Fr sheath having an inner diameter of 2.7 mm, for example. The anchor member 50 may be comprised of similar designs and shapes, although the anchor member 50 is generally smaller than the sealing member 40. The materials comprising the sealing member 40 and the anchor member 50 are bioabsorbable and biocompatible materials that ideally resorbs or endothelializes to minimize the chance of embolism in the target vessel V.
The various designs and shapes of the sealing member 40 shown in FIGS. 3A-3F further comprise at least one passageway 41 through which the suture 60 is threaded. The anchor member 50 further comprises at least one passageway 51 (FIG. 1) similar to the at least one passageway 41 of the sealing member 40. The connecting portion 61 of the suture 60 thus threads through the respective at passageways 41, 51 of the sealing member and the anchor member 50 in order to connect the feet and to enable the drawing and tightening thereof. Alternatively, a distal end of the connecting portion 61 of the suture 60 may be attached to the sealing member 40, as shown in FIGS. 1 and 2, for example, and threaded through the at least one passageway 51 provided in the anchor member 50 in order to connect the sealing member 40 and the anchor member 50 and to enable the drawing and tightening thereof.
In practice, referring to FIGS. 4A-4G, deployment of the vessel wound closure system and sealing of a vessel wound (vw) is described. In particular, in FIG. 4A the guidewire 30 is in place through the vessel wound, as from a preceding procedure, and into the target vessel V. Blood flow within the target vessel is shown by arrow a. In FIG. 4B, the delivery rod 20, having the sealing member and the anchor member connected by the suture loaded therein, is inserted through the outer sheath 10 and over the guidewire 30 into the target vessel V through the vessel wound. In FIG. 4C, the sealing member 40 is deployed in the target vessel by partially retracting the outer sheath 10. In FIG. 4D, the sealing member 40 is then positioned against an interior wall of the vessel by partial withdrawal of the deployment rod 20 and outer sheath 10 until resistance is felt by the medical practitioner indicating the sealing member 40 has oriented against the interior vessel wall. In FIG. 4E, the anchor member 50 and the connecting portion 61 of the suture 60 are then deployed outside the vessel and through the vessel wound, respectively, by further retraction of the outer sheath 10. In FIG. 4F, the anchor member 50 is then positioned against the exterior wall of the vessel, and the accessible portion 62 of the suture 60 proximal of the delivery rod 20 and outer sheath 10 is manipulated by the medical practitioner to draw and tighten the sealing member 40 and the anchor member 50 relative to one another on either side of the vessel in order to effect the seal of the vessel wound. Once tightened, the suture 60 is secured, by one way barbs 65 or other self-locking elements, to maintain the seal of vessel wound by the sealing member 40 and the anchor member 50. In FIG. 4G, a tamping tool 80 is illustrated that may be used to help push or maintain the anchor member 50 in place as tightening and securement occurs. Such tamping would occur after deployment of the anchor member 50 has occurred, as in FIG. 4E, for example. After tightening and securement of the sealing member, the anchor member and the suture has occurred, excess suture material is cut and unsecured portions of the system are removed from the patient's body.
FIGS. 5-7 illustrate another embodiment of a vessel wound closure system 100 and methods associated therewith. In the embodiment of FIGS. 5-7, the vessel wound closure system 100 comprises an introducer 110 (e.g., from a preceding procedure), an outer sheath 120 slidably disposed through the introducer 110 and having a proximal first position, a distal second position at, or beyond, a distal end of the introducer, and a partially withdrawn third position. The vessel wound closure system of FIGS. 5-7 further comprises an inner sheath 130 (FIG. 6 inset A shown in FIGS. 6A and 6B) slidably disposed within the outer sheath 120 and having a proximal first position and a distal second position at, or beyond, a distal end of the outer sheath in the third position, a handle associated with the outer sheath 120 and the inner sheath 130, a plunger 150 extending through the handle 140 and controlling the disposition of a support rod 190 associated with the plunger 150, a sealing member 170 configured to deploy from a distal end of the outer sheath 120 when the outer sheath 120 is in the third position, an anchor member 180 configured to deploy from a distal end of the inner sheath 130 by depression of the plunger 150, and a suture 160 connecting the sealing member 170 and the anchor member 180, a portion of which suture 160 extends proximal of the anchor member 180 and is accessible to a medical practitioner for manipulation thereof. Deployment of the sealing member 170 within the target vessel generally occurs by inserting the outer sheath 120 through the introducer 110 until a distal end of the outer sheath 120 is positioned at, or beyond, a distal end of the introducer 110 in the target vessel. Partially withdrawing the outer sheath 120 proximally then ideally disposes the sealing member 170 in the target vessel. Movement of the handle 140 distally to locate the inner sheath 130 at its second position such that a distal end of the inner sheath 130 is at, or beyond, a distal end of the outer sheath 120 in the third position helps ensure that the sealing member 170 is successfully deployed within the target vessel. Thereafter, the whole assembly, i.e., system 100, is partially retracted proximally until resistance is felt indicating the sealing member 170 is situated against the inner wall of the target vessel. Then, depressing the plunger 150 and support rod 190 connected thereto disposes the anchor member 180 beyond the distal end of the inner sheath 130, beyond the distal end of the outer sheath 120 and adjacent an outer surface of the target vessel.
The support rod 190 (FIG. 7, wherein the inner sheath 130 and the outer sheath 120 are omitted for illustrative purposes) is preferably connected to the plunger 150, provided within the inner sheath 130, and includes a tamper 193 at its distal end for disposing the anchor member 180 adjacent the outer wall of the target vessel when the plunger 150 is depressed, as discussed above. The support rod 190 further helps to push or maintain the anchor member 180 in place as the anchor member 180 and the sealing member 170 are tightened and secured by the manipulation of the suture 160. The support rod 190 may further comprise a recessed portion 191 and a cutting member 192 for cutting excess suture material after tightening and securing of the sealing member 170 and the anchor member 180 has occurred.
The introducer 110 may further comprise a flared end 111 into which a hub 121 of the outer sheath 120 is received when disposing the outer sheath 120 within the introducer 110. Ideally, receiving the hub 121 of the outer sheath 120 into the flared end 111 of the introducer 110 indicates that a distal end of the outer sheath 120 is positioned at, or beyond, a distal end of the introducer 110, and thus in the target vessel. The outer sheath 120 is then partially withdrawn to deploy the sealing member 170 within the target vessel. The handle 140 is then moved distally to locate a distal end of the inner sheath 130 at, or beyond, a distal end of the outer sheath 120, which helps ensure that the sealing member 170 is deployed within the target vessel. The entire system 100 is then partially retracted until resistance is felt indicating that the sealing member 170 is situated against the inner wall of the target vessel. The plunger 150 is then depressed to expel the anchor member 180 from the distal end of the inner sheath 130 and against the outer wall of the target vessel. The handle 140 may further comprise a removable pull-tab 145 that precludes movement of the handle 140 and inner sheath 130 the additional distance d until removal of the pull-tab 145 has occurred. In this manner, movement of the inner sheath 130 does not occur until the outer sheath 120 has been proximally withdrawn to dispose the sealing member 180 within the target vessel as discussed above. The distal end of the inner sheath 130 may further comprise an angled exit port 122 that helps orient the sealing member 170 or anchor member 180 if desired, to help effect the sealing of the vessel wound upon deployment thereof from the inner sheath 130 and outer sheath 120.
Ideally, the outer sheath 120 thus moves from a first proximal position to a distal second position such that distal end of the outer sheath 120 is located at, or beyond, the distal end of the introducer 110 and in the target vessel when the hub 121 of the outer sheath 120 is within the flared end 111 of the introducer 110. Then, the outer sheath 120 is partially withdrawn proximally to a third position to dispose the sealing member 170 within the target vessel. The handle 140 is then moved distally to locate the inner sheath 130 from a first proximal position to a distal second position such that the distal end of the inner sheath 130 is located at, or beyond, the distal end of the outer sheath 120 in the third position, which helps ensure that the sealing member 170 is deployed within the target vessel as intended. The system 100 is then retracted partially until resistance is felt indicating that the sealing member 170 is situated against the interior wall of the target vessel. The plunger 150, and the support rod 190 connected thereto, are then depressed to expel the anchor member 180 from the distal end of the inner sheath 130 and along an outer surface of the target vessel. The accessible portion of the suture 160 is preferably pulled taught prior to and during depression of the plunger 150 to help maintain the sealing member 170 in place against the interior surface of the target vessel while the anchor member 180 is deployed.
The accessible portion of the suture 160 extends proximal of the anchor member 180 and remains accessible to a medical practitioner to help tighten the sealing member 170 and the anchor member 180 relative to one another after deployment of the sealing member 170 and the anchor member 180 has occurred. Thereafter, the suture 160 is secured to maintain the sealing member 170 and the anchor member 180 about the vessel wound, excess suture material is cut by a cutter 192 (FIG. 7) provided with the support rod 190 within the inner sheath 130, and the unsecured components of the system are removed from the patient.
In practice, an introducer and an assembly is provided, the assembly comprising at least an outer sheath, an inner sheath, a handle, a plunger and a support rod. The sealing member, and the anchor member connected thereto via the suture, are provided in the assembly. The introducer placed through the vessel wound and into the target vessel of a patient. The outer sheath is inserted through the introducer from a proximal first position, to a distal second position, and then partially withdrawn proximally to a third position in order to deploy the sealing member in the target vessel. The handle is then moved distally to locate a distal end of the inner sheath at, or beyond, the distal end of the outer sheath in its third position, which helps ensure that the sealing member is successfully deployed within the target vessel. Thereafter, the assembly of the outer sheath, the inner sheath, the handle, the support rod and the plunger is partially withdrawn until resistance is felt indicating the sealing member is oriented against an interior surface of the target vessel. An accessible portion of the suture may be pulled taught to maintain the sealing member in place against the inner surface of the vessel. The plunger is then depressed to expel the anchor member from the inner sheath and position the anchor member extravascularly along the outer surface of the target vessel. Thereafter, the accessible portion of the suture is manipulated by the medical practitioner to tighten the sealing member and the anchor member relative to one another, and secured, to effect the seal of the vessel wound. Alternatively, the suture could be spring loaded to tighten the sealing member and the anchor member without manual tensioning of the suture. In any event, excess suture material is then cut and unsecured portions of the system are removed from the patient.
The sealing member 170 and the anchor member 180 may be as described above with respect to FIGS. 3A-3F, or may alternatively be as shown in either of FIG. 8A or 8B, for example. FIG. 8A shows an anchor member 180 having prongs 181 that penetrate into the exterior surface of the target vessel V to secure the anchor member 180 relative to the sealing member 170 after tightening has occurred. FIG. 8B shows an anchor member 180 having an “m” shape that penetrates into the exterior surface of the target vessel V to secure the anchor member 180 relative to the sealing member 170 after tightening has occurred.
The various exemplary embodiments of the invention as described hereinabove do not limit different embodiments of the systems and methods of the invention. The material described herein is not limited to the materials, designs or shapes referenced herein for illustrative purposes only, and may comprise various other materials, designs or shapes suitable for the systems and methods described herein, as should be appreciated by the artisan.
While there has been shown and described what is considered to be preferred embodiments of the invention, it will, of course, be understood that various modifications and changes in form or detail could readily be made without departing from the spirit or scope of the invention. It is therefore intended that the invention be not limited to the exact forms described and illustrated herein, but should be construed to cover all modifications that may fall within the scope of the appended claims.
wherein the delivery rod further comprises an exterior channel and a tapered distal section through which the guidewire slides for locating the system within a target vessel.
2. The vessel wound closure system of claim 1, further comprising a tamping tool, at least a portion of which is disposed within the delivery rod.
3. The vessel wound closure system of claim 2, further comprising a cutting element, at least a portion of which is disposed within the delivery rod.
4. The vessel wound closure system of claim 1, wherein the suture further comprises a connecting portion that connects the sealing member with the anchor member, and an accessible portion that extends proximally of the delivery rod for manipulation thereof by an operator, the connecting portion of the suture being oriented in the open channel of the delivery rod.
5. The vessel wound closure system of claim 4, wherein the anchor member further comprises at least one passageway through which some of the connecting portion of the suture extends.
6. The vessel wound closure system of claim 5, wherein the connecting portion of the suture further comprises one way barbs that pass through the at least one passageway of the anchor member to tighten and secure the anchor member in place relative to the sealing member.
7. The vessel wound closure system of claim 1, wherein the sealing member and the anchor member are comprised of bioresorbable material.
8. The vessel wound closure system of claim 1, wherein the sealing member is larger than the anchor member.
9. The vessel wound closure system of claim 8, wherein the sealing member is elliptical with a width less than an inner diameter of the delivery rod.
10. The vessel wound closure system of claim 8, wherein the sealing member is cylindrical with a diameter less than an inner diameter of the delivery rod.
11. The vessel wound closure system of claim 1, wherein the suture is comprised of bioresorbable material.
MX2008008345A MX2008008345A (en) 2005-12-23 2006-12-14 Systems for closing a vessel wound.
English language translation of Notification of Reasons for Refusal dated Jan. 10, 2012 for Japanese Patent Application No. 2008-547326.
European Office Action dated Apr. 2, 2009 relating to corresponding European Application No. 06 845 394.3.
European Search Report dated Oct. 7, 2009 relating to corresponding European Application No. 09075397.1.
Examiner's first report for Australian Patent Application No. 2006333048 dated Nov. 16, 2011.

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V.
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Application No. 2008
Application No. 06
Application No. 09075397
Application No. 2006333048


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