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WO2000072783A1 - Dispositif implantable d'allongement et de correction d'anomalies de position d'os du squelette - Google Patents

Dispositif implantable d'allongement et de correction d'anomalies de position d'os du squelette Download PDF

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Publication number
WO2000072783A1
WO2000072783A1 PCT/SE2000/001064 SE0001064W WO0072783A1 WO 2000072783 A1 WO2000072783 A1 WO 2000072783A1 SE 0001064 W SE0001064 W SE 0001064W WO 0072783 A1 WO0072783 A1 WO 0072783A1
Authority
WO
WIPO (PCT)
Prior art keywords
implantable device
absorbent body
lengthening
swelling
activation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/SE2000/001064
Other languages
English (en)
Inventor
Christian Högfors
Abbas Karladani
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from SE9901947A external-priority patent/SE514212C2/sv
Application filed by Individual filed Critical Individual
Priority to AU52620/00A priority Critical patent/AU5262000A/en
Priority to JP2000620897A priority patent/JP2003526401A/ja
Priority to EP00937448A priority patent/EP1180988A1/fr
Publication of WO2000072783A1 publication Critical patent/WO2000072783A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary devices, e.g. pins or nails
    • A61B17/7216—Intramedullary devices, e.g. pins or nails for bone lengthening or compression

Definitions

  • Implantable device for lengthening and correcting malpositions of skeletal bones
  • the present invention pertains to the field of orthopaedic surgery, and more specifically relates to an implantable device for lengthening, and also lor correction ol rotational and angular malpositions of skeletal bones
  • the invention advantageoush can be applied in connection with stabilisation oi fractures, post-traumatic bone defects, bone shortening, malpositions, congenital malformations and bone defects after tumour surgery
  • implantable devices e.g. for e g stabilisation of fractures, lengthening of skeletal bones, or for correction of different malpositions
  • a screw assembly oi the above- described type can be applied at one side of the skeletal bone with the aid of two attachment means, hereafter the skeletal bone between the two attachment means can be cut off
  • the screw assembh in accordance with the chosen lengthening scheme, a gradual bending oi the skeletal bone in question can be obtained
  • the screw assembh . the screw and the attachment means can be bv means ot a surgical operation
  • several screw assemblies in parallel can be applied around the skeletal bone in question.
  • intramedullary nails which during use are intended to be inserted into the bone-marrow cavity of a tubular skeletal bone. It is also previously known with such devices for which the lengthening action can be activated and/or controlled from the outside after the implantation.
  • the patent publication US-A-5.626.581 discloses a nail assembly for bone lengthening comprising a first nail body portion and a second nail body portion.
  • the assembly further comprises a power package inside either the first or the second nail body portion, wherein the power package comprises a power-supplied hydraulic pump which forces hydraulic fluid from a hydraulic fluid container and into a sealed chamber between the first and second nail body portions, thereby forcing the first nail portion to be extended longitudinally in relation to the second nail portion and increasing the length of the nail.
  • the disclosed assembly may comprise a spring of a heat- sensitive memory material such as nitinol, and a heating system with a battery-powered electrical heater acting on the spring.
  • external activation and/or control of the assembly may be accomplished e.g. by means of providing the heating system with a timer or a suitable circuit for remote control which acts on the heating system.
  • the previously known implantable devices for lengthening and correction of skeletal bones which can be controlled from the outside, or which otherwise can be controlled without any permanent skin lead-throughs. often comprise a large number of mechanical and electronic components, and can be perceived as complicated or unnecessarily expensive.
  • the external dimensions, the durability and the different lengthening properties are concerned, it may become expensive to tailor-make devices for each individual case in accordance with the prior art. since this often requires a number ot the many different components to be re-dimensioned
  • problems with lack of internal space may arise
  • a first object of the present invention is to provide a simple and reliable, implantable device for lengthening and correcting malpositions of skeletal bones, wherein the dimensions and the lengthening process of the device can be tailor-made in advance for the configuration and type of tubular skeletal bone in question into which the device is to be implanted, and where the device also can be designed with very small external dimensions thanks to its simple design
  • this first object of the invention is achieved by means of the device having an elongate shape comprising a first end, a second end. a length dimension and a cross-sectional dimension, and the device further comprising a lengthening menas for b ⁇ nging the first and second ends into displacement from each other to a predetermined distance between each other after an activation
  • the lengthening means comp ⁇ ses an absorbent body . which is arranged for bringing the first and second ends to the predetermined distance by means of a controlled swelling after the activation while the length dimension increases more than the cross-sectional dimension
  • a second object of the present inv ention is to provide an implantable device which, in addition to the above-mentioned advantages, also enables correction of rotational and angular malpositions of skeletal bones
  • this second object of the ⁇ n ⁇ ention is achieved by means of the absorbent body of the implantable device further comprising one or several stiffening elements and/or one or several swelling zones having a raised intrinsic swelling capacity in comparison to the remaining absorbent bod ⁇ w hich are arranged tor controlling the swelling so that the first and second ends striv e towards a predetermined angle in relation to each other after the acti ation
  • Fig 1 schematically show s a sectional view through an implantable device according to a preferred embodiment of the invention.
  • Fig 2 schematically shows a sectional view through an implantable device according to an alternative embodiment of the invention.
  • FIG. 3 A schematically shows a sectional view through an implantable device according to a particularh preferred embodiment of the invention, before activation.
  • Fig 3B schematically show s a sectional view through the implantable device in Fig 3 A. after activation and subsequent swelling, and
  • Fig 4 schematically show s a sectional view through an implantable dev ice according to another alternative embodiment of the invention
  • the implantable device 1 1 ; 1 1'; 21 : 1 1 1 according to the invention has an elongate shape comprising a first end 12: 12': 22; 1 12. a second end 13; 13'; 23: 1 13. a length dimension 14; 24: 1 14 and a cross-sectional dimension 15: 25; 1 15.
  • cross-sectional dimension e.g. refers to the outer diameter in case of a circle-cylindrical device, but can also refer to another cross-sectional dimension depending on the geometrical shape of the cross-section.
  • the device 1 1 ; 21 : 1 1 1 comprises a lengthening means 16; 16'; 26; 1 16, 216 for bringing the first 12: 12'; 22; 1 12 and second 13; 13'; 23; 1 13 ends into displacement from each other to a predetermined distance 14'; 24'; 1 14' between each other after an activation.
  • predetermined distance refers to the maximum distance of the implantable device which is desirable after it has been implanted into a tubular skeletal bone. The predetermined distance has to be adapted for each individual case.
  • the lengthening means comprises an absorbent body 16; 16'; 26; 1 16, which is arranged for bringing said first 12; 12'; 22; 1 12 and second 13; 13': 23; 1 13 ends to the predetermined distance 14'; 24'; 1 14' by means of a controlled swelling after the activation, while the length dimension 14; 24; 1 14 increases more than the cross-sectional dimension 15; 25; 1 15.
  • the absorbent body 16'. 16" comprises one or several stiffening elements 18'. 18". 19', 19", and/or one or several swelling zones 20'. 20" having a raised intrinsic swelling capacity in comparison to the remaining absorbent body 16'. 16".
  • the stiffening elements and/or the swelling zones are arranged for controlling the swelling so that said first 12'. 12" and second 13'. 13" ends strive towards a predetermined angle a in relation to each other after the activation.
  • the absorbent body 16: 16'. 16" primarily is constituted of a matrix of thermosetting melamine formaldehyde plastic on a needled reinforcement material of HT-rayon.
  • HT-rayon refers to rayon fibres or filaments having a high tenacity.
  • the absorbent body 16 advantageously comprises micro-crystalline cellulose as a filler.
  • the absorbent body preferably has been compression-moulded to its intended shape during heating. Within the scope of the invention, it is of course also conceivable with absorbent bodies with another matrix material, reinforcement material, or filler.
  • the matrix material can consist of or comprise another polymeric resin suitable for the purpose
  • the reinforcement material can consist of or comprise another fibre material suitable for the purpose
  • the filler can consist of or comprise a suitable superabsorbent. such as for example cellulose acetate.
  • the device 21 in addition to an absorbent body of e.g. the type shown in Fig. 1. the device 21 further comprises first 28 and second 29 cylinder members having closed ends 22. 23 and opposite open ends 30, 31. Thereby, the open end 30 of the first cylinder member 28 is at least partially slidably inserted into the open end 31 of the second cylinder member 29, so that the cylinder members 28.29 together form at least one internal cavity 32 within which the absorbent body 26 is arranged. Furthermore, a back stop device 33 is arranged between the open ends 30. 31 for enabling the first 22 and second 23 ends of the implantable device 21 to be irreversibly displaced to the predetermined distance 24' after the activation.
  • the device comprises valves 27', 27" for opening or closing a connection between the absorbent body 26 and the environment surrounding the device 21. wherein the valves 27'. 27" are arranged for being controlled by means of radio waves, ultrasonic, induction or magnetic control when accomplishing the activation and/or a deactivation.
  • the device according to the invention comprises cylinder members of the above-mentioned type which enclose the absorbent body, but it is also conceivable with embodiments where the absorbent body only is enclosed by a relatively impervious membrane through which the valve or valves are arranged.
  • the back stop device 33 comprises at least one spring-loaded member 34 of one of the cylinder members which is arranged for mechanical engagement with a member provided with steps 35 of the other cylinder member.
  • This type of back stop device is schematically depicted in the attached Fig. 2.
  • the cylinder members are slidably arranged with seals (not shown) against each other, wherein the internal cavity is divided into at least two portions by a stationary partition wall in which a connection having a check valve has been arranged.
  • the absorbent body 1 16 is accommodated within a cylindrical member 129 comprising water inlet means for allowing water transport into the absorbent body during the controlled swelling.
  • the second end 1 13 is connected to a piston means 128 arranged for sliding displacement within the cylindrical member 129, wherein at least one spring member 216 is embedded in the absorbent body 1 16 for exercising a lengthening force in cooperation with the absorbent body on the first 1 12 and second 1 13 ends during the controlled swelling.
  • the spring member 216 is preferably a helical steel spring. However, its also conceivable with embodiments with other geometrical spring shapes and/or materials.
  • the water inlet means can be constituted by one or several water-permeable portions 1 17 in the cylindrical member 129, by the piston means 128 being water-permeable, or by the piston means 128 consisting of a disc member with a plurality of axially extending through-apertures, which can be accomplished e.g. by means of punching or laser cutting.
  • the water inlet means can be constituted by the piston means comprising one or several nonreturn valves, for allowing water transport only in a direction towards the absorbent body.
  • the cylindrical member 129 preferably is sealed by a wall member 131 between the piston means 128 and the second end 1 13. thereby forming an internal cavity within the cylindrical member 129.
  • the internal cavity is intended to be filled with an aqueous liquid H 2 O for providing at least a part of the water during the controlled swelling.
  • opposing spring members are provided on both sides of the piston means 128 in order to facilitate the control of the lengthening course of the implantable device.
  • the absorbent body 1 16 and the spring member(s) 216 are adapted for bringing the first 1 12 and second 1 13 ends to the predetermined distance by means of exercising a pressure together on the first and second ends after the activation which is larger than about 500 N/cm2. Furthermore, the water inlet means 1 17,
  • the absorbent body 26 1 16 pa ⁇ icularly advantageously comprises cellulose acetate or another superabsorbent.
  • the cylinder members 28, 29: 129 are concerned, they particularly advantageously are constituted of titanium.
  • the absorbent body comprises another suitable absorbent material, or where the cylinder members are made of another material suitable for insertion into a shaft of a bone.
  • the absorption properties of the absorbent body 16: 16', 16"; 26; 1 16 are adapted so that the activation can be accomplished by means of wetting with water originating from a body fluid (BF).
  • the absorbent body 16; 26 is enclosed by a liquid-permeable membrane 17; 27 having permeation properties which are adapted for providing a controlled permeation rate of the water into the absorbent body during wetting.
  • the liquid-permeable membrane 17; 27 is advantageously constituted of cellophane, a stretched polymer film or the like and, in addition to a cohesive effect, provides a possibility to control the rate at which the absorbent body is wetted and, as a consequence, also the swelling rate of the absorbent body and the lengthening rate of the device.
  • the liquid-permeable membrane preferably is selected in such a way that only water molecules and no other components of the body fluid can penetrate the membrane.
  • the implantable device according to the invention lacks a liquid-permeable membrane.
  • the absorbent body 16: 26. or the absorbent body and the liquid-permeable membrane 17; 27 is/are enclosed by a biodegradable, initially water- impervious, barrier layer (not shown), which advantageously comprises a hydrophobic material which is sensitive to body enzymes, or a macromolecular material which can be hydrolysed.
  • the barrier layer can be constituted of or comprise for example polylactate or polyurethane-urea (PUU).
  • POU polyurethane-urea
  • a method comprising the following steps can be utilised for the lengthening and/or correction: a device according to the invention having appropriate dimensions and lengthening properties for the tubular skeletal bone in question is selected, the device according to the invention is implanted into the skeletal bone using techniques which are well-known to the skilled person.
  • the device is left in its place for 14 days, a lengthening of about 0.5 mm length increase is activated twice a day until the desired lengthening/correction L (mm) is achieved, and the device is left in its place within the skeletal bone for an approximate time of 5 x L weeks before the device is removed by means of techniques which are previously known per se
  • a method comprising the following steps can be utilised: analysis of the lengthening/correction which is required for the skeletal bone in question, a device according to the invention having appropriate dimensions and lengthening properties is selected.
  • the device is implanted using techniques which are previously known per se, the device is left in its place within the bone for a certain stabilisation time counted from the point in time when the desired lengthening/correction has been achieved, and the device is removed using techniques which are previously known er se.
  • the status of the skeletal bone should be regularly supervised by means of radiographs.
  • the swelling process of the absorbent body 16; 16'; 26; 1 16 is concerned, after the activation having been accomplished by means of an external signal or the device according to the invention coming into contact with body fluid after the implantation, the swelling process is controlled from the outside and/or is predetermined by the choice and adaptation of the components included in the device according to the invention, so that the swelling process at least will comp ⁇ se:

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un dispositif implantable (11) permettant d'allonger et de corriger les anomalies de position des os du squelette, ledit dispositif étant doté d'une forme allongée qui comprend une première extrémité (12), une seconde extrémité (13), une dimension de longueur (14) et une dimension transversale (15). Ledit dispositif (11) comporte en outre un dispositif d'allongement (16) servant à amener les première (12) et seconde (13) extrémités en déplacement l'une par rapport à l'autre à une distance prédéterminée (14') après activation. Ainsi, le dispositif d'allongement comprend un corps absorbant (16), qui est disposé de manière à amener les première (12) et seconde (13) extrémités à la distance prédéterminée (14') au moyen d'un gonflement régulé après activation, tandis que la dimension de la longueur (14) augmente plus que la dimension transversale (15). On peut mettre en oeuvre, de manière avantageuse, le dispositif décrit par cette invention pour allonger et également corriger les malpositions rotatoires et angulaires des os du squelette, par exemple pour stabiliser des fractures, des malformations osseuses post-traumatiques, des raccourcissements osseux, des anomalies de position, des malformations congénitales, et des anomalies osseuses apparaissant après opération chirurgicale d'une tumeur.
PCT/SE2000/001064 1999-05-28 2000-05-25 Dispositif implantable d'allongement et de correction d'anomalies de position d'os du squelette Ceased WO2000072783A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
AU52620/00A AU5262000A (en) 1999-05-28 2000-05-25 Implantable device for lengthening and correcting malpositions of skeletal bones
JP2000620897A JP2003526401A (ja) 1999-05-28 2000-05-25 骨格骨を延伸しその偏位を矯正するための埋め込み可能な器具
EP00937448A EP1180988A1 (fr) 1999-05-28 2000-05-25 Dispositif implantable d'allongement et de correction d'anomalies de position d'os du squelette

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
SE9901947-3 1999-05-28
SE9901947A SE514212C2 (sv) 1999-05-28 1999-05-28 Implanterbar anordning för förlängning och felställningskorrigering av skelettben
US14032699P 1999-06-21 1999-06-21
US60/140,326 1999-06-21

Publications (1)

Publication Number Publication Date
WO2000072783A1 true WO2000072783A1 (fr) 2000-12-07

Family

ID=26663581

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/SE2000/001064 Ceased WO2000072783A1 (fr) 1999-05-28 2000-05-25 Dispositif implantable d'allongement et de correction d'anomalies de position d'os du squelette

Country Status (4)

Country Link
EP (1) EP1180988A1 (fr)
JP (1) JP2003526401A (fr)
AU (1) AU5262000A (fr)
WO (1) WO2000072783A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE202023100127U1 (de) 2023-01-11 2023-02-03 Rüdiger Schloo Strom- und Wärmeerzeugung unter Verwendung von sog. Formgedächtnis-Legierungen durch Nutzung der Umgebungstemperatur

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0251583A2 (fr) * 1986-06-23 1988-01-07 Howmedica Inc. Système modulaire de fixation fémorale
US4904258A (en) * 1986-07-16 1990-02-27 La Cellulose Du Pin Biocompatible, hydrophilic material, method of manufacture and uses of same
WO1995034331A1 (fr) * 1994-06-10 1995-12-21 Ao-Forschungsinstitut Davos Obturateur de cavites a auto-dilatation et adaptable pour implantation de protheses endoarticulaires
US5626579A (en) * 1993-02-12 1997-05-06 The Cleveland Clinic Foundation Bone transport and lengthening system
US5626581A (en) * 1995-11-27 1997-05-06 Volunteers For Medical Engineering Implantable bone lengthening apparatus

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0251583A2 (fr) * 1986-06-23 1988-01-07 Howmedica Inc. Système modulaire de fixation fémorale
US4904258A (en) * 1986-07-16 1990-02-27 La Cellulose Du Pin Biocompatible, hydrophilic material, method of manufacture and uses of same
US5626579A (en) * 1993-02-12 1997-05-06 The Cleveland Clinic Foundation Bone transport and lengthening system
WO1995034331A1 (fr) * 1994-06-10 1995-12-21 Ao-Forschungsinstitut Davos Obturateur de cavites a auto-dilatation et adaptable pour implantation de protheses endoarticulaires
US5626581A (en) * 1995-11-27 1997-05-06 Volunteers For Medical Engineering Implantable bone lengthening apparatus

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE202023100127U1 (de) 2023-01-11 2023-02-03 Rüdiger Schloo Strom- und Wärmeerzeugung unter Verwendung von sog. Formgedächtnis-Legierungen durch Nutzung der Umgebungstemperatur

Also Published As

Publication number Publication date
AU5262000A (en) 2000-12-18
JP2003526401A (ja) 2003-09-09
EP1180988A1 (fr) 2002-02-27

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