US 20060184230 A1
A delivery system for delivering a prosthetic heart valve to a native valve site within the human vasculature. The prosthetic valve is disposed on a balloon at the end of a balloon catheter. The balloon catheter passes through a delivery sleeve assembly and handle. A pull wire travels from the handle to a distal end of the delivery sleeve assembly. Actuation of the handle pulls on the pull wire, which causes openings in a slotted tube of the delivery sleeve assembly to close, thus causing the delivery sleeve assembly to bend. A stretchable cover is placed over the slotted tube for biasing the steerable catheter toward a straight position. Once advanced to the native valve site, the prosthetic valve is deployed by inflating the balloon.
1. A method of reshaping a blood vessel in a patient, comprising:
providing a shape-changing member having a proximal end portion and a distal end portion;
maintaining the shape-changing member in a first configuration using a resorbable material;
inserting the shape-changing member into the blood vessel; and
fixing the proximal and distal end portions of the shape-changing member to an inner wall of the blood vessel;
wherein the resorbable material is resorbed in the patient's body, thereby causing the shape-changing member to adjust from the first configuration to a second configuration for reshaping the blood vessel.
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11. A method of reshaping a mitral valve annulus in a body, comprising:
providing a device having a shape-changing member and first and second self-expandable stents located at opposite ends of the shape-changing member, the shape-changing member having a first set of forces working towards shortening the shape-changing member along a longitudinal axis;
maintaining the shape-changing member in an elongated shape by applying a second set of forces for counteracting the first set of forces, wherein the second set of forces is configured to decrease after the device has been implanted in the body; and
inserting the device at least partially into a coronary sinus such that the first and second self-expandable stents engage an inner wall of the coronary sinus and wherein the shape-changing member shortens over time to draw the first and second self-expandable stents toward each other.
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16. A method of reshaping a mitral valve annulus in a body, comprising:
providing an elongate device having proximal and distal stents;
creating an incision in the body;
advancing an introduction sheath into a venous system;
advancing a guidewire through the introduction sheath and into a coronary sinus;
advancing the elongate device over the guidewire and through the introduction sheath to the coronary sinus;
expanding the proximal and distal stents to contact an inner wall of the coronary sinus;
removing the introduction sheath and the guidewire;
closing the incision in the body; and
transforming the elongate device into a shorter shape after closing the incision.
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The present application is a divisional of co-pending, commonly assigned U.S. patent application Ser. No. 10/141,348, filed on May 9, 2002, which is incorporated by reference herein in its entirety.
The present invention relates to a medical device for providing a change of shape in a part of the body of an organism. The invention further relates to a device and a method for reshaping a body vessel, and a device and a method for restraining growth of a body organ of an organism.
At present the treatment of mitral annulus dilatation and other mitral insufficiencies consists of either repair or mitral valve replacements. Both methods require open-heart surgery, by the use of total cardiopulmonary by-pass, aortic cross-clamping and cardioplegic arrest. To certain groups of patients, open-heart surgery is particularly hazardous and therefore a less invasive method for repair of mitral insufficiency is desired.
Such a less invasive method is proposed in U.S. Pat. No. 6,210,432, which describes a method for treatment of mitral insufficiency without the need for cardiopulmonary by-pass and opening of the chest and heart. The method uses a device comprising an elongate body having such dimensions as to be insertable into the coronary sinus, which is a vein that substantially encircles the mitral orifice and annulus and drains blood from the myocardium to the right atrium. The elongate body has two states, in a first of which the elongate body has a shape that is adaptable to the shape of the coronary sinus, and to the second of which the elongate body is transferable from said first state assuming a reduced radius of curvature. Consequently, the radius of curvature of the coronary sinus is reduced. Due to the coronary sinus encircling the mitral annulus, the radius of curvature as well as the circumference of the mitral annulus are reduced. Thus, the described method takes advantage of the position of the coronary sinus being close to the mitral annulus, which makes repair possible by the use of current catheter-guided techniques.
According to one method described in U.S. Pat. No. 6,210,432, a device comprising an elongate stent is used. The elongate stent includes hooks which are arranged to dig into the walls of the coronary sinus, by means of the surgeon retracting a cover sheet from the stent, in order to fix the position of the stent in the coronary sinus. A stabilizing instrument is used for keeping the elongate stent in its first state and then, after the hooks have dug into the walls, releasing it to its second state assuming a reduced radius of curvature. However, the position fixation of the elongate stent in the coronary sinus by means of the hooks might be insufficient, so that the sudden release of the contraction of the elongate stent dislocates it. This dislocation of the device might result in unsatisfactory reduction of the circumference of the mitral annulus.
According to an alternative method described in U.S. Pat. No. 6,210,432 the device comprises three stent sections that are positioned in the coronary sinus and connected by wires. The wires may be maneuvered from outside the vein system such that the distances between the adjacent stent sections are reduced. Also with this method there is a risk of dislocation of the device, since the surgeon might accidentally move insufficiently fixed stent sections out of their proper position while manipulating them from outside the vein system.
An object of the present invention is to provide a more secure fixation of a medical device for providing a change of shape in a part of the body of an organism.
A particular object of the invention is to provide a more secure fixation of a device for reshaping a body vessel, as described above.
These and other objects are achieved by a device and method as defined in the claims.
More particularly, according to one aspect of the present invention, a medical device being insertable into the body of an organism comprises a member having a preferred state of shape, towards which the member by means of inherent forces strives when being in a non-preferred state of shape, and a delay means having a weakenable inherent stiffness to hold the member in the non-preferred state of shape for a period of time after the device is inserted into the body of the organism. The member is by means of said inherent forces arranged to provide a change of shape in a part of the body of an organism, whereas the delay means is arranged to delay the change of shape for a period of time. The time period is determined by how fast the weakening of said inherent stiffness proceeds. By delaying the change of shape this way, the device is allowed to heal on to body tissue of the organism before a change of shape of the device occurs. Which parts of the device that become fixed by the healing process can be determined by means of the design of the device. The normal healing process that occurs in every living organism is thus allowed to provide a well-established fixation of the device. Hence, the present invention provides a more secure fixation of a medical device for providing a change of shape in a part of the body of an organism.
In a preferred embodiment of the invention, said delay means holds said member in a non-preferred state of shape by counteracting the inherent forces of the member. Thus, the delay means is arranged to apply force to the member by means of the inherent stiffness, in order to counteract the inherent shape-changing forces of the member and thereby restrain the member from changing its shape.
Preferably, said delay means holds said member in a non-preferred state of shape while the inherent stiffness of the delay means overcomes the inherent forces of the member. That is, there is an equilibrium between the inherent forces of the member and the inherent stiffness of the delay means, and when the stiffness of the delay means no longer is strong enough to balance the inherent forces of the member, the change of shape will occur.
In another preferred embodiment of the invention, said delay means comprises a decomposable material. In this way, the inherent stiffness of the delay means is allowed to weaken simply as a result of the decomposable material of the delay means being decomposed.
Preferably, said delay means comprises a resorbable material. A resorbable material is a material that when it is inserted into the body of an organism, it will be resorbed by the body by means of enzymatic processes, by active absorption by the cells in the blood and tissue cells of the body, and/or by hydrolysis. Thus, the resorbable material of the delay means will advantageously be decomposed and vanish from the device by time, without leaving any major waste products in the body.
In another preferred embodiment, said member comprises an elastic material. An elastic material can in a simple way be forced to adopt a non-preferred shape.
In yet another preferred embodiment, said member comprises a material having superelasticity properties. Superelasticity properties means that the material may be deformed and in the deformed state the material will use its superelasticity forces to return to its preferred shape. These superelasticity forces thus constitute advantageously at least part of said inherent forces providing said strive towards said preferred state of shape of the member.
Preferably, said member comprises a shape memory material. A shape memory material is a material that has two different forms, one at lower temperatures and another at higher temperatures. At the lower temperatures, e.g. below 30.degree. C., the material is elastic and may be introduced into the body. At the higher temperatures, the material is still elastic but becomes also superelastic and assumes its preferred original shape unless the transformation to this original shape is obstructed by external stress to the material. The use of a shape memory material in the member is advantageous inter alia because then one can easily provide the device with said delay means while the member, at a lower temperature outside the body, more easily remains in a shape corresponding to said non-preferred state of shape inside the body.
According to another aspect of the present invention, a medical device for providing a change of shape in a part of the body of an organism comprises a first set of forces working towards a change of shape of the device, and a second set of forces working for preserving a present shape of the device and thereby counteracting said first set of forces. Said first and said second sets of forces are each inherent in a solid material of the device, and the forces of said second set of forces are arranged to decrease as a result of said solid material interacting chemically with said part of the body. As a result of the chemical interaction between the solid material of the device and the surrounding body, the forces of the second set of forces decrease and thus allow the device to provide said change of shape after a while, when parts of the device have become fixed in the body by a healing process. An advantage of the present invention, except that it provides a more secure fixation, is that there is no need for a stabilizing surgical instrument for keeping a present shape of the device during operation, since the shape is preserved by means of said second set of forces being inherent in the device itself.
Preferably said second set of forces is inherent in a decomposable material as mentioned above.
Said forces of said second set of forces are preferably arranged to decrease as a result of said solid material being decomposed by said part of the body.
In a preferred embodiment of the invention, said second set of forces is inherent in a resorbable material as described above.
Preferably, said forces of said second set of forces are arranged to decrease as a result of said solid material being resorbed by said part of the body.
In another preferred embodiment, said first set of forces is inherent in an elastic material.
Preferably, said first set of forces is inherent in a material having superelasticity properties as described above.
Said first set of forces is preferably inherent in a shape memory material as also described above.
In one embodiment of the invention, said first set of forces is inherent in a shape memory metal.
In an alternative embodiment of the invention, said first set of forces is inherent in a shape memory polymer.
The device is in one embodiment arranged to contract into a new shape as a result of said second set of forces being decreased.
In an alternative embodiment, the device is arranged to expand into a new shape as a result of said second set of forces being decreased.
The device could be arranged to change its shape in one dimension only, but it could also be arranged to change its shape in two dimensions, or even in three dimensions.
According to yet another aspect of the present invention, a medical device being insertable into the body of an organism comprises a member having a preferred state of shape and having a tendency to transfer its shape towards said preferred state of shape when being in a non-preferred state of shape. The device further comprises a resorbable means being arranged to hold the member in the non-preferred state of shape and to delay the transfer when the device is inserted into the body of the organism by counteracting said transfer during resorption of the resorbable means by the surrounding body of the organism. The resorption of the resorbable means by the surrounding body makes the resorbable means gradually vanish. Thus, after some period of time when parts of the device have grown on to body tissue, there is nothing left to hold the member in the non-preferred state of shape, whereby said transfer is released.
Also according to this aspect of the invention, said member preferably comprises an elastic material.
Preferably, said member comprises a material having superelasticity properties.
It is also preferred that said member comprises a shape memory material.
According to a particular aspect of the present invention, a device for reshaping a body vessel is elongate and has such dimensions as to be insertable into the vessel and has two states, in a first of which the device has a shape that is adaptable to the shape of the vessel, and to the second of which the device is transferable from said first state. The device further comprises a fixing means for fixing the ends of the device within the vessel, when the device is first positioned therein, a member for transferring the device to the second state by reshaping it, and a resorbable means for delaying said reshaping until the ends of the device are fixed by keeping said device in said first state until the resorbable means is resorbed. By allowing the ends of the device to heal on to the walls of the vessel, e.g. the coronary sinus, by means of said fixing means, before said reshaping of the device occurs, the present invention provides a more secure fixation of a device for reshaping a body vessel.
Preferably, said resorbable means comprises a resorbable sheath being arranged to enclose said member. This is advantageous since with the shape of a sheath the resorbable means is both easy to manufacture and easy to arrange on the member.
In another preferred embodiment of the invention, said fixing means is arranged to expand against the wall of the vessel when first positioned therein. This expansion against the wall of the vessel initiates and contributes to the fixing of the ends of the device, thus enabling a rigid fixing.
In yet another preferred embodiment of the invention, said fixing means is arranged to grow into the wall of the vessel. By taking advantage of the healing process in the tissue of the vessel wall, the fixing means can be fixed effectively. This can be facilitated by an expansion against the wall of the vessel as mentioned above.
In a preferred embodiment, said fixing means comprises a self-expandable stent at each end of the device.
According to another preferred embodiment, said member comprises a shape memory material providing said reshaping of the device.
Preferably, said reshaping of said device comprises shortening of said device.
In another preferred embodiment, said device is used for treatment of mitral annulus dilatation. Since the device can be inserted into a body vessel using catheter-guided techniques, the use of this device for treatment of mitral annulus dilatation is advantageous compared to open-heart surgery, which is the present procedure for repairing or replacing the mitral valve.
In yet another preferred embodiment, said vessel is the coronary sinus. The coronary sinus encircles the mitral orifice and annulus. Therefore, a reshaping of this vein also has a compressing effect on the mitral annulus.
Preferably, said reshaping of said device is used for reducing the radius of curvature of the coronary sinus. Hence, the radius of curvature as well as the circumference of the mitral annulus are also reduced. According to the invention, a method for reshaping a body vessel comprises the steps of inserting a device into the vessel, fixing the ends of the device within the vessel, reshaping the device, and delaying said reshaping by a resorbable means so that the step of fixing the ends of the device is performed before the step of reshaping the device.
According to a preferred embodiment, said step of fixing the ends of the device comprises providing a growth of the ends into the wall of the vessel.
According to another preferred embodiment, a shape memory material is used in the device for said step of reshaping the device.
Preferably, Nitinol is used in the device for said step of reshaping the device.
In a preferred embodiment, said step of reshaping the device comprises the step of shortening the device.
In another preferred embodiment, the method is used for treatment of mitral annulus dilatation.
In yet another preferred embodiment, said device is inserted into the coronary sinus in the vicinity of the posterior leaflet of the mitral valve.
Preferably, said reshaping is used for reducing the curvature of the coronary sinus and thereby reducing the radius of circumference of the mitral valve annulus.
The basic inventive idea, that reshaping of an implantable device may be delayed by means of a delay means being comprised in the device itself, opens up for new possibilities within many medical applications.
The present invention could be used for instance when a delayed expansion of a stent is desired. The stent could then preferably be crimped to a small diameter by means of a resorbable suture or, alternatively, a resorbable film. The film or thread would slowly be eaten away and the shape-changing forces may be released after the desired delay which is programmed in the properties of the resorbable restraining material. Such a stent might be used inside vessels, the trachea, the biliary tract or any other hollow structure in the human or animal body.
The invention would also be useful where openings of human, or animal, organs or other structures need to be opened or closed slowly. For instance, when an opening between the left and right side of the heart is present, an immediate closure of the opening could be dangerous, whereas a slower closure would be tolerated.
Within many medical areas, the present invention would be useful when a continuous long-term effect of shape-changing forces is desired. One such application would be a device designed to shorten or lengthen a human or animal structure in one or more dimensions. The device according to the invention would then have time to heal into the body structure before shape-changing forces are released and force the body structure to slowly change its shape.
This could for example be useful in the area of orthopedics for lengthening of a bone structure.
For orthodontic treatment, the described invention would be useful when it comes to tooth-regulation and lengthening of the maxilla and/or mandibula, i.e. the upper and lower jaws.
In plastic surgery an extra growth of skin area is often used to cover skin defects. Using the present invention a slow growth of skin area would be augmented.
An example within the area of urology surgery is lengthening of a penis. In this case a device made of three segments could be designed, where the distal ends of the device first are allowed to grow into the tissue. After fixation of the two ends of the device in the penis tissue, the mid portion which temporarily has been restrained by means of a resorbable material as described above will be released and the mid portion of the device will grow in length. One specific capacity of a human or animal body is to allow slow deformation of organs or tissues by compensatory tissue adaptation. A penis would therefore grow slowly to a predetermined length.
By means of the present invention, a sequential effect of shape-changing forces could also be provided, i.e. change of shape could occur in two or several steps as a result of resorbable material releasing the shape-changing forces in predetermined steps. In each step, a part or parts of a device could first heal into a body structure and secondly the desired shape-changing effects could be released.
As seen from the examples above, a substantial advantage of the present invention is that a change of shape is allowed to be made slowly so that body tissues have time to adapt.
Other medical applications of particular interest, which could be improved by using the present invention, are treatment of pathological heart growth and treatment of pathological alveolar sac growth. Some background of these two diseases will be given next.
Dilated cardiomyopathy (DCM) and ischemic heart disease (IHD) are common reasons for heart failure (HF). Heart failure in its terminal status is a deadly disease, and it is by far the most common cause of death in most countries, developed and undeveloped. Progressive HF, when it is deteriorating, results in a growth in the diameters of the heart ventricles, thus resulting in a general heart growth. The growth in heart size by dilatation initiated by myocardial pathology creates itself by its increase in heart diameter a pathology of its own, in the way of functional disorders.
Dr. Randas Batista implemented a surgical treatment for this disease by resecting big parts of the left ventricle (LV) with or without repair of the mitral valve. The long time results were, however, dismal since the LV tends to dilate again a second time despite of having been reduced in size by surgery (see Kawaguchi, A. T. et al. “Mitral Regurgitation Redilates the Left Ventricle After Partial Left Ventriculectomy (Batista Operation).” Journal of the American College of Cardiology, February 1998, Vol. 31, No. 2, Suppl. A, page 376A, ISSN: 0735-1097; see also Kawaguchi, A. T. et al. “Intraoperative Left Ventricular Pressure-Volume Relationship in Patients Undergoing Left Ventricular Diameter Reduction.” Circulation, 1997, Vol. 96, No. 8, Suppl., page 1198, ISSN: 0009-7322; and Prez de la Sota, E. et al. “Early Results with Partial Left Ventriculectomy (the Batista Operation).” Revista Espanola de Cardiologia, August 2000, Vol. 53, No. 8, pages 1022-1027, ISSN: 0300-8932).
Supporting the LV and preventing progressive LV dilatation in HF actively by means of wrapping the heart with living skeletal muscle from the back of the patient, stimulated by pacemaker, was introduced by Dr. Carpentier in the eighties (Chachques, J. C. et al. “Dynamic Cardiomyoplasty: clinical follow-up at 12 years.” European Journal of Cardio-Thoracic Surgery: Official Journal of the European Association for Cardio-Thoracic Surgery, October 1997, Vol. 12, No. 4, pages 560-568, ISSN: 1010-7940). The method has been rarely used and its effectiveness has been questioned.
More recently, methods of restraining the heart from growing have been introduced by Acorn Cardiovascular, Inc, St. Paul, Minn., USA. They are supporting the heart by means of a polyester mesh sutured to the surface of the heart after exposing the heart by splitting the sternum and opening the pericardium.
Even reducing the LV diameter by force, using wires that transverse the LV cavity and subsequent fixation, has been introduced by Myocor, Maple Grove, Minn. 55311, USA.
Chronic obstructive pulmonary disease (COPD) is an umbrella term used to describe airflow obstruction that is associated mainly with emphysema and chronic bronchitis. COPD is the fourth leading cause of death in the U.S. in 1998, according to the National Center for Health Statistics, Report of Final Morbidity Statistics, 1998. Emphysema causes irreversible lung damage by weakening and breaking the air sacs within the lungs. Further, sick air sacs sometimes grow unrestrainedly and repress smaller air sacs, resulting in lack of oxygen and by time death. This disease is hard to treat. At present, surgical treatment of dilated air sacs involves cutting them away, but this treatment gives no long-term effect since a new air sac will soon start to grow.
All these known methods for treatment of pathological heart growth and said known method for treatment of alveolar sac growth require, whether they are effective or not, major heart or lung surgery which, as mentioned before, is particularly hazardous to certain groups of patients. Therefore less invasive methods for treatment of pathological heart growth and alveolar sac growth are desired as well.
It is an object of the present invention to also provide less invasive treatments of pathological growth of body organs, by which treatments more long-term effects can be achieved.
A particular object of the invention is to provide less invasive treatments of pathological heart growth and alveolar sac growth.
These further objects are achieved by a device as defined in claim 50 and by a method as defined in claim 53.
More particularly, according to a further aspect of the present invention, a device for restraining growth of a body organ of an organism is implantable into the body of the organism and comprises an elastic contractable member being arranged to enclose said body organ, and a resorbable means being arranged to delay contraction of the contractable member when the device is implanted in the body of the organism by counteracting the contraction during resorption of the resorbable means by the surrounding body of the organism.
A basic advantage of the device according to the invention is that the device, since said contractable member is elastic, can be inserted into the body using catheter-guided techniques. Hence, less invasive treatments can be provided.
Another advantage, which comes both from the elasticity and the delayed contraction, is that the device can be inserted by means of catheter-guided techniques even if said contractable member comprises a large area. This is due to the fact that the substantially elastic device at the insertion can be rolled up on a catheter and then be unfolded to enclose said organ.
After a period of time after the surgical or percutaneous insertion, the device will start to contract as a result of the resorbable means being resorbed. The contraction will then make the device enclose the organ tight and apply a restraining force which holds back the growth of the organ. Since the implanted device applies a continuous restraining force to the organ, more long-term effects can be achieved in treatment of growing body organs. It is to be noted that if the contraction of the device would not have been delayed, it would have been very difficult to roll up the device on a catheter and then unfold it round the organ.
Preferably, said contractable member comprises a shape memory material.
According to the invention, a method for restraining growth of a body organ of an organism comprises the steps of inserting a restraining device into the body of the organism, enclosing at least partly the body organ with the restraining device, compressing said restraining device by means of a contractable member of said restraining device, and delaying said compression by a resorbable means.
This inventive method could be used not only for treatment of pathological heart growth and alveolar sac growth, but also for treatment of bullous emphysema and for treatment of other body organs growing pathologically.
A device according to the present invention may be fixed in body tissue by other means in combination with or instead of the healing process allowed by the delaying of the change of shape. Hence, fixing of a device according to the invention may as well be accomplished for example by means of suturing, gluing, clipping or using hooks. These means of fixation would permit a better healing in of the device in the tissue and also prohibit dislocation while healing in.
As already seen, the number of advantages of the inventive device is large, of which a few are mentioned next. The present invention allows:
1. less invasive surgical treatments;
2. devices that are properly fixed inside the body by means of parts healing into the body tissue;
3. devices to be designed that have multiple purposes;
4. eliminating stabilizing surgical instruments for keeping a present shape of the device during operation;
5. engineering to decide when a shape-changing action by the device is to take place in the body;
6. a change of shape to be made slowly so that body tissue has time to adapt.
It should be understood that many modifications are possible within the spirit and scope of the invention, which is only limited by the appended claims. A few applications of the invention are mentioned above, of which some will be further described by way of illustration only in the detailed description. However, many other medical areas where the invention might be used will become apparent to those skilled in the art.
The invention will now be described in more detail with reference to the accompanying drawings, in which
FIGS. 1 to 4 show the principle of delayed shortening according to the invention.
The delay means 2 may be flexible enough to follow the curves in e.g. vessels, but has a stiffness, here especially in its radial direction, which withstands the shape-changing force of the shape-changing member 1. Thus, having been implanted into the human body, the shape-changing member 1 of the device will strive towards its original, here curved, shape according to
However, by manufacturing the delay means 2 from a resorbable material, the delay means 2 will be resorbed by time and the shape-changing member 1 will resume its original shape when the delay means 2 has been resorbed to such a degree or extent that it cannot restrain the shape-changing member 1 any longer, as schematically illustrated in
The device in
In order to clearly illustrate the shortening of the device, the curved thread 1 is located to the left in
FIGS. 5 to 8 show the principle of delayed elongation according to the invention.
As schematically illustrated in
In the illustrated embodiments, the length of the shape-changing member 1;3 is substantially unchanged by the transformation, whereas the shape of the shape-changing member 1;3 is changed so that the length of the device is changed.
According to the invention, the material from which the shape-changing member is made may consist of or at least include Nitinol, which is an alloy composed of nickel (54-60%) and titanium. Small traces of chromium, cobalt, magnesium and iron may also be present in Nitinol. Alternatively, other materials such as Shape Memory Polymers (SMP) could be used as the shape memory material.
Actually, as far as the present invention concerns, the shape-changing material does not have to be a shape memory material. Any superelastic material would function in most applications. For example stainless steel (and other metals) may also be forced into a non-preferred state of shape by means of a resorbable restraining means.
Examples of usable resorbable materials from which the delay means may be made, or that are at least included, are PDS (polydioxanon), Pronova (polyhexaflouropropylen-VDF), Maxon (polyglyconat), Dexon (PGA, polyglycolic acid), Vicryl (polyglactin), PLA (polylactic acid), PDLLA (polydexolactic acid), PLLA (pololevolactic acid), starch, different kinds of sugar, butyric acid, collagen, and collatamp.
Depending on the choice of material, the release of the shape-changing forces may be delayed for a desired period of time. Also design parameters such as the thickness of the resorbable material may be set so that the shape-changing forces are delayed as long as desired. The delay time may vary from e.g. a few days up to several years depending on the application.
The thickness of the delay means may vary along the device, so that the order in which different parts of the device are released by the delay means may be controlled.
FIGS. 9 to 20 show some different embodiments of a device according to the invention.
Resorbable crosslinks 6 (
In an alternative embodiment shown in
In another embodiment shown in
The patch in
It is to be noted that the above-described different embodiments are examples only. There are many possible different forms of a device according to the present invention. For example, the single shape-changing thread in FIGS. 1 to 9 may be replaced by several threads or by one or more bands. The scissors-shaped members 7 and 9 in FIGS. 10 to 13 may be multiplied so as to form a scissor-shaped area, which in turn may be shaped into different forms. The single tube in
Next, an embodiment according to the invention of a device for treatment of mitral annulus dilatation will be described.
The device shown in
The device may include one or more additional shape memory metal threads, e.g. if a stronger shortening force is desired.
The shape memory metal thread 20 may be made of Nitinol, or other similar material which has a memory of an original shape as illustrated in
The resorbable sheath 21 is made of PDS, but it may also be made of any other material which is resorbable by the surrounding blood and tissue when applied in a human body and has the required stability and bending properties. The thickness of the resorbable sheath 21 is chosen so that the time needed for the surrounding blood and tissue in the coronary sinus 24 to resorb the resorbable sheath 21 enough for the device to enter its second shorter state of shape K′ is adapted to the time needed for the ends of the device to be fixed within the coronary sinus 24.
The self-expandable stents 22 and 23 may be of conventional type with an elastic cylindrical unit, made of e.g. Nitinol, in an opened zigzag configuration.
The above-described device as seen in
An introduction sheath (not shown) of synthetic material may be used to get access to the venous system. Having reached the venous system, a long guiding metal wire (not shown) is advanced through the introduction sheath and via the venous system to the coronary sinus 24. This guiding wire and/or a delivery catheter is provided with X-ray distance markers so that the position of the device in the coronary sinus 24 may be monitored.
The elongate device in
After the insertion, the self-expandable stents 22 and 23 (or 22 a and 23 a) will grow into the wall of the coronary sinus 24 while at the same time the resorbable sheath 21 (or restraining threads 21 a) will be resorbed by the surrounding blood and tissue in the coronary sinus 24, as schematically illustrated in
The device may be positioned by catheter technique or by any other adequate technique. It may be heparin-coated so as to avoid thrombosis in the coronary sinus 24, thus reducing the need for aspirin, ticlopedine or anticoagulant therapy. At least parts of the device may contain or be covered with drugs like Tacrolimus, Rappamycin or Taxiferol to be delivered into the tissue to prohibit excessive reaction from surrounding tissue. At least parts of the device may be covered with or contain VEGF (Vascular Endothelial Growth Factor) to ensure smooth coverage with endothelial cells.
The bands 29 restrain the threads 28 from being folded to their original curved shapes as long as the fabric 29 is not resorbed.
Analogously to the device in
Further, the hollow space in each band 29 must not necessarily be cylindrical. In fact, if the width of each band 29 is small enough as compared to the curves that the threads 28 will assume when being “activated” as a result of the bands 29 being resorbed, the bands 29 may be hollow.
The contractable area in
Another possible way of making a contractable area according to the invention would be to arrange threads or bands of a memory material in a grid matrix and to fix the threads or bands together with resorbable crosslinks. The resorbable crosslinks would then restrain the threads or bands from being folded as long as enough resorbable material in the crosslinks is left unresorbed.
A contractable area according to the invention, as the one previously mentioned or as the one shown in
FIGS. 27 to 30 illustrate the use of a contractable sac 30 for treatment of pathological heart growth, according to another embodiment of the invention.
Now referring to
Now referring to
After a period of time, the resorbable material of the sac 30 will be resorbed and a restraining force by the shape memory metal threads against the heart 33 is released, and hence, the sac 30 is transformed to its activated state of shape L′, as illustrated in
A contractable area according to the invention can also be used as a contractable sheet for treatment of alveolar sac growth, e.g. in emphysematic pulmonary diseases.
The contractable sheet 34 may also be inserted into the body by means of open surgery or by means of endoscopic surgery and positioned on an organ surface.
Now referring to
The sheet 34 is arranged to grow fixed to the lung surface so that subsequent contraction of the sheet 34, as a result of the resorbable material of the sheet 34 being resorbed, causes the sheet 34 to compress the lung 38 by means of a force of the shape memory metal threads in the sheet 34. Hence, bullae and areas of enlarged alveolar sacs may be shrunk or eliminated and further pathological growth of alveolar sacs may be prevented.
In this embodiment the contractable sheet 34 contracts in two directions, one approximately vertical and one approximately horizontal. The sheet 34 could also be designed to contract in one direction only, e.g. the most horizontal one, or contract in a circular mode, and still be able to shrink bullous areas and prevent alveolar sacs from growing.
It is to be understood that modifications of the above described devices and methods can be made by people skilled in the art without departing from the spirit and scope of the invention.