The present invention relates to stents, such as removeable stents. The invention also relates to stent manoeuvring devices, such as devices for moving, deploying or contracting stents in lumens or vessels of patients, or for removing or retrieving stents from such lumens or vessels. The invention also relates to methods for manoeuvring stents in such lumens and vessels and to methods for servicing such stents.
A known removeable stent is disclosed in U.S. Pat. No. 6,821,291. The stent may be removed by applying a twisting force and then an axial pulling force to the stent and such forces are not always desirable. It also appears difficult to attach a stent removal lasso to hooks of the stent. Additionally, in the prior art, different apparatus is often required for applying stents and then removing them when they need to be removed, requiring stock of multiple types of apparatus in medical facilities. Additionally, it is sometimes difficult to locate stents in the actual desired location thereof and stents often do not provide a robust structure and often have a fixed expanded diameter or cross-dimension which is not suitable for all situations.
The present invention aims to alleviate at least to a certain extent at least one of the problems of the prior art. Another aim of the invention is to provide useful stents and stent manoeuvring devices and methods.
According to a first aspect of the present invention there is provided a stent manoeuvring device comprising a catheter and connector assembly operable through the catheter, the connector assembly having at least one connector element adapted to connect to a stent and apply a substantially radially inward contraction force thereto. This has the advantage that a stent may be contracted without the need to apply twisting or axial force thereto.
The connector assembly may comprise an expandable framework and the connector element may comprise one of a plurality of elongate arms of the framework. The arms may be pivotally retained at proximal ends thereof and may have distal ends arranged to engage a stent. The framework may be collapsible to a structure in which the arms are parallel to and closely adjacent one another and may be expandable to a configuration in which the distal ends of the arms are spaced apart. This provides a relatively strong structure which can nevertheless be operated and deployed through a catheter of relatively narrow diameter if desired.
The arms may be flexible for bending upon contact with a stent. This may advantageously allow increased surface contact between the stent and manoeuvring device for greater manoeuvring control of the stent.
In the preferred embodiments, the device may include an expandable filter for catching debris. When the stent is located in a lumen or vessel of a patient containing flowable material, the filter may be located downstream of the stent in order to advantageously catch debris which may be removed from the region of the stent during stent contraction.
The device may include an outer sheath arranged to retain a contracted stent inside the device. Accordingly, a stent may be advantageously manoeuvred around inside a patient such as before stent expansion by the device, or after stent contraction, for example when the stent is being moved or fully removed from a patient.
The arms may include ratchet elements or locking elements formed thereon for locking engagement with connector portions of a stent, such as internal loop portions of a stent. Accordingly, a secure connection may be provided between the device and a stent for a high level of control during stent expansion or contraction or manoeuvring.
In some embodiments, the arms may be provided with an end stop for restricting movement between the device and a stent.
The device may include an oscillator for applying vibrational force to a stent for example an ultrasonic piezo oscillator. It is envisaged that ultrasonic cleaning of a stent to remove debris or film thereon may be provided in this way. The arms may have sharpened ends for assisting in removing built up material from the vicinity of a stent. The arms may be of electrically conducting material or may include electrical pathways for applying power, for example EM energy such as RF or microwave energy to a stent for heating thereof.
According to a further aspect of the invention there is a provided a stent servicing device comprising a catheter and an expandable framework of arms which are pivotally connected at proximal ends thereof to a central portion of the device, and which have distal ends arranged to engage a stent. The device may include a central stern and they link extending from the stent to each arm. The links may be slidable along the stem for rotating the arms. Four said arms may be provided in one embodiment, although other numbers of arms such as 3, 6 or 8 are envisaged. The links may be pivotally connected to a collar slidable along the central stem. Accordingly, a stent servicing device with a very robust yet collapsible construction may be provided. The expandable framework of arms may have an umbrella configuration.
The stent servicing device may be arranged for contacting a stent for applying RF power thereto or microwave or other electromagnetic power thereto for tissue heating purposes. The device may be arranged for manoeuvring a stent into an expanded deployed configuration thereof, or may be arranged for manoeuvring a stent into a contracted configuration thereof. The highly versatile nature of the expandable framework of arms is therefore evident.
According to a further aspect of the present invention there is provided a stent comprising a stent body, the stent body having a connector arranged for connection to a stent manoeuvring or servicing device, and a guide for guiding a stent manoeuvring or servicing device towards the connector. Accordingly, a reliable structure for connecting a stent to a stent manoeuvring or servicing device may be provided and this may be particularly useful when the stent is, for example, a removeable stent. The guide may comprise a channel. The channel may have two converging walls extending inwardly from an inner surface of the stent body.
The connector may be located inside the stent. Accordingly, a stent manoeuvring or servicing device may be advantageously located inside the stent and connected to the stent at the connector inside the stent, rather than radially outside the stent.
The stent body may be metal, for example of silver palladium. This may advantageously inhibit the build up of biofilm and debris in the region of the stent.
The stent body may include resilient struts thereon allowing expansional contraction of the stent body. The stent body may be arranged to be contractable and subsequently re-expandable. A series of stent struts may be provided spaced circumferentially around the stent body. A series of stent struts may be provided spaced axially along the stent the body.
The connector may comprise a plurality of axially spaced lugs located in alignment with the guide on the stent body. Accordingly, the guide may provide a good connection between a stent manoeuvring or servicing device and a plurality of lugs on the stent in order to provide a very secure connection therebetween for good control of the stent during manoeuvring or servicing thereof, such as expansion or contraction thereof or movement thereof within a lumen or vessel of a patient.
According to a further aspect of the present invention there is provided a magnetic stent.
Such a stent has a number of advantages concerning particularly the location and removability of a stent.
The stent may include an implantable magnetic portion arranged to be implanted in the inner wall of a lumen or vessel of a patient, and a main stent body having a magnetic body portion moveable relative to and alignable with the magnetic portion for magnetically retaining the stent body. Accordingly, the main stent body may advantageously be inserted into the implanted magnetic portion and held in position accurately by magnetic forces acting between the implantable magnetic portion and the magnetic body portion of the main stent body.
The implanted magnetic portion may comprise at least one ring such as two magnetic rings axially spaced from one another along a lumen of a patient.
The magnetic body portion may comprise at least one body ring locatable inside the at least one ring.
The stent may be provided with measuring means for measuring the position of the implantable magnetic portion relative to the main stent body. Accordingly accurate positioning of the stent may be obtained. The measuring means may include a position-sensing coil.
According to a further aspect of the invention there is provided a removable stent comprising a body formed of elongate side members, the side members being linked by connection members, the connection members enabling the body to be contracted from an expanded configuration to a contracted configuration. Accordingly a reliable structure for a stent may be provided.
The connection members may comprise articulations connected to the side members by hinges. The hinges may therefore provide the stent with great versatility, since the stent may be expanded to a multiplicity of different expanded configurations and may also be contracted. Each connection member may include two parts, the two parts being hingedly connected together. A friction damper or indexed locking system may be provided at said hinges between the two parts, for advantageously holding the stent in a selected configuration.
Each connection member may comprise a spring, the spring may advantageously be arranged to provide a selected deployment force or radially outwardly pressure when or once it is deployed into the expanded configuration of the stent.
According to a further aspect of the present invention there is provided a combination of a stent according to one of the aforementioned aspects of the invention and a stent manoeuvring or servicing device according to one of the aforementioned aspects of the invention, the device being configured to contract the stent by application of radially inward force thereto. Accordingly, the stent advantageously need not be subjected to twisting or axial forces thereon during a contraction manoeuvre. The arms of the device may be arranged to be guided by a guide of the stent to securely connect the device with a connection element of the stent. The arms of the device, where provided, may be inwardly collapsible to pull on the stent with a substantially radially inward force for contracting the stent.
According to a further aspect of the invention there is provided a method of manoeuvring a stent comprising inserting a stent manoeuvring device into a stent and contracting the stent by applying a substantially radially inward force to the stent from the stent manoeuvring device. Advantageously, the stent manoeuvring device need not apply substantial twisting or axial forces to the stent. The stent may be located, relocated, or removed in a lumen or vessel of a patient and, accordingly, undesirable forces on the lumen or vessel may be avoided.
The method may include removing the stent from a lumen or vessel of a patient.
The method may comprise contracting the stent and moving it inside a patient and expanding the stent again at a different location inside a patient.
The method may comprise passing the stent while in a contracted configuration thereof through another stent located in a lumen, such as a lumen of a patient.
The method may include expanding the stent and locating it at a position in a vessel or a lumen of a patient, and then moving the stent manoeuvring device to the other stent and contracting the other stent and then manoeuvring the other stent, such as to remove or retrieve it from a patient.
A further aspect of the invention provides a method of servicing a stent in situ in a lumen or vessel of a patient, the method comprising inserting a cleaning device into the stent and applying vibrational energy to the stent with the cleaning device to remove debris therefrom. The vibrational energy may be ultrasound, the method may include providing a filter net to catch the debris. This method may be advantageous, for example when it is desired to clean electrical contacts on a stent such as when it is desirable intermittently or periodically to apply electrical power such as electromagnetic ablation power to a stent for heating tissue in the region of a stent. However, ultrasound may be used to clean the whole stent as well as the electrical contacts.
The aforementioned aspects of the invention enable the placements of stents and allow their removal. Often, in the prior art, metal stents have been inserted and left behind but once they become blocked they can cause problems and it can be very difficult to remove them. In accordance with some at least preferred embodiments of the present invention, removable metal stents may be inserted and then subsequently removed whether they are in the heart, prostate, lungs, rectum or other vessels or lumens inside patients.
The use of an umbrella-type system in a framework of arms to unfold and open a ring-structure metal stent and subsequent removal of the umbrella is highly advantageous. Later, the open umbrella can be used to connect with particular areas in a ring-type metal stent such that the ring may collapse and the stent may be removed and a new one may replace it.
The magnetic type embodiments in which a magnetic outer ring stays definitively implanted in the patient is also highly advantageous. This type of stent may be a wall stent and the inner barrel may be changed at frequent intervals. A magnet may be used such that the barrel stays attached to the outer metal, e.g. metal mesh. Later, an operative, such as an endoscopist or interventual radiologist, can touch the barrel inner part to deactivate or reverse polarity of the magnet and enable the release of the inner side/part thereof.
The framework/umbrella system discussed above may be arranged to open and subsequently remove a filter which can be placed in the vena cava or in all types of vascular or cardiac surgery to prevent emboli moving to carotid or distal vascular structures and the filter is therefore highly advantageous.
The use of magnetic forces or power in order to align devices or provide improved touching between electrodes of stents or other medical devices contained within patients is also highly advantageous.
It is envisaged that the umbrella/framework structure/delivery tool could be used for non-balloon placement of other types of stents or metal stents to those described herein. The use of vibrational means such as ultrasound to remove biofilm or debris may also be used on other types of stents or implanted medical devices.
The present invention may be carried out in various ways and a number of preferred embodiments of stents, stent manoeuvring and servicing devices and methods in accordance with the preferred embodiments of the present invention will now be described by way of example with reference to the accompanying drawings in which:
The stent is shown in
The outer sheath (30) may be pulled back to the position shown in
At a later point in time, the catheter (32) may be reinserted into the lumen and brought to a position with the tip (42) near guides (16). The sleeve (30) may then be withdrawn allowing the arms (40) to be expanded again by pulling remotely from outside the patient on inner shaft (46) so that arms (40) are moved from a substantially mutually parallel configuration by compression of linked arms (48) to bring tips (50) of the arms to engage the stent (10) between the guide lugs (16). The catheter may then be slid to the left as shown in
The framework (22) may then be collapsed by force on the stem (46) to bring the stent back to the collapsed or contracted configuration shown in
The ratchet or locking elements (54) ensure good engagement between the arms (40) and stent (10) such that the stent only moves relative to the arms (40) or detaches when required. In some embodiments, the arms (or struts) (14) may each have a single end stop and the ratchet elements (54) may be absent.
The stent may be heated using RF or ultrasonic power for tissue treatment.
The stent (10) shown in
The ultrasonics could be applied via a piezo driver (100) within strut pivot (102) instead of as shown at (82), in order to oscillate struts so as to remove build-up. This may be used with conventional stents to rub away build-up and the build-up may be captured by the net filter (34). As indicated above, the RF power or other EM power for heating may be supplied to the stent (10) via the struts, the RF or other EM power source being located outside the patient and fed along to the arms (40) through the catheter. In conventional metal stents, the framework of arms (22) may be rotated axially within the stent to completely clean the stent.
The magnetic rings (110, 112) may be delivered into position in the lumen or vessel (24) by catheter. The stent (114) may be removed and replaced with another. The stent may be coated in hydrogel to both slow biofilm or other debris build-up and to act as a lubricious coating to aid the stent to self-locate as the poles (122, 124) aligned with one another. Maximum holding forces obtained once the poles are aligned as shown in
In a modification of the magnetic stent (114), coils (140) may be employed and resistance in the coils may be measured in this modified stent (115). The coils may be wrapped either around the stent or the stent magnet and use an affect similar to LVDT to aid location. Changes in the magnetic field will affect the electrical response from the coils, thereby allowing location to be known. Additionally, pole change could be used by applying voltage across the coils to repel the stent in order to aid stent removal.
Various modifications may be made to the specific embodiments described without departing from the scope of the invention as defined by the accompanying claims as interpreted under Patent Law.
Number | Date | Country | Kind |
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0700560.6 | Jan 2007 | GB | national |
0709910.4 | May 2007 | GB | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/GB2008/000102 | 1/11/2008 | WO | 00 | 9/15/2010 |