APPARATUS AND METHOD FOR POSITIONING AN IMPLANTABLE DEVICE
A catheter assembly for implanting a medical device, comprising a first wire and a second wire, electrically insulated from each other, attached to the medical device at a first attachment point and a second attachment point, respectively. The first wire defines a first region susceptible to electrolytic disintegration, by passing an electric current through it, contiguous to a the first attachment point. Similarly, and the second wire defines a second region susceptible to electrolytic disintegration, by passing an electric current through it, contiguous to the second attachment point. Also, there is a separately controllable electric supply for the first and the second wire, so that the first wire may be disconnected from the medical device, without disconnecting the second wire.
This application is a continuation-in-part of application serial number PCT/US12/27259, filed on Mar. 1, 2012 which claims priority from provisional application Ser. No. 61/448,459, filed on Mar. 2, 2011 which are incorporated by reference as if fully set forth herein.
BACKGROUNDThe present disclosure is directed to repairing blood vessel defects, such as aneurysms, and other physiological defects or cavities formed in lumens, tissue, and the like, and, more particularly, to an endovascular implantable device and related endoluminal delivery procedure and deployment techniques.
Cranial aneurysms occur when a weakened cerebral blood vessel (root vessel) locally expands to form a bulge or balloon-like enlargement in the vessel wall. These aneurysms can occur along a vessel wall or at locations of vessel branches, such as a T-intersection or V-intersection.
Currently, options for the treatment of brain aneurysms are limited. In one technique, the cranium is opened and a clip is placed at the aneurysm neck to cut off blood flow from the root vessel, thereby reducing swelling and stopping expansion. In another technique, the interior of the aneurysm is accessed by way of a cranial artery, which in turn is reached with a device inserted into the femoral artery. In this technique, coiling material is inserted into the aneurysm, thereby causing clotting which closes off the aneurysm. Both techniques have drawbacks. Opening the cranium always entails some risk. Some locations in the cranium are difficult or impossible to access from the outside. On the other hand, causing clotting in the aneurysm can increase the mass and size of the aneurysm, causing it to press against delicate and critical tissue, and causing further damage.
Devices and techniques have been developed to facilitate treatment of aneurysms. The application herein is a joint inventor on the following U.S. Patent Publication Nos. 2006/0264905 (“Improved Catheters”), 2006/0264907 (“Catheters Having Stiffening Mechanisms”), 2007/0088387 (“Implantable Aneurysm Closure Systems and Methods”), and 2007/0191884 (“Methods and Systems for Endovascularly Clipping and Repairing Lumen and Tissue Defects”). All of these published applications are incorporated by reference herein in their entirety, to the extent legally possible.
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As can be seen in the foregoing, the structures may be difficult to place, particularly in the circuitous blood vessel network of the brain. For the typical aneurysm, extending in a perpendicular manner from its root blood vessel, it may be a challenge to insert the structure into the aneurysm. Moreover, for the device to seal or close the aneurysm, the anchoring structures must mutually press against the aneurysm sides. If one side wall of an aneurysm is not well suited for supporting an anchoring structure, the anchor for the opposite side will not be well supported to provide sufficient pressure on this opposite side wall. This problem drives the design of anchor structures 132 and 133 to be larger, to facilitate receiving sufficient support from the aneurysm interior surface. This, in turn, has the potential to create a mass effect problem, in which the mass of the structures 132 and 133, plus any clotting that occurs around them, causes the aneurysm to become more massive, potentially pressing against delicate nervous system tissue as a result.
Moreover, the situation is even more difficult for aneurysms formed at the intersection of vessels, such as a T-intersection or V-intersection.
Typically, to place device 130 into a blood vessel of the brain requires a number of steps. First, an incision is made into the femoral artery and a sheath is introduced, extending approximately to the aorta. A first guide catheter is inserted through the sheath and extended up into the carotid artery. A second guide catheter is coaxially introduced through the first guide catheter and extended up into the target aneurysm. Both guide catheters are introduced using a guide wire having a steerable tip of either stainless steel or nitinol. Then, microcatheter introducer is inserted through the guide catheter, to the aneurysm, and device 130 is placed at the aneurysm site. Heretofore, however, once reaching the aneurysm there has been no effective method for positioning a device that requires precise positioning. A device that would require a definite orientation, at least partially inside the aneurysm, presents particular challenges in positioning during implantation
Another difficulty in delivering a complex implant into an aneurysm is the lack of space to pack such an implant in a lumen at the end of a microcatheter. Any such device must fold into a cylinder having an internal diameter on the order of 1 mm and a length of about 10 mm. Upon delivery it must expand to anchor itself in place and to seal an area that could be as large as 10 mm2. The seal over the neck of the aneurysm although thinner than 1 mm, must be strong enough to affirmatively occlude the aneurysm, with a very high degree of certainty.
SUMMARYThe following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope. In various embodiments, one or more of the above-described problems have been reduced or eliminated, while other embodiments are directed to other improvements.
In a first separate aspect, the present invention may take the form of a method of implanting a medical device that utilizes an implantation catheter including a first wire and a second wire, electrically insulated from each other, attached to the medical device at a first attachment point and a second attachment point, respectively. The first wire defines a first region susceptible to electrolytic disintegration, contiguous to a the first attachment point, and the second wire defines a second region, also susceptible to electrolytic disintegration, contiguous to the second attachment point. The medical device is positioned at a first desired positioning and electricity is passed through the first wire, sufficient to heat and disintegrate the first region susceptible to electrolytic disintegration, thereby freeing the medical device from the first wire. Then, the medical device is manipulated with the second wire to achieve a second desired positioning. Finally, electricity is passed through the second wire, sufficient to heat and disintegrate the second region susceptible to electrolytic disintegration, thereby freeing the medical device from the second wire.
In a second separate aspect, the present invention may take the form of a catheter assembly for implanting a medical device, comprising a first wire and a second wire, electrically insulated from each other, attached to the medical device at a first attachment point and a second attachment point, respectively. The first wire defines a first region susceptible to electrolytic disintegration, by passing an electric current through it, contiguous to a the first attachment point. Similarly, and the second wire defines a second region susceptible to electrolytic disintegration, by passing an electric current through it, contiguous to the second attachment point. Also, there is a separately controllable electric supply for the first and the second wire, so that the first wire may be disconnected from the medical device, without disconnecting the second wire.
In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the drawings and by study of the following detailed descriptions.
Exemplary embodiments are illustrated in referenced drawings. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than restrictive.
In the following description, certain specific details are set forth in order to provide a thorough understanding of various disclosed embodiments. However, one skilled in the relevant art will recognize that embodiments may be practiced without one or more of these specific details, or with other methods, components, materials, etc. In other instances, well-known structures or components or both associated with endovascular coils, including but not limited to deployment mechanisms, have not been shown or described in order to avoid unnecessarily obscuring descriptions of the embodiments.
Unless the context requires otherwise, throughout the specification and claims that follow, the word “comprise” and variations thereof, such as “comprises” and “comprising” are to be construed in an open inclusive sense, that is, as “including, but not limited to.” The foregoing applies equally to the words “including” and “having.”
Reference throughout this description to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearance of the phrases “in one embodiment” or “in an embodiment” in various places throughout the specification are not necessarily all referring to the same embodiment.
Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
The present disclosure is directed to closing a bulge or aneurysm formed in blood vessel, such as an artery or vein (referred to more generally herein as “vessel”), in a manner that does not suffer from some of the drawbacks of prior art methods. For example, in the prior art method involving the insertion of a wire coil into the aneurysm, the resultant blood clot can create problems through its mass and the possibility of pressing against nearby nerves. In addition, the wire coil can have the effect of keeping the neck open, possibly causing another aneurysm to form.
The embodiments of the present disclosure combine the closure structure and the anchoring structure into a single unit to improve compactness, allow delivery into the tortuous intracranial circulation system via a microcatheter, and to improve the aneurysm neck closure. In addition, the embodiments of the present disclosure provide enhanced rotation control and placement of the device within the aneurysm via two attachment points for a microcatheter. Moreover, markers can be used at the junctions of the device structure to aid in tracking the movement of the closure device during insertion and placement.
Referring to
First anchors 16A and 18A act as a first clip, mutually applying gentle pressure toward each other, thereby clipping about the interposed tissue. In similar manner, second anchors 16B and 18B act as a second clip. Working together, anchors 16A, 18A, 16B and 18B hold the seal 20 in place, thereby blocking the flow of blood into aneurysm 12.
Closure device 10 includes a wire frame 22, which is made of nitinol, or some other shape-memory material. Prior to use, closure device 10 is maintained at a temperature below human body temperature, thereby causing wire frame to assume the shape shown in
In an alternative preferred embodiment at least some of the anchors, serving the function of anchors 16A-18B, are made of a thin sheet of nitinol, or a thin sheet of nitinol covered with a biocompatible silicone, or polymeric material, for forming a good grip on the tissue it contacts. In yet another embodiment, at least some of the anchors are made entirely of polymeric material. In an additional preferred embodiment, ePTFE thread 26 lattice, is replaced with metal filigree, made of a metal such as gold, having a high melting point. In addition, there is a broad range of engineered materials that can be created for this type of purpose. In yet another preferred embodiment, anchors, serving the function of anchors 16A-18B, are made of wire loops or arcs, some of which support an ePTFE reinforced silicone barrier, thereby providing a closure mechanism for an aneurysm.
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In one preferred embodiment, wires 48A and 48B are electrically isolated from each other, either by a thin layer of insulating material or simply by the layout of device 10 and the conductive characteristics of wires 48A and 48B. Each include a region 70 (
Although after the freeing of seal 20 from wire 48A, control may be less certain, it may in some instances be possible to have a greater freedom of positioning device 10 when a single wire 48B is attached, only. This may be particularly true when a portion of device 10 has contacted body tissue, for example entering aneurysm 12, and it is desired to orient device 10 properly for the setting of anchors 16A and 16B and 18A and 18B so that the extend along the length of blood vessel 14. Again verifying orientation by way of markings 30, when device 10 is properly oriented electricity is passed through wire 48B, causing its region 70 to disintegrate, and freeing closure device 10 from wires 48A and 48B, entirely so that it can be left in place in its target location, sealing aneurysm 12. In a preferred embodiment, handles 46A and 46B each includes an electrical contact connected to wire 48A and 48B, respectively, for attaching to a source of electricity for performing the above-described step.
Subassembly 42 is introduced into the femoral artery and guided through the carotid artery into the brain's arterial system, and further guided to the aneurysm 12. At this point closure device 10 is pushed out of fossa 56, anchors 16A and 16B are guided into aneurysm 12, and anchors 18A and 18B are positioned in root artery 14. Then a pulse of electricity severs closure device 10 from wires 48A and 48B and closure device 10 is installed in place.
Wires 48A and 48B are made of stainless steel alloy 304, which may also be referred to as alloy 18-8. This material is coated with poly tetrafluoroethylene, except for at detachment points 70 and the points where they are connected to a source of electricity. The nitinol alloy that frame 22 (
While a number of exemplary aspects and embodiments have been discussed above, those possessed of skill in the art will recognize certain modifications, permutations, additions and sub-combinations, thereof. It is therefore intended that the following appended claims and claims hereafter introduced are interpreted to include all such modifications, permutations, additions and sub-combinations as are within their true spirit and scope.
Claims
1. A method of implanting a medical device, including:
- a. providing an implantation catheter including a first wire and a second wire, electrically insulated from each other, attached to said medical device at a first attachment point and a second attachment point, respectively, said first wire defining a first region susceptible to electrolytic disintegration, contiguous to a said first attachment point, and said second wire defining a second region susceptible to electrolytic disintegration, contiguous to said second attachment point;
- b. positioning said medical device at a first desired positioning;
- c. passing electricity through said first wire, sufficient to heat and disintegrate said first region susceptible to electrolytic disintegration, thereby freeing said medical device from said first wire; and
- d. manipulating said medical device with said second wire to achieve a second desired positioning; and
- e. passing electricity through said second wire, sufficient to heat and disintegrate said second region susceptible to electrolytic disintegration, thereby freeing said medical device from said second wire.
2. The method of claim 1, wherein said medical device is a aneurysm seal.
3. The method of claim 1, wherein said medical catheter further includes:
- a. double lumen section, including a first lumen through which said first wire extends and a second lumen through which said second wire extends; and
- b. a control unit, having a first wire control handle affixed to said first wire and a second wire control handle affixed to said second wire, each control handle being capable of pushing its affixed wire distally through said corresponding lumen or retracting its wire proximally through said lumen, and where said first and second wire control handles can be rotated together to any rotational position.
4. A catheter assembly for implanting a medical device, comprising:
- a. a first wire and a second wire, electrically insulated from each other, attached to said medical device at a first attachment point and a second attachment point, respectively, said first wire defining a first region susceptible to electrolytic disintegration, by passing an electric current through it, contiguous to a said first attachment point, and said second wire defining a second region susceptible to electrolytic disintegration, by passing an electric current through it, contiguous to said second attachment point; and
- b. a separately controllable electric supply for said wire and said second wire, so that said first wire may be disconnected from said medical device, without disconnecting said second wire.
5. The catheter assembly of claim 4, wherein said medical catheter further includes:
- a. double lumen section, including a first lumen through which said first wire extends and a second lumen through which said second wire extends; and
- b. a control unit, having a first wire control handle affixed to said first wire and a second wire control handle affixed to said second wire, each control handle being capable of pushing its affixed wire distally through said corresponding lumen or retracting its wire proximally through said lumen, and where said first and second wire control handles can be rotated together to any rotational position.
Type: Application
Filed: Aug 29, 2013
Publication Date: Jan 2, 2014
Inventor: Joe Michael Eskridge (Clyde Hill, WA)
Application Number: 14/013,983
International Classification: A61B 18/08 (20060101);