Method for deploying a sleeve and tubing device for restricting and constricting aneurysms and a sleeve and tubing device and system

A sleeve device, system and method are provided for restricting and/or constricting aneurysms. More particularly, a sleeve and/or a double-walled sleeve is located in or on a vessel in the location of an aneurysm. When placed around the outside of a vessel, is used to restrict and/or constrict the aneurysm containing portion of the vessel. If desired, the sleeve may be constructed as a double-walled sleeve that can be inflated to apply pressure to and/or in the vessel.

BACKGROUND OF THE INVENTION

1. Field of the Invention

A system, device and method for constricting aneurysms using a sleeve are provided.

2. Description of the Related Art

The treatment of aneurysms poses an operating problem, marked by high risk, high rates of death, long surgical procedure and a long recovery time.

An aneurysm is a bulge, a hernia of an artery. There are several types of aneurysm locations on an aorta: ascending, descending, thoracic and abdominal aortic aneurysms.

Surgical Repair of Aortic Aneurysms

Any aortic aneurysms that are large, causing symptoms or rapidly getting bigger are considered at risk of rupturing. Surgery is usually recommended if any one of these factors is present.

Both traditional surgery and endovascular aortic repair are used to treat aortic aneurysms. If surgery is needed, the doctor will make a large cut in the chest or abdomen. Then, the aneurysm will be removed and the damaged portion of the aorta will be replaced with a man-made graft. Some aortic aneurysms can be repaired without traditional surgery, using endovascular aortic repair. A stent graft is inserted through an artery in the groin. The stent graft makes a bridge between the healthy parts of the aorta (above and below the aneurysm).

At the present time, for any aortic aneurysms, a doctor will recommend surgery based on the following guidelines:a. If the aneurysm is located where the aorta ascends up out of the heart, surgery is recommended when it reaches 5.5 to 6.0 cm in diameter.b. If the aneurysm is located where the aorta begins to descend, surgery is recommended when it reaches 6.0 cm in diameter.c. In those with Marfan's syndrome, surgery is recommended when the aneurysm reaches 5.5 cm in diameter.d. If the aneurysm causes significant aortic regurgitation, surgery is recommended.e. If the aneurysm is located in the thoracic or abdominal region, surgery is recommended when it reaches 5.5 to 6.0 cm in diameter.f. The aorta is the major artery which arises from the heart. It carries all the blood that is pumped out of the heart and distributes it via its many branches to all the organs of the body. The aorta is divided into four portions: 1) the ascending aorta, 2) the aortic arch, 3) the descending aorta, 4) the thoracic aorta, and 5) the abdominal aorta.

Surgeons and institutions around the world have differing experiences with aortic aneurysms and may follow different protocols in the treatment of the disease.

If surgery is chosen, the doctor will evaluate the overall health, including assessments of the heart, lungs, and circulatory system, the kidneys, and the gastrointestinal system. The decision whether to have surgery is based on the outcome of these evaluations. The risk of death or injury during the operation increases if other disease is present.

If the evaluation of the heart indicates that the patient has significant heart disease, the patient should undergo coronary artery bypass surgery (CABG) or coronary angioplasty prior to repairing an aortic aneurysm. This is because coronary artery disease is the most important underlying factor contributing to complications, such as heart attack, in the period before and after the operation. Other complications, such as stroke and infection of the graft, can also occur.

Kidney disease, chronic lung disease, and cirrhosis of the liver may raise the risk of death and complications during the operation.

Smoking and high blood pressure put a person at a higher risk for complications from surgery. They are also risk factors for the rupture of any aneurysms.

It is not an option to wait until an aneurysm has ruptured before surgery is done. Most people who have a ruptured aortic aneurysm die. Surgery for a ruptured aneurysm is dangerous because of the large amount of blood loss.

Two types of surgery are presently performed on aortic aneurysms:

1. The Traditional Surgery:

The affected portion of the Aorta is completely removed and replaced by a Dacron Tubing. The Dacron Tubing is stitched in different places. Many times, the stitches do not hold and one or more new operations need to be done.

The surgery is performed inside the aorta using thin, long tubes called stents. Through small incisions in the groin, the stents are used to guide and deliver a stent-graft through the blood vessels to the site of the aneurysm. The stent graft is then deployed in the diseased segment of the aorta.

An endovascular stent graft is a fabric tube supported by metal wire stents (also called a scaffold) that reinforces the weak spot in the aorta. By sealing the area tightly with the artery above and below the aortic aneurysm, the graft allows blood to flow through it without putting pressure on the aneurysm.

Endovascular repair of abdominal aneurysms is generally less painful and has a lower risk of complications than traditional surgery because the incisions are smaller. Endovascular aorta aneurysm procedures also allow a patient to leave the hospital sooner and make a faster recovery. However, possible complications of endovascular repair include:Leaking of blood around the graft, known as “endoleak”;Movement, or migration, of the graft away from its initial placement; andStent fracturing.

Additional complications that are rare but serious include:Paralysis;Delayed rupture of the aneurysm; andInfection.

The long-term durability of endovascular stent grafting to treat an abdominal aneurysm is yet unknown because this is a fairly new procedure. For this reason, patients who have endovascular repair of their thoracic aneurysms must be monitored closely on a regular basis with examinations and imaging studies.

Blood vessel sleeves are known. U.S. Pat. No. 7,818,084 to Boyden et al discloses a method and system for making a blood vessel sleeve having dimensions based on blood vessel data from an individual, while U.S. Patent Application Publication No. 2008/0133040 to Boyden et al discloses methods and systems for specifying a blood vessel sleeve. Similarly, U.S. Patent Application Publication No. 2009/0024152 to Boyden et al., discloses a custom-fitted blood vessel sleeve.

Additionally, U.S. Patent Application Publication No. 2008/0188923 to Chu discloses methods and systems for preventing aneurysm rupture and reducing the risk of migration and endoleak, wherein an inflatable multiple wall liner is applied directly to treat the interior of the aneurysm site. U.S. Pat. No. 6,599,302 to Houser et al., discloses a system and components for treating aortic aneurysms including a reinforcing graft and fittings for securing the graft to a host vessel and to branch vessels. In Houser, combinations of fittings and rings or other compression mechanisms secure vessels or grafts frictionally, for end-end or end-side couplings.

Further, an article entitled “Enabling Sutureless Vascular Bypass Grafting With The Exovascular Sleeve Anastomosis” by D. W. Chang, et al., (J. Vasc. Surg.) (2000) 32:524-530, disclosed the use of an exovascular sleeve bypass graft that is drawn over an artery and secured in place with a cable tie.

What is needed is a simplified device, system and method for preventing an aneurysm in the walls of a vessel containing from growing or expanding and/or for restricting and/or constricting the walls of a vessel containing an aneurysm. What is additionally needed is a blood vessel sleeve device and system that can remain localized to a desired location and does not, itself, cause damage or chafing to the vessel or associated organs.

SUMMARY OF THE INVENTION

In order to meet the foregoing needs, as well as to overcome disadvantages of the heretofore-known methods and devices of this general type, it is accordingly an object of the invention to provide a sleeve and tubing device for preventing an aneurysm from growing or expanding and/or for restricting and/or constricting aneurysms and a system and method for using such a device. In one particular embodiment of the invention, a sleeve is placed on the outside of the vessel exhibiting the aneurysm, wherein it is fixed in the desired location by being anchored to a geometrical fixture of the vessel. In another particular embodiment of the invention, the sleeve placed over the aneurysm includes a bellows to reduce chafing during pulsating of the vessel. In a further embodiment of the invention, the sleeve is inflatable around the outside of the vessel, in situ. In yet a further embodiment of the invention, an inflatable sleeve is secured inside a vessel at the site of an aneurysm, and inflated, in situ.

Although the invention is illustrated and described herein as embodied in a sleeve and tubing device for restricting and constricting aneurysms, and a system and method for using such a device, it is nevertheless not intended to be limited to the details shown. Various modifications and structural changes may be made to the embodiments described herein, without departing from the spirit of the invention and within the scope and range of equivalents of the claims.

The construction of the invention, however, together with the additional objects and advantages thereof will be best understood from the following description of the specific embodiments when read in connection with the accompanying drawings.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now toFIGS. 2-4, there is shown a sleeve110encapsulating a vessel100(shown in dotted line) that contains an aneurysm. In general, the sleeve110is formed very simply as a round tube that can be fitted over a vessel100and an aneurysm contained in that vessel100. Such a sleeve110may be made of any biocompatible material presently known, or to be developed in the future, such as, but not limited to, DACRON®, plastic biocompatible materials, metal biocompatible materials, composite material, or any other materials that can be used for the present purpose in the body.

The sleeve110is designed to encapsulate the vessel100, including any portion containing the aneurysm, and thus, is configured to closely approximate the vessel100. Note that, the sleeve110can be adapted for use with any vessel, and configured to conform to the particular anatomy of the vessel on which it is to be used. For example,FIG. 1shows an aneurysm sleeve210adapted to surround a patient's aorta200(shown in dotted line), and which includes, in accordance with one particular embodiment of the invention, a bellows, sleeves, and saddle sleeves provided over and around an ascending and descending aortic aneurysm.

Referring back toFIGS. 2-4, the sleeve110for encapsulating an aneurysm containing vessel100is provided. The sleeve110is formed as a sheet that can be rolled around the vessel100, from a location external to the vessel100, and locked together around the vessel100, by engaging the locking mechanism115. Locking mechanism115ofFIGS. 2-4includes interlocking, mating portions115aand115b(FIG. 2) or117aand117b(FIG. 3) that extend the length of the sleeve110and which mate to lock the sleeve110in the previously described form of a round tube.

In one particular embodiment of the invention, shown inFIGS. 2,4and17, the locking mechanism115includes an interlocking male tongue115aand female groove115b, or “angular omega”, locking configuration that snap together to form the round tube around the affected vessel. In another particular embodiment of the invention shown inFIGS. 3 and 16, a keystone or dovetailed configuration is used, wherein a male dovetail117ainterlocks (i.e., mates or “snaps together”) with a female dovetail117bto secure the sleeve110,111as a round tube and to prevent reopening of the sleeve110,111after installation. The same interlocking systems115,117can be used in connection with any tube, sleeve and/or saddle sleeve described herein. Note that, the foregoing is not meant to be limiting, as other mechanisms for locking the sleeve110,111into a tube can be used. For example, if desired, any other locking mechanism, including, but not limited to, gluing, stitching, snap-fitting, etc., may be used to secure and maintain the sleeve110,111in the form of a tube after installation.

FIGS. 7 and 8show further alternate embodiments of a sleeve150,160in accordance with the present invention, including an interlocking key or tab locking mechanism155,165, respectively, for ensuring that the locking mechanisms155and165of sleeves150,160, remain securely closed, once connected around the vessel100.

If desired, a sleeve110,111,150,160can be subdivided into two or more parts, instead of the single interlocking part shown inFIGS. 2-4. For example, referring more particularly inFIGS. 5-6, a sleeve120can be made in two halves120aand120b, which are matingly engaged about the vessel100, through the use of two locking mechanisms115or117(not shown inFIGS. 5-6).

The locking mechanisms115,117,125,155,165ofFIGS. 2-8are initially open, to permit sleeve placement, and can be snapped closed to secure the sleeves110,111,120,150,160, respectively, over and around the affected vessel, thus forming a sleeve having the geometrical configuration of the vessel to be to be repaired and/or mended.

For example, referring now toFIG. 1, in the case of an ascending and/or descending aneurysm, the sleeve210ofFIG. 1, will take the shape, the geometrical configuration, and the curvature of the aorta and the ascending and/or descending aneurysm, as it is unfolded and deployed over and around the affected aortic aneurysm. Similarly, in the case of a thoracic aneurysm, the sleeve430ofFIGS. 29,29a,29b, or in the case of an abdominal aneurysm, the sleeves520,520a, and520bofFIGS. 30,30a,31,32,34, will take the shape, the geometrical configuration, and the curvature of the aorta and the aneurysm, as it is unfolded and deployed over and around the affected aortic aneurysm.

Referring more particularly toFIG. 1, the sleeve210is placed over and around (i.e., surrounds or encapsulates) the affected portion of the particular aorta to stop the aneurysm from growing or expending. In addition to surrounding the portion of the aorta containing the aneurysm, the sleeve210should additionally extend beyond the affected portion of the particular aorta. The sleeve210ofFIG. 1can include a locking mechanism215extending the length thereof, as described more particularly in connection withFIGS. 2-8, or even another type of locking mechanism, such as glue or stitching. Further, the sleeve210can interface with saddle sleeves or “securing buttons”230to surround at least a portion of one or more vessels branching off from the affected aorta200. The saddle sleeves230can be provided as either separate sleeves (i.e., separate “saddle” sleeves or “securing buttons”235,237ofFIGS. 10 and 11), or as part of a three branch manifold (250ofFIGS. 9,12and13) having three saddle sleeves252.

More particularly, referring now toFIGS. 1,9and13, it can be seen that, in one particular embodiment of the invention designed for use with an ascending aortic aneurysm, the sleeve210can include, formed therein, one or more openings240to permit the three branching arteries202of the aorta200to exit the sleeve210. More particularly, a saddle sleeve230,235,237,252can be provided around each of the three branching arteries extending from the ascending aorta. As can be seen, a longitudinal axis defined through each of the saddle sleeves230is disposed substantially perpendicular to a longitudinal axis through the sleeve210at the point where the saddle sleeve230intersects the sleeve210. If desired and/or applicable, the longitudinal axis defined through the saddle sleeves230could be disposed at some other, non-zero angle relative to the axis through the sleeve210at the point of intersection of the two sleeves210,230.

For example, in one particular embodiment of the invention, a saddle sleeve or “securing button” of a type shown inFIGS. 10 and 11can be secured about one or more of the arteries202extending from the aorta200, using a locking mechanism running longitudinally along the entire length of the saddle sleeve, such as the locking mechanisms115,117,155,165ofFIGS. 2-8, or some other form of locking mechanism that permits securing the securing or saddle sleeve together about the arteries202.

In another particular embodiment of the invention shown inFIGS. 1,9,12and13, a three branch manifold can be secured at a desired position relative to the arteries202using a locking mechanism255, which may be used to snap together two halves250aand250baround the arteries202.FIG. 13shows such a manifold250(in dotted line) located below a sleeve210, which may, alternately, be a “securing” sleeve, as will be described hereinbelow in connection with the “securing” sleeve420ofFIGS. 22,22aand23.

Each of the saddle sleeves235,237,252includes at least one locking device, as discussed more particularly hereinabove in connection withFIGS. 2-8or any other locking, gluing, stitching device or system to secure the portions of the saddle sleeves235,237,252in tubular form. When used in connection with a three branch manifold, such as is shown inFIG. 9, it should be understood that the saddle sleeves252are integral with the body of the manifold, and thus, the locking mechanisms for the saddle sleeves252can be the same as, part of, and/or in alignment with, the locking mechanism255for the body of the manifold250.

Once the saddle sleeves235,237are engaged around the vessels202, or the three branch manifold250is engaged over the aorta200with each of the securing sleeves252secured around a vessel202, the sleeve210can be engaged around the ascending aorta200, as shown more particularly inFIG. 1. In particular, a sleeve210overlays at least a portion of the saddle sleeves235,237or the three branch manifold250, as shown more particularly inFIGS. 12 and 13, in order to maintain the saddle sleeves235,237,252at a desired location relative to the vessels202and the aorta200, and provides a buffer around the artery or vessel202, under the sleeve210.

The saddle sleeves235,237and/or of the saddle sleeves252of the three branch manifold250have two main functions. First, they help anchor the sleeve210, stopping it from sliding up or down along the ascending aorta. Second, they allow the sleeve210to move up and down without the risk of chaffing, scraping and/or otherwise damaging the walls of the arteries202.

When used in a ascending or descending aortic aneurysms and/or for a thoracic aortic aneurysm and an abdominal aortic aneurysm, the saddle sleeves235,237will be “saddle-shaped”, in order to be saddled over the aorta200. In particular, the “saddle portion” of a saddle sleeve or securing button235,237will be used wherever it is necessary, at the intersection of any branching arteries, in the manner shown inFIGS. 10,11and12. As indicated hereinabove, such a “saddle” shape will permit the up and down movement of the aorta, without the risk of chaffing, scraping, and/or damaging the walls of the aorta The saddle sleeves235,237will, preferably, additionally have the same curvature as the curvature of the arteries202and/or include a portion shaped to the shape of the aneurysm.

Additionally, referring now toFIGS. 1,14and15, the sleeve210of the present invention can optionally include a bellows220formed therewith and/or attached thereto. More particularly, in one particular embodiment of the invention one or both ends of the sleeve210includes a groove or “O”-ring like protuberance for engaging a corresponding “O”-ring like protuberance or groove on a bellows220. In the example shown inFIGS. 14 and 15, the sleeve210includes a groove212at one end thereof, which is sized to receive an “O” ring like protuberance222, formed on the inner wall of the mouth of the bellows220. This is not meant to be limiting, as it can be seen that the protuberance can be formed on the sleeve210, with the groove being formed in the inner wall of the mouth or “connector end”225of the bellows220, without deviating from the scope of the present invention. The groove212and protuberance222interlock or matingly engage to secure the bellows220to an end of the sleeve210, so as to secure the sleeve210in place and prevent it from sliding up or down the aorta.

The bellows220additionally serves another function. At the very rapid rates the heart is alternately contracting and relaxing (i.e., moving up and down) to pump blood, the bellows220permits this movement of the heart without restriction and without the risk of chaffing, scraping, and/or damaging the walls of the heart. Such movement is absorbed with, and/or compensated for by, the folds of the bellows220. Additionally, a part of the bellows220in direct contact with the heart205will have a flat surface227having the same curvature as the face of the heart205, thus permitting the heart to move without restriction and without the risk of chaffing, scraping, and/or damaging the walls of the heart.

Note that, although a bellows220is described, it is not intended that the invention be solely limited thereto, as a different mechanism can be used to safeguard the heart against a risk of chaffing, scraping, and/or damaging to the walls thereof while the heart205is pumping.

In one particular embodiment of the invention, a sleeve, such as the sleeve110ofFIG. 4or210ofFIG. 1, will be constructed as an “inner tube”, thus forming a chamber that can be pressurized to different pressures by the doctor or other treating attendant, at will, according to the patient's medical condition at the time of the operation, in order to restrict and/or constrict the aneurysm.

Referring now toFIG. 18, there is shown a chambered sleeve300, made in accordance with of the present embodiment, which is a double walled sleeve that is placed around the outside of a vessel100containing an aneurysm (an aorta, in the instant example). This chambered or double walled sleeve300, i.e., having an inner wall “I” and an outer wall “O”, provides a chamber305within the sleeve300that can be pressurized, at the doctor's discretion and other health conditions of the patient, including blood pressure related conditions.

In practice, the chambered sleeve300is installed over the aneurysm in a two-step process. In step one, the sleeve300is placed or positioned over the aorta, before the aneurysm, in an initial open and deflated state. See, for example,FIG. 21B. In step two, there are two possible options on how to proceed. In the first option, the locking mechanism435on the two lips of the sleeve300are interlocked (mated). Thereafter, a pressurized fluid is applied to the sleeve chamber (108ofFIG. 24) to enable the deployment unrolling of the sleeve300over the aneurysm. The sleeve is then unrolled and deployed to a point beyond the aneurysm, as determined by the physician. In the second option, the sleeve remains open and a pressurized fluid is applied to the chamber (108ofFIG. 24) to enable the sleeve to deploy over the aneurysm. See, for example,FIG. 29A. After the sleeve has been deployed over and beyond the aneurysm, the locking mechanism435of the lips of the sleeve00are interlocked (mated). The sleeve is deployed/unrolled in the direction of the blood flow. See, for example,FIGS. 22 and 22A. Being flexible, the sleeve300will take the shape, the geometrical configuration, and the curvature of the aorta and the aneurysm.

In particular, the chamber305between the inner wall “I” and the outer wall “O” will be pumped with air or fluid from an external air or fluid source310, via a valve in the sleeve, such as a ball air valve or other type of valve, such that the distance between the two walls “I”, “O” will change from the distance “A” in its uninflated state (sleeve300) to an inflated distance “B” (sleeve300a), depending on the final pressure, as determined by the physician. Alternately, the sleeve300can be deflated or left at the same pressure as during deployment of the sleeve300, as desired by the physician. In one particular embodiment of the invention, the double walled sleeve300is made from a medical grade of plastic and/or a medical grade metal material, or any other medical grade material approved by the FDA or another supervisory authority. In a further embodiment of the invention, the outer wall “O” of the double walled sleeve will be made from a harder and/or thicker material than the inner wall “I” of the double walled sleeve300.

Referring now toFIGS. 19-20and24, there is shown a “chambered” sleeve350, made in accordance with one particular embodiment of the invention. In the instant embodiment, the chambered sleeve350is formed of two layers352,354, wherein the outside wall352is made of a harder and thicker material than the inner wall354. The chambered sleeve350can be made in a fashion so that it is able to expand and contract similar to an accordion. When initially inserted over the vessel100, the chambered sleeve350will be in its deflated state, wherein it is collapsed upon itself and deflated, as shown more particularly inFIGS. 20 and 21b.

The collapsed and deflated chambered sleeve350will be secured over and around an aneurysm108ofFIG. 24(as will be described more particularly herebelow), using the locking mechanism355. The locking mechanism355can be any of the locking mechanisms described herein. However, in one particular embodiment shown inFIGS. 19 and 19a, the locking mechanism355is an interlocking male and female dovetail or keystone configuration that is used to secure the interlocking edges of the flat, open sleeve350into a tube. Being flexible and inflatable, the chambered sleeve350, after inflation, will automatically take the shape and curvature of both the vessel100and the aneurysm108.

Thereafter the chambered sleeve350can be inflated and pressurized by the physician, by applying an air or other fluid source to the valve360, if desired. Alternately, the valve360can be used to deflate the sleeve350, as desired. Note that, a single valve360can be used to inflate the entire sleeve350. The physician will then determine the required pressure necessary to allow the aneurysm (aortic or otherwise) to return to approximately its original size (contrast, for example,FIGS. 22-23), and can further inflate the sleeve, deflate the sleeve and/or leave the sleeve at the current pressure, in order to achieve the pressure determined. By equalizing the arterial blood pressure through the aneurysm (108ofFIG. 24), an unobstructed blood flow will occur and will minimize the risk of blood flow turbulence either at the point of entry from the healthy artery into the aneurysm chamber108, or at the exit from the aneurysm chamber108to the other side to the healthy artery100.

In another particular embodiment of the invention, the chambered sleeve of the invention can be constructed as two or more parts that are secured together around the vessel containing the aneurysm. For example, as shown more particularly inFIGS. 25 and 25a, the chambered sleeve350ofFIG. 19can, instead be constructed from two halves380matingly engaged to one another by the locking mechanisms385, with each half being inflatable via a valve387. Such a design is particularly useful for treating any of an ascending aortic aneurysm, a descending aortic aneurysm and/or a thoracic aneurysm. In certain instances, such as with an abdominal aortic aneurysm, the sleeve will be made in two halves, in the same fashion as the chambered sleeve380ofFIGS. 25-25a.

The inflating valves360,387can be of any type of valve useful for such a purpose, including, but not limited to, a ball air valve.

Referring now toFIGS. 19-29b, one particular method of installing a sleeve over an aneurysm in accordance with one particular embodiment of the invention will now be described. In particular, a sleeve in accordance with the instant invention must be installed in a very specific and careful manner, in the direction of blood flow, so as to not cause heart failure, drastic blood pressure changes in the artery or arteries, or significant changes in the blood flow of the artery or arteries. First, a patient is prepped for surgery, in any way deemed appropriate by the surgeon. This can include, among other things, performing procedures to slow down the patient's body metabolism to the greatest extent possible, by cooling down the body temperature. In one particular embodiment of the invention, the patient's body temperature is cooled about 11 percent for every 10 mm Hg rise in central aortic pressure.

Installation Procedure for an Ascending Aortic Aneurysm:

One particular method of installing a sleeve400,430in accordance with one particular embodiment of the present invention will now be described in connection withFIGS. 21-24and26. First, as shown more particularly inFIG. 26, a bellows410is installed next to the heart. In the embodiment shown, the bellows410is made up of two parts410aand410bthat are matingly engaged using two locking mechanisms, as described hereinabove. Note that this is not meant to be limiting, as the bellows410may be made up from a single piece and locking mechanism, or even more than two pieces, as desired.

Once the bellows has been secured next to the heart, the saddle sleeves422can be installed and secured over the small arteries402coming out of the aorta. The saddle sleeves may be individual securing buttons or saddle sleeves, as described hereinabove in connection withFIGS. 10-12, or may be part of a three branch manifold, as described in connection withFIGS. 9 and 13, as desired by the surgeon. However, in each case, the saddle sleeves (i.e., securing buttons) are secured around a portion of each of the small arteries402, with a portion straddling or saddling the aorta200. A further sleeve, securing sleeve420, is then secured over the manifold or saddling portions of the saddle sleeves422, in order to hold them in place in their desired location over the aorta. More particularly, the securing sleeve420and saddle sleeves422anchor the securing sleeve420in place relative to the vessels402. The saddle sleeve420includes openings to permit the passage of the saddle sleeves422therethrough, and a locking mechanism425for locking the securing sleeve420over the aorta and the saddle portions or manifold body, to maintain the saddle sleeves422in place. The securing sleeve420, may or may not be inflatable, as required. In the instant embodiment shown, the securing sleeve420is not inflatable.

Once sleeves422,420and bellows410have been placed and secured, an inflatable sleeve430can be secured over the aneurysm108and between the bellows and the anchoring combination formed from the securing sleeve420overlaying the saddle sleeves422. Initially, the sleeve430will be deflated and open on one side, as shown more particularly inFIG. 21. The sleeve430includes an inner surface430a, which will contact the aneurysm108, an outer surface430b, and a locking mechanism435, having mating edges435aand435b, which engage to form the sleeve430into a tube, as shown more particularly inFIGS. 21a,29,29aand29b. Additionally, the sleeve430, in its deflated and opened state, is rolled over onto itself multiple times (like a condom), as shown more particularly inFIG. 21b. At each end, the sleeve430has either a groove or an “O” ring type protuberance, or some other type of locking mechanism, as shown more particularly inFIGS. 27 and 28. A corresponding locking structure or mechanism will also be present on the connecting ends of the bellows410and the securing sleeve420.

As shown more particularly inFIGS. 22 and 27, the sleeve430is engaged at one end to the bellows410by forming the sleeve430into a tube over the end of the bellows410, using the locking mechanism435, and matingly engaging the “O” ring type protuberance412on the bellows410with a corresponding groove432on the sleeve430, or vice versa. Thereafter, the sleeve430will be unrolled (deployed) under pressure (i.e., having air or another fluid enter an internal chamber of the sleeve430, via the valve437to unroll/deploy the sleeve430) over the total length of the affected aorta, from the bellow410onwards up to the sleeve420, and locked by mating a groove434on the inner surface430aof the sleeve430over an “O” ring type protuberance421on the outer surface of the securing sleeve420(or vice versa). Compare, for example,FIGS. 22-23,27and28. The unrolling of the sleeve430, and the progressive engagement of the locking mechanism435as it is deployed (see also, for example,FIGS. 29,29aand29b) should be performed at a very slow advancing rate and should take several minutes. The initial pressure applied to unroll the sleeve430will be less than the final pressure of the sleeve430, in one particular embodiment of the invention. In another embodiment of the invention, the sleeve430will be left at the pressure present in the sleeve once the sleeve430has been deployed, which may equal the initial pressure applied to deploy the sleeve430.

In a further embodiment of the invention, once the sleeve430has been deployed under pressure and is in its final form and/or location, the air in the internal chamber may be removed or released, in order to deflate the sleeve430, and/or to avoid compressing or constricting the blood vessel, if desired. The amount of air left in the chamber after the sleeve430has been deployed around the vessel is preferably determined by a physician based on the sleeve materials selected and/or the particular conditions and anatomy of the patient.

Using a device similar to the inflation mechanism used for a sphygmomanometer or “blood pressure cuff”, the sleeve430will be gently inflated to the required arterial patient blood pressure. For the proper function of any aneurysm device, and so as to not endanger the patient's life, the pressure within the sleeve430must equalize the pressure within the aorta. To insure this correct and proper pressure between the sleeve430and the aorta, a special blood pressure monitoring device should be provided to measure this pressure through the device of the invention, and the aorta.

Installation Procedure for a Descending and/or Thoracic Aortic Aneurysm:

The same procedure for installing a sleeve over a descending and/or thoracic aortic aneurysm will be basically the same as is described above in connection with the installation of a device over the ascending aortic aneurysm, with the exception that a bellows410is not used in connection with a descending/thoracic aortic aneurysm. Referring more particularly now toFIGS. 35-36, in the case of a descending and/or thoracic aortic aneurysm, saddle sleeves455are installed in a similar manner as discussed in connection with saddle sleeves235,237or255ofFIGS. 9-12and13, and a securing sleeve450is placed there over. However, in association with the descending aorta106, an inflatable sleeve460is connected to the distal end of the securing sleeve450(i.e., the end distal from the heart). The sleeve460is applied and deployed under pressure over the affected portion of the descending and/or thoracic aorta106including the aneurysm108, in much the same way as was described in connection with the installation of the sleeve430ofFIGS. 22 and 22a. As noted above, pressure may be applied by introducing air from an air source into the sleeve halves, via a valve (not shown). Additionally, the unrolling of the sleeve460starts from the “O”-ring type protuberance452on the securing sleeve450, and moves away there from, so as to ensure that unrolling of the sleeve460is effectuated in the natural direction of the blood flow through the aorta. As discussed elsewhere herein, the final pressure in the sleeve460may be the same as, greater than or less than the pressure in the sleeve460during the unrolling step.

Installation Procedure for an Abdominal Aneurysm:

One particular method of treating an abdominal aortic aneurysm, in accordance with the present invention will now be described. More particularly, referring now toFIGS. 30-34, there is shown one particular embodiment of a sleeve device500for use with an abdominal aortic aneurysm. The aneurysm sleeve device500has a two part construction wherein a first sleeve or securing sleeve510is used to maintain the second sleeve520in a desired position relative to the aorta560and aneurysm.

In use, the securing buttons or saddle sleeves512are installed over the small arteries562of the abdominal aorta and aneurysm, in much the same way as was described in connection with the saddle sleeves235,237ofFIGS. 10,11and12. Alternately, a three branch manifold, as described in connection withFIGS. 9 and 13, could be reconfigured for use with the arteries562. Once the saddle sleeves512and/or manifold containing the saddle sleeves512have been placed, a securing sleeve510can be closed over a saddle portion of the saddle sleeves512, to maintain the saddle sleeves512in the proper position relative to the aorta and aneurysm, as shown more particularly inFIG. 33.

According to the present particular embodiment of the invention, after installation of the saddle sleeves512and the securing sleeve510(FIG. 33), the sleeve520can be placed and secured over and around the branched portion564of the abdominal aorta and the aneurysm. More particularly, a sleeve520, which, in the presently shown embodiment is made up of two halves520aand520b, is placed around the branched portion564of the abdominal aorta by connecting the two halves520aand520b, using a locking mechanism525in the manner discussed hereinabove. Additionally, the sleeve520is secured to the securing sleeve510by fastening the groove529on the sleeve520around an “O”-ring like protuberance517on the securing sleeve510, or vice versa. The securing sleeve510operates to maintain the sleeve520in its desired location.

As described in connection withFIGS. 21-23, hereinabove, the sleeve520, and its respective halves520aand520bmay be rolled for insertion. However, once the sleeve halves520aand520bare secured over the “O”-ring like protuberance517, and to one another at the end proximal to the protuberance517, the sleeve halves may be unrolled, under pressure, and progressively, matingly engaged to one another until the sleeve520extends over the total length of the affected portion of the aorta and the aneurysm (i.e., downwards from the connecting edge of the securing sleeve510). Pressure may be applied by introducing air from an air source into the sleeve halves520aand520b, via the valves527.

More particularly, the two halves520a,520bof the sleeve520will come deflated. One half520aor520bwill be placed below the affected abdominal aortic aneurysm area, while the other half520aor520bwill be placed above the affected abdominal Aneurysm area and unrolled slowly over the aneurysm (i.e., by introducing air into a chamber of each half520a,520bto unroll the respective half). The bottom half will serve as counter support resistance for the top half. See, for example,FIGS. 30-32.

The two halves520aand520bof the sleeve520will be snapped or locked and secured against each other and over “O”-ring type protuberance517of the securing sleeve510and, thereafter the two halves520aand520bwill be inflated simultaneously at a very low rate of inflation. The unrolling of the sleeve520should be performed at a very slow advancing rate. The initial pressure applied to deploy the sleeve520in the direction of the blood flow will be less than the final pressure of the sleeve520. Alternately, as discussed elsewhere herein, the final pressure in the sleeve halves520a,520bmay be the same as or less than the pressure in the sleeve halves520a,520bduring unrolling.

It is important to note that, in each of the foregoing cases, the inflatable sleeve should be deployed over any aneurysm in the direction of the natural blood flow through the vessel.

Referring now toFIG. 37, there is shown a further embodiment of an inflatable sleeve for treating an aneurysm in accordance with the instant invention. In the instant embodiment, a double-walled or inflatable sleeve610, as described herein, is disposed inside of the ascending aorta, and located so as to bypass the ascending aortic aneurysm608, proximal to the heart602. The sleeve610, which may be a double-walled tube formed by an inner wall612and an outer wall614, sealed together in an airtight manner. A valve617is disposed inside of the sleeve610. The valve617can be connected to an air source (not shown), so as to inflate the double-walled sleeve610. As air from the air source enters the sleeve, the outer wall of the tube614aextends away from the inner wall, as shown in dashed line. Thus inflated, the sleeve610, blood flows through the sleeve610, thus bypassing the walls of the aneurysm. The turbulent blood flow through the aneurysm is reduced and, eventually, the aneurysm608will shrink.

The sleeve610may be secured inside the vessel at the point of the aneurysm, as desired. In one preferred embodiment of the invention, the sleeve610is not stitched inside the aorta600, but rather is held in place by gluing, clamping or another type of fixation, and/or by using any of the sleeves ofFIGS. 4,6,7,8,20,21ainflated over only at the “O”619ofFIG. 37. In a further embodiment of the invention, the sleeve610is secured in place by magnets619, which are held in place by an electromagnetic field generated by a pacemaker620that is placed in the chest or abdomen of a patient, for regulating the heart602. Alternately, magnets619ofFIG. 37may be permanent magnets used to secure the sleeve610in a desired place.

Although shown in the ascending aorta inFIG. 37, it should be understood that a double-walled sleeve (like the double-walled sleeve610) can be adapted for use in the descending, thoracic and/or the abdominal aorta. For example, referring now toFIG. 38, a double-walled sleeve640having a valve647therein can be made in the form of a forked tube, for placement in the branches of the abdominal aorta630, and thus, bypassing an abdominal aortic aneurysm in the wall thereof. As with the double-walled sleeve610, such a double walled sleeve640can be fixed inside the descending, thoracic and/or abdominal aorta by gluing, clamping, or some other method of fixation. In one particular embodiment of the invention, such a double-walled sleeve is secured in place by magnets649that are held in place by an electromagnetic field generated by a pacemaker620that is placed in the chest or abdomen of a patient, as described hereinabove, or with permanent magnets. In a further alternate embodiment of the invention, the double-walled sleeve610,640can include non-inflatable portions at each end that can be stitched, stapled and/or clipped to the walls of the vessel, without violating the integrity of the airtight inner chamber of the sleeve. Note that the double-walled sleeves610and640, although disposed inside of the vessel, rather than external to the vessel, may be provided in rolled form (as described in connection with sleeve430,460and halves520aand520b) and deployed inside of the vessel by applying pressure to the rolled sleeve by the introduction of air into the chamber between the double-walls of the sleeve610,640.

Referring now toFIGS. 39A and 39B, there is shown another embodiment of a system700utilizing a chambered or double walled sleeve710, which may be used in accordance with the present invention. The chambered sleeve710resembles the chambered sleeve300ofFIG. 18, and includes an inner wall and an outer wall. However, the chambered or double walled sleeve710, instead of being inflatable over a large portion of its circumference, is inflatable over a smaller portion of the device710. In particular, rather than including a fully inflatable sleeve, the sleeve710includes an inflatable pocket into which a pressurized fluid may be injected by the fluid source720. Thus, one portion of the sleeve710remains at the uninflated thickness A′, while a second portion (i.e., a fluid-filled pocket of sleeve710) is inflated to a second, greater thickness B′.

In the particular embodiment shown, the sleeve710includes two portions710aand710b, mated by locking mechanism712around the vessel located in the chamber715formed by the mating of the locking mechanism712. In the embodiment shown, the portion710bis inflatable by a fluid source720(preferably, an air source), while the portion710ais not. In this way, the physician can determine whether one portion of the underlying vessel should be subjected to a different pressure than the other (for example, the aneurysm side being inflated to a greater pressure than the non-aneurysm side of the vessel, or vice-versa). Although a two part device is shown inFIGS. 39A and 39B, this is not meant to be limiting, as it should be understood that a single part device including a fluid chamber formed in an isolated and/or limited part of the sleeve, only, could be made and used, as desired. In one particular embodiment of the invention, a double chambered sleeve710including a single locking mechanism712is formed having the chamber size limited by a thermal weld or other fabrication technique to delimit the fillable portion of the chamber (between the inner and outer walls) to a predetermined size less than the entire usable area of the sleeve710. The sleeve710may be installed in accordance with any of the methods described previously herein. Additionally, a sleeve710of this type is particularly suited for application on the ascending aorta.

It should be understood from the foregoing, that the sleeves of the present invention can be applied in or around a particular blood vessel adjacent a desired location by a physician, manually, or with robotic assistance.

Although the invention is illustrated and described herein, various modifications and structural changes may be made therein without departing from the spirit of the invention and within the scope and range of equivalents of the claims.