WO2009094025A1

WO2009094025A1 - Intraluminal detachable biodegradeable thrombogenic catheter device and method of use

Info

Publication number: WO2009094025A1
Application number: PCT/US2008/051797
Authority: WO
Inventors: Joseph V. Lombardi
Original assignee: VASCUCORP LLC
Current assignee: VASCUCORP LLC
Priority date: 2008-01-23
Filing date: 2008-01-23
Publication date: 2009-07-30
Anticipated expiration: 2010-07-23

Abstract

The present invention related to a device for intervention in cases of aortic dissection, and a method of use of that device.

Description

Intraluminal Detachable Biodegradeable Thrombogenic Catheter Device and Method of Use

Background of the Invention The present invention related to a device for intervention in cases of aortic dissection, and a method of use of that device.

Aortic dissection occurs because of a tear or damage to the inner wall of the artery. This primarily occurs in the thoracic portion of the aorta, but also occurs in the abdominal portion. When the tear occurs, it creates two channels or lumens: One in which blood continues to travel (the true lumen) and another where blood pools (the false lumen) or flows through reentry tears distally. As the aortic dissection grows larger in volume and longer along the axis of the vessel, the lumen with pooling blood can also grow and block other branches of the aorta. An aortic dissection may also involve abnormal ballooning of the aorta (aneurysm). In general, treatment of aortic dissection involves either open surgical repair or a more minimally invasive insertion of an endograft into the artery at the location of the tear, to define and support the vessel wall while closing entry flow through the primary tear. Unless the false lumen results in thrombosis, secondary complications may become acute over time, leading to death. In the patent art, U.S. Patent No. 5,211, 658 to Clouse provides an overview of endovascular repair of aneurysms.

Brief Description of the Invention

The present invention initiates false lumen thrombosis in aortic dissection. In the acute setting of aortic dissection the invention prevents thoracic aortic rupture. The invention will also help prevent aneurysmal degeneration of the thoracic/abdominal aorta in the chronic phase of aortic dissection by promoting false lumen thrombosis. Patients presenting with chronic dissection who have developed aneurysmal degeneration may also benefit with the invention by inducing thrombosis within the aneurysmal false lumen.

The method of use of the present invention is to place the invention within the false lumen adjunctively with a thoracic endograft (placed in the true lumen). As the primary entry tear (which caused the dissection) is sealed, false lumen flow is diminished and the device serves to create further thrombogeni city. Early reduction or cessation of flow and resulting false lumen thrombosis has been associated in the medical literature with longer survival, better patient outcomes and decreased aneurysmal degeneration for patients with aortic dissection.

Brief Description of the Figures

Fig. 1 depicts the catheter-inserted thrombogenic device of the present invention.

Fig. 2 depicts the insertion of a catheter through the subclavian artery, into the true lumen of the aorta, and thence into the false lumen of the aorta via the primary entry tear in the vessel wall.

Fig. 3 depicts the deployment of an aortic endograft to define and support the wall of the aorta around the location of the primary entry tear.

Fig. 4 depicts the deployment of the catheter-inserted thrombogenic device of the present invention into the false lumen of the aortic dissection.

Fig. 5 depicts the detaching site of the device of the present invention in relation to the manipulation apparatus of the catheter by which the device is delivered and positioned.

Detailed Description of the Invention

A catheter-delivered device according to the present invention is delivered either percutaneously or through an open vessel at the time of endograft repair of aortic dissection. The device itself has side holes which allow for selective multilevel coiling with commercially available coils. The device itself is "feathered" with thrombogenic and biodegradable coils that both interrupt blood flow patterns and promote thrombin activation.

Part of the device is placed inside the subclavian artery and into the aortic false lumen via the primary entry tear. This serves to aid occlusion of the subclavian orifice and prevent type Ha endovascular leak. The device can be permanently detached in the false lumen and the catheter portion will biodegrade over time. The device also has a "low-flow" net at its base that "windsocks" adjacent to reentry tears and prevents thrombus migration or embolization while allowing thrombosis of the false lumen adjacent to reentry tears. The device may be produced in many sizes appropriate to the length of vessel lumen needed to be treated and may either be extended to the abdominal aorta via increasing length or separate delivery of a second device. It may also be preferable to have the catheter adjustable to variable lengths based on the patients' anatomy by sliding the catheter portion over the stem.

The device of the present invention is preferably comprised of a permanent (non-bioreactive) metallic alloy, Small Intestinal Submucosa ("SIS") or a mixture thereof. The device preferably ranges in length from about 100 mm to about 300 mm. Referring to Fig. 1, the proximal component (PC) comprises a cluster of coils or a similar occlusive device that is mounted onto a stem (S) comprising either flexible Nitinol or similar wire or SIS. The stem is contiguous with the remainder of the device and provides longitudinal structural support. Distal to the proximal occlusive device is a helical or similarly configured matrix of titanium or other similarly non-bioreactive metal, titanium or Nitinol coils (TC) anchored to the stem. The diameter of these coils preferably about 15 -20 mm. Optionally, such coils may be coated or otherwise treated with thrombogenic materials.

The structure of the stem resembles in some respects a catheter with several side holes (SH) at given lengths. These side holes are contiguous with a central lumen (CL) that is accessible to the user of the device. Attached to the stem, most distally, are one or more semi-porous membranes that deploy in the blood flow like a "windsock" (WS) and abut the reentry tear, thereby limiting flow and preventing thrombus migration or embolization. Alternatively, other structures that exhibit high hydrodyamic drag in the blood flow may be employed as the windsock member. The terminal end of the catheter comprises a mechanism to detach the device after the false lumen has been properly mitigated.

Referring now to Fig. 2, the method of use of the present invention is illustrated. After gaining access to the false lumen (FL), a catheter (C), is directed to the subclavian artery (SCA), over a guide wire through the primary entry tear (PET), thereby reentering the true lumen (TL). As shown in Fig. 3, the catheter is positioned properly and a thoracic endograft is deployed within the false lumen (TEG) anchoring the device against the aortic wall. Fig. 4 depicts the device as it is then unsheathed with the proximal component (PC) within the subclavian artery (SCA) and the helical thrombogenic "feathers" (TC) is deployed down to the semiporous membrane windsock (WS). Assessment is then made with the device in place for;

1. Angiography

2. Intravascular Ultrasound

3. Additional coils via one or more of the side holes (SH), where needed. These side holes may be accessed via a micro-catheter as long as the device of the present invention is still attached to the delivery catheter.

Referring now to Fig. 5, after satisfactory mitigation of the false lumen, the device is then detached via the detachment mechanism after the thoracic endograft has been deployed. The device of the present invention serves as a permanent (though partially biodegradable) graft to prevent additional damage to the arterial wall in the area of the tear and aneurysm. Its use is potentially less invasive, and more effective at quickly slowing the growth of the false lumen, and allowing thrombosis that effectively prevents further enlargement of the dissected vessel wall. This, in turn, may be expected to reduce mortality, length of hospitalization, and costs associated with treatment of this serious condition.

Statement of Industrial Utility

The present invention may be used by physicians to treat patients who have suffered aortic dissection and aortic dissection with aortic aneurysm to mitigate the life-threatening effects of such conditions.

While the invention has been described in its preferred embodiments, it is to be understood that the words which have been used are words of description rather than of limitation and that changes may be made within the purview of the appended claims without departing from the true scope and spirit of the invention in its broader aspects. Rather, various modifications may be made in the details within the scope and range of equivalents of the claims and without departing from the spirit of the invention. The inventor further requires that the scope accorded the claims be in accordance with the broadest possible construction available under the law as it exists on the date of filing hereof (and of the application from which this application obtains priority, if any) and that no narrowing of the scope of the appended claims be allowed due to subsequent changes in the law, as such a narrowing would constitute an ex post facto adjudication, and a taking without due process or just compensation,

Claims

Claims:

1. A catheter-inserted thrombogenic device comprising an insertion member, a stem having disposed thereon one or more blood-flow occlusive members proximal to the insertion member, and one or more thrombogenic members distal to the blood-flow occlusive members.

2. The device of Claim 1 wherein the stem is hollow and has one or more holes disposed along its length.

3. The device of Claim 1 wherein the stem comprises a material selected from the group of a non-bioreactive metal or metallic alloy, or small intestinal submucosa, or a mixture thereof.

4. The device of Claim 1 wherein the blood-flow occlusive members comprise semi-porous membrane.

5. The device of Claim 1 wherein the thrombogenic members comprise coils of a non-bioreactive metal.

6. The device of Claim 5 wherein the thrombogenic members comprise titanium coils.

7. The device of Claim 5 wherein the thrombogenic members are coated with a thrombogenic material.

8. The device of claim 1 wherein the thrombogenic members are biodegradable in vivo.

9. A method of treating aortic dissection comprising the steps of: a. Inserting and guiding a delivery catheter, either percutaneously or through an open vessel, into the false lumen, traversing the primary entry tear into the true lumen and into or near the subclavian artery; b. Inserting an aortic endograft into the true lumen of the aorta adjacent the primary entry tear; c. Inserting a thrombogenic device comprising an insertion member, a stem having disposed thereon one or more blood-flow occlusive members proximal to the insertion member, and one or more thrombogenic members distal to the blood-flow occlusive members, into the false lumen; d. Adjusting the device within the false lumen to promote thrombogenesis therein; e. Detaching the device from the delivery catheter; and f. Withdrawing the remaining delivery catheter from the patient.

10. The method of Claim 9 wherein the step of adjusting the device is performed with the aid of angiography or intravascular ultrasound.

11. The method of Claim 9 wherein the step of adjusting the device comprises deploying one or more thrombogenic members to improve and/or speed thrombosis within the false lumen.