CA2465923A1

CA2465923A1 - Filter with integrated obturator tip and methods of use

Info

Publication number: CA2465923A1
Application number: CA002465923A
Authority: CA
Inventors: Richard O. Murphy
Original assignee: Individual
Current assignee: Edwards Lifesciences Corp
Priority date: 2001-11-06
Filing date: 2002-10-31
Publication date: 2003-05-15
Also published as: WO2003039339A3; EP1441796B1; AU2002363427B2; EP1441796A4; DE60232001D1; ATE428465T1; US6790219B1; WO2003039339A2; EP1441796A2

Abstract

An endoluminal device (1) having an elongate tubular member (2) and a filter (13) slideably received within a lumen of the tubular member (2). An obturat or tip (10) is carried by the filter (13) and shaped to rest against the distal end (5) of the elongate tubular member (2) when the filter (13) is within th e lumen of the tubular member (2). Methods of using the obturator tip (10) and the elongate tubular member (2) for introducing the filter into a vessel, su ch as an aorta, are also disclosed.

Description

3 Field of the Invention 4 The present invention generally relates to the field of embolic protection, and more particularly to endoluminal devices that can be used to provide embolic 6 protection during a surgical procedure.
7 Baclc~round of the Invention 8 During various cardiothoracic, pulmonary, and vascular surgeries, 9 including coronary artery bypass grafting, heart valve repair or replacement, atrial or ventricular septal defect repair, angioplasty, atherectomy, aneurysm repair, and 11 pulmonary thrombectomy, or any other procedure that males use of cardiopulmonary 12 bypass, cannulation of a patient's vessels) are often required to provide vascular access 13 for delivery of various diagnostic and therapeutic devices. In a conventional approach, 14 incisions generally made by a surgical blade are needed for introduction of medical device(s). For example, during coronary artery bypass grafting (CABG) surgeries, 16 cardiopulmonary bypass is established by cannulation of the aorta to provide circulatory 17 isolation of the heart and coronary blood vessels. Multiple incisions on the aorta may be 18 required, i.e., one for insertion of the arterial canrlula, another for insertion of a balloon 19 occluder to provide coronary isolation from the peripheral vascular system, and another for insertion of an arterial filter to provide protection against distal embolization. Once 21 the incisions are made on the aorta, the devices often remain in the aorta throughout the IRl :1007748.1 1 entire procedure despite only being used.intennittently, e.g., the cardioplegia catheter.
2 Due to significant mortality and morbidity associated with the 3 conventional CABG surgeries from the use of cardiopulmonary bypass for circulatory 4 support and the traditional method of access by median sternotomy, minimally invasive concepts recently have been adopted to male cardiothoracic procedures less invasive.
6 Minimally invasive alternatives include the minimally invasive direct CABG
procedure 7 in which the operation is performed through minimal access incisions, eliminating 8 cardiopuhnonary bypass. The second alternative is to perform the procedure through 9 minimal access incisions, and cardiopulmonary support is instituted through an extra-thoracic approach, i.e., the port access approach. The third alternative is to perform the 11 procedure on a beating heart which allows greater access for more extensive 12 revascularization, i.e., the "off pump" sternotomy approach. hl any of the minimally 13 invasive alternatives, the space allowed for multiple incisions and device insertion is 14 limited.
The disadvantages associated with the conventional or minimally invasive 16 approach are that (1) the current methods require bully valves and plastic housings that 17 interfere with a surgeon's worl~ing space, thereby reducing the space available for the 18 surgeon to perform procedures, and (2) the aorta is traumatized as a result of multiple 19 incisions, which may result in aortic dissection, aortic wall hematoma, and/or embolization of calcium plaque from the aortic wall. The greater the aortic trauma, the 21 higher the perioperative morbidity a patient will endure.
22 Accordingly, there is a need for devices and methods which provide access to a IRI :1007748.1 1 vessel or body cavity and allow introduction of medical instrument(s), such as an arterial 2 filter, through a single incision with minimal blood loss and with maximum convenience 3 for the physician.

Summary of the Invention 6 The present invention provides a medical device for introducing a blood 7 filter into a body tissue, such as a vessel, or cardiac tissue, for preventing distal 8 embolization. Obturators are also provided for atraumatic insertion through an incision 9 in body tissue. In a first embodiment, the medical device comprises an elongate tubular member having a lumen between a proximal end and a distal end. A
filter, having 11 an obturator tip at its distal end, is slideably received within the lumen of the elongate 12 tubular member. The obturator tip is shaped to rest against the distal end of the elongate 13 tubular member when the filter is within the lumen of the elongate tubular member. The 14 filter is capable being advanced distally beyond the distal end of the elongate tubular member after the device is inserted into a vessel. A distal region of the elongate tubular 16 member may include a suture flange for securing the device onto a vessel.
The proximal 17 end of the elongate tubular member may include a hemostatic valve to minimize blood 18 loss.
19 In another embodiment, the elongate tubular member is flexible, thereby allowing a physician to manipulate the device in crowded surgical space. The filter 21 comprises an expansion frame having an attached filter mesh that is generally conical.
22 The obturator tip is attached at the apex of the conical mesh. The obturator tip, which IRl :1007748.1 1 may be made of thermoplastic polymer, silicone, urethane, or other suitable material, may 2 be olive-shaped or star-shaped. The expansion frame, wluch comprises a generally 3 circular ring of a flexible material, e.g., nitinol, may be attached to an elongate member 4 that extends through the lumen of the elongate tubular member, e.g., hypotube. An optional cantilever beam bisects the generally circular ring and attaches to the ring at a 6 distal end.
7 In a first method of using the obturators and introducers described above 8 for introduction of a blood filter, the filter is contracted and withdrawn into the lumen of 9 the elongate tubular member so that the obturator tip rests against the distal end of the elongate tubular member. The obturator tip and the distal end of the elongate tubular 11 member are inserted into a blood vessel, e.g., an aorta, after an incision is made on the 12 vessel wall. A hemostatic valve mounted within the lumen of the introducer prevents 13 blood loss. In certain embodiments, a suture flange is provided on the distal end of the 14 introducer, and sutures can be placed on the flange to stabilize the device onto the body tissue. The filter and the obturator tip are then advanced beyond the distal end of the 16 elongate tubular member. The filter is deployed in the vessel to prevent embolization of 17 materials, such as atheromatous plaque, thrombus, or tissue debris generated during the 18 procedure. Vascular surgeries, including coronary artery bypass grafting, heart valve 19 repair or replacement, atrial or ventricular septal defect repair, angioplasty, atherectomy, aneurysm repair, and pulmonary thrombectomy, can then be performed after 21 establishment of cardiopulmonary bypass. After completion of the surgical procedure, 22 the filter and the captured embolic debris are withdrawn into the lumen of the elongate IRl :1007748.1 1 tubular member. The device is then removed from the vessel.
2 There are several advantages in using the device disclosed herein for 3 performing arterial filtration during vascular surgeries. For example, the devices (1) are 4 constructed of fewer parts, thereby allowing easy manipulation of the device, (2) are less bully, thereby allowing the ease of use in a crowded surgical space, (3) have less 6 manufacturing cost, (4) have a flexible delivery system that allows added flexibility for 7 worl~ing in a limited space, (5) have a reduced outer diameter as compared with an 8 introducer sheath adapted to receive a length of hypotube that carries a filter, and (6) 9 eliminate the step of removing a separate obturator during use (a step that can cause blood loss).
11 Additional features of the present invention will become apparent from 12 consideration of the following description tal~en in conjunction with the accompanying 13 drawings.
14 Brief Description of the Drawings Fig. lA depicts the medical device having a filter with obturator tip 16 according to one embodiment of the invention.
17 Fig. 1B depicts the device of Fig lA with filter deployed.
18 Fig. 2A depicts the device of Fig. lA inserted in a blood vessel.
19 Fig. 2B depicts the device of Fig. 2A having the filter deployed in the blood vessel.
21 Fig. 3A depicts another embodiment of the device having a rounded 22 obturator tip.

IR1:1007748.1 1 Fig. 3B depicts a filter mesh covering the obturator tip of Fig. 3A.
2 Fig. 3C depicts a filter mesh inserted inside the obturator tip of Fig. 3A
3 Fig. 4A depicts another embodiment of the device having a star-shaped 4 obturator tip.
Fig. 4B depicts an end view of the obturator tip of Fig. 4A when laid flat.

6 Fig. 4C depicts a lateral view of the obturator tip of Fig. 4A having a filter 7 mesh attached.

8 Fig. 5 depicts another embodiment of the device having a filter carried by 9 a flexible elongate tubular member.
Fig. 6A depicts another embodiment of the obturator tip having an olive 11 shape.
12 Fig. 6B depicts a wire attached to the olive obturator tip of Fig. 6A.
13 Detailed Description 14 A filter for use in a surgical procedure to prevent distal embolization is depicted in Fig. lA. Device 1 includes tubular member 2 (e.g., a hypotube) having a 16 proximal end, distal end 5, and a lumen that extends from the proximal to the distal end.
17 The proximal end terminates proximally in handle 3 having finger grips as a handle for 18 the operator. Suture flange 4 is shown near distal end 5 of tubular member 2.
19 Elongate member 11 is slideably received through the lumen of tubular member 2. Elongate member 11 is typically a tubular member having a lumen that 21 communicates proximally with porous plug 12, which allows venting of air but not fluid 22 or blood. Obturator tip 10 is shown in Fig. lA seated against distal end 5 of tubular IRl :1007748.1 1 member 2.
2 In use, elongate member 11 slideably advances to deploy the filter as 3 shown in Fig. 1B. Filter 13 is carried by expansion frame 14, typically a wire frame 4 constructed of nitinol material. Cantilever beam 15 slideably extends from elongate member 11 at distal end 5 of tubular member 2. The cantilever beam stabilizes expansion 6 frame 14 and acts as a frame sizing mechansm to size the frame to fit and conform to the 7 endoluminal surface of the vessel in which the instrument is deployed.
8 The filter as described herein will fmd use in any procedure for which 9 distal embolization presents a complication. Illustrative procedures include cardiopuhnonaiy bypass, CABG, valve repair, abdominal aortic aneurysm repair, carotid 11 endarterectomy, carotid stenting, and carotid a~igioplasty. In use, an incision is made in 12 the vessel where filter protection is desired, e.g., the ascending aorta for cardiopulmonary 13 bypass, a coronary artery bypass grafting, or valve repair procedures, the abdominal aorta 14 or femoral arteries for aortic aneurysm repair, the common carotid artery or internal carotid artery for carotid procedures. Obturator tip 10 is advanced atraumatically through 16 the incision into the vessel as depicted in Fig. 2A. Suture flange 4 is secured to the wall 17 of vessel 100. While holding handle 3, the operator depresses elongate member 11 by 18 pushing on plug 12, much lilce the plunger of a syringe. This action causes obturator 10 19 to disengage from distal end 5 of tubular member 2. Filter l3 advances beyond distal end 5 and deploys within vessel 100 as shown in Fig. 2B. Expansion frame 14 and cantilever 21 15 ensure proper expansion of the filter into contact with the endoluminal surface of the 22 vessel. The vessel, e.g., aorta, aorta is then cross-clamped or occluded upstream of the IRl :1007748.1 1 filter which catches dislodged debris. The surgeon then proceeds with the CABG or 2 other desired procedure. Embolic materials, e.g., atheromatous plaque, calcium, 3 thrombus, and tissue debris, are captured by the filter.
4 After the operative procedure is completed, the operator pulls bacl on plug 12 while holding handle 3. Filter 13, expansion frame 14, and cantilever beam 15 6 are thereby retracted into tubular member 2. Obturator tip 10 is pulled into engagement 7 with distal end 5 of tubular member 2. The suture flange is released, and the device with 8 the captured embolic debris is removed from the vessel.
9 Another embodiment of the medical device having rounded obturator tip 10 is depicted in Fig.3A. Filter mesh 20 may be disposed around tip 10 as shown in Fig.

11 3B. Alternatively, mesh 20 may be insert molded into tip 10 using thermoplastic 12 polymer, silicone, or urethane as shown in Fig. 3C.

13 Figs. 4A, 4B, and 4C depict another embodiment of the obturator tip 14 having a star shape. In Fig. 4C, obturator tip 10 is seated against the distal end of elongate tubular member 2. The mesh may be glued or molded onto the tip, or inserted 16 onto the tip by two part heat staled inside and outside.
17 Another embodiment of the device having flexible elongate tubular 18 member 25 is depicted in Fig. 5. This design allows the operator to manipulate the 19 device in limited surgical space.
Figs. 6A and 6B depict another embodiment of the obturator tip having an 21 olive shape. Mesh 20 is disposed about the tip at a mid-region. Olive tip 40 comprises 22 proximal section 42, positioned inside mesh 20, and distal section 41, positioned outside IR1:1007748.1 1 mesh 20. Safety wire 30 is attached at a proximal end of section 41 and continues 2 proximally through section 42 as shown in Fig. 6B. The olive-shaped tip and the 3 attached safety wire facilitate re-placement of the tip against the distal end of the elongate 4 tubular member, minimize movement of the filter from blood flow, and reduce areas where blood may pool around the filter.
6 The overall length of the device 1 will generally be approximately 7 between 10 and 20 centimeters, preferably approximately 12 to 15 centimeters. The 8 outer diameter of tubular member 2 will generally be approximately between 5 and 10 9 millimeters, preferably approximately 6 and 7 millimeters. The diameter of the filter when expanded will vary depending on the vessel of use. For use in the aorta, the filter 11 will expand to an endoluminal diameter of approximately 2.5 centimeters.
The foregoing 12 ranges are set forth solely for the purpose of illustrating typical device dimensions. The 13 actual dimensions of a device constructed according to the principles of the present 14 invention may obviously vary outside of the listed ranges without departing from the principles disclosed herein.
16 Although the foregoing invention has, for purposes of clarity of 17 understanding, been described in some detail by way of illustration and example, it will 18 be obvious that certain changes and modifications may be practiced wluch will still fall 19 within the scope of the appended claims. It will also be understood that each feature of each embodiment discussed herein and of each reference cited herein, can be used in 21 combination with the features of any other embodiment.

IR1:1007748.1

Claims

What is claimed is:

1. A medical device for open surgery, comprising:
an elongate tubular member having a proximal end, a distal end, and a lumen therebetween;
a filter slideably received within the lumen of the elongate tubular member; and an obturator tip carried by the filter and shaped to rest against the distal end of the elongate tubular member when the filter is within the lumen of the elongate tubular member.

2. The medical device of claim 1, wherein the filter is advanced distally beyond the distal end of the elongate tubular member after the device is inserted into a vessel.

3. The medical device of claim 1, wherein the obturator tip is olive-shaped.

4. The medical device of claim 1, wherein the filter comprises an expansion frame and a filter mesh attached to the expansion frame.

5. The medical device of claim 4, wherein the expansion frame is attached to an elongate member that extends through the lumen of the elongate tubular member.

6. The medical device of claim 4, wherein the expansion frame comprises a IR1:1007748.1 generally circular ring of a flexible material.

7. The medical device of claim 6, further comprising a cantilever beam that bisects the generally circular ring and attaches to the ring at a distal end.

8. The medical device of claim 1, wherein the filter comprises a generally conical mesh.

9. The medical device of claim 8, wherein the obturator tip is attached at the apex of the conical mesh.

10. The medical device of claim 1, further comprising a suture flange at a distal region of the elongate tubular member.

11. The medical device of claim 1, further comprising a hemostatic valve at the proximal end of the elongate tubular member.

12. A method for open surgery, comprising the steps of:
providing an elongate tubular member having a proximal end, a distal end, a lumen, a filter slideably received within the lumen, and an obturator tip carried by the filter;
inserting the obturator tip and distal end of the elongate tubular member into a vessel;
advancing the filter and obturator tip beyond the distal end of the elongate tubular member; and deploying the filter in the vessel.

13. The method of claim 12, further comprising the step of withdrawing the filter into the lumen of the elongate tubular member so that the obturator tip rests against the distal end of the elongate tubular member.

14. The method of claim 13, further comprising the step of removing the medical device from the vessel.

15. The method of claim 12, wherein the vessel is an artery.

16. The method of claim 12, wherein the vessel is the aorta.

17. The method of claim 12, wherein the vessel is the ascending aorta.

18. The method of claim 12, wherein the vessel is the descending aorta.

IR1:1007748.1

19. The method of claim 12, wherein the vessel is the abdominal aorta.

20. The method of claim 12, wherein the vessel is the carotid artery.

21. The method of claim 12, further comprising the step of clamping the vessel upstream of the filter.

22. The method of claim 12, further comprising the step of performing cardiopulmonary bypass.

23. The method of claim 12, further comprising the step of installing a graft upstream of the filter to repair an abdominal aortic aneurysm.

24. The method of claim 12, further comprising the step of performing surgery on the vessel upstream of the filter.