WO2008058017A2

WO2008058017A2 - Flow isolation device

Info

Publication number: WO2008058017A2
Application number: PCT/US2007/083503
Authority: WO
Inventors: Martin S. Dieck
Original assignee: Tsunami Innovations Llc
Priority date: 2006-11-02
Filing date: 2007-11-02
Publication date: 2008-05-15
Also published as: WO2008058017A3

Abstract

Devices and methods are provided for a variably adjustable flow isolation device that can be axially adjusted along a length of a working catheter. The flow isolation device allows for an adjustable occlusion member along the length of a working catheter so that other therapeutic treatments can be delivered via the working lumen of the working catheter.

Description

FLOW ISOLATION DEMCE

CROSS-REFERENCE TO RELATED APPLICATIONS

[00011 The present application claims the benefit of U.S. Provisional Patent Application Number 60/864,015 filed November 2, 2006, the content of which is incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

[0002] In arteries and veins it is sometimes necessary to artificially occlude blood flow in order to perform intravascular diagnostic or therapeutic work. Certain types of therapeutic procedures may inadvertently or intentionally occlude the vasculature. Whether intentional or not. occluding certain areas in the vasculature presents potential risks to the patient. Therefore, prior to occluding the vasculature, a physician may temporarily occlude the vasculature using an occluding device (e.g., a mechanical device such as a balloon) to cease blood flow as a test to see if the patient can tolerate the occlusion. During the occlusion, the physician may perform several tests may to determine the patient 's tolerance for a more permanent procedure. If the patient tolerates the procedure, the physician can deliver additional implantable devices from or through the temporary occluding device for permanent implantation to occlude the vessel.

[0003] Other procedures might require occlusion of blood flow in the vasculature. In such cases, similar devices may also be used to change the flow dynamics in the circulatory system. For example, a physician might occlude a vessel to support other therapies such as thrombus retrieval. In another example, a physician might use a temporary occlusion device to halt flow to contain or redirect embolic material broken off during an associated intravascular therapy. If left to migrate in the vessel, such broken embolic material could potentially migrate causing undesirable complications in the patient.

[0004] The majority of temporary occlusion devices are made up of elastomeric balloons fixed on delivery catheters where the balloons are inflated with fluid to open and occlude a vessel until the balloon is subsequently deflated by drawing negative pressure on the fluid column. [0005| Such devices are available from various medical device manufacturers. including Concentric Medical. Inc. as well as Medtronic, Inc. Fig. IA shows a general example of such a device. As shown, the catheter 50 includes a fluid lumen 52 and a working lumen (also called a through-lumen) 54. The physician injects fluid injected through the inflation lumen 52 and into the balloon 56 through an inflation port 58. The balloon 56 expands as it fills with fluid. However, because the inflation lumen 52 is fluidly separated from the working lumen 54, the physician can introduce wires, implants, or other therapeutic devices beyond the distal end of the catheter 50. Such devices include, but are not limited to, balloon catheters, thrombus retrieval devices, etc.

[0006] Fig. 2 illustrates another example of a catheter design for occluding vessels, As shown, this catheter 60 has a design comprising a single inflation lumen 62 fluidly coupled to a balloon 64. Because this catheter 60 does not have separate inflation lumen and through-lumen, the design typically provides an advantageous a smaller delivery profile. However, such a device cannot deliver additional devices through beyond where flow is arrested. Such a device has limited therapeutic utility. Moreover, the device design makes it difficult for the physician to advance the device through vasculature.

SUMMARY OF THE INVENTION

[0007] The description, objects and advantages of the present invention will become apparent from the detailed description to follow, together with the accompanying drawings.

[0008] The current invention is an adjustable flow isolation system whose inflation lumen and occluding balloon are axially adjustable along a length of a working lumen where the inflation lumen and working lumen are fluidly isolated. This configuration allows placement of the occluding balloon along any location on the inner or working catheter or tube containing the working lumen. Although the working catheter may be specially configured, variations of the invention allow for any off the shelf catheter to be substituted as a working catheter.

[0009] The configuration of the adjustable flow isolation system allows for insertion into the patient via a smaller access hole as compared to other conventional dual lumen catheters. In yet another advantage of the system is that the ability to customize balloon location and associated through lumen catheter leads to a potential reduction of inventory.

[0010] In one variation, the invention includes a flow isolation system for use within a body lumen, where the system comprises a catheter body having a length and working lumen extending therethrough and an exterior surface. As noted herein, the catheter body can comprise any conventional catheter or may be a catheter specifically designed for use with the system. In another variation, the device may simply comprise a balloon (as described herein) along with an inflation lumen where the inflation lumen and balloon are used with a pre-existing catheter.

[0011] The system further includes an inflation lumen fluidly couple to a balloon, where the balloon and inflation lumen are axially adjustable along at least a portion of the length of the catheter body such that the balloon can be repositioned along the length of the catheter body, where the working lumen and inflation lumen are fluidly isolated such that upon inflation of the balloon, the balloon remains inflated while the working lumen is unobstructed. This configuration not only allows for a smaller profile device. It also provides an additional means to adjust the site of the occlusive balloon prior to or during expansion.

[0012] The system can further include an inflation sheath containing the inflation lumen, where the inflation sheath is slidable over the exterior surface of the catheter body. Alternatively, the inflation lumen may reside in an inflation tube that is designed to remain parallel to and outside the catheter body.

[0013] The balloons of the current invention can be manufactured from any commonly known balloon material. The balloon can be distensible or non-distensible. In addition, the balloon can include a support structure that provides a shape for the balloon prior to expansion or that directs expansion in a preferential manner.

[0014] In additional variations, the balloon can be formed from an elastic tube that is configured into a shape that defines a passageway (where the catheter can advance through the passageway.) For example, the shape can be selected from a circle, helix, oval, rectangular, square, or other shape.

[0015] The balloon can include any number of additional features such as coating, additives (for increased visualization), radiopaque markers, etc. Clearly, the inflation tube, sheath, or catheter body can also include one or more radiopaque markers as well.

[0016] The invention also includes methods for selectively arresting flow within a body lumen, comprising advancing a catheter body into the body lumen, where the catheter body includes an exterior surface, a length and working lumen extending therethrough, positioning a balloon along a length of the catheter body, such that the balloon encircles the exterior surface of the catheter body where the balloon can be repositioned, and inflating the balloon through an infusion lumen such that it expands about the exterior surface of the catheter body, where the infusion lumen is fluidly isolated from the working lumen such that the working lumen remains unobstructed.

[0017| Inflation of the balloon can either fully arrest flow within the body lumen or at least partially arrest flow within the body lumen. In either case, the lumen of the catheter body permits the physician to advance therapeutic devices through the working lumen while the balloon remains inflated.

[0018] The disclosure and invention specifically include combination of features of various embodiments as well as combinations of the various embodiments where possible.

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Fig. 1 shows a general example of a conventional dual lumen occlusion device. [0020] Fig. 2 shows a conventional single lumen occlusion device. [0021] Fig. 3A shows a variable flow isolation system according to the present invention.

[0022] Fig. 3B shows a magnified view of a distal end of the device of Fig. 3 A. [0023J Figs. 4A to 4C show components of one variation of a variable flow isolation system according to the present invention. [0024] Figs. 5 A to 5D show an example of the deployment of one variation of a variable flow isolation system according to the present invention. [0025| Figs. 6A to 6E show another variation of an occlusion balloon for use in the present invention. [0026] Fig. 6A shows an elastic tube that is shaped to foπn the balloon of Fig. 6B. As illustrated the shape of the balloon allows for creation of a passage through the balloon. [0027] Fig. 6C shows the balloon of Fig. 6B once expanded. [0028] Figs 6D and 6E show the system placed about a catheter body within a body lumen in a prc-expanded and expanded configuration. [0029] Fig. 7 shows a variation of a balloon having a support structure that provides for expansion of a balloon in a desired direction. DETAILED DESCRIPTION OF THE INVENTION

[003Oj Fig. 3 A illustrates a first variation of a variable flow isolation system 100 having a first working tube or catheter 102. The working catheter 102 can be of any known construction, where such construction depends upon the desired target region for treatment. For example, the working catheter 102 can be a microcatheter suited for advancement to the cerebral region of the vasculature. Alternatively, the working catheter 102 can be a catheter designed to reach any of the peripheral vasculature. However, the working catheter 102 is not limited to such indications. In any case, the working catheter 102 can have one or more working lumens 104 located therein. The working lumen(s) 102 can terminate at a distal end of the working catheter 102 as shown, on a sidewall. or a combination thereof (in cases of a multi-lumen working catheter).

[0031] The variable flow isolation system 100 shown in Fig. 3A also includes an outer sheath 106 having an occlusion balloon 108 located towards a distal end of the sheath 106. The outer sheath 106 includes an inflation lumen 110 for delivering fluid to expand the occlusion balloon 108. The inflation lumen 110 is fluidly isolated from the working lumen 104. In addition, the outer sheath 106 is axially adjustable along a length of the working catheter 106. As such, and as shown in Fig. 3B, the distal end of the sheath 106 has a valve-type seal 112 to prevent leading of fluid through the distal end of the sheath. However, the valve-type seal 112 permits the outer sheath 106 to move axially along the working catheter 102. Though not shown, the outer sheath 106 shall also have additional sealing features proximally to the balloon 108 so that fluid does not escape in a rearward or proximal direction.

[0032] The outer sheath 106 can be fabricated from a flexible material having a low profile such that it can be folded over the working catheter 102. In such a case, this design allows for the variable flow isolation system 100 to be introduced into a smaller portal during insertion into the body (such as via the femoral artery). In other variations, the outer sheath 106 can have a high radial strength or stiff construction. In use. the location of the occlusion balloon 108 on the working catheter can be set while the system 100 is outside of the patient. In other variations, the location of the occlusion balloon can be adjustable when the device is located within the body.

[0033] Figs. 4A-4C show another variation of a variable flow isolation system according to the present invention. Fig. 4A illustrates a working catheter 130 having a working lumen extending therethrough. The working catheter 130 shown includes a shaped distal end 132. However, variations of working catheter 130 may also comprise any number of shapes. Moreover, the working catheter 130 may or may not include a hub located on a proximal end 134. As noted above, variations the working catheter 130 can be selected depending upon the intended target area to be treated.

(00341 Fig. 4B illustrates an occlusion component 136 of the variable flow isolation system. In this example, the occlusion component 136 includes a separate inflation tube 138 having an inflation lumen extending therethrough. The balloon 140 comprises a passageway or opening 144 allowing for the balloon 140 to advance over the working catheter 130. As discussed below, the location of the balloon 140 can be axially adjusted along the length of the working catheter 130 to provide for flow isolation system that can vary the location where flow is arrested. The illustrated variation shows the inflation tube 138 entering the occlusion balloon 140 at a port 142 in the balloon 140. However, in additional variations, the inflation tube 138 can enter the balloon 140 at any location either on an exterior of the balloon 140 or within the interior passageway 144 of the balloon 140.

[0035] Fig. 4C illustrates a variation of an occlusion balloon 140 for use with systems according to the present invention. In this variation, the balloon 140 includes a port 142 for inflation as well as a passageway 144 for placement of the balloon 140 over a working catheter. The balloon 140 can also include a support frame 146. The support frame 146 can be a shape memory alloy or other resilient or expandable structure. The support frame 146 can be wrapped with an elastomeric material to form the balloon cover. The support frame 146 maintains the balloon in a semi-expanded profile so that it can advance over the working catheter. Once the physician places the balloon 146 in the desired position, the physician expands the balloon 140. During expansion, the support frame 146 allows the balloon to expand towards a diameter of the vessel or body lumen as well as pinch or close about the working catheter.

[0036] The support frame 146 can also serve to identify the balloon under fluoroscopy. AltemahVely, or in combination, the balloon 146 (or any portion of the system) can be made radiopaque or be fitted with radiopaque markers for visualization under x-ray, fluoroscopy, or other non-invasive imaging.

[0037] Fig. 5 A illustrates one variation of a variable flow system 120 according to the present invention. The working catheter 130 can be placed within the vasculature or other body lumen. Alternatively, the working catheter 130 can be placed within the body but not advanced to a target site. Regardless, when the physician deems it appropriate, the physician can advance the occlusion component 130 axially along the working catheter 130. Fig. 5B illustrates the balloon 140 after advancement to the desired location along the working catheter 130.

[0038] Fig. 5C shows a fluid source 122 coupled to the inflation tube 138 for delivery of fluid to expand the balloon 140 at the desired site. Fig. 5D shows the balloon 140 expanding radially outward (to seal against the vessel or body lumen 2). As shown, the balloon 140 also expands inward about the working catheter 130 to effectively form a seal and occlude the vessel 2. This action also secures the balloon 140 about the working catheter 130. As noted herein, if the physician determines that repositioning of the balloon is necessary, the physician can withdraw fluid from the balloon 140, thereby deflating the balloon for repositioning.

[0039] Once the balloon 140 is expanded and occludes flow, the physician can deliver any number of devices, implants, or therapeutic devices/substances through the working lumen 104 distally to the site of the occlusion. Fig. 5D also illustrates an optional variation where the inflation tube 110 is removed from the balloon 140.

[0040] Figs. 6A to 6E illustrate another variation of a variable flow isolation system 124 under the present invention. In this variation, and as shown in Fig. 6A, a balloon 140 can be formed from a silicone tube 150. The tube 150 is then wrapped and affixed to an inflation tube 130 to form an occlusion balloon 140. In such a case, the interior of the tube 150 is in fluid communication with the inflation lumen of the inflation tube 130. The tube 150 can be wrapped into the shape of a circle, helix, oval, square, or other shape. The shape may or may not be wrapped about the inflation tube 138. However, the shape should be sufficient so that upon inflation it occludes (fully or partially) the vessel about the working catheter. As with the above variations, a wire or other support structure can be integrated within or about the tube 150.

[0041] Fig. 6C shows the balloon 140 in an expanded state. As shown, the balloon 140 expands radially to seal against a vessel. Furthermore, the passageway of the balloon 144 closes about the working catheter.

[0042] Figs. 6D to 6E illustrate the device of Fig. 6B in operation within a vessel 2. As shown in Fig. 6D. the physician advances the device 120 to the desired region. Next, and as shown in Fig. 6E, the balloon 144 expands against the vessel 2 as well as seals about the working catheter 130.

[0043] In any of the variations, the balloon can be fabricated to inflates inward against the working catheter as well as expand against the lumen body. It is noted that the tube can be fabricated to preferentially expand radially outward or radially inward. Moreover, the tube can be fabricated to expand in both radially directions but with a bias to have a greater degree of expansion in one particular direction.

[0044] For example. Fig. 7 show an aspect of a balloon 140 for use with the present invention where the balloon 140 can be designed to expand radially outward but is restrained when expanding radially inward against the working catheter. For example, and as illustrated, the balloon 140 may have a support 148 (e.g., the shape memory support discussed herein) that prevents constriction of the interior opening 144 in the balloon 140. Accordingly, the region between the interior of the balloon 140 and the exterior of a working catheter is not occluded. This feature allows perfusion through an opening in the main vessel to stabilize patient during acute rupture. Such a feature may be particularly useful in such regions as the aortic abdominal arch. The support member 148 can be any type of support or stent member that provides a path through the expandable member. Moreover, while the variation shown below does not allow for contact between the interior 144 of the balloon 140 and the exterior of the working catheter 130, variations of the device include support members that allow one or more portions of the balloon member to contact the surface of the working catheter while leaving one or more channels open between the two surfaces. Such a variation allows for fixation between the expandable member and Tlirough Catheter while also providing one or more perfusion paths. In addition, the interior of the balloon can have an inelastic material 152 to prevent constriction of the passage 144. The inelastic material can also have additional mechanical support such as coils, braids, tubes, etc.

[0045] In an additional variation of the devices described herein, the inflation lumen/conduit can be detachable from the balloon or expandable member. Typically the detachment may occur at the inflation port. However, other locations are possible as well. This feature allows for deployment of the balloon or expandable member as a temporary or permanent occlusive implant.

[0046] It is noted that the features of the devices described as well as the devices themselves can be combined to provide additional variations of devices. In addition, the materials used for the fabrication of such devices may include any standard component or material known to be used in combination with medical devices or other such materials having the characteristics required of the particular device.

[0047] Although the foregoing invention has been described in some detail by way of illustration and example, for purposes of clarity of understanding, it will be obvious that various alternatives, modifications and equivalents may be used and the above description should not be taken as limiting in scope of the invention which is defined by the appended.

Claims

CLAIMSWe claim:

1. A flow isolation system for use within a body lumen, the system comprising: a catheter body having a length and working lumen extending therethrough and an exterior surface; an inflation lumen fluidly couple to a balloon, where the balloon and inflation lumen are axially adjustable along at least a portion of the length of the catheter body such that the balloon can be repositioned along the length of the catheter body, where the working lumen and inflation lumen are fluidly isolated such that upon inflation of the balloon, the balloon remains inflated while the working lumen is unobstructed.

2. The isolation system of claim 1, further comprising an inflation sheath containing the inflation lumen, where the inflation sheath is slidable over the exterior surface of the catheter body and where the balloon is located towards a distal portion of the inflation sheath.

3. The isolation system of claim 3. where the inflation sheath further comprises a seal located at a distal end, where the seal forms a fluid tight barrier against the exterior surface of the catheter body.

4. The isolation system of claim 1, further comprising an inflation tube containing the inflation lumen and the balloon located at a distal end of the inflation tube, where the inflation tube is located adjacent to the catheter body and the balloon is located coaxial to the catheter body.

5. The isolation system of claim 1, where the balloon further comprises a support structure.

6. The isolation system of claim 5, where the support structure causes the balloon to assume a cylindrical shape when deflated.

7. The isolation system of claim 1. where the balloon comprises an elastic tube configured in a shape having an opening extending therethrough.

8. The isolation system of claim 7. where the shape comprises a shape selected from a circle, helix, oval, rectangular, square, or other shape.

9. The isolation system of claim 1, where the balloon comprises a passageway such that the catheter body may extend therethrough.

10. The isolation system of claim 9, where on inflation of the balloon the passageway closes on the catheter body.

11. The isolation system of claim 9, where the balloon includes a non-elastic support member in the passageway such that on inflation of the balloon the passageway is unable to fully close on the catheter body.

12. The isolation system of claim 1 , where the balloon includes at least one radiopaque marker.

13. A flow isolation balloon for use within a body lumen on a catheter body having an exterior surface, an axial length, and a working lumen extending therethrough, the isolation balloon comprising comprising: a balloon member; and an inflation lumen fluidly couple to the balloon member, where the balloon member includes a passageway allowing the balloon member to be advanced coaxially over the catheter body such that the balloon member and inflation lumen are axially adjustable along at least a portion of the length of the catheter body such that the balloon can be repositioned along the length of the catheter body.

14. The flow isolation balloon of claim 13, further comprising an inflation tube, where the inflation lumen extends through the inflation tube.

15. The isolation system of claim 13, further comprising an inflation sheath where the inflation lumen extends through the inflation sheath, where the inflation sheath is slidable over the exterior surface of the catheter body and where the balloon is located towards a distal portion of the inflation sheath.

16. The isolation system of claim 15, where the inflation sheath further comprises a seal located at a distal end, where the seal forms a fluid tight barrier against the exterior surface of the catheter body.

17. The isolation system of claim 13, where the balloon further comprises a support structure.

18. The isolation system of claim 17. where the support structure causes the balloon to assume a cylindrical shape when deflated.

19. The isolation system of claim 13, where the balloon comprises an elastic tube configured in a shape that defines the passageway.

20. The isolation system of claim 19, where the shape comprises a shape selected from a circle, helix, oval, rectangular, square, or other shape.

21. The isolation system of claim 13, where the balloon comprises a passageway such that the catheter body may extend therethrough.

22. The isolation system of claim 21, where on inflation of the balloon the passageway closes on the catheter body.

23. The isolation system of claim 21 , where the balloon includes a non-elastic support member in the passageway such that on inflation of the balloon the passageway is unable to fully close on the catheter body.

24. The isolation system of claim 13, where the balloon includes at least one radiopaque marker.

25. A method of selectively arresting flow within a body lumen, the method comprising: advancing a catheter body into the body lumen, where the catheter body includes an exterior surface, a length and working lumen extending therethrough; positioning a balloon along a length of the catheter body, such that the balloon encircles the exterior surface of the catheter body and can be repositioned along the catheter body; and inflating the balloon through an infusion lumen such that it expands about the exterior surface of the catheter body, where the infusion lumen is fluidly isolated from the working lumen such that the working lumen remains unobstructed.

26. The method of claim 25, where inflating the balloon comprises inflating the balloon to fully arrest flow within the body lumen.

27. The method of claim 25, where inflating the balloon comprises inflating the balloon to at least partially arrest flow within the body lumen.

28. The method of claim 25. further comprising advancing a therapeutic device through the working lumen while the balloon remains inflated.

29. The method of claim 25, where advancing the catheter body into the body lumen comprises advancing the catheter body into a femoral vein.

30. The method of claim 25, where advancing the catheter body into the body lumen comprises advancing the catheter body into the cerebral vasculature.