Catheter for forming an intervascular bridge to relieve vascular compression

Abstract

The present invention provides a catheter (10) for relieving pressure between blood vessels by introducing packing material into the intravascular space to form a bridge connecting the blood vessels for pressure relief. The catheter is provided with: a shaft (14); expandable elements (16, 18) supported by the shaft for temporary pressure relief in the blood vessels; and a retractable needle (30) located between the expandable elements. When deployed, such as by using an actuator (40), the needle can deliver packing material into the intervascular space to form a bridge between the blood vessels for pressure relief after catheter removal.

Description

[0001] References

[0002] All publications and patent applications mentioned in this specification are incorporated herein by reference, as if each individual publication or patent application were specifically and individually indicated as incorporated herein by reference. Background Technology

[0003] When the left iliac vein (LIV) is compressed by the right iliac artery (RIA), it can lead to a condition called May-Thurner syndrome (see [link to relevant documentation]). Figure 1 The cross-sectional diagram provided illustrates the location of these vessels relative to the right iliac vein (RIV), the left iliac artery (LIA), and the adjacent (typically the fifth lumbar vertebra) vertebra (V). This condition makes deep vein thrombosis more likely, which can have harmful consequences.

[0004] Current treatments for vascular compression involve surgical repair, which is highly invasive and undesirable, or attempts to restore patency of the left iliac vein using endovascular implants (e.g., stents). While endovascular surgery is superior to surgery in many cases due to its non-invasiveness, it requires leaving an implant in the vein to relieve the compression. This can sometimes cause problems such as thromboembolism, discomfort, or even collapse.

[0005] Therefore, there is a need for an improved method to relieve pressure between blood vessels, such as that used to treat May-Thurner syndrome. Specifically, there is a need for an improved method to relieve pressure between blood vessels that avoids leaving intravascular implants in the body. Summary of the Invention

[0006] In one aspect, this disclosure relates to a catheter comprising a shaft. An expandable element is supported by the shaft and, when expanded, can be used to relieve pressure by expanding the associated blood vessel. Needles located between the expandable elements can be deployed and used to deliver packing material into the intervascular space to form a bridge, which can thus form a connection between the blood vessels and, once the expandable elements deflate and are removed from the blood vessel, contribute to a more permanent relief of pressure.

[0007] In one embodiment, the shaft includes a lumen, and the needle is hollow and communicates with the lumen. The needle may be retractable within the lumen and can be deployed by an actuator. The shaft may also include an inflatable lumen, and the inflatable element includes an inflatable balloon in fluid communication with the inflatable lumen.

[0008] In use, the balloon is inflated to open up a compressed or constricted blood vessel (such as a vein compressed due to May-Thurner syndrome). While the balloon is inflating, a filler can be delivered via a deployed needle and then hardened (e.g., within three minutes). Once the filler has hardened or solidified, the balloon can deflate, and the resulting blood vessel is either open or uncompressed because it has been externally sealed to the adjacent vessel along its arc length. In addition to the lumen for filler delivery, the axis may also include a guidewire lumen that can be used to place a catheter into the blood vessel via a guidewire.

[0009] Multiple needles can be positioned between expandable elements, such as those for injecting material on different sides of a target blood vessel. When deployed, the needles(s) can be flexible and may include shape memory material, which can exhibit a specific orientation when the shape memory is activated due to temperature conditions. Fillers, such as adhesives, can be supplied from a remote source to the catheter for delivery via the needles to the intervascular space.

[0010] According to another aspect of this disclosure, a system for relieving pressure between blood vessels having adjacent intervascular spaces is provided. The system includes a catheter comprising a needle adapted to extend into the intervascular space upon deployment. The system also includes packing material for delivery via the needle into the intravascular space.

[0011] In one embodiment, the catheter includes spaced-apart expandable elements, with a needle positioned between these elements during deployment. The expandable elements may include an inflatable balloon. The needle may be flexible during deployment and may incorporate a shape-memory material. The needle can be deployed using an actuator, and multiple needles may be provided for delivering filler to different locations within the intervascular space.

[0012] This disclosure also relates to a method for relieving pressure between blood vessels. The method includes injecting a filler into the intervascular space between the blood vessels. The injection step may include injecting the filler into the intervascular space using a needle connected to a catheter. Prior to the injection step, the method may involve inserting a catheter into one of the blood vessels, expanding an expandable element on the catheter, and inserting the needle through the vessel wall and into the intervascular space. The injection step may include deploying the needle from a retracted position within the catheter into the space between the expandable elements. Attached Figure Description

[0013] The above and further advantages of this disclosure can be better understood by referring to the following description in conjunction with the accompanying drawings, wherein:

[0014] Figure 1 It is a cross-sectional view of the environment in which the proposed invention is used in the human vascular system.

[0015] Figure 2This is a side schematic diagram of a conduit that forms one aspect of this disclosure.

[0016] Figure 2A and Figure 2B They are along Figure 2 The points intercepted by lines 2A-2A and 2B-2B Figure 2 Cross-sectional view of the conduit.

[0017] Figure 3 This is a side schematic diagram of a conduit that forms one aspect of this disclosure.

[0018] Figure 3A It is along Figure 3 The line 3A-3A cut Figure 3 Cross-sectional view of the conduit.

[0019] Figure 4 and Figure 5 The illustration shows various actuators used to deploy one or more needles into the intervascular space.

[0020] Figure 6 , Figure 7 , Figure 8 , Figure 9 , Figure 10 and Figure 11 This is a step-by-step view of the steps for treating vascular compression by using a catheter to create a bridge, according to one aspect of this disclosure.

[0021] Figure 12 This is a cross-sectional view of the vascular environment, showing the location of bridges used to relieve pressure between blood vessels.

[0022] For clarity, the dimensions of some components may be exaggerated relative to others, or several physical parts may be included in a single functional block or component. Furthermore, reference numerals in the figures may sometimes be repeated to indicate corresponding or similar components. Additionally, some items depicted in the figures may be combined to form a single function. Detailed Implementation

[0023] This disclosure provides a catheter and related method for forming a bridge in an intervascular space, which can be used to relieve pressure between blood vessels and is intended to eliminate the need for implanted endovascular devices or surgical intervention. The catheter will be able to expand the compressed blood vessel into which the expandable element is inserted, for example, by using an expandable element, and then inject filler into the intervascular space using one or more needles deployed between the expandable elements. The bridge serves to maintain pressure relief even after the catheter is withdrawn.

[0024] Numerous specific details are set forth in the following detailed description to provide a thorough understanding of the invention. Embodiments of this disclosure may be practiced without these specific details. In other instances, well-known methods, procedures, components, or structures may not have been described in detail so as not to obscure aspects of this disclosure.

[0025] This disclosure relates to systems and methods for treating blood vessels. The principles and operation of the systems and methods of this disclosure can be better understood with reference to the accompanying drawings and description.

[0026] The application of this invention is not limited to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The invention can have other embodiments, or can be practiced or performed in various ways. Furthermore, it should be understood that the wording and terminology used herein are for descriptive purposes and should not be considered limiting. For clarity, certain features of the invention described in the context of individual embodiments may also be provided in combination in a single embodiment. Conversely, for brevity, various features of the invention described in the context of a single embodiment may also be provided individually or in any suitable sub-combination.

[0027] Reference Figure 2 A catheter 10 is provided for intervascular use. This catheter includes a shaft 14 having a distal end portion 14a supporting at least two expandable elements. The expandable elements may take the form of expandable balloons 16, 18 positioned anteriorly and posteriorly. Balloons 16, 18 may be of a type typically used in percutaneous transluminal angioplasty; however, in this application, balloons 16, 18 are not designed to compress plaque but are simply inflated to a diameter similar to that of the vessel in which the balloon is located to relieve compression and may provide anchoring and positioning functions, as will be further understood upon reading the description below.

[0028] The proximal end portion 14b of shaft 14 may include a hub 20, which includes an inflation port 22 for delivering inflation fluid within shaft 14 via an inflation lumen 25 to balloons 16, 18 (shaft 14 includes a port or opening 14c communicating with the internal compartment of the balloon). Hub 20 may also include a guidewire port 24 communicating with a guidewire lumen 26 within shaft 14. Guidewire lumen 26 may receive a guidewire 28 for guiding catheter 10 to an intravascular location, such as the junction of a compressed left iliac vein and right iliac artery.

[0029] At least one needle 30 may be attached to shaft 14 for deployment from a retracted position between inflatable elements such as balloons 16, 18. The needle 30 is hollow and, when balloons 16, 18 are inflated in a blood vessel, is adapted to protrude laterally to a degree greater than the maximum diameter of balloons 16, 18, such that the tip of the needle located between balloons 16, 18 pierces or penetrates the vessel wall and enters the intervascular space (i.e., the space outside the vessel and adjacent to another vessel). More specifically, the needle 30 may initially retract into the lumen 32 of shaft 14 and may extend from shaft 14 via an opening or port 14c between balloons 16, 18, such that its distal tip enters the intervascular space. Deployment of the needle 30 can be made from a remote location, such as outside the body into which a catheter 10 is to be introduced. In a simple example, the needle 30 may simply comprise an elongated tube 30a extending through the lumen 32 to an adjacent hub 20. Then, the tube 30a can be moved forward from the adjacent hub 20 to move in the shaft 14 and deploy the needle 30 (this can be guided in part by gradually bending the distal end of the lumen 32 toward the opening or port 14c).

[0030] Alternatively, tube 30a can be connected to actuator 40 for moving tube 30a forward and retracting relative to shaft 14, and thus moving and retracting needle 30. For example, in Figure 4 In this block, the proximal end of tube 30a can be connected to slider 42, which has a slot 42a for engaging a transverse post 42b connected to tube 30a. Block 42 may also include a guidewire lumen 26 and a port 24 for communication with the inflatable lumen. Thus, distal movement of post 42b within block 42 is used to deploy needle 30 into the intervascular space, and opposite proximal movement is used to retract the needle into shaft 14 for removal from the vessel. The length of slot 42a can define a maximum deployment distance corresponding to the maximum diameter of balloons 16, 18 plus the additional extension required to allow the needle tip into the intervascular space.

[0031] Figure 5 Alternative actuator 50 is shown. This embodiment uses a ratchet and pawl arrangement, whereby the thumb wheel 52 includes a pawl 54, which is biased by a spring 56 to engage with a linear actuator or rack 58. The rack 58 is in turn connected to a tube 30a, which is located in the lumen 32 of the shaft 14. Thus, rotation of the wheel 52 moves the rack 58, and thus moves the tube 30a, such as in a distal direction, to deploy the needle 30 into the intervascular space, and then retracts it again. Actuator 50 may form part of hub 20, as shown by dashed lines, or may comprise a separate structure.

[0032] The needle 30 may optionally be made of a shape memory material such as nitinol. Shape memory can be generated during manufacturing and can be activated at a specific temperature (which can be adjusted, for example, by a clinician introducing fluid at a temperature used to activate the shape memory, and thus causing the needle to take on a specific preset shape or orientation). When activated by body temperature and moved forward from the straight configuration within the shaft 14, the needle 30 will stiffen and take on its preset shape. For example, as shown, the needle 30 may take on a preset curved configuration and protrude radially outward from the shaft 14.

[0033] During deployment, the needle 30 is positioned to communicate with a remote port 34 outside the body, such as by connection to a tube 30a. This remote port 34 is connected to a source 36 of filler material, such as an adhesive (e.g., Tridyne, cyanoacrylate, natural chitosan adhesive, etc.). The source 36 may include a syringe or other delivery device for delivering the filler material under pressure into the lumen 32, causing the material to flow along the tube 30a located within the lumen 32 and exiting the tip of the needle 30 when the tip is deployed between balloons 16 and 18, thus entering the intervascular space at a location corresponding to vessel-to-vessel compression.

[0034] Figure 3 and Figure 3A The illustration shows two or more needles 30 that can be positioned between the expandable elements 16, 18 for protruding in different directions during deployment (this can be accomplished using a single actuator or individual actuators as discussed above). Providing two or more needles 30 allows for the delivery of packing material to different locations within the intervascular space, such as different sides of a compressed vessel into which the catheter 10 is inserted. The needles 30 can extend in different radial directions, which may... Figure 3A The best understanding is obtained in the middle, and it can retract in the shaft 14, and when deployed, it protrudes from the longitudinally spaced openings 14a along the shaft 14 of the conduit 10. As with the single-needle embodiment, the two needles 30 can communicate with the associated lumen for delivering packing from a remote source.

[0035] In use, catheter 10 can be tracked via guidewire 28 to the location L of the compression C in the blood vessel, such as... Figure 4 The left iliac vein (LIV) is shown to be compressed by the right iliac artery (RIA), a characteristic feature of May-Thurner syndrome. Once catheter 10 is positioned in this location (which can be achieved by means of radiopaque markings on catheter 10 and the use of fluoroscopy), as... Figure 5 As indicated, balloons 16 and 18 are inflated, which is used to inflate the compressed blood vessel and anchor the catheter in place (see...). Figure 6 ).like Figure 7As shown, this position allows the tip of the needle 30 to enter the intervascular space when the needle 30 is deployed and activated via shape memory. The filler material M can then be delivered from the source 36 via a tube 30a located in the lumen 32. This material enters the intervascular space via the needle 30 (and, in the case of two or more needles, the material can be delivered simultaneously to two different locations, such as different sides of the compressed vessel). Once sufficient filler material M has been delivered—which can be observed by volume, time, and / or under fluorescence fluoroscopy—and the material has solidified or hardened (this can occur quite rapidly, e.g., less than three minutes from the start of injection), balloons 16 and 18 can deflate, and catheter 10 is withdrawn.

[0036] Once material M dries and hardens, it forms a bridge S on the exterior of the vascular LIV and vascular RIA, and between the vascular LIV and vascular RIA. This may... Figure 10 This is best understood and can be further used to connect or combine adjacent blood vessels to each other. In any case, even after catheter 10 is removed, bridge S is used to remove pre-existing compression (note). Figure 9 The left iliac vein (LIV) is patent. Therefore, a more patent venous system is achieved, which can alleviate the effects of May-Thurner syndrome without surgical intervention and the use of endovascular implants.

[0037] In summary, this disclosure can be considered to relate to the following items:

[0038] 1. A catheter for relieving pressure between blood vessels by introducing a packing material into the intravascular space, the catheter comprising:

[0039] axis;

[0040] An expandable element, which is supported by a shaft; and

[0041] The needle, supported by an axis, includes a tip located between expandable elements for introducing a filter into the intravascular space when deployed.

[0042] 2. The catheter according to Item 1, wherein the shaft includes a lumen and the needle is hollow.

[0043] 3. The catheter according to any one of items 1, 2 or 4 to 9 below, further comprising an actuator for deploying a needle from a retracted position in the lumen to place the tip between expandable elements and into the intervascular space for delivery of packing material.

[0044] 4. The catheter according to any one of items 1-3, wherein the shaft includes an inflatable lumen and the inflatable element includes an inflatable balloon in fluid communication with the inflatable lumen.

[0045] 5. The catheter according to any one of items 1-4, wherein the shaft includes a guidewire lumen.

[0046] 6. The catheter according to any one of items 1-5, wherein the plurality of needles have tips located between expandable elements when deployed.

[0047] 7. For any of the catheters in items 1-6, one or more needles are bent.

[0048] 8. The conduit according to Project 1, wherein the needle comprises a shape memory material.

[0049] 9. The catheter according to item 1, further comprising packing material for delivery via needle to a location in the intervascular space.

[0050] 10. A system for relieving compression between blood vessels having adjacent intervascular spaces, the system comprising:

[0051] The catheter includes a retractable needle adapted to extend into the intervascular space during deployment; and

[0052] The filler material is used to deliver the filler material into the intravascular space via the needle.

[0053] 11. The system according to item 10, wherein the conduit includes spaced-out expandable elements, and the needle is positioned between the expandable elements during deployment.

[0054] 12. The system according to item 10 or item 11, wherein the inflatable element comprises an inflatable balloon.

[0055] 13. The system according to any one of items 11-12, wherein the needle is bent during deployment.

[0056] 14. The system according to any one of items 11-13, wherein the needle comprises a shape memory material.

[0057] 15. The system according to any one of items 11-14, further comprising an actuator for moving the needle from a retracted position within the catheter to a deployment position to deliver packing material into the intervascular space.

[0058] 16. The system according to any one of items 11-15, wherein the catheter includes a plurality of needles and an actuator optionally for deploying each needle.

[0059] 17. A method for relieving pressure between blood vessels, the method comprising:

[0060] The filler is injected into the intervascular space between blood vessels.

[0061] 18. The method of claim 17, wherein the injection step comprises injecting the filler into the intervascular space using a needle connected to a catheter.

[0062] 19. The method according to item 17 or item 18, wherein, prior to the injection step, the method comprises:

[0063] Insert the catheter into the compressed blood vessel in the blood vessel;

[0064] Inflate the expandable element on the catheter to relieve pressure; and

[0065] The needle is passed through the blood vessel wall and inserted into the space between the blood vessels.

[0066] 20. The method of claim 19, wherein the injection step includes, for example, deploying a needle from a retracted position within a catheter using an actuator to place the tip of the needle between expandable elements.

[0067] As used herein, the following terms have the following meanings:

[0068] The words “one,” “a,” and “the” used here refer to both the singular and the plural, unless the context clearly specifies otherwise. As an example, “a compartment” refers to one or more compartments.

[0069] As used herein, “about,” “substantially,” or “approximately” refers to measurable values, such as parameters, quantities, durations, etc., and is intended to cover variations from a specified value of + / - 20% or less, preferably + / - 10% or less, more preferably + / - 5% or less, even more preferably + / - 1% or less, and still more preferably + / - 0.1% or less, variations that are suitable for implementation in the disclosed invention to date. However, it should be understood that the values ​​referenced by the modifier “about” are themselves specifically disclosed.

[0070] As used herein, “comprising,” “including,” “including,” and “containing” are synonyms with “containing,” “containing,” “containing,” or “having,” “having,” and are inclusive or open-ended terms that specify the presence of, for example, content following a component, and do not exclude or preclude the presence of additional, unlisted components, features, elements, components, or steps known in the art or disclosed herein.

[0071] Although the invention has been described in conjunction with specific embodiments, many alternatives, modifications, and variations will be apparent to those skilled in the art. Therefore, it covers all alternatives, modifications, and variations falling within the spirit and scope of the appended claims. All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety, as if each individual publication, patent, or patent application were specifically and individually indicated and incorporated herein by reference. Furthermore, any reference citation in this application should not be construed as an admission that such reference is prior art to this disclosure.

Claims

1. A catheter for relieving pressure between blood vessels, the catheter comprising: axis; An expandable element, which is supported by the shaft; A curable filler, the curable filler being suitable for forming bridges between blood vessels in the intervascular space; as well as The needle, supported by the shaft, includes a tip located between the expandable elements when deployed, the tip for introducing the filler into the intervascular space.

2. The catheter of claim 1, wherein the shaft includes a lumen, and the needle is hollow and communicates with the lumen.

3. The catheter of claim 2, wherein the catheter further comprises an actuator for deploying the needle from a retracted position within the lumen.

4. The catheter of claim 1, wherein the shaft includes an inflatable lumen, and the inflatable element includes an inflatable balloon in fluid communication with the inflatable lumen.

5. The catheter according to claim 4, wherein the shaft includes a guidewire lumen.

6. The catheter of claim 1, wherein a plurality of needles are provided, each needle having a tip located between the expandable elements.

7. The catheter of claim 1, wherein the needle is bent when deployed between the expandable elements.

8. The catheter of claim 1, wherein the needle comprises a shape memory material.

9. The catheter of claim 1, wherein the needle is adapted to deliver the packing material from a remote source to a location in the intervascular space.

10. A system for relieving compression between blood vessels having adjacent intervascular spaces, the system comprising: A catheter, the catheter including a needle adapted to extend into an intervascular space upon deployment; as well as A curable filler is used to deliver the filler via the needle into the intervascular space to relieve pressure between the blood vessels.

11. The system of claim 10, wherein the conduit includes a shaft having a distal end having spaced-out expandable elements, and the needle, when deployed, includes a tip located between the expandable elements.

12. The system according to claim 11, wherein, The expandable element includes an inflatable balloon.

13. The system of claim 11, wherein the needle is bent during deployment.

14. The system of claim 11, wherein the needle comprises a shape memory material.

15. The system of claim 11, wherein the system further comprises an actuator for moving the needle from a retracted position within the catheter to a deployment position to deliver the packing material into the intervascular space.

16. The system of claim 11, wherein the catheter comprises a plurality of needles.

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