Extensible lumen catheter device

Abstract

Disclosed is a catheter system comprising: an outer member; an inner member translating within the lumen of the outer member; and a probe configured to fit within the lumen of the inner member. The inner member is translatable within the outer member to selectively extend beyond a distal end of the outer member, and the probe has a greater bending stiffness and / or columnar stiffness than the inner member to assist in navigating the inner member to a target anatomical structure. The catheter system may be proximate to a target anatomy to allow better treatment. In particular, the catheter system can be used in adhesive embolism.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of and priority to U.S. Utility Application No. 18 / 218,974, filed on July 6, 2023, entitled “Extendable Lumen Catheter Device,” and U.S. Provisional Patent Application No. 63 / 359,690, filed on July 8, 2022, entitled “Extendable Lumen Catheter Device.” The entire contents of each of the above applications are incorporated by reference in their entirety. Background Art

[0003] Catheter and guidewire device are usually used for specific medical problems in patients. Usually need catheter to move along narrow blood vessels to reach lesions (lesions, damage) (such as vascular lesions) and embolize the lesions. Usually, adhesive embolization is performed by guiding microcatheter to treatment site and then using adhesive (interchangeably referred to as embolic agent and / or embolic adhesive in this article) to embolize lesions, and the adhesive is usually cyanoacrylate (such as n-BCA) or the product sold by trade name Onyx (it includes ethylene vinyl alcohol copolymer (ethylene vinyl-alcohol copolymer, EVOH), dimethyl sulfoxide (dimethyl-sulfoxide, DMSO) and micronized tantalum powder (tantalum powder, TA)). For example, when treating the lesion in MMA during embolization of middle meningeal artery (Middle Meningeal Artery, MMA), this operation is common.

[0004] One of the challenges of moving the catheter to the treatment site is the size and path of the blood vessels. The blood vessels are often narrow and tortuous, making it difficult to reach the target anatomy in question. Catheters and guidewires sometimes fail to reach the target location or are not as close to the target location as desired. Often, the physician must inject the adhesive from a greater distance than is preferred to treat the lesion.

[0005] For example, instead of applying the adhesive directly to the embolization site, the physician may need to release the adhesive from a more distant site. This requires filling the blood vessel with the adhesive until it reaches the target site. This also complicates the already difficult balancing act between not polymerizing the adhesive before it reaches the target and allowing it to polymerize a short distance along the blood vessel after passing the target. In addition, if the extra space of the catheter has not yet been filled with adhesive but has advanced closer to the target, the extra space in the blood vessel will unnecessarily lose its physiological function. In addition, the adhesive can be quite expensive, and the extra amount required to fill the space between the catheter and the target alone can significantly increase the total cost of the operation.

[0006] In summary, current medical technologies that require catheters have multiple variables that may affect the procedure. Some of these variables include the vascular path to the target anatomical structure, how the catheter can be moved through the path, the type of adhesive used and its characteristics, and other medical complications that may arise. Therefore, there has long been a need for an improved catheter that minimizes the number of variables in a medical procedure and can be easily moved throughout the vascular system. Summary of the invention

[0007] The present disclosure relates to a catheter system comprising an outer member and an inner member. The embodiments described herein solve one or more problems associated with adhesive embolization that requires the use of a catheter. During an adhesive embolization procedure, the closer the catheter can be to a lesion or treatment site, the better the physician can manage variables associated with the procedure, and the less adhesive is required. The catheter system described herein uses an outer member to initially navigate toward a target anatomical structure, and then a second inner member is inserted into the outer member and distally passed through the distal end of the outer member to move even closer to the target treatment site.

[0008] Embodiments of the catheter system include a stylette that can be inserted into the inner member. This allows increased rigidity, which can help navigate the inner member toward the target anatomical structure. That is, the probe can be configured to have greater bending stiffness and / or columnar stiffness than the inner member. The probe can include a radiopaque marker that can show the position of the probe and therefore the position of the inner member when inserted. Some embodiments may include a hydrophilic coating around the probe, thereby allowing the probe to slide more easily into the inner member.

[0009] In some embodiments, the outer member and probe can be microfabricated to provide properties such as flexibility when navigating through the vascular system. The outer member and probe can be manufactured to produce circumferentially extending rings and axially extending beams through similar various cuts with different depths, widths and spacings, which can occur with or without angular offsets between consecutive beams.

[0010] Other embodiments may include an inner member wherein the distal section is selectively detachable. The distal section may be detached after the embolic agent is injected. For example, if the distal section of the inner member is bonded with an adhesive, the physician may advantageously detach the distal section so that the remainder of the inner member and the rest of the catheter system may be safely removed from the patient.

[0011] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as a delineation of the scope of the claimed subject matter. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Various objects, features, characteristics and advantages of the present invention will become apparent and more easily understood from the following description of the embodiments in conjunction with the accompanying drawings and the appended claims, all of which constitute a part of this specification. In the drawings, the same reference numerals may be used to designate corresponding or similar parts in the various drawings, and the various elements depicted are not necessarily drawn to scale, wherein:

[0013] Figure 1 An example of an outer member having a lumen and a hub is shown;

[0014] Figure 2 An example of an inner member having a lumen, a selectively removable distal section, and a hub is shown;

[0015] Figure 3 An example of a probe having a microfabricated distal section, a radiopaque marker at the distal end, and a connector element is shown;

[0016] Figure 4 An example of a catheter system comprising an outer member, an inner member, and a stylet is shown, wherein the inner member has a selectively removable distal section; and

[0017] Figure 5 An example of a catheter system including an outer member and an inner member is shown, wherein a distal section of the inner member has been disassembled. DETAILED DESCRIPTION

[0018] Example Embodiments

[0019] The following detailed description solves one or more of the problems discussed above. As described in more detail below, the outer member can move toward the target anatomical structure until it cannot easily advance further. At this point, the inner member can be inserted into the outer member and translated through the outer member until the distal end of the inner member moves distally past the distal end of the outer member, thereby moving the functional distal end of the catheter system closer to the target anatomical structure. The closer the catheter system is to the target anatomical structure, the better the physician can adopt the desired treatment.

[0020] For example, when injecting adhesive, the closer the distal end of the system is to the target anatomy, the less adhesive is needed to seal the target lesion. Adhesives are expensive, and injecting adhesives into a vessel increases the variability of the entire procedure. Therefore, the ability to navigate the functional distal end of the catheter system closer to the target anatomy (or at least closer than is the case with conventional systems) can beneficially reduce procedural variability and costs, thereby improving patient outcomes.

[0021] Figure 1 An example of an outer member 100 is shown that includes a hub 104 and an elongated member 102. The hub 104 can be coupled to the elongated member 102 using adhesives, friction fit, molding, and / or other suitable attachment means. In the illustrated embodiment, the elongated member 102 is formed of Nitinol. Other embodiments can use other materials to form the elongated member 102. For example, the elongated member 102 can be formed of one or more polymers such as polyetheretherketone (PEEK) or polyaryletherketone (PAEK).

[0022] The elongated member 102 is microfabricated to include a circumferentially extending ring 110 and an axially extending beam 112. The cut depth, width, and spacing may be consistent or may vary. Embodiments may include a single beam pattern or a multi-beam pattern, in which the beams are configured in various arrangements. The single beam pattern includes an axially extending member between each continuous circumferentially extending ring. Similarly, the double beam pattern includes two axially extending members between each continuous circumferentially extending ring. A three-beam pattern and more than three-beam patterns can be created in a similar manner. In a multi-beam pattern, the beams can be spaced equidistantly or randomly. For example, in a double beam pattern, the two beams can be spaced 180 degrees apart from each other. In another embodiment, the two beams can be spaced 90 degrees apart from each other. Various additional cut patterns that can be used to form different configurations of rings and beams are disclosed in U.S. Patent Publication No. 2020 / 0121308, which is incorporated herein by reference.

[0023] The angular offset arrangement can vary based on the amount of angular offset and / or how often the angular offset is applied between continuous beams. The angular offset is the angle between continuous beams. By rotating the position of the continuous beam, a preferred bending orientation can be achieved or avoided. For example, a single beam mode can have a 0 degree offset (i.e., no angular offset) between continuous beams. This angular offset will align all beams along the "spine" of the external member and will result in a preferred bending orientation toward the side where the beam is positioned (e.g., if the beam is positioned on the "right" side, the catheter will preferably bend to the right). Another example is a single beam mode with a 180 degree offset between continuous beams. The 180 degree angular offset reduces some of the preferred bending seen in the 0 degree offset example. Other embodiments may include other angular offsets in between. For example, a dual beam mode may have a 90 degree angular offset, while a triple beam mode may have a 60 degree angular offset. As described above, various additional cutout patterns that can be used to form different configurations of rings and beams are disclosed in U.S. Patent Publication No. 2020 / 0121308, which is incorporated herein by reference.

[0024] Figure 1 The illustrated embodiment includes three microfabricated segments: a first segment 114, a second segment 116, and a third segment 118. In other embodiments, the number of microfabricated segments may include one segment, two segments, three segments, or more than three segments. When bending the catheter through turns formed in the vascular system, these microfabricated segments provide flexibility while maintaining pushability to ensure that the catheter can be adequately moved through the blood vessel.

[0025] The length, diameter and rigidity of the outer member 100 can be varied according to application needs. For example, the elongated member 102 of the outer member can be about 50cm to about 200cm, but shorter or longer lengths can be used when appropriate. The diameter of the lumen of the outer member can be in the range of about 0.010 inch to 0.100 inch. Possible examples include 0.013 inch, 0.017 inch, 0.021 inch, 0.027 inch, 0.030 inch, 0.035 inch, 0.038 inch, 0.045 inch, 0.065 inch, 0.086 inch or the lumen diameter of the scope of any two as endpoints included in the aforementioned values. The outer catheter 100 is configured to have a transitional stiffness distribution, wherein the proximal section has a higher rigidity and a smaller bending flexibility than the distal section, and the distal section has a lower rigidity and a higher bending flexibility. Increased flexibility in the distal section allows for easier navigation through tortuous vasculature, while the more proximal section beneficially provides greater pushability and torquability.

[0026] The above-mentioned stiffness distribution gradient can be produced by adjusting the micro-fabricated elongated member 102 and / or by utilizing different polymer materials. For example, the first micro-fabricated section 114 can be formed by a first polymer material, the second micro-fabricated section 116 can be formed by a second polymer material, and the third micro-fabricated section 118 can be formed by a third polymer material. The hardness and / or modulus of the first polymer material can be greater than the hardness and / or modulus of the second polymer material, and the hardness and / or modulus of the second polymer material can be greater than the hardness and / or modulus of the third polymer material. Therefore, the difference in polymer hardness and / or modulus affects the stiffness of the appropriate section in the elongated member 102. The micro-fabrication mode can also affect the overall stiffness of the elongated member 102. For example, the single beam mode can have greater flexibility than the three beam mode. The gap and / or incision in the micro-fabrication part can be filled with another polymer. For example, a flexible soft polymer (e.g., PEBAX) can be filled in the gap and / or incision between the ring 110 and the beam 112.

[0027] Figure 2 An example of an inner member 200 including a hub 204 and an elongated member 202 is shown. An example of a hub 204 may be a Luer connector. The elongated member 202 is typically formed of a polymer. In some embodiments, one or more materials may be used that do not bond to an embolic adhesive that has passed through the lumen of the elongated member 202. In some embodiments, the elongated member 202 includes a thermoplastic polyurethane (TPU), a thermoplastic polyolefin (TPO), a polyether block amide (PEBA), other suitable polymers, or combinations thereof.

[0028] The diameter of the elongated member 202 is preferably smaller than the diameter of the lumen of the outer member to allow the inner member 200 to pass through the lumen of the outer member. The inner member 200 is shown with a removable distal section 206. The joint between the removable distal section 206 and the more proximal section of the inner member 200 may include perforations, grooves, thinned sections, partial breaks, intentional weak points, or other mechanically weakened structures configured to detach the distal section 206 from the lumen 202 when sufficient tension is applied. In other embodiments, the lumen 202 may be continuous and not include a removable distal section 206.

[0029] The length of the elongated member 202 is preferably long enough to completely pass through and exceed the lumen of the external member. The length of the elongated member 202 can extend beyond the lumen of the external catheter to reach 40cm. For example, the elongated member 202 can have a length that allows the distal end of the external member to extend beyond about 40cm, 35cm, 32cm, 18cm, 15cm, 10cm, 8cm, 5cm or 2cm. Similarly, the length of the detachable distal section 206 can vary. The detachable distal section 206 can be the last 2cm of the elongated member 202. For example, other embodiments can include a detachable distal section 206 with a length of about 1.8cm, 1.5cm, 1.3cm, 1cm, 0.7cm or 0.5cm (or a length falling within the range of the endpoints defined by any two of the aforementioned values).

[0030] Figure 3 An example of a stylet 300 is shown that includes a connecting element 304 and an extension member 302. The extension member 302 is made of Nitinol. Other embodiments may additionally or alternatively include other materials suitable for use in a catheter stylet, such as stainless steel or polymer / polymer blend materials (including those polymer materials described herein for other components of the system). The stylet 300 shown includes a microfabricated distal section 306. The microfabricated distal section 306 may include cutouts of varying depths, widths, and spacings to create circumferential rings and axial beams that are similar to the distal section 306. Figure 1 The outer member lumen 102 in the probe 300 is similar. Therefore, the distal section 306 of the probe 300 is less rigid and more flexible than the more proximal section. The microfabricated distal section 306 is preferably flexible enough to be atraumatic when pushed through the vascular system.

[0031] In another embodiment, the probe 300 can omit the microfabricated distal section 306. In some embodiments, a radiopaque marker 308 is disposed at or near the distal end of the probe 300 that is configured to align near or at the distal end of the inner member 200 to aid in visualization of the distal end of the inner member 200. Another embodiment omits the radiopaque marker 308. In some embodiments, the probe 300 can include a hydrophilic coating to allow the probe 300 to be more easily inserted into and moved through the inner member 200.

[0032] Figure 4An example of a fully assembled catheter system 400 is shown, which includes an outer member 100, an inner member 200 and a probe 300. In exemplary use, the outer member 100 will first be inserted into the vascular system and navigated toward the treatment site at the target anatomical structure. At some point, due to the tortuosity of the vascular system, the outer member 100 may not be able to get closer to the target treatment site. In traditional surgery, the doctor either has to apply adhesive from a suboptimal distance, or has to retract the catheter and retry navigation to get closer to the target. In contrast, when using the present catheter system 400, the inner member 200 is inserted into the outer member 100 and passes through the distal end of the outer member 100, to functionally extend the length of the system 400 and allow the distal end of the inner member 200 to be closer to the treatment site.

[0033] In some embodiments, multiple inner members 200 can be used with a single outer member 100. For example, a first inner member can be used to deliver an embolic agent to a target treatment site. The first inner member can then be removed from the system, after which a second inner member can be introduced through the outer member 100, past the distal end of the inner member 100, and toward the treatment site. For example, the second inner member can be used to deliver a different agent. Additionally or alternatively, the outer member 100 can be moved to a different target treatment site between use of the first inner member and the second inner member.

[0034] In some cases, the inner member may need greater structural rigidity to move toward the treatment site. In these cases, a probe 300 can be used. The probe 300 provides greater rigidity for the inner member 200 to help guide the inner member 200 closer to the treatment site. In other embodiments, the inner member 200 can reach the target anatomical structure without the help of the probe 300. In these cases, the probe 300 does not need to be inserted into the inner member 200. The inner member 200 may include a stop element at the distal section, which is configured to prevent the distal section of the probe from squeezing through the inner member 200 distally. For example, the stop element can be a notch, a friction fit or other appropriate means to prevent the distal end of the probe from squeezing through the distal end of the inner member.

[0035] Figure 4 and Figure 5 An example of a catheter system 400 is shown that includes an inner member 200 having a selectively removable distal section 206. Figure 5In the embodiment of the present invention, the selectively removable distal section 206 has been removable. An example of where this feature may be used is where the inner member 200 is formed of a material that bonds with an embolic agent injected into the catheter system 400. In this example, if the distal section 206 is stuck in a ball of adhesive after the embolic agent is injected, the distal section 206 may be removable. The removable distal section 206 may be configured to be removable due to perforations, grooves, thinned sections, partial breaks, intentional weak points, or other means that are suitable for allowing the distal section 206 to be selectively removable when sufficient tension is applied. In other embodiments, the inner member 200 may omit the selectively removable distal section 206. For example, if the inner member 200 is made of a material that does not bond with an embolic adhesive, the removable distal section 206 may be unnecessary. In other cases, the inner member may be used to deliver some component other than an adhesive (eg, a drug), also making a removable distal section 206 unnecessary.

[0036] Additional Terms and Definitions

[0037] Although certain embodiments of the present disclosure have been described in detail with reference to specific configurations, parameters, components, elements, etc., these descriptions are illustrative and should not be construed as limiting the scope of the claimed invention.

[0038] Furthermore, it should be understood that for any given element of the components of the described embodiments, any possible alternatives listed for that element or component can generally be used alone or in combination with each other, unless implicitly or explicitly stated otherwise.

[0039] In addition, unless otherwise indicated, the numbers used in the specification and claims to represent quantities, constituents, distances or other measured values ​​should be understood to be optionally modified by the term "about" or its synonyms. When the terms "about", "approximately", "substantially", etc. are used in conjunction with the amount, value or condition, they can be considered to refer to an amount, value or condition that is less than (less than) 20%, less than 10%, less than 5%, less than 1%, less than 0.1% or less than 0.01% of the amount, value or condition. At least and without attempting to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should be interpreted according to the number of reported significant figures and by applying ordinary rounding techniques.

[0040] Any headings and sub-headings used herein are for organizational purposes only and are not intended to limit the scope of the description or the claims.

[0041] It should also be noted that, as used in this specification and the appended claims, the singular forms "a", "an", and "the" do not exclude plural referents unless the context clearly indicates otherwise. Thus, for example, an embodiment referring to a singular referent (e.g., "a widget") may also include two or more such referents.

[0042] It should also be understood that the embodiments described herein may also include properties and / or features (e.g., ingredients, components, members, elements, parts, and / or portions) described in one or more separate embodiments, and are not necessarily strictly limited to the features explicitly described for that particular embodiment. Therefore, the various features of a given embodiment may be combined with and / or incorporated into other embodiments of the present disclosure. Therefore, the disclosure of certain features relative to a particular embodiment of the present disclosure should not be interpreted as limiting the application or inclusion of the features to a particular embodiment. On the contrary, it should be understood that other embodiments may also include such features.

Claims

1. A catheter system, comprising: an outer member including a lumen extending therethrough; an inner member, comprising a distal section and a proximal section, the inner member configured to fit within the lumen of the outer member, wherein the inner member is translatable within the outer member to selectively extend beyond a distal end of the outer member; and A stylet is configured to fit within the lumen of the inner member, wherein the stylet has a greater bending stiffness and / or column stiffness than the inner member.

2. The catheter system according to claim 1, wherein: The proximal section of the inner member has a greater stiffness than the distal section of the inner member.

3. The catheter system of claim 1, wherein: The probe includes a distal section and a proximal section, wherein the distal section of the probe is microfabricated to have greater flexibility than the proximal section.

4. The catheter system of claim 1, wherein: The probe has a radiopaque marker disposed at or near its distal end.

5. The catheter system of claim 1, wherein: The probe includes a hydrophilic coating.

6. The catheter system of claim 1, wherein: The proximal end of the inner member includes a Luer connection.

7. The catheter system of claim 1, wherein: The inner member is configured to avoid bonding to adhesive passing therethrough.

8. The catheter system of claim 1, wherein: The distal section of the inner member is selectively detachable from the proximal section of the inner member.

9. The catheter system of claim 8, wherein: The distal section of the inner member includes a weakened portion that enables the distal section to be selectively detached from the proximal section under application of tension.

10. The catheter system of claim 1, wherein: The outer member is formed of Nitinol and / or a polymer.

11. The catheter system of claim 1, wherein: At least a distal section of the outer member is microfabricated to include a circumferentially extending ring and an axially extending beam.

12. The catheter system of claim 11, wherein: The outer member includes a polymer disposed within a space defined by the ring and the beam.

13. The catheter system of claim 1, wherein: The internal components are formed from a variety of polymers.

14. The catheter system of claim 13, wherein: The plurality of polymers have different stiffnesses and are arranged to provide a gradient stiffness that decreases toward the distal end of the inner member.

15. The catheter system of claim 1, wherein: The inner member includes a stop element configured to prevent distal advancement of the distal end of the probe beyond the stop element.

16. A catheter system comprising: an outer member including a lumen extending therethrough; an inner member comprising a distal section and a proximal section, the inner member being configured to fit within the lumen of the outer member, wherein the inner member is translatable within the outer member to selectively extend beyond the distal end of the outer member, and wherein the proximal section of the inner member has a greater stiffness than the distal section of the inner member; and A stylet is configured to fit within the lumen of the inner member, wherein the stylet has a greater bending stiffness and / or column stiffness than the inner member, and wherein a distal section of the inner member is selectively detachable from a proximal section of the inner member.

17. The catheter system of claim 16, wherein: The distal section of the inner member includes a weakened portion that enables the distal section to be selectively detached from the proximal section under application of tension.

18. A method for embolizing a target anatomical structure, comprising: Providing a catheter system according to claim 1; directing the outer member toward the target anatomical structure; directing the inner member to the target anatomical structure by translating the inner member within the outer member, wherein a distal end of the inner member extends past a distal end of the outer member; injecting an embolic agent toward the target anatomical structure; and The inner member is withdrawn from the outer member.

19. The method of claim 18, further comprising inserting an additional inner member into the outer member and injecting an embolic agent through the additional inner member.

20. The method of claim 18, further comprising disassembling a distal section of the inner member after injecting the embolic agent.

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