Fistula device

Abstract

A fistula device is provided that operates in a first state and a second state, wherein the first state the fistula device include two flanges and a channel with a through-hole defined therethrough, and in the second state, the fistula device is elongated and has a smaller circumference relative to the first state. The fistula device is delivered to a target site in the second state, and is transitioned to the first state to form a fistula between two blood vessels via the through-hole, and is anchored in place via the channel pulling the first flange and the second flange against the inner walls of the two blood vessels.

Description

FISTULA DEVICECROSS-REFERENCES TO RELATED APPLICATIONS

[0001] The present disclosure claims the benefit of U.S. Provisional Patent Application No.: 63 / 530,404 entitled “FISTULA DEVICE” and filed on 2023-08-02, which is incorporated herein by reference in its entirety.BACKGROUND

[0002] Fistulas (or fistulae) define pathways between body parts or to the body surface. In some cases, the fistulas may be the result of an injury, disease, or a disorder, while in other cases, the fistulas may be intentionally formed by various surgical procedures or devices to allow the passage of fluid from one body part to another.BRIEF DESCRIPTION OF THE DRAWINGS

[0003] The accompanying figures depict various elements of the one or more embodiments of the present disclosure, and are not considered limiting of the scope of the present disclosure.

[0004] In the Figures, some elements may be shown not to scale with other elements so as to more clearly show the details. Additionally, like reference numbers are used, where possible, to indicate like elements throughout the several Figures.

[0005] It is contemplated that elements and features of one embodiment may be beneficially incorporated in the other embodiments without further recitation or illustration. For example, as the Figures may show alternative views and time periods, various elements shown in a first Figure may be omitted from the illustration shown in a second Figure without disclaiming the inclusion of those elements in the embodiments illustrated or discussed in relation to the second Figure.

[0006] Figure 1 shows the fistula device in a resting shape, according to embodiments of the present disclosure.

[0007] Figure 2 shows the fistula device in a resting shape, according to embodiments of the present disclosure.

[0008] Figure 3 shows transitions between the first state and the second state for the fistula device, according to embodiments of the present disclosure.

[0009] Figure 4 shows transitions between the first state and the second state for the fistula device, according to embodiments of the present disclosure.

[0010] Figure 5 is a flowchart of an example method for deploying a fistula device, as described herein, according to embodiments of the present disclosure.DESCRIPTION

[0011] The present disclosure is generally related to an improved fistula device. The device is used to maintain a fistula between two blood vessels, and uses the structural support of those blood vessels to maintain the relative positions of thedevice and the blood vessels. The fistula device operates in a first state and a second state. In the first state, the fistula device includes two flanges and a channel with a through-hole defined therethrough. In the second state, the fistula device is elongated and has a smaller circumference relative to the first state, to aid in navigation to a target site in a biological subject. The fistula device is delivered to a target site in the second state via a transdermal needle used to puncture the blood vessels to form a fistula between those blood vessels. After creating the puncture, the fistula device is positioned in each of the blood vessels, and is transitioned to the first state to form a fistula between the two punctured blood vessels via the through-hole. The needle can then be removed, and the fistula device is anchored in place via the channel pulling the first flange and the second flange against the inner walls of the two blood vessels.

[0012] In various embodiments, the length of the channel (e.g., the distance between the two flanges in the first state), the bore size of the through-hole, and the relative circumferences of the flanges and channel may be varied based on the desired characteristics of the fistula to maintain flow between those blood vessels. The fistula device may be made of various memory shape materials, such as nitinol, stainless steel, and platinum, and has a resting shape in which the flanges are fully extended that the fistula device returns to when external forces are removed from the fistula device.

[0013] Figure 1 and Figure 2 show the fistula device 100 in a first state / resting shape, according to embodiments of the present disclosure. A delivery attachment150 is shown on one flange 110a (generally or collectively, flange 110), on which an external force may be applied to transition the fistula device 100 to the second state, having an elongated length but reduced circumference relative to the first state / resting shape for the fistula device 100. Additionally, a marker band 160 is shown on the other flange 110b, which aids operators or technicians in tracking the fistula device 100 while navigating to the target site (or verifying that the fistula device remains at the correct location post insertion) via x-ray, magnetic resonant imaging (MRI), or ultrasound imaging.

[0014] Each of the flanges 110 is shown in the resting state as having a first circumference C1 , which is greater than a second circumference C2 of the channel 120 between the flanges 110. The channel 120 includes a lumen 140 that opens on a first side at a first port 130a (generally or collectively, ports 130) in an outer face of the first flange 110a, and opens on a second side at a second port 130b in an outer face of the second flange 110b. The lumen 140 has a first bore B1 .

[0015] Figure 3 and Figure 4 show transitions between the first state and the second state for the fistula device 100, according to embodiments of the present disclosure.

[0016] In Figure 3, the fistula device 100 is secured to a transdermal needle 310 that is run through the lumen 140 or through-hole defined by the fistula device 100, and a control wire 320 is affixed to the delivery attachment 150. The control wire 320 pulls on the fistula device 100 secured to the needle 310, thereby elongating the material in the body of the fistula device 100 and reducing thecircumference thereof to bring the fistula device 100 to the second state from the first state. Once the control wire 320 is released, the fistula device 100 returns to the first state; which may deploy the flanges 110 in separate blood vessels designated to link via a fistula. Accordingly, the body of the fistula device 100 provides a fistula forming means that is able to link two blood vessels or other bodily cavities when deployed therebetween.

[0017] In Figure 4, the fistula device 100 is shown as being secured to a transdermal needle 310 that is run through the lumen 140 or through-hole defined by the fistula device 100, and an outer sheath 330 is positioned relative to the fistula device 100 to transition the fistula device 100 between the first and second states. The outer sheath 330 pushes the fistula device 100 inward to the needle 310, elongating the material in the body of the fistula device 100 and reducing the circumference thereof to bring the fistula device 100 to the second state from the first state. Once the outer sheath 330 is retracted, the fistula device 100 returns to the first state; which may deploy the flanges 110 in separate blood vessels designated to link via a fistula. Accordingly, the body of the fistula device 100 provides a fistula forming means that is able to link two blood vessels or other bodily cavities when deployed therebetween.

[0018] Figure 5 is a flowchart of an example method 500 for deploying a fistula device 100, as described herein, according to embodiments of the present disclosure. Method 500 begins at block 510, where an operator secures the fistula 100 device to a delivery system (e.g., a transdermal needle 310) and collapses thefistula device 100 from the first state to the second state via a control wire 320, outer sheath 330, or other control means.

[0019] At block 520, the operator navigates the fistula device 100 (via the delivery system) to the target site for fistula creation.

[0020] At block 530, the operator punctures a first and a second blood vessel (e.g., an artery and a vein, a first artery and a second artery, a first vein and a second vein, a first portion and a second portion of one blood vessel).

[0021] At block 540, the operator positions a first end of the fistula device 100 in the first blood vessel and a second end, opposite to the first end, of the fistula device 100 in the second blood vessel.

[0022] At block 550, the operator relaxes the fistula device 100 from the second state to the first state (e.g., by removing tension on a control wire 320 or removing an external sheath 330) so that the first flange 110a is positioned in the first blood vessel, the second flange 110b is positioned in the second blood vessel, and a channel 120 between the two flanges 110 pulls the two blood vessels towards one another.

[0023] At block 560, the operator then removes the delivery system from the biological subject with the fistula device 100 anchored in place within the biological subject to thereby form a fistula between the two blood vessels.

[0024] In various embodiments, the larger circumferences of the flanges 110 relative to the punctured holes (and the circumference C2 of the channel 120) and the smaller distance between the flanges 110 relative to the pre-insertion distancebetween the two blood vessels pulls the flanges 110 into contact with the inner walls of the respective blood vessels. The hoop strength of the fistula device 100 maintains the fistula device 100 in the first state while inserted in the biological subject, even as the blood vessels pull against the respective flanges 110. In various embodiments, the ratio between the circumferences of the flanges 110 and a bore size of a puncture between the two blood vessels and is between 2:1 to 5:1 . In various embodiments, the ratio between the distance between the flanges and a bore size of a puncture between the two blood vessels is between 1 :1 to 4:1 .

[0025] In addition to the embodiments described above, many examples of specific combinations are within the scope of the disclosure, some of which are detailed below:

[0026] Clause 1 : A device (100), comprising: a collapsible body having a lumen (140) that opens at a first port (130a) on a first end and at a second port (130b) on a second end, opposite to the first end, and that operates in a first state and a second state; wherein in the first state, the lumen includes: a first flange (110a) on the first end that has a first circumference (C1 ), and that concentrically positions the first port on a first face; a second flange (110b) on the second end that has the first circumference, and that concentrically positions the second port on a second face; and a channel (120) of a second circumference (C2), less than the first circumference, disposed between the first flange and the second flange, connected to a third face of the first flange, opposite to the first face, and connectedto a fourth face of the second flange, opposite to the second face; and wherein in the second state, the lumen has an outer wall less than the first circumference.

[0027] Clause 2: The device of any of clauses 1 -6, wherein the first flange includes a delivery attachment (150) that is non-concentrically positioned on the first face.

[0028] Clause 3: The device of any of clauses 1 -6, further comprising a transdermal needle (310) positioned in the lumen and connected to the delivery attachment via a control wire (320) when the collapsible body is in the second state.

[0029] Clause 4: The device of any of clauses 1-6, wherein the second flange includes a marker band (160) that is non-concentrically positioned on the second face.

[0030] Clause 5: The device of any of clauses 1 -6, wherein the collapsible body is made of a memory shape material with a resting shape for the first state, the memory shape material including at least one of: nitinol; stainless steel; and platinum.

[0031] Clause 6: The device of any of clauses 1-5, wherein a ratio for the first circumference to the second circumference is between 2:1 to 5:1.

[0032] Clause 7: A method (500) comprising: attaching (510) a fistula device (100), in a first state, to a transdermal needle (310), wherein in the first state the fistula device has a first length and includes a first flange (110a) of a firstcircumference (C1 ) on a first end, a second flange (110b) of the first circumference on a second end, opposite to the first end, and a channel (120) of a second circumference (C2), less than the first circumference, connected between the first flange and the second flange, wherein the transdermal needle is inserted through an operational lumen (140) defined between a first port (130a) in the first flange and a second port (130b) in the second flange that runs through the channel; collapsing (510) the fistula device to a second state, wherein in the second state the fistula device has a second length, greater than the first length, and includes a collapsed lumen defined between the first port and the second port of the first circumference; navigating (520) a first blood vessel to a target site in a biological subject; puncturing (530) the first blood vessel and a second blood vessel via the transdermal needle; positioning (540) the first end of the fistula device in the first blood vessel and the second end of the fistula device in the second blood vessel; relaxing (550) the fistula device from the second state to the first state, wherein the first flange is disposed in the first blood vessel, the second flange is disposed in the second blood vessel, and the channel is disposed between the first blood vessel and the second blood vessel; and removing (560) the transdermal needle from the biological subject.

[0033] Clause 8: The method of any of clauses 7-12, wherein relaxing includes releasing a control wire (320) connected to a delivery attachment (150) on the second flange.

[0034] Clause 9: The method of any of clauses 7-12, wherein relaxing includes removing an outer sheath (330) that compresses the fistula device from the first state to the second state.

[0035] Clause 10: The method of any of clauses 7-12, wherein a distance between the first flange and the second flange in the first state is less than an initial distance between the first blood vessel and the second blood vessel before the fistula device is secured in the first blood vessel and the second blood vessel.

[0036] Clause 11 : The method of any of clauses 7-12, wherein a ratio between the first circumference and a bore size of a puncture between the first blood vessel and the second blood vessel and is between 2:1 to 5:1.

[0037] Clause 12: The method of any of clauses 7-12, wherein a ratio between a distance between the first flange and the second flange and a bore size of a puncture between the first blood vessel and the second blood vessel and is between 1 :1 to 4: 1.

[0038] Clause 13: A device (100), comprising: a fistula forming means having a lumen (140) that opens at a first port (130a) on a first end and at a second port (130b) on a second end, opposite to the first end, and that operates in a first state and a second state; wherein in the first state, the lumen includes: a first flange (110a) on the first end that has a first circumference (C1), and that concentrically positions the first port on a first face; a second flange (110b) on the second end that has the first circumference, and that concentrically positions the second porton a second face; and a channel (120) of a second circumference (C2), less than the first circumference, disposed between the first flange and the second flange, connected to a third face of the first flange, opposite to the first face, and connected to a fourth face of the second flange, opposite to the second face; and wherein in the second state, the lumen has an outer wall less than the first circumference.

[0039] Clause 14: The device of any of clauses 13-18, wherein the first flange includes a delivery attachment (150) that is non-concentrically positioned on the first face.

[0040] Clause 15: The device of any of clauses 13-18, further comprising a transdermal needle (310) positioned in the lumen and connected to the delivery attachment via a control wire (320) when the fistula forming means is in the second state.

[0041] Clause 16: The device of any of clauses 13-18, wherein the second flange includes a marker band (160) that is non-concentrically positioned on the second face.

[0042] Clause 17: The device of any of clauses 13-18, wherein the fistula forming means is made of a memory shape material with a resting shape for the first state, the memory shape material including at least one of: nitinol; stainless steel; and platinum.

[0043] Clause 18: The device of any of clauses 13-18, wherein a ratio for the first circumference to the second circumference is between 2:1 to 5:1 .

[0044] The descriptions and illustrations of one or more embodiments provided in this disclosure are intended to provide a thorough and complete disclosure the full scope of the subject matter to those of ordinary skill in the relevant art and are not intended to limit or restrict the scope of the subject matter as claimed in any way. The aspects, examples, and details provided in this disclosure are considered sufficient to convey possession and enable those of ordinary skill in the relevant art to practice the best mode of the claimed subject matter. Descriptions of structures, resources, operations, and acts considered well-known to those of ordinary skill in the relevant art may be brief or omitted to avoid obscuring lesser known or unique aspects of the subject matter of this disclosure. The claimed subject matter should not be construed as being limited to any embodiment, aspect, example, or detail provided in this disclosure unless expressly stated herein. Regardless of whether shown or described collectively or separately, the various features (both structural and methodological) are intended to be selectively included or omitted to produce an embodiment with a particular set of features. Further, any or all of the functions and acts shown or described may be performed in any order or concurrently.

[0045] Having been provided with the description and illustration of the present disclosure, one of ordinary skill in the relevant art may envision variations, modifications, and alternate embodiments falling within the spirit of the broader aspects of the general inventive concept provided in this disclosure that do not depart from the broader scope of the present disclosure.

[0046] As used in the present disclosure, a phrase referring to “at least one of” a list of items refers to any set of those items, including sets with a single member, and every potential combination thereof. For example, when referencing “at least one of A, B, or C” or “at least one of A, B, or C”, the phrase is intended to cover the sets of: A, B, C, A-B, B-C, and A-B-C, where the sets may include one or multiple instances of a given member (e.g., A-A, A-A-A, A-A-B, A-A-B-B-C-C-C, etc.) and any ordering thereof.

[0047] As used in the present disclosure, the term “determining” encompasses a variety of actions that may include calculating, computing, processing, deriving, investigating, looking up (e.g., via a table, database, or other data structure), ascertaining, receiving (e.g., receiving information), accessing (e.g., accessing data in a memory), retrieving, resolving, selecting, choosing, establishing, and the like.

[0048] As used in the present disclosure, the terms “substantially”, “approximately”, “about”, and other relative terms encompass values within ± 5% of a stated quantity, percentage, or range unless a different approximation is explicitly recited in relation to the stated quantity, percentage, or range or if the context of the value indicates that a different approximation would be more appropriate. For example, a value identified as about X% may be understood to include values between 0.95*X% and 1 ,05*X% or between X-0.05X and X+0.05X percent, but may stop at zero or one hundred percent in various contexts. In another example, a feature described as being substantially parallel orperpendicular to another feature shall be understood to be within ± 9 degrees of parallel or perpendicular. Any value stated in relative terms shall be understood to include the stated value and any range or subrange between the indicated or implicit extremes.

[0049] As used in the present disclosure, all numbers given in the examples (whether indicated as approximate or otherwise) inherently include values within the range of precision and rounding error for that number. For example, the number 4.5 shall be understood to include values from 4.45 to 4.54, while the number 4.50 shall be understood to include values from 4.495 to 4.504. Additionally, any number or range that explicitly or by context refers to an integer amount (e.g., approximately X users, between about Y and Z states), shall be understood to round downward or upward to the next integer value (e.g., X±1 users, Y-1 and Z+1 states).

[0050] The following claims are not intended to be limited to the embodiments shown herein, but are to be accorded the full scope consistent with the language of the claims. Within the claims, reference to an element in the singular is not intended to mean “one and only one” unless specifically stated as such, but rather as “one or more” or “at least one”. Unless specifically stated otherwise, the term “some” refers to one or more. No claim element is to be construed under the provision of 35 U.S.C. § 112(f) unless the element is expressly recited using the phrase “means for” or “step for”. All structural and functional equivalents to the elements of the various aspects described in the present disclosure that are knownor come later to be known to those of ordinary skill in the relevant art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed in the present disclosure is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.

Claims

WE CLAIM:1 . A device (100), comprising: a collapsible body having a lumen (140) that opens at a first port (130a) on a first end and at a second port (130b) on a second end, opposite to the first end, and that operates in a first state and a second state; wherein in the first state, the lumen includes: a first flange (110a) on the first end that has a first circumference (C1), and that concentrically positions the first port on a first face; a second flange (110b) on the second end that has the first circumference, and that concentrically positions the second port on a second face; and a channel (120) of a second circumference (C2), less than the first circumference, disposed between the first flange and the second flange, connected to a third face of the first flange, opposite to the first face, and connected to a fourth face of the second flange, opposite to the second face; and wherein in the second state, the lumen has an outer wall less than the first circumference.

2. The device of claim 1 , wherein the first flange includes a delivery attachment (150) that is non-concentrically positioned on the first face.

3. The device of claim 2, further comprising a transdermal needle (310) positioned in the lumen and connected to the delivery attachment via a control wire (320) when the collapsible body is in the second state.

4. The device of claim 1 , wherein the second flange includes a marker band (160) that is non-concentrically positioned on the second face.

5. The device of claim 1 , wherein the collapsible body is made of a memory shape material with a resting shape for the first state, the memory shape material including at least one of: nitinol; stainless steel; and platinum.

6. The device of claim 1 , wherein a ratio for the first circumference to the second circumference is between 2:1 to 5:1.

7. A method comprising: attaching (510) a fistula device (100), in a first state, to a transdermal needle (310), wherein in the first state the fistula device has a first length and includes a first flange (110a) of a first circumference (C1 ) on a first end, a second flange (110b) of the first circumference on a second end, opposite to the first end, and a channel (120) of a second circumference (C2), less than the first circumference, connected between the first flange and the second flange, wherein the transdermal needle is inserted through an operational lumen (140) defined between a first port (130a) in the first flange and a second port (130b) in the second flange that runs through the channel; collapsing (510) the fistula device to a second state, wherein in the second state the fistula device has a second length, greater than the first length, and includes a collapsed lumen defined between the first port and the second port of the first circumference; navigating (520) a first blood vessel to a target site in a biological subject; puncturing (530) the first blood vessel and a second blood vessel via the transdermal needle; positioning (540) the first end of the fistula device in the first blood vessel and the second end of the fistula device in the second blood vessel;relaxing (550) the fistula device from the second state to the first state, wherein the first flange is disposed in the first blood vessel, the second flange is disposed in the second blood vessel, and the channel is disposed between the first blood vessel and the second blood vessel; and removing (560) the transdermal needle from the biological subject.

8. The method of claim 7, wherein relaxing includes releasing a control wire (320) connected to a delivery attachment (150) on the second flange.

9. The method of claim 7, wherein relaxing includes removing an outer sheath (330) that compresses the fistula device from the first state to the second state.

10. The method of claim 7, wherein a distance between the first flange and the second flange in the first state is less than an initial distance between the first blood vessel and the second blood vessel before the fistula device is secured in the first blood vessel and the second blood vessel.11 . The method of claim 7, wherein a ratio between the first circumference and a bore size of a puncture between the first blood vessel and the second blood vessel and is between 2:1 to 5:1 .

12. The method of claim 7, wherein a ratio between a distance between the first flange and the second flange and a bore size of a puncture between the first blood vessel and the second blood vessel and is between 1 :1 to 4:1.

13. A device (100), comprising: a fistula forming means having a lumen (140) that opens at a first port (130a) on a first end and at a second port (130b) on a second end, opposite to the first end, and that operates in a first state and a second state; wherein in the first state, the lumen includes:a first flange (110a) on the first end that has a first circumference (C1 ), and that concentrically positions the first port on a first face; a second flange (110b) on the second end that has the first circumference, and that concentrically positions the second port on a second face; and a channel (120) of a second circumference (C2), less than the first circumference, disposed between the first flange and the second flange, connected to a third face of the first flange, opposite to the first face, and connected to a fourth face of the second flange, opposite to the second face; and wherein in the second state, the lumen has an outer wall less than the first circumference.

14. The device of claim 13, wherein the first flange includes a delivery attachment (150) that is non-concentrically positioned on the first face.

15. The device of claim 14, further comprising a transdermal needle (310) positioned in the lumen and connected to the delivery attachment via a control wire (320) when the fistula forming means is in the second state.

16. The device of claim 13, wherein the second flange includes a marker band (160) that is non-concentrically positioned on the second face.

17. The device of claim 13, wherein the fistula forming means is made of a memory shape material with a resting shape for the first state, the memory shape material including at least one of: nitinol; stainless steel; and platinum.

18. The device of claim 13, wherein a ratio for the first circumference to the second circumference is between 2:1 to 5:1.

Images