WO2018081084A1

WO2018081084A1 - Methods and devices for delivery of lung device

Info

Publication number: WO2018081084A1
Application number: PCT/US2017/058038
Authority: WO
Inventors: Benjamin David BELL; Gerhard Andrew Foelsche
Original assignee: Soffio Medical Inc.
Priority date: 2016-10-25
Filing date: 2017-10-24
Publication date: 2018-05-03

Abstract

A medical device installation tool including: a tubular body with a circular cross section connected to a user end and an opposite tapered delivery end with a locking tip, and the locking tip includes a chuck and adjustable jaws, wherein the body is dimensioned to slideably receive a coaxial inner rod, which may be actuated within the tubular body to reconfigure the locking tip between a first and second position.

Description

METHODS AND DEVICES FOR DELIVERY OF LUNG DEVICE

RELATED APPLICATION

[0001] This application claims the benefit of U.S. provisional application

62/412,670 filed October 25, 2017.

BACKGROUND OF THE INVENTION

[0002] The present disclosure is generally directed to a medical delivery device, also known as an installation tool. Implantable medical devices may be used to improve chest mechanics in diseased patients by providing a mechanism to bypass or partially bypass natural airways and reduce

overinflated lung volume. Traditional surgical methods may present

disadvantages including the requirement for costly equipment, drug side- effects, and long recovery periods. A reduction of cost and complexity are weighed against efficacy to determine the feasibility of procedures.

Therefore, minimally invasive device delivery using an installation tool is preferred as a less invasive treatment option, which avoids surgery and large area pleurodesis, minimizes disturbance and irritation of lung tissue, minimizes inflammation or damage to untargeted areas of the lung and chest, better controls of healing processes, and establishes long-term patency of artificial air passages.

[0003] To implant a device in the lung using minimally invasive methods, device dimensions must conform to certain limitations. Under these

limitations, traditional delivery devices may also have reduced functionality. The present disclosure provides an installation tool with the combined dimensions and functionality necessary for the various treatment options described. These installation tools may fulfill the need for a delivery and deployment device and system that conforms to the dimensional

requirements of minimally invasive methods, without compromising device and system functionality.

SUMMARY OF THE INVENTION

[0004] Systems, methods and devices have been conceived for improving the mechanics of a diseased lung of a patient by implanting one or more natural airway bypass ventilation devices in a lung. For example, the patient may suffer from COPD, emphysema, chronic bronchitis, or asthma. An airway bypass device may comprise a pressure relief device connecting lung parenchyma distal to abnormally high resistance airways to the atmosphere. This bypass may cause pressure and lung volume to decrease, thus improving lung mechanics. To maintain the patency of the bypass device the, the internal components of the device may comprise features (e.g. an expandable structure) of certain dimensions to allow a bypass device to perform

optimally. The relatively large volumes of these bypass devices offers unique advantages in reducing the risk of blockage or occlusion.

[0005] However, to minimize damage and subsequent trauma to a patient, it is preferable that only a small incision is made to deliver the device when using minimally invasive delivery technique. The incision is envisioned to be minimal in both size and depth. Therefore, to accommodate the reduced dimensioned of this incision, the dimension the bypass device along with any installation tool must be also be reduced during delivery. Specifically, in certain aspects, the expandable structure of a bypass device must be collapsed; in addition, the installation tool must secure and position the airway bypass device within the internal lung before releasing and

subsequently deploying the device.

[0006] To achieve device delivery, one delivery system of the present disclosure comprises at least an installation tool with a handle or handle assembly, connected to a tubular body with a locking tip. The tubular body is formed of an outer tubular member and an inner rod member, which coaxially passes within the outer tubular member. The handle is connected to the rod member and the rod member may slidably reciprocate within the outer tube member to actuate a locking mechanism of the locking tip.

[0007] This illustrative embodiment is mentioned not to limit or define the invention, but to provide examples to aid understanding thereof. Additional illustrative embodiments are discussed in the disclosure provided, and further description of the invention is provided therein. Advantages offered by various embodiments of this invention may be further understood by examining the details of this Specification.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 is a schematic illustration of an installation tool in the unlocked configuration.

[0009] Figure 2A is a schematic illustration of an installation tool in the unlocked configuration.

[00010] Figure 2B is a schematic illustration of an installation tool in the locked configuration. [00011] Figure 3A is a close-up schematic illustration of the handle of an installation tool in the locked configuration.

[00012] Figure 3B is a close-up schematic illustration of the locking tip of an installation tool in the locked configuration.

[00013] Figure 4A is a close-up schematic illustration of the handle of an installation tool in the unlocked configuration.

[00014] Figure 4B is a close-up schematic illustration of the locking tip of an installation tool in the unlocked configuration.

[00015] Figure 5 is an illustration showing the locking tip of an installation tool prior to securing an airway bypass device.

[00016] Figure 6 is an illustration showing the locking tip of an installation tool in the unlocked configuration after having secured an airway bypass device for device delivery.

[00017] Figure 7 is an illustration showing the locking tip of an installation tool in the locked configuration after having secured an airway bypass device for device delivery.

[00018] Figure 8 is an illustration showing a perspective view of an

installation tool in the unlocked configuration securing an airway bypass device.

[00019] Figure 9 is an illustration showing a perspective view of an

installation tool in the locked configuration securing an airway bypass device. [00020] Figure 10 is an anatomical illustration showing an installation tool delivering a sheathed and collapsed airway bypass device.

[00021] Figure 11 is a close-up illustration showing the delivery of FIG. 10.

[00022] Figure 12A is close-up illustration prior to the actuation of the locking tip of an installation tool before anchor placement.

[00023] Figure 12B is close-up illustration showing the actuation of the locking tip of the installation tool through anchor placement.

[00024] Figure 12C is close-up illustration showing the removal of the installation tool after device placement is complete.

DETAILED DESCRIPTION OF THE DRAWINGS

[00025] The present invention is illustrated and described herein in greater detail. Embodiments described herein provide systems and methods for a medical installation tool 10. In at least one embodiment, the description relates to an installation tool 10 to secure, deliver and release a deliverable device 100, specifically an airway bypass device, in a minimally invasive procedure. As follows, numerous specific details are set forth in order to provide an understanding of the systems and methods relating to the device. It will be apparent, however, to one skilled in the art that the systems and methods may be practiced without some of these specific details without obscuring the underlying principles of the present invention.

[00026] In the embodiment illustrated in FIG. 1, 2A and 2B, the installation tool 10 comprises a tubular body 30 of circular cross section having a forward tapering locking tip 50 located at the conical delivery end 14 of the tool, the tip further interfacing with a chuck 54 mechanism. The user end 12 of the tubular body 30 is open with an inner diameter sufficient to accommodate an inner rod 40 member, which coaxially passes within the outer tubular member and connects in the rear of the tool to a handle 20 or handle 20 assembly. The handle 20 of the user end 12 is connected to the rod 40 member and the rod 40 member may slideably reciprocate within the tubular body 30 between a first and second position to actuate the chuck 54

mechanism.

[00027] In at least one envisioned embodiment, the forward portion of the chuck 54 extending from the tubular body 30 has a concave or forward diverging conical surface to the rear of which the chuck 54 mechanism merges into a forward converging conical body of the delivery end 14. The locking tip 50 comprises angularly spaced jaws 60 with a rearward tapering surface that slideably interfaces the chuck 54. The jaws 60 may be actuated by the telescopic reciprocation of the rod 40 member by depressing the handle 20 towards delivery end 14 or by retracting the handle 20 away from the delivery end 14. In a first, unlocked position seen in FIG. 1, the handle 20 is retracted by operation from the user end 12 and the jaws 60 are advanced within the groove along the conical body of the delivery end 14. The handle is also shown retracted in the perspective view of FIG 2A. In a second, locked position, as seen in FIG. 2B, the jaw are retracted within grooves along the conical body. [00028] The handle 20 projects through the rear user end of the tubular body 30 and is positioned telescopically to advance past the user end 12 tubular body. In at least one embodiment, the handle 20, which is shown in greater detail in FIG. 3A, may further comprise a rearward button 22 or grip. In both FIG. 3A and 3B, is shown in a rearward configuration corresponding to the unlocked position. The rearward button 22 may provide a gripping surface to facilitate the handling of the tool. In some embodiments, in addition to being depressed or retracted, the rod 40 may actuate and secure the tool in an unlocked, or locked positions. Providing a reliable mechanism (e.g. a pin 42) to secure the installation tool 10 in its various configurations may be critical for facilitating tool use in medical applications, as it may free the hands of a practitioner to perform other important functions or tasks that may arise during device delivery. As seen in FIG. 3A, the mechanism, may extend from rod 40 into grooves or slots along the tubular body 30.

Manipulation of the rod or other components may retract the pin, providing a reversible security to the tool.

[00029] FIG. 3B shows a close-up view of the delivery end 14 of the installation tool 10 in the unlocked position, which correspond to FIG. 1. The jaws 60 are fully advanced within the groove along the conical body. In some embodiments, the jaws 60 may further comprise one or more structures at the end of the delivery end 14 (e.g. studs 64) configured to interface with a deliverable device 100. Outward facing structures configured to interface with a deliverable device may be advantageous in some embodiment, mainly due to their reduced dimensions (i.e. diameter) in both the locked and unlocked configurations. In some embodiments, the structures are rounded and smooth studs and are positioned evenly distributed along the outer

circumference of the device. With each stud fixed to the end of each jaw 60, an atraumatic and secure tip is formed at the delivery end of the installation tool 10. The resulting atraumatic and secure tip of such a tool may provide the necessary advantageous for safe, quick and effective device delivery.

[00030] In contrast to FIGS 3A-B, which show the unlocked position, FIGS. 4A-B show similar close-up views of the installation tool 10, but in a locked configuration. In FIG. 4A, the handle 20 is depressed as the rod 40 is telescopically advanced into the tubular body 30. This sliding action advances the pin 42 of FIG. 4A a corresponding distance forward, while also moving the jaws 60 of FIG. 4B, retracted within grooves along the conical body, back into a locked position.

[00031] An additional feature that would facilitate the loading and release of an airway bypass device 100 by the installation tool 10 is a mechanism that locks and releases the jaws 60 of the tool 10 through a second repeated depression of the inner rod 40 or handle 20 from the locked configuration. It is envisioned, in at least one embodiment that the tubular body 30 of the tool 10 would contain a spring or other mechanism to store elastic potential energy (not shown) that may internally stores energy when the tool 10 is the locked position and the rod 40 is depressed from the rear end of a tubular body 30. Further, the rod 40 may be held in place in this locked position. With the release of the rod, the stored energy would automatically extend the studs 64 of the tool 10, unlocking the jaws 60 of the device. This release may be actuated by a trigger mechanism 22 (e.g. button, plunger, etc.) along the rear or side of the tool, the handle 20, handle assembly or other part of the installation tool 10.

[00032] Specifically, the reversible loading sequence between the

installation tool 10 and at least one deliverable medical device 100 (e.g. an airway bypass device) is shown in the sequence of FIG. 5-7. In FIG. 5, the device 100 is shown prior to interface with the installation tool 10. In FIG. 6, the device 100 is passed over the conical delivery end 14 of the installation tool 10. The taper of the delivery end 14 of the installation tool 10 may prevent the device from advancing beyond the preferred delivery position onto the tubular body 30 of the device. In FIG. 6, the studs 64 of the jaws in an unlocked position. As the loading sequence is fully reversible, the position seen in FIG. 6 is the same position the jaws and device 100 assume upon the unlocking of the jaws prior to device delivery. In FIG. 7, the device is positioned for delivery and the installation tool 10 is locked by retracting one or more studs 64 of the jaws 60 to secure the assembly. The deliverable medical device 100 may be collapsed prior to device delivery to reduce the diameter of the device 100 and tool 10. A reduction in dimensions allows for device delivery to be minimally invasive, which may help to minimize trauma and risk to the patient.

[00033] FIGS. 8-9 provide a detailed view of the jaws 60 and locking mechanism. FIG. 8 is a perspective view of the jaw 60 of an installation tool 10 positioned in the unlocked configuration within a deliverable device 100. Figure 9 is a perspective view of said jaw 60 in the locked configuration with the studs 64 of the jaw 60 retracted to secure the device against the installation tool 10. In perspective, it is possible to view a central channel 34, which may be centered and run the length of the installation tool 10. The channel 34 may be used to accommodate guidance mechanisms such as a guide wire 88.

[00034] FIG. 10-11 illustrate one possible and envisioned use for an installation tool 10. The minimally invasive delivery of an airway bypass device into the interior lung of a patient is only one exemplary use of the device, but illustrates the dimensional limitation that are common to many minimally invasive therapies. FIG. 11 provides a detail illustration of the delivery end 14 of the installation tool 10 at a possible delivery location through the chest wall. It is envisioned, as shown, that the use of the installation tool 10 may be combined with other delivery mechanisms (e.g. guide wire 88, delivery sheath 92, needle, trocar, or catheter) that may be rigid, semi-rigid or flexible. To accommodate these additional mechanisms, it is envisioned that the installation tool 10 may comprise, for example, an additional channel 34 that may allow the passage of a guide wire 88.

[00035] In FIG. 11, the device is shown with a guide wire 88, which may travel with this system. In other aspects, the tool may be configured to reside partially within an outer layer, such as a sheath, needle, trocar, or catheter. These outer mechanisms may also act to further reduce the profile of the devices delivered in this way and may offer advantages that may be unique to each specific mechanism.

[00036] In a further embodiment, it is envisioned that the release of the installation tool 10 following device delivery may be automated or partially automated. It is envisioned that the release of the tool 10 may be actuated by the delivery of further external mechanism, such as an external anchor 96. It is envisioned that internal anchor 96 For example, as seen in FIGS. 12A-C, the external anchor 96 of an airway bypass device may interface with the tubular body or delivery end 14 of the installation tool 10. In some envisioned embodiments, the external anchor 96 may comprise a flange and neck. Said flange, positioned external to the skin 105, may be annular and concentric with the neck, and configured to remain in contact with tissue preventing the neck from over-extending during device delivery. In certain embodiments, the flange may be further secured to the exterior skin using fixation

mechanisms (e.g. sutures, dermal adhesives, etc.) The anchor may further comprise graduations or delineations along the length of the neck to provide visual landmarks to assist device delivery.

[00037] In addition, the graduations or delineations along the neck of the external anchor 96 may denote points along the anchor that lock to the access port 98 of the device. Retraction of the anchor may be prevented once each graduated mark is advanced past the surface of the skin and into the access port. FIG 12A shows the external anchor 96 aligned with the access port 98 and enclosing the installation tool 10 in the moment before the advancement of the external anchor. Further, as shown in FIG. 12B and 12C the interaction between the external anchor 96 and the tubular body or delivery end 14 of the installation tool 10 may actuate the jaws 60 of the tool moving them to the unlocked position. [00038] In FIG 12B, the external anchor 96 is partially advanced, but the installation tool 10 remains in the locked position. However, once the anchor is fully advanced, the anchor repositions the jaws 60 with the studs 64 extended, allowing for the release of the installation tool 10 from the delivered device. FIG 12C shows the actual removal of the tool, leaving only a guide wire 88 in this illustration. The subsequent removal of the guide wire is generally one the final steps of device delivery.

[00039] Generally, the installation tool 10 may be formed of materials use in biomedical applications. One or more materials, alone or in combination, may be advantageous in forming part or all of the parts of the installation tool 10. In some embodiments, stainless steel is preferred as the material safe for surgical and medical applications. Specifically, "surgical" steels including austenitic 316 stainless and martensitic 440 and 420 stainless steels steel may be considered for use. The tool including the tubular body, delivery end 14 and all protruding pins 42 and studs 64 may be smoothed and polished with electro or mechanical polishing methods to render a smooth and atraumatic finish to reduce unnecessary tissue damage resulting from device delivery.

[00040] In some instances, installation tools are supplied by their

manufacturers in single-use packaging and may be pre-loaded with an airway bypass device. To ensure sterility, the installation tool may be pre-packaged for single use and may be disposable (i.e. the entire device is discarded after a single use) and arrive in said packaging to ensure sterility. Components that make up the installation tool 10 may be permanently affixed such that the elements are assembled and are not readily removable during normal use of the device.

[00041] Pre-loaded devices are generally able to increase the efficiency of device placement and reduce the overall duration of surgery. In addition, as current equipment and techniques for loading airway bypass devices into an installation tool has not been fully refined to allow the majority of medical practitioners can simply perform the loading steps in the pre-operating room environment.

[00042] On the other hand, pre-loaded devices with relatively high

manufacturing costs have incentivized the use of medical devices that can be sterilized and reused. To be effective, a tool that could be sterilized and reusable depends on an easy and effective loading technique and foolproof method of use. Further, it may be necessary for reusable installation tools to be partially or completely disassembled to assist in sterilization. Once the tool is sterilized, it may undergo additional treatment to prepare it for reuse.

Specifically, a tool may be coated with additional bioactive agents, as needed (e.g. a coating of epinephrine may be used to minimize bleeding at wound sites and within the body cavity). In some embodiments, the installation tool 10 described herein is envisioned to be durable, and simple to use in order to maximize its effectiveness as a reusable delivery device.

[00043] It is envisioned, in at least one embodiment, that the tool or deliverable device 100 may be configured with radiopaque areas to allow imaging technology to assist in assessing if the device is implanted

satisfactorily. Imaging may also be used during and following the steps of implanting the device to facilitate the proper placement of the device.

Imaging technology such as x-ray or fluoroscopy may be used to image radiopaque markers placed on the device, for example on at the delivery end 14 of the installation tool 10. In addition, it is envisioned that the tip of the installation tool 10 may be configured with a further visualization mechanism that may relay the position of the tool from within the internal lung.

[00044] As illustrated, at least one envisioned use of the tool is to facilitate the delivery or implantation procedure of lung airway bypass device. Delivery may generally comprise preparing the patient, suitably positioning the patient, sedating the patient, and forming an annular access area into the patient either through a laparoscopic port or through an incision. The tissue of the access area is subsequently dissected to provide access to the target area of the lung.

[00045] Following the a loading sequence in which the deliverable device 100 (e.g. airway bypass device) is placed on the delivery end 14 of the installation tool 10 and secured in place, the method of delivery may comprise aligning the installation tool 10 with an the annular port or incision, advancing the installation tool 10 to the target location, deploying the delivered device, disengaging the delivery end 14 of the installation tool 10 and retracting the installation tool 10.

[00046] While at least one exemplary embodiment of the present

invention(s) is disclosed herein, it should be understood that modifications, substitutions and alternatives may be apparent to one of ordinary skill in the art and can be made without departing from the scope of this disclosure. This disclosure is intended to cover any adaptations or variations of the exemplary embodiment(s).

[00047] In this disclosure, the terms "comprise" or "comprising" do not exclude other elements or steps, the terms "a" or "one" do not exclude a plural number, and the term "or" means either or both. Furthermore, characteristics or steps which have been described may also be used in combination with other characteristics or steps and in any order unless the disclosure or context suggests otherwise. This disclosure hereby incorporates by reference the complete disclosure of any patent or application from which it claims benefit or priority.

Claims

CLAIMS The invention is:

1. A medical device installation tool comprising:

a tubular body with a circular cross section connected to a user end and an opposite tapered delivery end with a locking tip, and

the locking tip includes a chuck and adjustable jaws, wherein the body is dimensioned to slideably receive a coaxial inner rod, which may be actuated within the tubular body to reconfigure the locking tip between a first and second position.

2. The medical device installation tool of claim 1, wherein the chuck extending from the tubular body has a forward diverging conical surface and delivery end merges into a forward converging conical body of the delivery end.

3. The medical device installation tool as in claim 1 or 2 wherein the tubular body is annular in cross section.

4. The medical device installation tool of any of claims 1 to 3, further comprising a handle connected to the coaxial inner rod at the user end of the tool.

5. The medical device installation tool of any of claims 1 to 4, further comprising a pin connected to coaxial inner rod to temporarily secure the rod in at least one of a first or second position.

6. The medical device installation tool of any of claims 1 to 5, wherein the handle may be retracted to place the tool is in a first, unlocked position and may be extended to place the tool is in a second, locked position.

7. The medical device installation tool of any of claims 1 to 6, wherein the jaws are spaced angularly.

8. The medical device installation tool of any of claims 1 to 7, wherein the jaws further comprise one or more outward facing studs.

9. The medical device installation tool of any of claims 1 to 8, further comprising a central hollow channel in the tubular body that is configured to accept a guide wire or guide wire system.

10. The medical device installation tool of any of claims 1 to 9, wherein the tool is configured to secure and delivery a lung volume reduction device.

11. The medical device installation tool of any of claims 1 to 10, wherein the diameter of the tool does not exceed 30 French.

12. The medical device installation tool of any of claims 1 to 11, wherein the tool is a single-use disposable device.

13 The medical device installation tool of claim 12, wherein the tool is a sterile packaged single-use disposable device.

14. A medical device installation tool comprising:

a tubular body with a circular cross section and connected to a user end and an opposite tapered delivery end with a locking tip, the locking tip comprising a chuck and adjustable jaws with one or more outward facing studs, wherein the chuck extending from the tubular body has a forward diverging conical surface and delivery end merges into a forward converging conical body of the delivery end and the tubular body is dimensioned to slideably receive a coaxial inner rod, which may be actuated within the tubular body to reconfigure the locking tip between a first, unlocked position and a second, locked position, where this distance between jaws is greater in the second, locked position.

15. A method

14. A medical device installation tool comprising:

attaching a porous basket to a distal end of a tubular insertion tool; inserting the distal end with the porous basket through the chest wall and into a diseased portion the lung of a patient;

releasing the basket from the distal end of the tubular insertion tool while the basket is implanted in the diseased portion of the lung;

sliding a cylindrical access port over the tubular insertion tool and implanting the access port in the chest wall of the patient, wherein the access port is connected via a conduit to the basket;

removing the tubular insertion tool from the chest wall while the access port remains implanted in the chest wall and while the basket remains implanted in the diseased portion of the lung, and

fixing a vent cap at an end of the access port to skin covering the chest wall.

15. The method of claim 14 wherein the tubular insertion tool is a first tubular insertion tool and the method further comprising inserting a second tubular insertion tool through the chest wall wherein the first insertion tool with the basket is inserted through the second tubular insertion tool.

16. The method of claim 14 or 15 further comprising expanding the basket after the basket slides out of the tubular insertion tool and enters the diseased portion of the lung.