Positioning device and method

Abstract

The invention relates to a positioning device (1) comprising a distal portion (8) adapted to be delivered through a defect, preferably through an opening in a ventricular or atrial septum. The positioning device comprises a mechanism for selectively dilating the distal portion (8) such that the distal portion can be deployed through the defect prior to dilation and, upon dilation, mechanically prevents retraction through the same defect. Thus, the positioning device (1) temporarily engages the defect site.

Description

[0001] This application is a divisional application of the application with application number 2019800991217, application date August 20, 2019, and invention title "Positioning Device and Method". Technical Field

[0002] This invention relates to an apparatus and method for deploying a delivery device for medical implants according to the preamble of the independent claim. Background Technology

[0003] Many medical conditions are best treated with minimally invasive techniques. Therefore, numerous implantable devices have been proposed in the current technology, many of which can be deployed using minimally invasive methods. For example, Lock et al. (DOI: 10.1161 / 01.CIR.79.5.1091) have disclosed the use of a catheter to deploy an umbrella-shaped implant to close atrial septal defects (ASD).

[0004] However, minimally invasive treatment remains challenging because direct access to the treatment site is not possible during the procedure. Therefore, adjusting the position or orientation of the delivery device is not easy for surgeons. Similarly, if the delivery device comprises multiple parts, changing the position of one part while keeping the others in the same position relative to the implantation site is also challenging. Furthermore, holding the delivery device at the desired location is difficult. Summary of the Invention

[0005] Therefore, the object of the present invention is to overcome the deficiencies of the prior art, and in particular to provide a simpler method for determining the location of a delivery device, and in particular to enable the movement or implantation of the delivery device without the need for additional means of locating the device.

[0006] This and other objectives are achieved by a positioning device for the feature portion according to the independent claim of the invention.

[0007] The positioning device according to the invention is particularly suitable for deploying delivery devices for medical implants. The positioning device includes a distal portion adapted for delivery through an opening in a defect, preferably through the ventricular or atrial wall or vascular wall; "distal" in the context of the device should be understood as a direction away from the operator. The positioning device also includes a mechanism for selectively expanding the distal portion, allowing the operator to expand it autonomously. Before expansion, the distal portion can be deployed through the defect, and after expansion, it is mechanically prevented from retracting through the same defect. Thus, the positioning device temporarily engages the defect site. The distal portion is also adapted to collapse again and retract through the medical implant, causing the positioning device to retract along with the delivery device.

[0008] In particular, the device according to the invention can be fixedly connected to a delivery device for medical implants.

[0009] Those skilled in the art will understand that the positioning device according to the invention is not designed or adapted to remain inside a patient's body. Therefore, unlike prior art medical implants, it is adapted to be removed in a simple manner at any time, especially during the same treatment as its deployment. However, the positioning device is certainly also suitable for deployment with medical implants, particularly facilitating the deployment of implants known in the art.

[0010] By engaging at the defect site, the positioning device provides or indicates anchoring points for the delivery device or implant. Therefore, if the position of any part of the delivery device or implant relative to the positioning device is known, its position relative to the defect site can be inferred. Furthermore, anchoring at the defect site eliminates the need to monitor the precise position of the delivery device relative to the defect site.

[0011] Preferably, the positioning device includes a balloon. Specifically, the balloon can be positioned in a deployed state such that it is located at a defect site different from the distal portion. In particular, the balloon can be located on different sides of the foramen ovale (PFO).

[0012] This allows the operator or user to provide a reaction force to the balloon. For example, if the balloon is used to press a medical implant against a tissue wall to close a defect, the positioning device can provide a reaction force to assist in deployment.

[0013] Preferably, the positioning device comprises at least one filament. The filament has at least a first shape and a second shape. For example, the first shape may be adapted to allow easy transfer through the defect, and the second shape may be adapted to allow engagement at the defect.

[0014] Preferably, the second shape is generally planar. This is particularly advantageous for engaging the positioning device at the implantation site and providing a uniform reaction force. Alternatively, the first shape may be substantially linear to allow for easy transfer through the defect.

[0015] Preferably, the positioning device includes an actuation mechanism to pull back a distal portion of the positioning device relative to the rest of the positioning device. The actuation mechanism may in particular be a mechanical actuation mechanism. In a particularly preferred embodiment, the actuation mechanism includes a pull cable. For example, the pull cable may be operatively connected to the distal portion of the positioning device such that pulling the pull cable directly pulls back the distal portion relative to the rest of the positioning device.

[0016] Preferably, at least one filament is moved from its first shape to its second shape by actuation of the actuation mechanism.

[0017] Preferably, the second shape is selected from the group consisting of spiral, disc, and star shapes.

[0018] Preferably, the positioning device comprises a tubular structure, and more preferably a hypotube.

[0019] A hypothetical hypothetical tube should be understood as a thin, hollow structure similar to a hypodermic needle. Unlike a hypodermic needle, a hypothetical tube does not necessarily include a sharp tip. However, it can also be inserted perforated. Hypothetical tubes can be made of or constructed from various materials, depending on the desired mechanical properties. The use of hypothetical tubes made of biocompatible materials is particularly advantageous. In particular, hypothetical tubes made of metals or polymers are very suitable for this application.

[0020] Preferably, the tubular structure is made of shape memory material, or even more preferably of nickel-titanium alloy.

[0021] Preferably, the tubular structure includes at least one slit. Preferably, the at least one slit is arranged such that it forms at least one support rod that can extend away from the tubular structure. The support rod may also include a first shape and a second shape, and engages at the defect location with its second shape.

[0022] Preferably, at least one slit is adapted to allow at least one filament to unfold through the slit. In particular, the filament may be adapted to be arranged in a first shape within the tubular structure and to expand away from the tubular structure in a second shape.

[0023] Preferably, at least one slit extends spirally around the circumference and longitudinal axis of the tubular structure. In this arrangement, if a portion of the tubular structure is rotated, at least one support rod can extend away from the tubular structure. In particular, for example by applying a torque, the distal portion of the tubular structure can rotate about the longitudinal axis of the tubular structure and relative to the tubular structure and / or the positioning device.

[0024] The present invention also relates to a delivery device.

[0025] The delivery device according to the invention includes the positioning device described herein. Preferably, the delivery devices are concentrically mounted above the positioning device. They are axially movable relative to each other and share a common axis, particularly a longitudinal axis. This can be achieved, for example, by arranging the positioning device in a dedicated tube within the delivery device. This allows the delivery devices to move along the axis of the positioning device.

[0026] The present invention also relates to a method for delivering a medical implant into the human body. The method according to the invention is particularly advantageous for delivering a medical implant to an opening in the ventricular wall or atrial wall. The method comprises the following steps:

[0027] - Delivery positioning devices, especially the positioning devices described herein, pass through openings in tissue, particularly through openings in the atrial or ventricular walls.

[0028] - Engage the positioning device at the opening

[0029] -Delivering medical implants

[0030] - Detach and remove the positioning device while leaving the implant in the body.

[0031] Preferably, the positioning device is retracted via a medical implant.

[0032] The positioning device may include portions having a first shape and a second shape. Engaging the positioning device at the opening may include positioning the portion in its second shape. Preferably, it may be adapted to return to its first shape before retraction.

[0033] Optionally, the method may also include the step of applying a longitudinal force or torque, in particular moving a portion of the positioning device from the first shape to the second shape. Attached Figure Description

[0034] The invention will now be described in detail with reference to the following accompanying drawings, which illustrate:

[0035] Figure 1 : A schematic diagram of a positioning device including a tubular structure.

[0036] Figures 2a to 2b : An embodiment of a positioning device in the delivery state and the engagement state.

[0037] Figure 3: Alternative embodiments of the positioning device in the deployment state and the deployed state.

[0038] Figures 4a to 4c Another alternative embodiment of the positioning device in the deployment and deployed states is shown, with a top view.

[0039] Figures 5a to 5c Different embodiments of the distal portion of the positioning device.

[0040] Figures 6a to 6b Another alternative embodiment of the positioning device in the deployment state and the already deployed state.

[0041] Figures 7a to 7b Another alternative embodiment of the positioning device in the deployment state and the already deployed state.

[0042] Figure 8 : Figures 7a to 7b A detailed view of the distal portion of the positioning device shown.

[0043] Figure 9 : A cross-sectional view along the longitudinal axis of the distal portion of the positioning device.

[0044] Figure 10 Another alternative embodiment of the positioning device.

[0045] Figure 11 Positioning device combined with delivery device. Detailed Implementation

[0046] Figure 1 An embodiment of a positioning device 1 according to the invention is shown. The positioning device comprises a tubular structure 5 in the form of a thiocyanate tube made of metallic material. The distal portion 8 of the positioning device includes a laser-cut slit 2. Alternative methods can also be used to form the slit within the thiocyanate tube. An anchor (not shown) that engages with tissue can be deployed in the slit. However, in the arrangement shown, the anchor is placed within the thiocyanate tube and may not be engaged. Therefore, the positioning device can be conveyed through an opening in the atrial wall. Similarly, retracting the anchor into the slit allows the device 1 to retract through the same defect.

[0047] Figure 2a and Figure 2b An alternative embodiment of the positioning device 1 is shown. The positioning device includes a polymer sodium thiosulfate tube 5 with six slits 2 evenly distributed around the circumference of the tube 5 and cut along the longitudinal axis L. In the perspective view shown, only two of the six slits 2 are visible. Six support rods 3 are formed between these slits. Therefore, the support rods 3 and the tubular structure 5 are integrally formed. Figure 2a In this configuration, positioning device 1 is in a deployed state, meaning its distal portion 8 can be deployed through an opening, such as through a PFO. Figure 2b In this configuration, the positioning device 1 is in its deployed state, with the distal portion 8 capable of engaging tissue to anchor the positioning device. In this embodiment, a longitudinal force 4 can be used as the actuation mechanism. Any mechanism that allows the application of this longitudinal force 4 can be used, such as a spring, a pull wire, a screw with a nut, or even an electric or magnetic mechanism. By applying the longitudinal force 4, the distal portion 8 moves relative to the rest of the positioning device. The support rod 3 thus extends away from the positioning device, forming six arms extending beyond the positioning device. In this state, the distal portion 8 of the positioning device is too large to move through an opening such as a PFO. Therefore, if a longitudinal force is applied after deployment through said opening, the positioning device 1 engages with the wall and prevents the positioning device from being withdrawn from the opening.

[0048] Figure 3a and Figure 3b An alternative embodiment of positioning device 1 is shown. This device essentially corresponds to... Figure 2a and Figure 2b The device described and shown also includes a wave tube 5 with a slit 2 forming a support rod 3. However, in this embodiment, the slit 2 extends spirally along the circumference and longitudinal axis L of the wave tube 5. When not actuated, the overall shape of the positioning device 1 substantially corresponds to the shape of the wave tube 5, such as... Figure 3aAs shown. The spiral slit 2 allows the distal portion 8 to rotate 6 relative to the positioning device 1, causing the support rod 3 to expand. Therefore, instead of as Figure 2b The longitudinal force shown is actuated by an applied torque in this embodiment. Upon rotation 6, the support rod 3 expands, thus engaging the opening at the distal portion 8 of the positioning device 1.

[0049] Figures 4a to 4c An alternative embodiment of the positioning device according to the invention is also shown. This positioning device includes a tubular structure 5, in this case, a surgical steel hypotube. It also includes four slits 2 evenly distributed along the circumference of the hypotube 5. Four wires 7 are arranged within the wall of the hypotube, such that the wires... Figure 4a The deployment shown is substantially parallel to and overlaps with slit 2. In this embodiment, the filament is made of a nickel-titanium alloy with shape memory properties. Therefore, for example, due to temperature rise caused by exposure to human body temperature, the filament 7 is positioned in its second shape and expands away from the positioning device 1 and the hysteresis tube 5 through multiple slits 2. Thus, the distal portion 8 can engage with the wall around the opening and anchor the positioning device 1. Figure 4c A top view of the positioning device 1 in its deployed state is shown (viewed from the far side to the near side). The wire 7 extends away from the hysteresis tube 5 and around the circumference of the positioning device at a 90-degree angle. o The angle is evenly distributed.

[0050] Figure 5a , Figure 5b and Figure 5c Different embodiments of the distal portion 8 of the positioning device 1 are illustrated schematically. Figure 5a The distal portion, comprising a helical filament, is shown. This arrangement is particularly advantageous because the helical shape allows for easy compression within the outer sheath of, for example, a hypodermic tube or other tubular structure. Specifically, if the distal portion is made of an elastic material such as nickel-titanium, it can be compressed like a helical spring. Furthermore, shape memory properties can be utilized, such as restoring the helix to its initial shape, enabling the distal portion to retract through the medical implant and opening. However, those skilled in the art will understand that the shape of the distal portion depicted herein is not limited to a specific actuation mechanism, but merely illustrates different embodiments of the distal portion. Therefore, Figure 5a The helix shown can also expand under other mechanical or electrodynamic forces. Alternatively, the distal portion can be arranged as a helical spring, where the relaxed shape is the first shape for deployment and requires force to expand. This arrangement will facilitate the retraction of the distal portion 8 by simply restoring its initial shape when the applied force is stopped.

[0051] Figure 5bA different embodiment 1 with a star-shaped distal portion 8 is shown. An advantage of this embodiment is that the five rods forming the star can be rotatably mounted along an axis orthogonal to the longitudinal axis of the positioning device 1. For example, the rods to be formed into the star can be arranged parallel to the longitudinal axis during deployment and are orthogonal in the deployed state. It can also consist of more or fewer than five rods as shown herein, depending on the space constraints of the intended application.

[0052] Figure 5c Another embodiment is shown, in which the distal portion 8 comprises a flat plate made of a polymer. The polymer is a shape memory polymer and / or a flexible polymer for ease of deployment. Of course, the flat plate can also be made from different materials with similar mechanical properties, such as metals.

[0053] Figure 6a and Figure 6b An embodiment of the positioning device 1 is shown, which includes a balloon 10 in its distal portion 8. The positioning device 1 also includes a tubular structure 5. However, this tubular structure has a closed end 13, preventing it from fluidly communicating with its surroundings. Instead, the tubular structure includes a plurality of orifices 9 on its sidewalls. The balloon 10 is arranged around the sidewalls of the tubular structure such that all the orifices 9 are within the balloon. The balloon is sealed, preventing fluid communication between the inside of the balloon and its outside. Figure 6a The deployment state of the positioning device is shown, which has a substantially linear external shape that can be unfolded through an opening such as a PFO. Figure 6b The image shows the deployed state, with fluid pressurized through orifice 9 and filling balloon 10. The balloon's expansion diameter prevents it from retracting through the opening and thus engaging with the positioning device. Balloon 10 can be elastic, allowing the surgeon more flexibility to apply greater pressure to the fluid to inflate the balloon to the desired size. However, non-elastic materials can also be used. In this case, the expansion size of balloon 10 cannot be changed.

[0054] Figure 7a and Figure 7bAnother embodiment of the positioning device 1 according to the invention is shown. Tubular structures 5a and 5b are divided into two parts, with one part 5b arranged in the distal portion 8. The two parts of the tubular structure are connected by four elastic wires 7. Furthermore, a pull wire 11 is connected to the distal portion 8, particularly the two distal portions of the tubular structure 5b. Pulling the pull wire causes the distal portion 8 to be pulled closer relative to the rest of the positioning device 1, thereby bending the wires to form partial loops extending from the positioning device. These partial loops are adapted to contact the tissue surrounding the opening, thereby positioning the positioning device 1. The positioning device 1 can be easily placed in its initial position by releasing the pull wire 11. The elasticity of the bent wires 7 pushes the distal portion 8 back to its initial position. Those skilled in the art will understand that the pull wire 11 is a mechanism very suitable for actuating the bending of the wires. However, any other mechanism, such as a helical mechanism, spring mechanism, hydraulic mechanism, or electric or magnetic device, can also be used to move the distal portion 8 closer to the positioning device 1.

[0055] Figure 8 It shows Figure 7a and Figure 7b A more detailed view of the distal portion 8 of the positioning device shown. The tubular structures 5a and 5b comprise two sections connected by four wires 7 and a draw wire 11. Additional features of the wires 7 are clearly visible in this illustration. To facilitate bending of the wires 7 by pulling the draw wire 11, each wire 7 includes a groove 12. Here, the groove has a tangential and spherical cut on the inside of the wire 7. However, other shapes may also be used. For example, a tangential cut may be more suitable for a particular application. Alternatively, a simple cut on the outside of the wire may also be used. The groove 12 reduces the force required to pull the distal portion 8 back relative to the positioning device 1. Furthermore, it allows for better control over the most prominent point of the wire bending. By using multiple grooves, the shape of the wire 7 can also be controlled when the draw wire 11 is actuated. For example, each wire 7 with two grooves 12 would form a rectangular rather than spherical wire 7. The positioning device 1 shown here has a diameter of approximately 1 millimeter (mm), but this diameter may be larger or smaller depending on the defect to be treated. The diameter of each wire 7 is 0.15 mm, and the length of the wire 7 connecting the distal portion and the remainder of the positioning device 5a is 1 cm. Of course, these values ​​can be changed to suit a specific application, but they should not be construed as limitations of the invention.

[0056] Figure 9 It shows the relationship with Figure 7a , Figure 7b and Figure 8The cross-section of the distal portion 8 is shown in a similar manner. Unlike the positioning device shown in these figures, the embodiment shown here comprises twelve filaments 7 instead of four. This allows for a stronger bond, while each individual filament 7 exerts less force on the tissue. Therefore, this embodiment is particularly advantageous for sensitive tissues. Except for the number of filaments 7, this embodiment is identical to the embodiments described and referenced above. It also includes a pull wire 11 connected to the tubular structure 5 for pull-back. Similarly, the filaments 7 are connected to the tubular structure 5.

[0057] Figure 10 Different embodiments of the positioning device 1 are shown, which include a balloon 10. Here, the balloon 10 is arranged in a deployed state, located on a side different from the distal portion relative to the opening and the wall being treated of the positioning 14. Here, the distal portion 8 is similar to... Figure 5b The star-shaped filament arrangement is described. However, the distal portion 8 can of course be any distal portion described herein. This particular arrangement allows the distal portion 8 to act as a reaction force against the balloon 10. For example, if the positioning device 1 is used to assist in the deployment of a patch-like medical implant, the balloon 10 can apply force to the medical implant as the distal portion pushes the medical implant back.

[0058] Figure 11 A combination of a delivery device 16 and a positioning device 1 is shown. The delivery device 16 includes a balloon 10 to which an implant 15 can be attached. Here, the delivery device 16 includes an inner tube that extends through the balloon 10 and yields in an orifice 17 on the surface of the balloon. This allows the positioning device 1 to be deployed and retracted regardless of the balloon's inflation state. However, those skilled in the art will certainly understand that the delivery device can be adapted to be combined with the positioning device in any other manner. Therefore, the illustrated embodiment should not be construed as a limitation of the invention. The positioning device 1 is similar to... Figure 2a and 2b One of the devices shown is a positioning device comprising a metal tube (in this case, made of titanium) and a laser-cut strut 3. A pull wire 11 is located inside the tube. By pulling the pull wire 11, the distal portion 8 of the positioning device moves along the longitudinal axis of the delivery device 16 toward the balloon 10. This causes the strut 3 to expand. The system shown is particularly advantageous for treating defects in the atrial wall. The positioning device is adapted for delivery through said defect (not shown) and engages with tissue as the strut 3 expands away from the longitudinal axis. The area 14 of the positioning device can be positioned in the atrial defect during delivery. An implant 15 can be attached to the defect to close it, after which the positioning device 1 can be retracted by releasing the pull wire to allow the positioning device 1 to return to a substantially linear shape and retract through the orifice 17 of the implant 15.

Claims

1. A positioning device (1) for a delivery system for deploying a medical implant, comprising a distal portion (8) adapted to deliver through an opening in a defect, preferably a ventricular wall, atrial wall, or vascular wall, wherein the positioning device includes a mechanism for selectively expanding the distal portion (8) such that the distal portion (8) is adapted to be deployed through the defect prior to expansion, and upon expansion, mechanically preventing retraction through the same defect, thereby temporarily engaging the positioning device (1) at the defect site, and the distal portion is adapted to retract through the medical implant such that upon deployment of the implant, the positioning device (1) retracts along with the delivery device.

2. The positioning device (1) according to claim 1, wherein the positioning device includes a balloon (10), the balloon (10) preferably being arranged in a deployed state such that the balloon (10) is located on the side of the defect that is different from the distal portion (8).

3. The positioning device (1) according to any one of the preceding claims, wherein the distal portion (8) of the positioning device (1) comprises at least one filament (7) having a first shape and a second shape.

4. The positioning device (1) according to claim 3, wherein the second shape is generally planar.

5. The positioning device (1) according to any one of claims 3 or 4, wherein the positioning device (1) includes an actuation mechanism, preferably a mechanical actuation mechanism, and even more preferably a pull wire (11), for pulling back the distal portion of the positioning device (1) relative to the positioning device (1).

6. The positioning device (1) according to claim 5, wherein the positioning device (1) is adapted to move the at least one filament (7) from a first shape to a second shape by actuation of the actuation mechanism.

7. The positioning device (1) according to any one of claims 3 to 6, wherein the second shape is selected from the group consisting of spiral, disc, and star.

8. The positioning device (1) according to any one of the preceding claims includes a tubular structure (5), preferably a hyaluronic acid tube.

9. The positioning device (1) according to claim 8, wherein the tubular structure (5) is made of a shape memory material, preferably a nickel-titanium alloy.

10. The positioning device (1) according to any one of claims 8 or 9, wherein the tubular structure (5) includes at least one slit (2).

11. The positioning device (1) according to claim 10, wherein the at least one slit (2) is arranged to form at least one support (3) capable of expanding away from the tubular structure (5).

12. The positioning device (1) according to claim 10 or any one of claims 3 to 7, wherein the at least one slit (2) is adapted to allow the at least one wire (7) to be deployed through the slit (2).

13. The positioning device (1) according to any one of claims 8 to 12, wherein the at least one slit (2) extends spirally about the circumference and longitudinal axis (L) of the tubular structure (5), such that the at least one of the support rods (3) can expand away from the tubular structure (5) by rotation of a portion of the tubular structure (5).

14. A catheter device, characterized in that, The catheter device includes a positioning device (1) according to any one of claims 1 to 12.

15. A method for delivering a medical implant into the human body, particularly through an opening into the wall of the ventricle or atrium, comprising the following steps: -Delivery positioning device (1), especially the positioning device according to any one of claims 1 to 13, which passes through an opening in the atrial wall or blood vessel wall; -The positioning device engages at the opening; -Deliver the medical implant; - Disconnect the positioning device (1).

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