Catheter assembly lock

Abstract

A medical device for use in a catheter assembly including an elongate catheter coaxially disposed within a sheath is disclosed. The medical device includes a deformable tube having a proximal end, a distal end, an outer wall having an outer diameter, and an inner wall forming an axial lumen. The distal end is attached to the sheath, and the proximal end receives the catheter within the lumen. The medical device also includes opposing paddles disposed relative to the outer wall, each having a generally planar locking region disposed relative to the outer wall at the outer diameter, the locking surface being tangential to the deformable tube. The opposing paddles are movable laterally relative to the deformable tube at locations along the outer diameter.

Description

[Technical Field]

[0001] This disclosure generally relates to medical systems and methods for using catheter assemblies. More specifically, this disclosure relates to medical systems and methods for locking catheter assemblies in the correct position within a patient during a procedure. [Background technology]

[0002] Medical devices in the form of catheter systems are widely used in a variety of medical procedures to access remote anatomical locations or to deploy therapeutic devices. For example, electrophysiological procedures involve guiding a catheter assembly into the heart and tracking the position of the catheter assembly relative to the heart. Catheter ablation is a minimally invasive electrophysiological procedure for treating various cardiac diseases, such as supraventricular and ventricular arrhythmias. Cardiac mapping with a catheter is another minimally invasive electrophysiological procedure for identifying temporal and spatial potentials during cardiac rhythm. A catheter assembly, including a catheter assembly in an electrophysiological procedure, may include multiple catheter elements such as a catheter, sheath, guidewire, and needle. For example, a catheter assembly may include a long catheter in a long sheath. Access to the patient's heart can be achieved through a blood vessel (e.g., peripheral artery or vein) via a large-bore sheath or introducer sheath. Once access to the blood vessel is obtained, the catheter assembly can be guided into the patient's heart, and the catheter can be selectively deployed from within the sheath. [Overview of the Initiative]

[0003] Example 1 describes a medical device for use in a catheter assembly including a long catheter coaxially arranged within a sheath. The medical device includes a deformable tube having a proximal end, a distal end, an outer wall having an outer diameter, and an inner wall forming an axial lumen, the distal end being configured to be attached to a sheath, and the proximal end being configured to receive a catheter into the lumen. The medical device also includes a plurality of opposing paddles positioned against the outer wall, each of which has a substantially planar locking area configured to be positioned against the outer wall in its outer diameter, the locking surface being positioned tangentially to the deformable tube, and the plurality of opposing paddles being laterally movable relative to the deformable tube in a position along the outer diameter. The medical device has a first compression state in which the catheter is coaxially positioned within the sheath, and a plurality of opposing paddles are releasably urged against a deformable tube in its outer diameter, collapsing the deformable tube and holding the catheter in place relative to the sheath and the deformable tube, with the collapsed deformable tube forming a long opening along the inner wall and the catheter. The medical device has a second compression state in which the catheter is not coaxially positioned within the sheath and has been removed from the deformable tube, and a plurality of opposing paddles are releasably pressed against a deformable tube in its outer diameter, collapsing the deformable tube and sealing the lumen.

[0004] In Example 2, the catheter assembly is integrated into the medical device, as in Example 1. In Example 3, the catheter assembly is configured to perform irreversible electroporation in one of the medical devices in Examples 1 or 2.

[0005] Example 4 further comprises a nominal state in any of the medical devices in Examples 1 to 3, in which the catheter is coaxially positioned within the sheath and the catheter is movable relative to the sheath and the deformable tube.

[0006] In Example 5, the medical device of Example 4 has a circular cross-section in the standard state. In Example 6, in the medical device of Example 5, the locking area includes height, the inner wall includes circumference, and the height is at least half of the circumference.

[0007] In Example 7, in any of the medical devices of Examples 4-5, the inner wall includes an elliptical cross-section in the first compressed state. In Example 8, the medical device in any of Examples 1-7 includes two opposing paddles.

[0008] In Example 9, the locking regions are approximately parallel to each other in the medical device of Example 8. In Example 10, in any of the medical devices in Examples 1-9, the locking region forms an overlapping region on the deformable tube.

[0009] In Example 11, in the medical device of Example 10, the inner wall related to the overlapping region grips the catheter in the first compression state. In Example 12, in any of the medical devices of Examples 10-11, the inner wall associated with the overlapping region seals the lumen in the second compression state.

[0010] In Example 13, in any of the medical devices from Examples 10 to 12, the proximal and distal ends are positioned with a gap between them and the overlapping region. In Example 14, in any of the medical devices of Examples 1 to 13, the proximal end includes a proximal hub configured to guide the catheter into the lumen, and the distal end includes a distal hub configured to be attached to a sheath.

[0011] Example 15 further comprises a drive mechanism operably connected to a plurality of opposing paddles in any of the medical devices of Examples 1 to 14, the drive mechanism being configured to move the plurality of opposing paddles laterally relative to a deformable tube.

[0012] Example 16 describes a medical device for use in a catheter assembly including a long catheter coaxially positioned within a sheath. The medical device includes a deformable tube having a proximal end, a distal end, an outer wall having an outer diameter, and an inner wall forming an axial lumen, the distal end being configured to be attached to a sheath, and the proximal end being configured to receive a catheter within the lumen. The medical device also includes a plurality of opposing paddles positioned against the outer wall, each of the plurality of opposing paddles having a substantially planar locking area configured to be positioned against the outer wall in its outer diameter, the locking surface being positioned tangentially with respect to the deformable tube, and the plurality of opposing paddles being movable laterally with respect to the deformable tube at positions along the outer diameter. The medical device has a first compressed state in which the catheter is coaxially positioned within the sheath, the plurality of opposing paddles are releasably pressed against the deformable tube in its outer diameter, crushing the deformable tube to hold the catheter in place relative to the sheath and the deformable tube, the crushed deformable tube forming a long opening along the inner wall and the catheter. The medical device has a second compression state in which the catheter is not coaxially positioned within the sheath and is detached from the deformable tube, and multiple opposing paddles are releasably pressed against the deformable tube in terms of outer diameter, thereby crushing the deformable tube and sealing the lumen.

[0013] In Example 17, the medical device of Example 16 further comprises a baseline state in which the catheter is coaxially positioned within the sheath and the catheter is movable relative to the sheath and the deformable tube.

[0014] In Example 18, the medical device of Example 17 has an inner wall with a circular cross-section in the standard state. In Example 19, in the medical device of Example 18, the locking area includes height, the inner wall includes circumference, and the height is at least half of the circumference.

[0015] In Example 20, the medical device of Example 18 has an elliptical cross-section in the first compression state. In Example 21, in the medical device of Example 16, the locking region forms an overlapping region on the deformable tube, and the proximal and distal ends are positioned at a distance from the overlapping region.

[0016] In Example 22, the medical device of Example 16 further comprises a drive mechanism operably connected to a plurality of opposing paddles, the drive mechanism configured to move the plurality of opposing paddles laterally relative to a deformable tube.

[0017] In Example 23, the medical device of Example 16 has a proximal end which includes a proximal hub configured to guide the catheter into the lumen, and a distal end which includes a distal hub configured to be attached to a sheath.

[0018] In Example 24, in the medical device of Example 16, the multiple opposing paddles include two opposing paddles, and the locking regions are substantially parallel to each other. In Example 25, the medical system includes a catheter assembly having a long catheter that can be coaxially disposed within a sheath, and a locking mechanism. The locking mechanism includes a deformable tube and a plurality of opposing paddles. The deformable tube has a proximal end, a distal end, an outer wall having an outer diameter, and an inner wall forming an axial lumen. The distal end is configured to be attached to the sheath, and the proximal end is configured to receive the catheter within the lumen. The plurality of opposing paddles are disposed relative to the outer wall, and each of the plurality of opposing paddles has a generally planar locking region configured to be disposed relative to the outer wall at the outer diameter. The locking surface is disposed tangentially relative to the deformable tube, and the plurality of opposing paddles are movable laterally relative to the deformable tube at a position along the outer diameter. The medical system has a first compressed state in which the catheter is coaxially disposed within the sheath, and the plurality of opposing paddles are releasably pressed against the deformable tube at the outer diameter to crush the deformable tube and hold the catheter in a predetermined position relative to the sheath and the deformable tube, and the crushed deformable tube forms an elongated opening along the inner wall and the catheter. The medical system has a second compressed state in which the catheter is not coaxially disposed within the sheath and is removed from the deformable tube, and the plurality of opposing paddles are releasably pressed against the deformable tube at the outer diameter to crush the deformable tube and seal the lumen.

[0019] In Example 26, in the medical system of Example 25, the catheter assembly is configured to perform irreversible electroporation. In Example 27, the medical system of Example 25 further includes a reference state in which the catheter is coaxially disposed within the sheath and the catheter is movable relative to the sheath and the deformable tube.

[0020] In Example 28, the medical system of Example 25 further includes a drive mechanism operably coupled to a plurality of paddles, the drive mechanism being configured to laterally move the plurality of opposing paddles relative to the deformable tube.

[0021] In Example 29, a method for use in a catheter assembly having an elongate catheter coaxially disposed within a sheath. A medical device is provided. The medical device includes a deformable tube having a proximal end, a distal end, an outer wall having an outer diameter, and an inner wall forming an axial lumen, the distal end being configured to be attached to the sheath and the proximal end being configured to receive the catheter within the lumen. The medical device also includes a plurality of opposing paddles disposed relative to the outer wall, each of the plurality of opposing paddles having a generally planar locking region configured to be disposed relative to the outer wall at the outer diameter, the locking surface being disposed tangentially relative to the deformable tube, and the plurality of opposing paddles being laterally movable relative to the deformable tube at positions along the outer diameter. The catheter is coaxially disposed within the sheath. The plurality of opposing paddles are releasably pressed against the deformable tube at the outer diameter to crush the deformable tube and hold the catheter in a predetermined position relative to the sheath and the deformable tube, the crushed deformable tube forming an elongate opening along the inner wall and the catheter. The catheter is removed from the deformable tube. The plurality of opposing paddles are releasably pressed against the deformable tube at the outer diameter to crush the deformable tube and seal the lumen.

[0022] In Example 30, the method of Example 29 further includes flowing fluid through the elongate opening. In Example 31, in the method of Example 30, providing the medical device includes providing a deformable tube having an inner wall with a circular cross-section, and holding the catheter in a predetermined position relative to the sheath includes shaping the cross-section to be elliptical to form the elongate opening.

[0023] In Example 32, the method of Example 29 includes forming an overlapping region on a deformable tube. In Example 33, in the method of Example 32, holding the catheter in a predetermined position relative to the sheath includes clamping the catheter with the inner wall relating to the overlapping region.

[0024] In Example 34, in the method of Example 32, sealing the lumen by crushing the deformable tube includes crushing the deformable tube in the overlapping region. In Example 35, preparing the medical device in the method of Example 29 includes preparing a proximal hub attached to the proximal end, and the method further includes guiding the catheter into the lumen via the proximal hub.

[0025] While several embodiments are disclosed, further embodiments of the Disclosure will become apparent to those skilled in the art from the following detailed description illustrating and describing exemplary embodiments of the Disclosure. Accordingly, the drawings and detailed description should be considered illustrative and not restrictive. [Brief explanation of the drawing]

[0026] [Figure 1] This figure shows an exemplary clinical environment with an exemplary electrophysiological system for treating a patient and treating the patient's heart. [Figure 2] Figure 1 is a schematic diagram showing an exemplary catheter assembly locking mechanism for use in an exemplary electrophysiological system. [Figure 3A] Figure 2 is a schematic diagram showing various exemplary states of an exemplary cross-section of an exemplary catheter assembly locking mechanism. [Figure 3B] Figure 2 is a schematic diagram showing various exemplary states of an exemplary cross-section of an exemplary catheter assembly locking mechanism. [Figure 3C] Figure 2 is a schematic diagram showing various exemplary states of an exemplary cross-section of an exemplary catheter assembly locking mechanism. [Figure 4A]This is a perspective view of an exemplary catheter assembly locking mechanism for use in the exemplary electrophysiological system shown in Figure 1, in the state of Figure 3A. [Figure 4B] This is a perspective view of an exemplary catheter assembly locking mechanism for use in the exemplary electrophysiological system of Figure 1, in the state shown in Figure 3B. [Figure 4C] This is a perspective view of an exemplary catheter assembly locking mechanism for use in the exemplary electrophysiological system of Figure 1, in the state shown in Figure 3C. [Figure 5A] Figure 4A is an exemplary top view of the catheter assembly locking mechanism in the state shown in Figure 4A. [Figure 5B] Figure 4B is a top view of an exemplary catheter assembly locking mechanism in the state shown in Figure 4B. [Figure 5C] Figure 4C is a top view of an exemplary catheter assembly locking mechanism in the state shown. [Figure 6A] Figure 5A shows an exemplary top cross-sectional view of the catheter assembly locking mechanism in its current state. [Figure 6B] Figure 5B shows an exemplary top cross-sectional view of the catheter assembly locking mechanism in its current state. [Figure 6C] Figure 5C is an exemplary top cross-sectional view of the catheter assembly locking mechanism in its current state. [Figure 7A] This is a cross-sectional side view of an exemplary catheter assembly locking mechanism in the state shown in Figure 4A. [Figure 7B] Figure 4B is a cross-sectional side view of an exemplary catheter assembly locking mechanism in the state shown. [Figure 7C] Figure 4C is a cross-sectional side view of an exemplary catheter assembly locking mechanism in the state shown. [Modes for carrying out the invention]

[0027] While this disclosure can be adapted to various modifications and alternative forms, specific embodiments are shown in the drawings as examples and are described in detail below. However, the intent is not to limit this disclosure to the specific embodiments described. Rather, this disclosure is intended to encompass all modifications, equivalents, and alternative forms that fall within the scope of this disclosure as defined by the appended claims.

[0028] For the purpose of facilitating an understanding of the principles of this disclosure, examples shown in the drawings described below will be referenced. The exemplary examples disclosed herein are not intended to be exhaustive or to limit this disclosure to the exact forms disclosed for carrying out the inventions described below. Rather, these exemplary embodiments are selected and described so that those skilled in the art can use their teachings. It is not beyond the scope of this disclosure to use multiple (e.g., all) features across all examples. Accordingly, no drawing should be construed as having any dependencies or requirements relating to any single component or combination of components shown. In addition, various components shown in the drawings may, in some examples, be integrated with various other components shown (or not shown), all of which are considered to be within the scope of this disclosure.

[0029] Examples of electrophysiological procedures and systems in electroanatomical mapping systems and cardiac ablation systems using catheter assemblies are described in this disclosure, along with electrophysiological testing and ablation systems, for illustrative purposes. Ablation procedures are used to treat many different conditions in patients. Ablation may be used to treat cardiac arrhythmias, benign tumors, cancerous tumors, and to control bleeding during surgery. Typically, ablation is performed by thermal ablation techniques, including radiofrequency (RF) ablation and cryoablation. In RF ablation, a probe is inserted into the patient, and radiofrequency waves are transmitted through the probe to the surrounding tissue. The radiofrequency waves generate heat, which destroys the surrounding tissue and cauterizes the blood vessels. In cryoablation, a hollow needle or cryoprobe is inserted into the patient, and a cold, thermoconductive fluid is circulated through the probe, freezing and killing the surrounding tissue. RF ablation and cryoablation techniques can indiscriminately kill tissue by cell necrosis, which can damage or kill other healthy tissues, such as tissues in the esophagus, phrenic nerve cells, and tissues in the coronary arteries.

[0030] Another ablation technique uses electroporation. In electroporation, or electro-permeabilization, an electric field is applied to cells to increase the permeability of the cell membrane. Electroporation can be reversible or irreversible depending on the strength and duration of the electric field. If electroporation is reversible, the temporarily increased permeability of the cell membrane can be used to introduce chemicals, drugs, or deoxyribonucleic acid (DNA) into the cells before cell healing and recovery. Tissue recovery can occur over minutes, hours, or days after the ablation is complete. If electroporation is irreversible, the affected cells die, for example, through a form of cell death (e.g., programmed cell death via apoptosis, or traumatic cell death via necrosis).

[0031] Irreversible electroporation can be used as a non-thermal ablation technique. In irreversible electroporation, a short-duration high-voltage pulse train is used to generate an electric field strong enough to kill cells. In cardiac tissue ablation, irreversible electroporation may be a relatively safe and effective alternative to the indiscriminate cell death of thermal ablation techniques such as RF ablation and cryoablation. While irreversible electroporation can be used to kill target tissues such as myocardial tissue, it can also be used to kill target tissues by selecting electric field strengths and durations that are not effective in permanently killing other cells or tissues such as non-target myocardial tissue, red blood cells, vascular smooth muscle tissue, endothelial tissue, and nerve cells.

[0032] Such exemplary electrophysiological procedures often involve guiding a catheter assembly into the patient's heart. Access to the patient's heart can be achieved through a blood vessel via an introducer sheath. Once access to the blood vessel is obtained, the catheter assembly can be guided into the patient's heart. Other examples of procedures using large-bore sheaths include transcatheter aortic valve replacement, endovascular aneurysm repair, and mechanical circulatory support devices that employ large-bore access for deployment. However, the current use of large-bore sheaths involves issues related to air entry during device introduction and removal. To address the problem of air entry, clinicians use informal methods such as high-flow flushing, aspiration, and water baths to mitigate the risk of complications, including air embolism.

[0033] Figure 1 illustrates an exemplary clinical environment 10 for treating a patient 20 (for example, to treat the heart 30 of patient 20) using an electrophysiological system 50 according to this disclosure. The electrophysiological system 50 includes an ablation catheter system 60 and an electroanatomical mapping (EAM) system 70. The exemplary catheter system 60, in this example, includes a long catheter assembly 100 containing a catheter 105 in a sheath, an introducer sheath 110, a locking mechanism 120, and a console 130. The electroporation console 130 is configured to control an aspect of the electroporation catheter system 60. In addition, the catheter system 60 includes various connecting elements (e.g., cables) that operably connect the components of the catheter system 60 to each other and to the components of the EAM system 70. Generally, the EAM system 70 includes a localization field generator 80, a mapping and navigation controller 90, and a display 92. The EAM system 70 can track the positions of various components of the catheter system 60 and operate to generate a high-fidelity three-dimensional electroanatomical map of the heart, including parts of the heart (e.g., chambers of interest or other structures of interest (e.g., sinoatrial node or atrioventricular node)) from a catheter or probe equipped with sensing electrodes. In one exemplary example, the EAM system 70 may include the RHYTHMIA® HDx mapping system, marketed by Boston Scientific Corporation. One exemplary probe is the INTELLAMAP ORION® mapping catheter, marketed by Boston Scientific Corporation. The clinical environment 10 may also include additional equipment (e.g., imaging equipment 94 (represented by a C-arm)) and various controller elements (e.g., foot controller 96) configured to allow the operator to control various aspects of the electrophysiological system 50.The clinical environment 10 may have other components and arrangements of components not shown in Figure 1.

[0034] The introducer sheath 110 is operable to provide a delivery conduit through which the catheter assembly 100 can be deployed to a specific target site within the patient's heart 30. Access to the patient's heart can be made through a blood vessel (e.g., a peripheral artery or vein). Once access to a blood vessel is obtained, the catheter assembly 100 can be guided into the patient's heart (e.g., into a cardiac chamber). The locking mechanism may be a separate component of the catheter system 60 or a feature of another component, such as the introducer sheath 110 or other components.

[0035] An exemplary catheter 105 includes a long catheter shaft and a distal end configured to deploy near a target tissue (e.g., within the patient's heart chambers). The distal end may include a basket, balloon, spline, configured tip, or other electrode deployment mechanism. The electrode deployment mechanism includes an electrode assembly or electrode array with electrodes for performing treatment or sensing the effect within the heart. For example, the electrode assembly may include multiple spaced electrodes, multiple sets of spaced electrodes, or multiple groups of spaced electrodes. In some examples, electrodes (e.g., multiple spaced electrodes) may be deployed on the catheter shaft in addition to, or instead of, the electrodes on the electrode deployment mechanism. In one example, the multiple electrodes may be formed from a biocompatible material with a conductive solid surface and spaced apart via an insulator. Each of the multiple electrodes is electrically connected to a corresponding long lead conductor extending along the shaft to the proximal end of the catheter. Multiple lead conductors can be electrically connected, for example, directly or via an intermediate electrical conductor such as cable wiring, to a plug in the proximal region of the catheter 105 (for example, a plug configured to be mechanically and electrically connectable to the console 130).

[0036] In one example, the console 130 is configured to supply electrical signals (e.g., multiple simultaneous or time-staggered electrical signals) to a catheter 105 electrically connected along lead conductors leading to spaced electrodes. In one example of an ablation catheter, multiple spaced electrodes are configured to generate selected electrical signals near the target tissue based on electrical signals from the console 130 in order to perform ablation.

[0037] The ablation catheter system 60 is configured to deliver energy to target tissue within the patient's heart 30 to induce cell death in the tissue, for example, so that the tissue is unable to conduct electrical signals. A long catheter assembly (e.g., catheter assembly 100) may include multiple coaxially arranged catheter elements. For example, a catheter element (e.g., a sheath or catheter) defines a longitudinal axis passing through the centroid of the cross-section of the catheter element (e.g., the centroid of the cross-section of the catheter shaft or the centroid of the cross-section of the lumen of the sheath). Multiple coaxially arranged catheter elements are configured such that one catheter element is located within another catheter element, and the longitudinal axis of each catheter element follows the same three-dimensional curve or path as a whole to the most distal point where both exist.

[0038] The catheter elements may include a first catheter element (e.g., a long sheath) or an outer catheter element in the catheter assembly 100. Furthermore, the catheter elements may include a second catheter element (e.g., a long catheter) or an inner catheter element in the catheter assembly 100. The first catheter element includes a long lumen, and the second catheter element is positioned within the lumen. For example, the outer diameter of the catheter is selected to be smaller than the inner diameter of the lumen in the sheath. The first and second catheter elements are relatively movable relative to each other along their longitudinal axes. For example, the distal end of the catheter may be manipulated to extend from the distal tip of the sheath, or the distal tip of the sheath may be retracted from the distal end of the catheter, including by expanding the basket to expose the deployment mechanism. In addition, the distal end of the catheter may be retracted from the distal tip of the sheath in the assembly 100, for example, to retract the deployment mechanism or to retract an electrode.

[0039] A selected electric field can be generated using electrodes to perform electroporation. An electric field can be generated between the anode and cathode based on a signal (e.g., a pulse) supplied to the electrodes from the electroporation console 130 by selecting a first electrode or a first group of electrodes as the anode and a different second electrode or second group of electrodes as the cathode. The console 130 supplies electrical pulses of different lengths and magnitudes to the electrodes on the catheter 105. The electrical pulses can be supplied as a continuous pulse stream or as a series of separate pulses. Pulse parameters of interest include the number of pulses, the duty cycle of the pulses, the interval between pulse trains, the voltage or magnitude of the pulses (including peak voltage), and the duration of the voltage. For example, the console 130 can select two or more electrodes of an electrode assembly and supply pulses to the selected electrodes to generate an electric field between the selected electrodes, thereby providing pulsed field ablation (PFA). For example, PFA can be performed with single-phase and two-phase waveforms. While not limited to any particular theory, electric field strengths in the range of approximately 200–250 volts / cm (V / cm) with pulse durations on a microsecond scale have been demonstrated to provide reversible electroporation in cardiac tissue. Electric field strengths of approximately 400 V / cm have been demonstrated to provide irreversible electroporation in cardiac tissue of interest (e.g., target myocardial tissue and endocardial tissue) with demonstrable preservation of red blood cells, vascular smooth muscle tissue, endothelial tissue, nerves, and other non-target nearby tissues.

[0040] Another problem encountered during cardiac ablation is that the catheter electrode may accidentally move back into the elongated sheath during the procedure without the clinician noticing. For example, a bipolar catheter may include a shaft electrode proximal to an electrode deployment mechanism such as a basket, and if the shaft electrode is misplaced in the sheath during ablation, it can lead to reduced efficiency or ineffectiveness, potentially resulting in a prolonged procedure or even treatment failure.

[0041] Figure 2 shows a catheter assembly locking mechanism 200 that can correspond to a locking mechanism 120 of an exemplary electroporation catheter system 60, which can be used with an exemplary electrophysiological system 50 and can be used with an introducer sheath 110. In this example, the locking mechanism 200 is configured to be operably connected to a long sheath 202 and to coaxially receive a long catheter 204 into the long sheath 202 to form a catheter assembly 206. The locking mechanism 200 includes a deformable tube 210 and a plurality of opposing paddles 230a, 230b. The deformable tube 210 includes an outer wall 212 and an inner wall 214. The inner wall 214 forms an axial lumen 216 along axis A. For illustrative purposes, the outer wall 212 has an outer diameter D out It includes a secant line segment passing through axis A, as defined by [the specified definition].

[0042] In the illustrated example, the deformable tube 210 includes an open proximal end 220 and an open distal end 222. The distal end 222 is configured to operably connect to a long sheath 202 having a see-through lumen along axis A. The proximal end 220 is configured to receive the catheter 204 along axis A into the lumen 216 and into the see-through lumen of the sheath 202 to form a catheter assembly 206.

[0043] In the illustrated example, multiple opposing paddles 230a, 230b, including two paddles, are positioned against the outer wall 212 of the deformable tube 210. Each of the paddles 230a, 230b has an outer diameter D out The lock regions 232a and 232b are configured to contact the outer wall 212 at a substantially perpendicular angle to the secant line, and the substantially planar lock regions 232a and 232b are tangential to the outer wall 212 when they are in contact with the outer wall 212 at a point in their reference state or undeformed state. For example, the plane of the lock regions 232a and 232b is the outer diameter D outIt is perpendicular to the secant line. In the illustrated example, the substantially planar locking regions 232a and 232b are substantially parallel to each other. Multiple paddles 230a and 230b are movable relative to each other. In one example, at least one of the paddles 230a and 230b is movable relative to the deformable tube 210. In another example, the paddles 230a and 230b are movable relative to the deformable tube 210 along a line of movement substantially perpendicular to axis A. In yet another example, the planes of the locking regions 232a and 232b are outer diameter D out The deformable tube 210 is movable so as to move perpendicularly and approximately parallel to each other along the secant line. In the figure, the approximately planar locking regions 232a and 232b of the opposing paddles 230a and 230b overlap with the deformable tube 210 when they come into contact with the outer wall 212 in the overlapping region 234. The locking regions 232a and 232b include a height H and a width W. In one example, the heights of the locking regions 232a and 232b are the same, and the widths of the locking regions 232a and 232b are the same.

[0044] The drive mechanism 236 may be used to move the paddles 230a and 230b relative to the deformable tube 210 for selective positioning. Several suitable drive mechanisms 234 are envisioned, including manual positioning of the paddles 230a and 230b relative to the deformable tube 210. For example, the drive mechanism 236 can cause selective movement of the paddles 230a and 230b along a line of movement perpendicular to the axis or outer diameter D out To maintain the line of movement along the secant line, it can be electrically or mechanically actuated along the rail as a piston, as a rack and pinion, or as other suitable device. In one example, the position of the paddles 230a, 230b relative to the deformable tube 210, or the outer diameter D of the locking regions 232a, 232b. outThe position along the secant line can be held at a predetermined position by a suitable stop mechanism used in relation to the drive mechanism 236. The drive mechanism 234 can be configured to move both paddles 230a, 230b simultaneously towards the shaft A with respect to the deformable tube 210, or to move both paddles 230a, 230b simultaneously away from the shaft A with respect to the deformable tube 210. In another example, the drive mechanism 236 can be configured to move one paddle towards the deformable tube 210 and the other paddle, or to move one paddle away from the shaft A with respect to the deformable tube 210 and the other paddle.

[0045] Figures 3A - 3C show various exemplary states of a cross - section 300 of an exemplary catheter assembly lock mechanism 200 taken along the line 3 - 3 of FIG. 2 or in a cross - sectional plane perpendicular to the shaft A. As shown, the paddles 230a, 230b are selectively positionable with respect to the deformable tube 210 and set the lock mechanism to one of a plurality of states based on the compression of the deformable tube brought about by the paddles 230a, 230b that deform the lumen 216. For the sake of explanation, there is a bisector line B passing through the shaft A and perpendicular to the outer diameter D out There is a bisector line B passing through the shaft A and perpendicular to the outer diameter D out The shaft A and the outer diameter D are located within a diametral plane, and the shaft A and the bisector line B are located within a bisector plane perpendicular to the diametral plane. Also, the inner wall 214 includes a line segment of a secant line passing through the shaft A defined as the inner diameter D in The catheter 204 received within the lock mechanism 200 is selected such that the length of the outer diameter of the catheter is shorter than the length of the inner diameter D in

[0046] As shown in FIG. 3A, in the first state, i.e., the reference state 320, the paddles 230a, 230b are not in contact with or are lightly in contact with the outer wall 212 of the deformable tube 210. The catheter 204 is received within the lock mechanism 200. The length of the outer diameter of the catheter 204 is the inner diameter D inShorter than the length of the sheath 202, the catheter 204 can move freely along axis A relative to the sheath 202. In the standard state, the paddles 230a and 230b do not compress the inner wall 214, deform the lumen 216, or pinch the catheter 204, nor compress the inner wall 214 or deform the lumen 216 sufficiently to apply force to the catheter 204, thereby allowing the catheter 204 to move along axis A relative to the locking mechanism 200 and the sheath 202. Furthermore, in the standard state 320, fluids such as saline solution can flow between the inner wall 214 and the catheter 204, and flow down the catheter assembly 206, including the lumen of the sheath 202 between the catheter 204 and the sheath 202.

[0047] As shown in Figure 3B, in the second state, the first compression state, i.e., the sheath-locked state 330, the catheter 204 is received within the locking mechanism 200. The paddles 230a and 230b are releasably pressed against the deformable tube 210 at its outer wall 212, causing the inner wall 214 to deform, thereby trapping the catheter 204 in the overlapping region 234 or against the outer diameter D of the catheter 204. out A force along the line is applied to hold the catheter 204 in place relative to the deformable tube 210 and sheath 202. In the sheath-locked state 330, the paddles 230a and 230b compress the inner wall 214 and deform the lumen 216. In one example, the shape of the lumen 216 formed by the inner wall 214 in a cross-sectional plane perpendicular to the axis A of the overlapping region 234 is no longer circular but elliptical. Outer diameter D of the cross-sectional shape of the lumen 216 formed by the inner wall 214 outThe distance along the line is equal to the length of the diameter C of the catheter 204. The distance along the bisector B of the cross-sectional shape of the lumen 216 formed by the inner wall 214 is longer than the length of the diameter C of the catheter 204. In one example, the distance along the bisector B of the cross-sectional shape of the lumen 216 formed by the inner wall 214 is longer than the length of the diameter of the lumen 216 in the reference state. The crushed, deformable tube 210 that clamps the catheter 204 along the bisector plane in the overlapping region 234 includes an opening 240 between the catheter 204 and the inner wall 214 along the bisector plane, as shown along the bisector B.

[0048] In the sheath-locked state 330, the catheter 204, which is trapped within the locking mechanism 200, is not movable relative to the sheath 202, but fluids such as saline solution can still flow through the locking mechanism 200 down the catheter assembly 206.

[0049] As shown in Figure 3C, in the third state, the second compression state, i.e., the airlock state 340, the catheter 204 is detached from the locking mechanism 200. The paddles 230a and 230b are releasably pressed against the deformable tube 210 at the outer wall 212, deforming the inner wall 214 to crush the deformable tube 210 and seal the lumen 216. The inner walls 214 are pressed against each other in the overlapping region 234 along the diameter plane and the bisector plane, as shown along the bisector B. In the airlock state 340, no fluid, such as saline or air, enters the sheath 202 from the proximal end 220. In the illustrated example, the height H of the locking region is longer than the diameter of the outer wall 212. For example, the height H is longer than half the circumference of the inner wall 214. For example, at least one-quarter of the circumference of the inner wall 214 is on each side of the diameter plane. In this configuration, the locking regions 232a and 232b can apply force to the entire inner wall 214 along the overlapping region 234 against the deformable tube 210 in the airlock state 340. Furthermore, the width W is an effective dimension for maintaining a sealed state under the applied pressure within the locking mechanism 200.

[0050] Figures 4 and 5 show a catheter locking mechanism 400 that can be used with an exemplary electrophysiological system 50 and may correspond to the locking mechanism 120 and exemplary locking mechanism 200 of an exemplary electroporation catheter system 60. In this example, the locking mechanism 400 is configured to be operably coupled to a long sheath 402 and to coaxially receive a long catheter 404 into the long sheath 402 to form a catheter assembly 406. The locking mechanism 400 includes a deformable tube 410 and a plurality of opposing paddles 430a, 430b. The deformable tube 410 includes an outer wall 412. The deformable tube 410 includes a proximal end 420 and a distal end 422. The locking mechanism 400 includes a proximal hub 424 connected to the proximal end 420 of the deformable tube 410 to receive the catheter 404. The locking mechanism 400 also includes a distal hub 426 connected to the distal end 422 of a deformable tube 410 coupled to the sheath 402. In one example, the proximal hub 424 is a valve hub that can be connected to tubes to introduce a fluid, such as saline solution, into the locking mechanism 400. The valve hub also forms a dynamic seal on the catheter 404, reducing the possibility of air entering or fluid leakage during use, even when the catheter is moved or translated. The proximal hub 424 may be shaped to receive and guide the catheter 404 along axis AA of the locking mechanism 400 and the catheter assembly 406. The distal hub 426 is configured to be operably connected to the elongated sheath 402 to hold the sheath 402 in a predetermined position relative to the locking mechanism 400.

[0051] In the illustrated example, a plurality of opposing paddles 430a, 430b, including two paddles, are positioned relative to the outer wall 412 of the deformable tube 410. Each of the paddles 430a, 430b includes substantially planar locking regions 432a, 432b that are substantially parallel to each other. The locking regions 432a, 432b are configured to contact the outer wall 412 in a substantially overlapping region 434. The substantially planar locking regions 432a, 432b are tangential to the outer wall 412 when they are in point contact with the outer wall 412 in their reference state or undeformed state. The plurality of paddles 430a, 430b are movable relative to each other and together with the deformable tube 410 via a drive mechanism (not shown), etc. In one example, the paddles 430a, 430b are connected to shafts 436a, 436, and the shafts 436a, 436b may be connected to a drive mechanism.

[0052] The flexible tube 410 is selected from a soft and elastic material so as to flex through numerous locking and unlocking cycles without cracking or permanent deformation. In addition, the wall thickness of the flexible tube is selected so as to compress under the pressure of the paddles 430a and 430b. Furthermore, the length of the flexible tube is selected so as not to put excessive stress on the connections between the ends 420 and 422 and the hubs 424 and 426 when deformed under the pressure of the paddles. For example, the ends 420 and 422 are spaced apart from the overlapping region 434.

[0053] Figures 4A and 5A show the locking mechanism 400 in the first state, i.e., the baseline state 520. The paddles 430a and 430b are not in contact with the outer wall 412 of the deformable tube 410, or the locking areas 432a and 432b are in light contact with the outer wall 412, and the locking areas 432a and 432b are separated by a first distance. The catheter 404 is received within the locking mechanism 400 and can move freely along axis AA relative to the locking mechanism 400 and the sheath 402. In the baseline state, a fluid such as saline solution flows into the locking mechanism 400 and can flow down the catheter assembly 206, such as in the lumen of the sheath 202 between the catheter 204 and the sheath 202 in the baseline state 520.

[0054] Figures 4B and 5B show the locking mechanism 400 in the second state, i.e., the sheath-locked state 530. The catheter 404 is received within the locking mechanism 400 in the sheath-locked state 530. The paddles 430a and 430b are releasedly pressed against the deformable tube 410 in the overlapping region 434 using a drive mechanism or the like, so that the tube 410 is deformed or flattened. The locking regions 432a and 432b are spaced apart from each other by a second distance shorter than the first distance. The deformable tube is compressed against the catheter 404, and the pressure applied by the paddles 430a and 430b in the direction toward axis AA is at least sufficient to hold the catheter 404 in place relative to the deformable tube 410 and the sheath 402. Before performing ablation by electroporation or other methods, clinicians can reduce the possibility of the catheter 404 moving through the shaft 402, particularly the possibility of the electrode on the catheter shaft moving into the sheath 402, by selecting the sheath-lock state 530.

[0055] Figures 4C and 5C show the locking mechanism 400 in the third state, i.e., the airlock state 540. The catheter 404 is detached from the locking mechanism 400 and is not present within the locking mechanism 400 in the sheath-lock state 540. The paddles 430a and 430b are releasedly pressed against the deformable tube 410 in the overlapping region 434 using a drive mechanism or the like, causing the tube 410 to deform or flatten. The locking regions 432a and 432b are spaced apart from each other by a third distance shorter than the second distance. The deformable tube is crushed, and the pressure applied by the paddles 430a and 430b in the axial direction is at least sufficient to seal the inner lumen within the deformable tube. By selecting the airlock state 540 before inserting the device into the sheath 402, the clinician can reduce the possibility of air entering the sheath 402. The paddles 430a and 430b may be configured to apply a constant positive pressure to the deformable tube 410 via a drive mechanism while in the sheath-lock state 430 and the air-lock state 440.

[0056] Figures 6A to 6C show cross-sections (e.g., top cross-sections) of the locking mechanism 400 along line 6-6 in Figures 5A to 5C in various states of the locking mechanism 400. For example, the cross-section may be obtained along the diameter plane in Figures 3A to 3C. Figures 6A to 6C show that the proximal hub 424 is configured to guide the catheter 404 into the inner lumen 416 of the deformable tube 410, which is formed by the inner wall 414 of the deformable tube 410. The distal hub 426 is attached to the sheath 402 and is configured to hold the sheath 404 in place relative to the locking mechanism 400. When the locking mechanism 400 is viewed in the diameter plane, the inner wall 414 is within the inner diameter D in The outer wall 412 includes a secant line segment passing through axis AA, which is defined as outer diameter D out It includes the line segment of the secant passing through axis A, which is defined as follows.

[0057] In Figure 6A (obtained along the line 6A-6A in Figure 5A), the substantially planar lock regions 432a and 432b are tangential to the outer wall 212 when they are in contact with the outer wall 412 at a point in their reference state or undeformed state. Furthermore, the plane of the lock regions 432a and 432b corresponds to the outer diameter D in Figures 6A to 6C. out It is perpendicular to the secant line. In the illustrated example, the substantially planar locking regions 432a and 432b are substantially parallel to each other. Multiple paddles 430a and 430b are movable relative to each other. In one example, paddles 430a and 430b are movable relative to a tube 410 that is deformable along a line of movement substantially perpendicular to axis AA. In another example, the planes of the locking regions 432a and 432b are outer diameter D out The deformable tube 410 is movable so as to move perpendicularly and substantially parallel to each other along the secant line. In the figure, the substantially planar locking regions 432a, 432b of the opposing paddles 430a, 430b overlap with the deformable tube 410 when they contact the outer wall 412 in the overlapping region 434. The locking regions 432a, 432b include a width W that provides a sufficiently long overlapping region 434 on axis AA to maintain catheter retention in the sheath-locked state 530 in Figure 6C and to maintain the seal of the inner wall 414 under positive pressure within the locking mechanism 400 in the air-locked state 540 in Figure 6C. In one example, the paddles 430a, 440b are positioned such that the width of each locking region 432a, 432b lies within the overlapping region 434.

[0058] As shown in Figure 6A, in the first state, i.e., the baseline state 520, the paddles 430a and 430b are in light contact with the outer wall 412. The length of the outer diameter of the catheter 404 is equal to the inner diameter D. in Shorter than the length of the inner wall 414 and the sheath 402, the catheter 404 can move freely along axis A.

[0059] As shown in Figure 6B (taken along the line 6B-6B in Figure 5B), in the second state, i.e., the sheath-locked state 530, the catheter 404 is received within the locking mechanism 400. The paddles 430a and 430b are releasably pressed against the deformable tube 410 at the outer wall 412, causing the inner wall 414 to deform, thereby trapping the catheter 404 in the overlapping region 434 or against the outer diameter D of the catheter 404. out A force is applied along the line to hold the catheter 404 in place relative to the deformable tube 410 and sheath 402. In the sheath-locked state 530, the paddles 430a and 430b compress the inner wall 414 and deform the lumen 416.

[0060] As shown in Figure 6C (taken along the 6C-6C line in Figure 5C), in the third state, i.e., the airlock state 540, the catheter 504 is detached from the locking mechanism 500. The paddle is releasably pressed against the deformable tube 510 at its outer wall 512, deforming the inner wall 514 to crush the deformable tube 510 and seal the lumen 516 in the diameter plane. The inner walls 414 are pressed against each other in the overlapping region 434, so that fluids such as saline or air do not enter the sheath 402 from the locking mechanism 400.

[0061] Figures 7A to 7C show cross-sections (e.g., side cross-sections) of the locking mechanism 400 along line 7-7 in Figures 4A to 4C in various states of the locking mechanism 400. For example, the cross-section may be obtained along the bisector plane in Figures 3A to 3C. When the locking mechanism 400 is viewed in the bisector plane, the outer wall 412 contains a secant line segment passing through axis AA, which is defined as bisector B.

[0062] As shown in Figure 7A (taken along the line 7A-7A in Figure 4A), in the first state, i.e., the baseline state 520, the catheter 404 is received within the locking mechanism 400. The paddles 430a and 430b are not in contact with the deformable tube in such a way that they deform the inner wall 414 sufficiently to prevent the catheter 404 from moving freely along axis AA. In particular, the inner wall 414 is not deformed along the bisector B in such a way that it prevents the catheter 404 from moving freely along axis AA.

[0063] As shown in Figure 7B (taken along the line 7B-7B in Figure 4B), in the second state, i.e., the sheath-lock state 530, the paddles 430a and 430b are releasably pressed against the deformable tube 410 at the outer wall 412, causing the inner wall 414 to deform, thereby trapping the catheter 404 in the overlapping region 434 or against the outer diameter D of the catheter 404. outA force is applied along the line to hold the catheter 404 in place relative to the deformable tube 410 and sheath 402. Paddles 430a and 430b compress the inner wall 414, deforming the lumen 416. In one example, the shape of the lumen 416 formed by the inner wall 414 in the overlapping region 434 is no longer circular but elliptical. The distance along the bisector B of the cross-sectional shape of the lumen 416 formed by the inner wall 414 is longer than the length of the diameter C of the catheter 404. In one example, the distance along the bisector B of the cross-sectional shape of the lumen 416 formed by the inner wall 414 is longer than the length of the diameter of the lumen 416 in the reference state. The crushed deformable tube 410 that clamps the catheter 404 along the bisector plane in the overlapping region 434 includes an opening 440 between the catheter 404 and the inner wall 414 along the bisector plane, as shown along the bisector B. In the sheath-locked state 530, the catheter 404, which is clamped within the locking mechanism 400, is not movable relative to the sheath 402, but fluids such as saline can still flow through the locking mechanism 400 and down the catheter assembly 406. As shown in Figure 7B, even when the catheter 404 is clamped against the inner wall 414 along the diameter plane as shown in Figure 6B, saline can still flow down the catheter assembly 406 through the opening 440.

[0064] As shown in Figure 7C (taken along the 7C-7C line in Figure 4C), in the third state, i.e., the airlock state 540, the catheter 404 is detached from the locking mechanism 400. The paddles 430a and 430b are releasably pressed against the deformable tube 410 at the outer wall 412, deforming the inner wall 414 to crush the deformable tube 410 and seal the lumen 416. The inner walls 414 are pressed against each other in the overlapping region 434 along the diameter plane and the bisector plane, as shown along the bisector B. In the airlock state 540, no fluid, such as saline or air, enters the sheath 402 from the proximal end 420. In the illustrated example, the height H of the lock region is longer than the diameter of the outer wall 412. In this configuration, the locking regions 432a and 432b can apply force to the entire inner wall 414 along the overlapping region 434 against the deformable tube 410 in the airlock state 440. Furthermore, the width W is an effective dimension for maintaining a sealed state under the applied pressure within the locking mechanism 400.

[0065] Various modifications and additions can be made to the exemplary embodiments described without departing from the scope of this disclosure. For example, while the embodiments described above refer to specific features, the scope of this disclosure also includes embodiments having different combinations of features, and embodiments that do not include all of the described features. Accordingly, the scope of this disclosure is intended to encompass all such alternative forms, modifications, and variations included in the claims, along with all their equivalents.

Claims

1. A medical device for use in a catheter assembly including a long catheter coaxially arranged within a sheath, A deformable tube having a proximal end, a distal end, an outer wall having an outer diameter, and an inner wall forming an axial lumen, wherein the distal end is configured to be attached to the sheath, and the proximal end is configured to receive the catheter into the lumen, A plurality of opposing paddles arranged against the outer wall, each of the plurality of opposing paddles having a substantially planar locking region configured to be positioned against the outer wall in the outer diameter, the locking surface being positioned tangentially to the deformable tube, and the plurality of opposing paddles being movable laterally relative to the deformable tube at a position along the outer diameter, comprising: The medical device has a first compressed state in which the catheter is coaxially positioned within the sheath, the plurality of opposing paddles are releasably pressed against the deformable tube in their outer diameter, compressing the deformable tube and holding the catheter in a predetermined position relative to the sheath and the deformable tube, and the compressed deformable tube forms an elongated opening along the inner wall and the catheter. The medical device has a second compressed state in which the catheter is not coaxially positioned within the sheath and is removed from the deformable tube, and the plurality of opposing paddles are releasably pressed against the deformable tube in their outer diameter to crush the deformable tube and seal the lumen.

2. The medical device according to claim 1, wherein the catheter assembly is incorporated into the medical device.

3. The medical device according to claim 1 or 2, wherein the catheter assembly is configured to perform irreversible electroporation.

4. The medical device according to claim 1 or 2, further comprising a reference state in which the catheter is coaxially positioned within the sheath and the catheter is movable relative to the sheath and the deformable tube.

5. The medical device according to claim 4, wherein the inner wall includes a circular cross-section in the reference state.

6. The medical device according to claim 5, wherein the locking region includes height, the inner wall includes circumference, and the height is at least half of the circumference.

7. The medical device according to claim 4, wherein the inner wall includes an elliptical cross-section in the first compressed state.

8. The medical device according to claim 1 or 2, wherein the plurality of opposing paddles include two opposing paddles.

9. The medical device according to claim 8, wherein the locking regions are substantially parallel to each other.

10. The medical device according to claim 1 or 2, wherein the locking region forms an overlapping region on the deformable tube.

11. The medical device according to claim 10, wherein the inner wall relating to the overlapping region holds the catheter in the first compressed state.

12. The medical device according to claim 10, wherein the inner wall relating to the overlapping region seals the lumen in the second compressed state.

13. The medical device according to claim 10, wherein the proximal end and the distal end are arranged at a distance from the overlapping region.

14. The medical device according to claim 1 or 2, wherein the proximal end includes a proximal hub configured to guide the catheter into the lumen, and the distal end includes a distal hub configured to be attached to the sheath.

15. The medical device according to claim 1 or 2, further comprising a drive mechanism operably connected to the plurality of opposing paddles, wherein the drive mechanism is configured to move the plurality of opposing paddles laterally relative to the deformable tube.

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