Catheter assembly lock
By using a locking mechanism with a deformable tube and a lever, the problem of air entry during device introduction and removal of the catheter system is solved, achieving stable locking and positioning of the catheter and improving the safety and efficiency of the surgery.
Patent Information
- Application Number
- CN202380095505.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-01-06
- Filing Date
- 2023-12-21
- Publication Date
- 2025-10-24
AI Technical Summary
Existing catheter systems are prone to air ingress during device introduction and removal, leading to an increased risk of complications. Furthermore, the catheter electrode may inadvertently migrate during surgery, affecting the surgical outcome.
A locking mechanism employing a deformable tube and multiple opposing paddles is used. By deforming the deformable tube and moving the paddles, the catheter is stably locked within the sheath, preventing air from entering and keeping the catheter in the proper position.
It effectively prevents air from entering, ensures stable positioning of the catheter during surgery, reduces the risk of complications, and improves surgical efficiency and effectiveness.
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Figure CN120835772A_ABST
Abstract
Description
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This application claims the benefit of and priority to U.S. Provisional Patent Application Serial No. 63 / 478,866, filed on January 6, 2023, the entire contents of which are incorporated herein in their entirety. Technical Field
[0003] The present disclosure generally relates to medical systems and methods for using catheter assemblies. More particularly, the present disclosure relates to medical systems and methods for locking a catheter assembly in place within a patient's body during surgery. Background Art
[0004] Medical devices in the form of catheter systems are widely used in various medical surgeries to approach remote anatomical locations or deploy therapeutic devices. For example, electrophysiology surgery includes 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 electrophysiology surgery for treating various heart diseases, such as supraventricular and ventricular arrhythmias. Cardiac mapping via a catheter is another minimally invasive electrophysiology surgery for identifying the time and space potential during cardiac rhythm. The catheter assembly (including the catheter assembly in electrophysiology surgery) can include multiple catheter elements, such as catheters, sheaths, guide wires, and needles. For example, the catheter assembly can include an elongated catheter in an elongated sheath. The patient's heart can be entered through a blood vessel, such as via a peripheral artery or vein of a large-caliber sheath or an introducer sheath. Once the blood vessel is entered, the catheter assembly can be navigated into the patient's heart, and the catheter can be selectively deployed from the sheath. Summary of the Invention
[0005] In Example 1, a medical device for use with a catheter assembly includes an elongate catheter coaxially disposed 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 configured to be attached to the sheath, the proximal end configured to receive the catheter into the lumen. The medical device further includes a plurality of opposing tabs disposed against the outer wall, each of the opposing tabs having a generally flat locking region configured to be disposed against the outer wall at the outer diameter, the locking surface disposed tangentially to the deformable tube, the plurality of opposing tabs being laterally movable relative to the deformable tube along the outer diameter. The medical device has a first compressed state in which the catheter is coaxially disposed within the sheath and the opposing tabs releasably push against the deformable tube at the outer diameter to collapse the deformable tube to hold the catheter in place relative to the sheath and the deformable tube, the collapsed deformable tube forming an elongate opening along the inner wall and the catheter. The medical device has a second compressed state in which the catheter is disposed non-coaxially within the sheath and removed from the deformable tube and the opposing tabs releasably push against the deformable tube at the outer diameter to collapse the deformable tube and seal the lumen.
[0006] In Example 2, the medical device of Example 1, wherein the catheter assembly is integrated into the medical device.
[0007] In Example 3, the medical device of any of Examples 1-2, wherein the catheter assembly is configured to perform irreversible electroporation.
[0008] In Example 4, the medical device of any of Examples 1-3, and further comprising a nominal state in which the catheter is coaxially disposed within the sheath and the catheter is movable relative to the sheath and the deformable tube.
[0009] In Example 5, the medical device of Example 4, wherein the inner wall comprises a circular cross-section in the nominal state.
[0010] In Example 6, the medical device of Example 5, wherein the locking region comprises a height and the inner wall comprises a circumference, and wherein the height is at least half of the circumference.
[0011] In Example 7, the medical device of any of Examples 4-5, wherein the inner wall comprises an elliptical cross-section in the first compressed state.
[0012] In Example 8, the medical device of any of Examples 1-7, wherein the plurality of opposing tabs comprises two opposing tabs.
[0013] In Example 9, the medical device of Example 8, wherein the locking regions are generally parallel to each other.
[0014] In Example 10, the medical device of any of Examples 1-9, wherein the locking region forms an overlap region on the deformable tube.
[0015] In Example 11, the medical device of Example 10, wherein the inner wall associated with the overlap region presses against the catheter in the first compressed state.
[0016] In Example 12, the medical device of any of Examples 10-11, wherein the inner wall associated with the overlap region seals the lumen in the second compressed state.
[0017] In Example 13, the medical device of any of Examples 10-12, wherein the proximal end and the distal end are spaced apart from the overlap region.
[0018] In Example 14, the medical device of any of Examples 1-13, 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 attach to the sheath.
[0019] In Example 15, the medical device of any of Examples 1-14, and further comprising a drive mechanism operably coupled to the plurality of paddles, the drive mechanism configured to move the plurality of opposing paddles laterally relative to the deformable tube.
[0020] In Example 16, a medical device for use with a catheter assembly includes an elongate catheter coaxially disposed 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 configured to attach to the sheath and the proximal end configured to receive the catheter into the lumen. The medical device further includes a plurality of opposing paddles disposed against the outer wall, each of the opposing paddles having a generally flat locking region configured to be disposed against the outer wall at the outer diameter, the locking surface disposed tangentially to the deformable tube, the plurality of opposing paddles moveable laterally relative to the deformable tube along the outer diameter. The medical device has a first compressed state in which the catheter is coaxially disposed within the sheath and the opposing paddles releasably push against the deformable tube at the outer diameter to collapse the deformable tube to hold the catheter in place relative to the sheath and the deformable tube, the collapsed deformable tube forming an elongate opening along the inner wall and the catheter. The medical device has a second compressed state in which the catheter is non-coaxially disposed within the sheath and removed from the deformable tube and the opposing paddles releasably push against the deformable tube at the outer diameter to collapse the deformable tube and seal the lumen.
[0021] In Example 17, the medical device of Example 16, and further comprising a nominal state in which the catheter is coaxially disposed within the sheath and the catheter is moveable relative to the sheath and the deformable tube.
[0022] In Example 18, the medical device of Example 17, wherein the inner wall comprises a circular cross-section in the nominal state.
[0023] In Example 19, the medical device of Example 18, wherein the locking region comprises a height, and the inner wall comprises a circumference, and wherein the height is at least half of the circumference.
[0024] In Example 20, the medical device of Example 18, wherein the inner wall comprises an elliptical cross-section in the first compressed state.
[0025] In Example 21, the medical device of Example 16, wherein the locking region forms an overlap region on the deformable tube, and the proximal end and the distal end are spaced apart from the overlap region.
[0026] In Example 22, the medical device of any of Example 16, and further comprising a drive mechanism operably coupled to the plurality of paddles, the drive mechanism configured to move the plurality of opposing paddles laterally relative to the deformable tube.
[0027] In Example 23, the medical device of Example 16, wherein the proximal end comprises a proximal hub configured to guide the catheter into the lumen, and the distal end comprises a distal hub configured to attach to the sheath.
[0028] In Example 24, the medical device of Example 16, wherein the plurality of opposing paddles comprises two opposing paddles, and wherein the locking regions are generally parallel to each other.
[0029] In Example 25, a medical device comprises a catheter assembly having an elongate catheter coaxially disposed within a sheath and a locking mechanism. The locking mechanism comprises 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 configured to attach to the sheath, the proximal end configured to receive the catheter into the lumen. The plurality of opposing paddles are disposed against the outer wall, each of the opposing paddles having a generally flat locking region configured to be disposed against the outer wall at the outer diameter, the locking surface disposed tangentially to the deformable tube, the plurality of opposing paddles moveable laterally relative to the deformable tube along the outer diameter; the medical system having a first compressed state, wherein the catheter is coaxially disposed within the sheath, and the opposing paddles releasably push against the deformable tube at the outer diameter to collapse the deformable tube to hold the catheter in place relative to the sheath and the deformable tube, the collapsed deformable tube forming an elongate opening along the inner wall and the catheter. The medical system having a second compressed state, wherein the catheter is non-coaxially disposed within the sheath and removed from the deformable tube, and the opposing paddles releasably push against the deformable tube at the outer diameter to collapse the deformable tube and seal the lumen.
[0030] In Example 26, the medical system of Example 25, wherein the catheter assembly is configured to perform irreversible electroporation.
[0031] In Example 27, the medical system of Example 25, and further comprising a nominal state, wherein the catheter is coaxially disposed within the sheath, and the catheter is movable relative to the sheath and the deformable tube.
[0032] In Example 28, the medical system of Example 25, and further comprising a drive mechanism operably coupled to the plurality of paddles, the drive mechanism configured to move the plurality of opposing paddles laterally relative to the deformable tube.
[0033] In Example 29, a method for 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 configured to attach to the sheath, the proximal end configured to receive the catheter into the lumen. The medical device further includes a plurality of opposing paddles disposed against the outer wall, each of the opposing paddles having a generally flat locking region configured to be disposed against the outer wall at the outer diameter, the locking surface disposed tangentially to the deformable tube, the plurality of opposing paddles movable laterally relative to the deformable tube along the outer diameter, the catheter coaxially disposed within the sheath. The opposing paddles are releasably urged against the deformable tube at the outer diameter to collapse the deformable tube to hold the catheter in place relative to the sheath and the deformable tube, the collapsed deformable tube forming an elongate opening along the inner wall and the catheter. The catheter is removed from the deformable tube. The opposing paddles are releasably urged against the deformable tube at the outer diameter to collapse the deformable tube and seal the lumen.
[0034] In Example 30, the method of Example 29, and further comprising flowing a fluid into the elongate opening.
[0035] In Example 31, the method of Example 30, wherein providing the medical device includes providing the deformable tube having a circular cross-sectional inner wall, and wherein holding the catheter in place relative to the sheath includes elliptically shaping the cross-section to form the elongate opening.
[0036] In Example 32, the method of Example 29, including forming an overlap region on the deformable tube.
[0037] In Example 33, the method of Example 32, wherein holding the catheter in place relative to the sheath includes pinching the catheter with the inner wall associated with the overlap region.
[0038] In Example 34, the method of Example 32, wherein collapsing the deformable tube and sealing the lumen includes collapsing the deformable tube at the overlap region.
[0039] In Example 35, the method of Example 29, wherein providing the medical device includes providing a proximal hub attached to the proximal end, and further including guiding the catheter into the lumen via the proximal hub.
[0040] While several embodiments have been disclosed, other embodiments of the present disclosure will become apparent from the detailed description that follows, which shows and describes illustrative embodiments of the disclosure. The drawings provided herein are in fact a part of the detailed description and thus should be considered in conjunction with the detailed description. The detailed description is intended to be illustrative and not limiting. BRIEF DESCRIPTION OF DRAWINGS
[0041] Figure 1 is a diagram illustrating an example clinical setting for treating a patient and for treating a heart of a patient, the example clinical setting having an example electrophysiology system.
[0042] Figure 2 is a diagram illustrating an example catheter assembly locking mechanism for use with Figure 1 an example electrophysiology system of
[0043] Figures 3A-3C is a diagram illustrating an example catheter assembly locking mechanism for use with Figure 2 an example electrophysiology system of
[0044] Figures 4A-4C is a diagram illustrating an example catheter assembly locking mechanism for use with Figures 3A-3C an example electrophysiology system of Figure 1
[0045] Figures 5A-5C is a diagram illustrating an example catheter assembly locking mechanism for use with Figures 4A-4C an example electrophysiology system of
[0046] Figures 6A-6C is a diagram illustrating an example catheter assembly locking mechanism for use with Figures 5A-5C an example electrophysiology system of
[0047] Figures 7A-7C is a diagram illustrating an example catheter assembly locking mechanism for use with Figures 4A-4C an example electrophysiology system of
[0048] While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail in the following description. The disclosure, however, is not limited to the particular embodiments described. Rather, the disclosure is intended to cover all modifications, equivalents and alternatives falling within the scope of the disclosure as defined by the appended claims. DETAILED DESCRIPTION
[0049] To facilitate an understanding of the principles of the present disclosure, reference is made to the examples illustrated in the drawings, which are described in the following detailed description. The illustrated examples disclosed herein are not meant to be exhaustive or limited to the precise forms disclosed in the detailed description. Rather, the selection and description of these exemplary embodiments are chosen and described for use in explaining the principles of the disclosure. In all examples, use of multiple (e.g., all) features in one example is not beyond the scope of the disclosure. Thus, no single figure is to be construed as having any dependency or requirement related to any single component or combination of components illustrated therein. Moreover, in examples, various components depicted in the figures can integrate various other components (or components not shown) depicted therein, all of which are considered within the scope of the present disclosure.
[0050] Examples of electrophysiology procedures and systems of an electroanatomical mapping system and a cardiac ablation system employing a catheter assembly are described in the present disclosure, where the electrophysiology testing and ablation system is used for illustration. Ablation procedures are used to treat many different conditions in patients. Ablation can be used to treat cardiac arrhythmias, benign tumors, cancerous tumors, and to control bleeding during surgery. Typically, ablation is accomplished by thermal ablation techniques, including radiofrequency (RF) ablation and cryoablation. In radiofrequency 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 blood vessels. In cryoablation, a hollow needle or cryoprobe is inserted into the patient and a cold, heat-conducting fluid is circulated through the probe to freeze and kill the surrounding tissue. RF ablation and cryoablation techniques kill tissue indiscriminately through cell necrosis, which can damage or otherwise kill healthy tissue, such as tissue in the esophagus, phrenic nerve cells, and tissue in the coronary arteries.
[0051] Another ablation technique uses electroporation. In electroporation or electropermeabilization, an electric field is applied to a cell 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 the electroporation is reversible, then the temporary increase in cell membrane permeability can be used to introduce a chemical, a drug, or a deoxyribonucleic acid (DNA) into the cell before the cell heals and recovers. Minutes, hours, or days after the ablation is complete, the tissue recovers. If the electroporation is irreversible, then the affected cells are killed, such as via a form of cell death, like for example, programmed cell death, possibly through apoptosis, or like for example, traumatic cell death through necrosis.
[0052] Irreversible electroporation can be used as a non-thermal ablation technique. In irreversible electroporation, a short burst of high voltage pulses is used to generate an electric field sufficient to kill cells. In the ablation of cardiac tissue, irreversible electroporation can be a safe and effective alternative to thermal ablation techniques, such as RF ablation and cryoablation. Irreversible electroporation can be used to kill targeted tissue, such as cardiac muscle tissue, by using an electric field strength and duration that kills the targeted tissue but does not permanently damage other cells or tissue, such as non-targeted cardiac muscle tissue, red blood cells, vascular smooth muscle tissue, endothelial tissue, and nerve cells.
[0053] This example electrophysiology procedure typically involves guiding a catheter assembly into a patient's heart. The catheter assembly can be accessed into the patient's heart through a blood vessel via an introducer sheath. Once in the blood vessel, the catheter assembly can be navigated within the patient's heart. Other examples of procedures involving large-bore sheaths are also within the scope of consideration, such as transcatheter aortic valve replacement, endovascular aneurysm repair, and mechanical circulatory support devices deployed with large-bore access. However, the large-bore sheaths currently in use have a problem with air ingress during device introduction and removal. To address the problem of air ingress, clinicians have employed informal methods, such as high flush, suction, and water bath, to mitigate the risk of complications including air embolism.
[0054] Figure 1An example clinical setting 10 is shown that uses an electrophysiology system 50 to treat a patient 20, such as treating a heart 30 of the patient 20, in accordance with the present disclosure. The electrophysiology system 50 includes an ablation catheter system 60 and an electroanatomical mapping (EAM) system 70. The example catheter system 60 includes an elongated catheter assembly 100 that, in this example, includes a catheter 105 within a sheath, an introducer sheath 110, a locking mechanism 120, and a console 130. The electroporation console 130 is configured to control various aspects of the electroporation catheter system 60. In addition, the catheter system 60 includes various connecting elements, such as cables, that operatively connect components of the catheter system 60 to each other and to 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 is operable to track the location of various components of the catheter system 60 and generate a high-fidelity three-dimensional electroanatomical map of the heart, including portions of the heart, such as a lumen of interest or other structure of interest, such as the sinoatrial node or atrioventricular node, from a catheter or probe equipped with sensing electrodes. In one illustrative example, the EAM system 70 can include the RHYTHMIA HDx® mapping system sold by Boston Scientific Corporation. An example probe is the INTELLAMAP ORION® mapping catheter sold by Boston Scientific Corporation. In addition, the clinical setting 10 can include additional equipment, such as imaging equipment 94 (represented by a C-arm) and various controller elements, such as foot controls 96, that are configured to allow an operator to control various aspects of the electrophysiology system 50. The clinical setting 10 can have other components and component arrangements not shown in FIG. 1. TM HDx mapping system. An example probe is the INTELLAMAP ORION TM mapping catheter sold by Boston Scientific Corporation. In addition, the clinical setting 10 can include additional equipment, such as imaging equipment 94 (represented by a C-arm) and various controller elements, such as foot controls 96, that are configured to allow an operator to control various aspects of the electrophysiology system 50. The clinical setting 10 can have other components and component arrangements not shown in FIG. 1. Figure 1
[0055] In embodiments, the introducer sheath 110 is operable to provide a delivery conduit through which the catheter assembly 100 can be deployed to a particular target site within the heart 30 of the patient. The heart of the patient can be accessed through a blood vessel, such as a peripheral artery or vein. Once the blood vessel is accessed, the catheter assembly 100 can be navigated within the heart of the patient, for example, within a chamber of the heart. The locking mechanism can be a stand-alone component in the catheter system 60 or a feature of another component, such as the introducer sheath 110 or other component.
[0056] The example catheter 105 includes an elongate catheter shaft and a distal end configured to be deployed proximate to a target tissue, such as in a chamber of a patient's heart. The distal end can include a basket, a balloon, a spline, a shaped tip, or other electrode deployment mechanism. The electrode deployment mechanism includes an electrode assembly or array that includes electrodes for effecting a therapeutic or sensing effect within the heart. For example, the electrode assembly can include a plurality of spaced-apart electrodes or a plurality of spaced-apart sets or groups of electrodes. In some examples, in addition to or instead of electrodes on the electrode deployment mechanism, electrodes can be deployed on the catheter shaft, such as a plurality of spaced-apart electrodes. In one example, the plurality of electrodes can be formed of an electrically conductive, solid surface, biocompatible material and spaced apart on an insulator. Each of the plurality of electrodes is electrically coupled to a respective elongate wire catheter that extends along the shaft to a catheter proximal end. The wire catheter can be electrically coupled to a plug in a proximal region of the catheter 105, such as a plug configured to be mechanically and electrically coupled to the console 130, e.g., directly or via an intermediate electrical conduit such as wiring.
[0057] In one example, the console 130 is configured to provide electrical signals, such as a plurality of concurrent or time-spaced electrical signals, to the electrically connected catheter 105 along the wire catheter leading to the spaced-apart electrodes. In the example of an ablation catheter, the spaced-apart electrodes are configured to generate selected electrical signals proximate to the target tissue based on the electrical signals from the console 130 to effect ablation.
[0058] The ablation catheter system 60 is configured to deliver energy to a target tissue in a patient's heart 30 to cause cell death in the tissue, e.g., to render the tissue incapable of conducting electrical signals. An elongate catheter assembly, such as the catheter assembly 100, can include a plurality of coaxially arranged catheter elements. For example, a catheter element, such as a sheath or catheter, defines a longitudinal axis that passes through a centroid of a cross-section of the catheter element, such as a centroid of a cross-section of the catheter shaft or a centroid of a cross-section of a lumen of the sheath. The coaxially arranged catheter elements include a catheter element arranged within another catheter element such that the longitudinal axis of each catheter element generally follows the same three-dimensional curve or path until a distal-most point at which both exist.
[0059] The catheter element can include a first catheter element, such as an elongate sheath, or an outer catheter element in the catheter assembly 100. Further, the catheter element can include a second catheter element, such as an elongate catheter, or an inner catheter element in the catheter assembly 100. The first catheter element includes an elongate lumen, and the second catheter element is disposed within the lumen. For example, the outer diameter of the catheter is selected to be less than the inner diameter of the lumen within the sheath. The first catheter element and the second catheter element can be moved relative to each other along the longitudinal axis. For example, the distal end of the catheter can be manipulated to extend from the distal tip of the sheath, or the distal tip of the sheath can be retracted from the distal end of the catheter, thereby exposing a deployment mechanism, which can include a dilation basket. Further, the distal end of the catheter can be retracted from the distal tip of the sheath in the assembly 100 in order to collapse the deployment mechanism or retract the electrodes.
[0060] Electroporation can be achieved with the selected electric field generated by the electrodes. A first electrode or a first set of electrodes can be selected as an anode, while a different second electrode or a second set of electrodes can be selected as a cathode, such that an electric field can be generated between the anode and the cathode based on signals, such as pulses, provided to the electrodes from the electroporation console 130. The console 130 provides electrical pulses of varying length and amplitude to the electrodes on the catheter 105. The electrical pulses can be provided in a continuous stream of pulses or in a plurality of separate pulse trains. Pulse parameters of interest include the number of pulses, the duty cycle of the pulses, the interval of the pulse trains, the voltage or amplitude of the pulses including the peak voltage, and the duration of the voltage. For example, the console 130 can select two or more electrodes of the electrode assembly and provide pulses to the selected electrodes to generate an electric field between the selected electrodes, thereby providing pulsed field ablation (PFA). PFA can be performed with uniphasic and biphasic waveforms, for example. Without being bound by a particular theory, electric field strengths, typically in the range of 200-250 volts per centimeter (V / cm) with microsecond pulse durations, have been shown to provide reversible electroporation in cardiac tissue. Electric field strengths of about 400 V / cm have been shown to provide irreversible electroporation in cardiac tissue of interest, such as targeted myocardial tissue and endocardial tissue, and can be shown to not damage red blood cells, vascular smooth muscle tissue, endothelial tissue, nerves, and other non-target adjacent tissue.
[0061] Another problem encountered during cardiac ablation is the inadvertent migration of the catheter electrodes back into the elongate sheath during manipulations unknown to the clinician. For example, a bipolar catheter can include a shaft electrode proximal to an electrode deployment mechanism, such as a basket, and if inadvertently positioned within the sheath during ablation, the shaft electrode can become ineffective or inefficient, which can result in prolonged procedures or unsuccessful therapy.
[0062] Figure 2A catheter assembly locking mechanism 200 is shown, which can be used with the example electrophysiology system 50 and can correspond to the locking mechanism 120 of the example electroporation catheter system 60, which can be used with the introducer sheath 110. In this example, the locking mechanism 200 is configured to be operably coupled to an elongate sheath 202 and configured to coaxially receive an elongate catheter 204 within the elongate sheath 202 to form a catheter assembly 206. The locking mechanism 200 includes a deformable tube 210 and a plurality of opposing tabs 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 an axis A. For illustration, the outer wall 212 includes a line segment of a secant through the axis A, which is defined as an outer diameter D out .
[0063] 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 be operably coupled to the elongate sheath 202 having a sheath lumen along the axis A. The proximal end 220 is configured to receive the catheter 204 along the axis A into the lumen 216 and into the sheath lumen of the sheath 202 to form the catheter assembly 206.
[0064] The plurality of at least partially overlapping opposing tabs 230a, 230b, which in the illustrated example includes two tabs, are arranged against the outer wall 212 of the deformable tube 210. Each of the tabs 230a, 230b includes a generally planar locking region 232a, 232b configured to engage with the outer wall 212 generally perpendicular to a secant of the outer diameter D out of the outer wall 212 such that the generally planar locking region 232a, 232b is tangent to the outer wall 212 at a point when in its nominal or undeformed state. For example, the plane of the locking region 232a, 232b is perpendicular to a secant of the outer diameter D out of the outer wall 212. In the illustrated example, the generally planar locking regions 232a, 232b are generally parallel to each other. The plurality of tabs 230a, 230b are movable relative to each other. In one example, at least one of the tabs 230a, 230b is movable relative to the deformable tube 210. In one example, the tabs 230a, 230b are movable relative to the deformable tube 210 along a line of travel that is generally perpendicular to the axis a. In another example, the tabs 230a, 230b are movable relative to the deformable tube 210 such that the planes of the locking regions 232a, 232b are generally parallel to each other along the outer diameter D outThe bisector travels perpendicularly. In the illustration, the generally planar locking regions 232a, 232b of the opposing paddles 230a, 230b overlap the deformable tube 210 when in contact with the outer wall 212 in the overlap region 234. The locking regions 232a, 232b include a height H and a width W. In one example, the height of each locking region 232a, 232b is the same, and the width of each locking region 232a, 232b is the same.
[0065] A drive mechanism 236 can be employed to move and selectively position the paddles 230a, 230b relative to the deformable tube 210. Several suitable drive mechanisms 236 are contemplated, including manual positioning of the paddles 230a, 230b relative to the deformable tube 210. For example, the drive mechanism 236 can cause selective movement of the paddles 230a, 230b, which can be electrically or mechanically actuated, such as along a track, as a piston, as a rack and pinion, or other suitable means to maintain the line of travel perpendicular to the axis A or along the bisector of the outer diameter D out . In one example, the position of the paddles 230a, 230b relative to the deformable tube 210, or the position of the locking regions 232a, 232b along the bisector of the outer diameter D out , can be maintained in place by a suitable stop mechanism used in connection with the drive mechanism 236. The drive mechanism 236 can be configured to move both paddles 230a, 230b simultaneously relative to the deformable tube 210 toward the axis A, or to move both paddles 230a, 230b simultaneously relative to the deformable tube 210 away from the axis A. In another example, the drive mechanism 236 can be configured to move one paddle toward the axis A and relative to the deformable tube 210 and the other paddle, or to move one paddle away from the axis A and relative to the deformable tube 210 and the other paddle.
[0066] Figures 3A-3C Various exemplary states of the cross-section 300 of the example catheter assembly locking mechanism 200 taken along line 3-3 of Figure 2 or in a cross-sectional plane perpendicular to the axis A are shown. As illustrated, the paddles 230a, 230b can be selectively positioned relative to the deformable tube 210 to place the locking mechanism in one of a plurality of states based on the compression of the deformable tube that deforms the lumen 216 achieved by the paddles 230a, 230b. For illustration, a bisector B passes through the axis A and is perpendicular to the outer diameter D out . The axis A and the outer diameter D out are located in a diametric plane, and the axis A and the bisector B are within a bisector plane perpendicular to the diametric plane. Further, the inner wall 214 includes a line segment of the bisector passing through the axis A, which is defined as the inner diameter D inThe catheter 204 received in the locking mechanism 200 is selected to have an inner diameter D smaller than in The length is the length of the outer diameter of the catheter.
[0067] In the first or nominal state 320, as Figure 3A As shown, the paddles 230a, 230b do not touch the outer wall 212 of the deformable tube 210 or only touch the outer wall 212 slightly. The catheter 204 is received in the locking mechanism 200. The length of the outer diameter of the catheter 204 is less than the length of the inner diameter D in , and the catheter 204 can freely travel along the axis A relative to the sheath 202. In the nominal state, the paddles 230a, 230b do not compress the inner wall 214 and do not deform the lumen 216, or do not compress the inner wall 214 or deform the lumen 216 enough to squeeze or apply force to the catheter 204, which allows the catheter 204 to travel along the axis A relative to the locking mechanism 200 and the sheath 202. In addition, a fluid (such as saline) can flow between the inner wall 214 and the catheter 204 and down the catheter assembly 206, such as in the lumen of the sheath 202 between the catheter 204 and the sheath 202 in the nominal state 320.
[0068] In the second state, the first compressed state or the sheath locked state 330, as Figure 3B As shown, the catheter 204 is received in the locking mechanism 200. The tabs 230a, 230b are releasably urged against the deformable tube 210 at the outer wall 212 to deform the inner wall 214 along the outer diameter D in the overlap region 234. out The wires of the overlap region 234 are pressed against the catheter 204 to compress or apply force, thereby maintaining the catheter 204 in an appropriate position relative to the deformable tube 210 and the sheath 202. In the sheath locked state 330, the paddles 230a, 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 section perpendicular to the axis A of the overlap region 234 is no longer circular, but becomes elliptical. The cross-sectional shape of the lumen 216 formed by the inner wall 214 is along the outer diameter D out The distance along the bisector line B becomes the same as the length of the diameter C of the catheter 204. The cross-sectional shape of the lumen 216 formed by the inner wall 214 becomes longer along the bisector line B than the length of the diameter C of the catheter 204. In one example, the distance along the bisector line B of the cross-sectional shape of the lumen 216 formed by the inner wall 214 becomes longer than the length of the diameter C of the catheter 204 in the nominal state. The collapsed deformable tube 210 that compresses the catheter 204 in the overlap region 234 along the bisector plane includes an opening 240 between the catheter 204 and the inner wall 214 along the bisector plane, as shown along the bisector line B.
[0069] In the sheath locked state 330 , the catheter 204 , which is squeezed within the locking mechanism 200 , cannot move relative to the sheath 202 , but fluid (eg, saline) can still flow through the locking mechanism 200 and down the catheter assembly 206 .
[0070] In the third state, the second compressed state or air locked state 340, as Figure 3C As shown, the catheter 204 is removed from the locking mechanism 200. The paddles 230a, 230b releasably push against the deformable tube 210 at the outer wall 212 to deform the inner wall 214, thereby collapsing the deformable tube 210 and sealing the lumen 216. The inner wall 214 is compressed together along the diametrical plane and the bisector plane in the overlap region 234, as shown along the bisector B. In the air lock state 340, fluid (such as saline or air) cannot enter the sheath 202 from the proximal end 220. In the illustrated example, the height H of the locking region is longer than the diametrical length 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 diametrical plane. In this configuration, the locking regions 232a, 232b can apply force to the entire inner wall 214 along the overlap region 234 to the deformable tube 210 in the air lock state 340. Furthermore, the width W is effectively in an amount to maintain a seal under the pressure applied within the locking mechanism 200 .
[0071] FIGS. 4 and 5 illustrate a catheter locking mechanism 400, which can be used with the example electrophysiology system 50 and can correspond to the locking mechanism 120 of the example electroporation catheter system 60 and the example locking mechanism 200. In this example, the locking mechanism 400 is configured to be operably coupled to an elongated sheath 402 and configured to coaxially receive an elongated catheter 404 within the elongated sheath 402 to form a catheter assembly 406. The locking mechanism 400 includes a deformable tube 410 and a plurality of opposing tabs 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 coupled 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 coupled to the distal end 422 of the deformable tube 410, which is coupled to the sheath 402. In this example, the proximal hub 424 is a valve hub, which can be coupled to a tubing to receive fluid, such as saline, into the locking mechanism 400. The valve hub can also generate a dynamic seal on the catheter 404 to reduce the likelihood of air ingress or fluid leakage during use, even if the catheter is moved or translated. The proximal hub 424 can be configured in a shape to receive and guide the catheter 404 along an axis AA of the locking mechanism 400 and the catheter assembly 406. The distal hub 426 is configured to be operably coupled to the elongated sheath 402 to hold the sheath 402 in place relative to the locking mechanism 400.
[0072] The plurality of at least partially overlapping opposing tabs 430a, 430b, which in the illustrated example includes two tabs, are arranged against the outer wall 412 of the deformable tube 410. Each tab 430a, 430b includes a generally planar locking region 432a, 432b that is generally parallel to each other. The locking regions 432a, 432b are configured to generally engage the outer wall 412 in an overlapping region 434. The generally planar locking regions 432a, 432b are tangent to the outer wall 412 when in contact with the outer wall 412 at a point in a nominal or undeformed state of the outer wall. The plurality of tabs 430a, 430b are movable relative to each other and the deformable tube 410, for example, via a drive mechanism (not shown). In one example, the tabs 430a, 430b are coupled to shafts 436a, 436b, and the shafts 436a, 436b can be coupled to the drive mechanism.
[0073] The flexible tube 410 is selected from a material that is soft and resilient to bend without tearing or permanently deforming through multiple locking and unlocking cycles. In addition, the wall thickness of the flexible tube is selected to compress under the force of the paddles 430a, 430b. In addition, the length of the flexible tube is selected so that the portion that deforms under the force of the paddles does not overly compress the junctions of the end portions 420, 422 with the hubs 424, 426. For example, the end portion 420 and the end portion 422 are spaced apart from the overlap region 434.
[0074] Figure 4A and Figure 5A The locking mechanism 400 is shown in a first state or nominal state 520. The paddles 430a, 430b do not touch the outer wall 412 of the deformable tube 410, or the locking regions 432a, 432b lightly touch the outer wall 412, and the locking regions 432a, 432b are spaced apart a first distance. The catheter 404 is received in the locking mechanism 400, and the catheter 404 can freely travel along the axis AA relative to the locking mechanism 400 and the sheath 402. In the nominal state, fluid, such as saline, can flow into the locking mechanism 400 and down the catheter assembly 206, such as in the lumen of the sheath 202 between the catheter 204 and the sheath 202 in the nominal state 520.
[0075] Figure 4B and Figure 5B The locking mechanism 400 is shown in a second state or sheath locking state 530. In the sheath locking state 530, the catheter 404 is received within the locking mechanism 400. The paddles 430a, 430b are releasably urged against the deformable tube 410 in the overlap region 434, such as with a drive mechanism, to deform or flatten the tube 410. The locking regions 432a, 432b are spaced apart from each other a second distance that is less than the first distance. The deformable tube is collapsed relative to the catheter 404, and the force of the paddles 430a, 430b in the direction toward the axis AA is at least sufficient to hold the catheter 404 in place relative to the deformable tube 410 and the sheath 402. The clinician can select the sheath locking state 530 prior to performing an ablation, such as by electroporation, to reduce the likelihood that the catheter 404 will migrate via the shaft 402, particularly the electrodes on the catheter shaft will migrate into the sheath 402.
[0076] Figure 4C and Figure 5CThe locking mechanism 400 is shown in a third state or air lock state 540. In the sheath lock state 540, the catheter 404 is removed from the locking mechanism 400 and is not present in the locking mechanism 400. The paddles 430a, 430b are releasably urged against the deformable tube 410 in the overlap region 434, such as with a drive mechanism, to deform or flatten the tube 410. The locking regions 432a, 432b are spaced apart from each other by a third distance that is less than the second distance. The deformable tube is collapsed and the force of the paddles 430a, 430b in the direction toward the axis is at least sufficient to seal the inner lumen of the deformable tube. The clinician can select the air lock state 540, such as before the device is inserted into the sheath 402, to reduce the likelihood of air entering into the sheath 402. While in the sheath lock state 430 and the air lock state 440, the paddles 430a, 430b can be configured to provide a constant positive pressure against the deformable tube 410 via the drive mechanism.
[0077] Figures 6A-6C Cross sections 600 of the locking mechanism 400 are shown taken along line 6-6 in Figures 5A-5C , such as a top-down cross-sectional view. For example, the cross section can be taken along a diametric plane in Figures 3A-3C . Figures 6A-6C A proximal hub 424 is shown configured to guide the catheter 404 into an inner lumen 416 of the deformable tube 410 formed by an inner wall 414 of the deformable tube 410. A distal hub 426 is configured to attach to the sheath 402 and hold the sheath 404 in place relative to the locking mechanism 400. As a view of the locking mechanism 400 in a diametric plane, the inner wall 414 includes a line segment that is a secant through the axis AA defined as an inner diameter D in , and the outer wall 412 includes a line segment that is a secant through the axis A defined as an outer diameter D out .
[0078] When in a nominal or undeformed state, the generally planar locking regions 432a, 432b are tangent to the outer wall 412 when contacted by the outer wall 212 taken along the 6A-6A line of Figure 6A . Figure 5A Further, the plane of the locking regions 432a, 432b is perpendicular to the secant of the outer diameter D out in Figures 6A-6C . In the illustrated example, the generally planar locking regions 432a, 432b are generally parallel to each other. The plurality of paddles 430a, 430b are movable relative to each other. In one example, the paddles 430a, 430b are movable relative to the deformable tube 410 along a line of travel that is generally perpendicular to the axis AA. In another example, the paddles 430a, 430b are movable relative to the deformable tube 410 such that the plane of the locking regions 432a, 432b is along the outer diameter Dout The bisector lines generally travel vertically in parallel to each other. In the illustration, the generally planar locking regions 432a, 432b of the opposing paddles 430a, 430b overlap with the deformable tube 410 when in contact with the outer wall 412 in the overlap region 434. The locking regions 432a, 432b include a width W to provide an overlap region 434 long enough on the axis A to maintain the catheter in Figure 6C the sheath locking state 530, and to maintain a seal against the inner wall 414 under positive pressure within the locking mechanism 400 in the air locking state 540. In one example, the paddles 430a, 430b are positioned such that the width of each locking region 432a, 432b is in the overlap region 434. Figure 6C
[0079] In the first or nominal state 520, as shown in Figure 6A the paddles 430a, 430b are lightly touching the outer wall 412. The length of the outer diameter D in of the catheter 404 is less than the length of the inner diameter D
[0080] In the second or sheath locking state 530, as shown in Figure 6B taken along line 6B-6B of Figure 5B the catheter 404 is received in the locking mechanism 400. The paddles 430a, 430b releasably push against the deformable tube 410 at the outer wall 412 to deform the inner wall 414 along the outer diameter D out of the catheter 404 in the overlap region 434 to squeeze or apply a force, thereby holding the catheter 404 in place relative to the deformable tube 410 and the sheath 402. In the sheath locking state 530, the paddles 430a, 430b compress the inner wall 414 and deform the lumen 416.
[0081] In the third or air locking state 540, as shown in Figure 6C taken along line 6C-6C of Figure 5C the catheter 504 is removed from the locking mechanism 500. The paddles releasably push against the deformable tube 510 at the outer wall 512 to deform the inner wall 514 to collapse the deformable tube 510 and seal the lumen 516 in the diameter plane. The inner wall 414 is compressed together in the overlap region 434 such that fluid, such as saline or air, does not pass from the locking mechanism 400 into the sheath 402.
[0082] Figures 7A-7C illustrates the length of the outer diameter D Figures 4A-4C FIG. 7B is a cross-sectional view of the locking mechanism 400 taken along the line 7B-7B of FIG. 7A, for example, a side cross-sectional view. For example, the cross- sectional view can be taken along the bisecting plane in FIG. 7A. Figures 3A-3C FIG. 7B is a cross-sectional view of the locking mechanism 400 taken along the line 7B-7B of FIG. 7A, for example, a side cross-sectional view. For example, the cross- sectional view can be taken along the bisecting plane in FIG. 7A.
[0083] FIG. 7B is a cross-sectional view of the locking mechanism 400 taken along the line 7B-7B of FIG. 7A, for example, a side cross-sectional view. For example, the cross- sectional view can be taken along the bisecting plane in FIG. 7A. Figure 7A FIG. 7B is a cross-sectional view of the locking mechanism 400 taken along the line 7B-7B of FIG. 7A, for example, a side cross-sectional view. For example, the cross- sectional view can be taken along the bisecting plane in FIG. 7A. Figure 4A FIG. 7B is a cross-sectional view of the locking mechanism 400 taken along the line 7B-7B of FIG. 7A, for example, a side cross-sectional view. For example, the cross- sectional view can be taken along the bisecting plane in FIG. 7A. FIG. 7B is a cross-sectional view of the locking mechanism 400 taken along the line 7B-7B of FIG. 7A, for example, a side cross-sectional view. For example, the cross- sectional view can be taken along the bisecting plane in FIG. 7A.
[0084] FIG. 7B is a cross-sectional view of the locking mechanism 400 taken along the line 7B-7B of FIG. 7A, for example, a side cross-sectional view. For example, the cross- sectional view can be taken along the bisecting plane in FIG. 7A. Figure 7B FIG. 7B is a cross-sectional view of the locking mechanism 400 taken along the line 7B-7B of FIG. 7A, for example, a side cross-sectional view. For example, the cross- sectional view can be taken along the bisecting plane in FIG. 7A. Figure 4B FIG. 7B is a cross-sectional view of the locking mechanism 400 taken along the line 7B-7B of FIG. 7A, for example, a side cross-sectional view. For example, the cross- sectional view can be taken along the bisecting plane in FIG. 7A. out FIG. 7B is a cross-sectional view of the locking mechanism 400 taken along the line 7B-7B of FIG. 7A, for example, a side cross-sectional view. For example, the cross- sectional view can be taken along the bisecting plane in FIG. 7A. Figure 7B FIG. 7B is a cross-sectional view of the locking mechanism 400 taken along the line 7B-7B of FIG. 7A, for example, a side cross-sectional view. For example, the cross- sectional view can be taken along the bisecting plane in FIG. 7A. Figure 6B FIG. 7B is a cross-sectional view of the locking mechanism 400 taken along the line 7B-7B of FIG. 7A, for example, a side cross-sectional view. For example, the cross- sectional view can be taken along the bisecting plane in FIG. 7A.
[0085] FIG. 7B is a cross-sectional view of the locking mechanism 400 taken along the line 7B-7B of FIG. 7A, for example, a side cross-sectional view. For example, the cross- sectional view can be taken along the bisecting plane in FIG. 7A. Figure 7C FIG. 7B is a cross-sectional view of the locking mechanism 400 taken along the line 7B-7B of FIG. 7A, for example, a side cross-sectional view. For example, the cross- sectional view can be taken along the bisecting plane in FIG. 7A. Figure 4CThe third state or air lock state 540 is taken with the line 7C-7C. With the catheter 404 removed from the locking mechanism 400. The paddles 430a, 430b releasably push against the deformable tube 410 at the outer wall 412 to deform the inner wall 414, collapsing and sealing the lumen 416. The inner wall 414 is compressed together in the overlap region 434 along the diametric plane and bisecting plane as shown along bisecting line B. In the air lock state 540, fluid such as saline or air does not enter the sheath 402 from the proximal end 420. In the illustrated example, the height H of the locking region is longer than the length of the diameter of the outer wall 412. In this configuration, the locking regions 432a, 432b can exert a force along the overlap region 434 to the deformable tube 410 to the entire inner wall 414 in the air lock state 440. Further, the width W is effectively the amount that maintains a seal under pressure applied within the locking mechanism 400.
[0086] Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present disclosure. For example, while the embodiments described above refer to particular features, the scope of this disclosure also includes embodiments that do not include all of these features. Thus, embodiments falling within the scope of the claims are intended to cover all such alternatives, modifications and variations, and all equivalents thereof.
Claims
1. A medical device for use with a catheter assembly comprising an elongated catheter coaxially disposed within a sheath, the medical device comprising: 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 configured to be attached to the sheath, the proximal end configured to receive the catheter into the lumen; and a plurality of opposing tabs disposed against the outer wall, each of the opposing tabs having a generally flat locking region configured to be disposed against the outer wall at the outer diameter, a locking surface disposed tangentially to the deformable tube, the plurality of opposing tabs being transversely movable relative to the deformable tube along the outer diameter; the medical device having a first compressed state in which the catheter is coaxially disposed within the sheath and the opposing tabs are releasably urged against the deformable tube at the outer diameter to collapse the deformable tube to hold the catheter in place relative to the sheath and the deformable tube, the collapsed deformable tube forming an elongated opening along the inner wall and the catheter; and the medical device having a second compressed state in which the catheter is non-coaxially disposed within the sheath and removed from the deformable tube and the opposing tabs are releasably urged against the deformable tube at the outer diameter to collapse the deformable tube and seal the lumen. the catheter assembly is integrated into the medical device.
2. The medical device of claim 1, wherein, the catheter assembly is configured to perform irreversible electroporation.
3. The medical device of any of claims 1-2, wherein, the catheter is coaxially disposed within the sheath and is movable relative to the sheath and the deformable tube.
4. The medical device of any of claims 1-3, and further comprising a nominal state, wherein, the inner wall comprises a circular cross-section in a nominal state.
5. The medical device of claim 4, wherein, the locking region comprises a height and the inner wall comprises a circumference, and wherein the height is at least half of the circumference.
6. The medical device of claim 5, wherein, the inner wall comprises an elliptical cross-section in the first compressed state.
7. The medical device of any of claims 4-5, wherein, the plurality of opposing tabs comprises two opposing tabs.
8. The medical device of any of claims 1-7, wherein, the locking regions are generally parallel to each other.
9. The medical device of claim 8, wherein, the locking regions form an overlap region on the deformable tube.
10. The medical device of any of claims 1-9, wherein, the inner wall associated with the overlap region compresses the catheter in the first compressed state.
11. The medical device of claim 10, wherein, the inner wall associated with the overlap region seals the lumen in the second compressed state.
12. The medical device of any of claims 10-11, wherein, the proximal end and the distal end are spaced apart from the overlap region.
13. The medical device of any of claims 10-12, wherein, the proximal end comprises a proximal hub configured to guide the catheter into the lumen, the distal end comprises a distal hub configured to be attached to the sheath.
14. The medical device of any of claims 1-13, wherein, 15. The medical device of any of claims 1-14, and further comprising a drive mechanism operably coupled to the plurality of tabs, the drive mechanism configured to transversely move the plurality of opposing tabs relative to the deformable tube.
16. A medical device for use with a catheter assembly comprising an elongated catheter coaxially disposed within a sheath, the medical device comprising: 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 configured to be attached to the sheath, the proximal end configured to receive the catheter into the lumen; and a plurality of opposing tabs disposed against the outer wall, each of the opposing tabs having a generally flat locking region configured to be disposed against the outer wall at the outer diameter, a locking surface disposed tangentially to the deformable tube, the plurality of opposing tabs being transversely movable relative to the deformable tube along the outer diameter; a plurality of opposing tabs arranged against the outer wall, each of the opposing tabs having a generally planar locking region configured to be arranged against the outer wall at the outer diameter, the locking surface arranged tangentially to the deformable tube, the plurality of opposing tabs being transversely movable relative to the deformable tube along the outer diameter; the medical device having a first compressed state in which the catheter is coaxially arranged within the sheath and the opposing tabs releasably urge against the deformable tube at the outer diameter to collapse the deformable tube to hold the catheter in place relative to the sheath and the deformable tube, the collapsed deformable tube forming an elongated opening along the inner wall and the catheter; and the medical device having a second compressed state in which the catheter is arranged non-coaxially within the sheath and removed from the deformable tube and the opposing tabs releasably urge against the deformable tube at the outer diameter to collapse the deformable tube and seal the lumen.
17. The medical device of claim 16, and further comprising a nominal state, wherein, the catheter is coaxially arranged within the sheath and the catheter is movable relative to the sheath and the deformable tube.
18. The medical device of claim 17, wherein, the inner wall comprises a circular cross-section in a nominal state.
19. The medical device of claim 18, wherein, the locking region comprises a height and the inner wall comprises a circumference, and wherein the height is at least half of the circumference.
20. The medical device of claim 18, wherein, the inner wall comprises an elliptical cross-section in the first compressed state.
21. The medical device of claim 16, wherein, the locking region forms an overlap region on the deformable tube and the proximal end and the distal end are spaced apart from the overlap region.
22. The medical device of claim 16, and further comprising a drive mechanism operably coupled to the plurality of tabs, the drive mechanism configured to transversely move the plurality of opposing tabs relative to the deformable tube.
23. The medical device of claim 16, the proximal end comprising a proximal hub configured to guide the catheter into the lumen, the distal end comprising a distal hub configured to be attached to the sheath.
24. The medical device of claim 16, wherein, the plurality of opposing tabs comprises two opposing tabs, and wherein the locking regions are generally parallel to each other.
25. A medical system, comprising: a catheter assembly having an elongated catheter coaxially arranged within a sheath; and a locking mechanism comprising: 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 configured to be attached to the sheath, the proximal end configured to receive the catheter into the lumen; and a plurality of opposing tabs arranged against the outer wall, each of the opposing tabs having a generally planar locking region configured to be arranged against the outer wall at the outer diameter, the locking surface arranged tangentially to the deformable tube, the plurality of opposing tabs being transversely movable relative to the deformable tube along the outer diameter; The medical system has a first compressed state in which the catheter is coaxially disposed within the sheath, and the opposing tabs releasably push against the deformable tube at the outer diameter to collapse the deformable tube to hold the catheter in place relative to the sheath and deformable tube, the collapsed deformable tube forming an elongated opening along the inner wall and the catheter; and The medical system has a second compressed state in which the catheter is disposed non-coaxially within the sheath and removed from the deformable tube, and the opposing tabs releasably push against the deformable tube at the outer diameter to collapse the deformable tube and seal the lumen.
26. The medical system of claim 25, wherein, The catheter assembly is configured to perform irreversible electroporation.
27. The medical system of claim 25, and further comprising a nominal state, wherein, The catheter is coaxially disposed within the sheath, and the catheter is movable relative to the sheath and the deformable tube.
28. The medical system of claim 25, and further comprising a drive mechanism operably coupled to the plurality of tabs, the drive mechanism configured to move the plurality of opposing tabs laterally relative to the deformable tube.
29. A method for a catheter assembly having an elongated catheter coaxially disposed within a sheath, the method comprising: providing a medical device comprising: 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 configured to attach to a sheath, the proximal end configured to receive a catheter into the lumen; and a plurality of opposing tabs disposed against the outer wall, each of the opposing tabs having a generally flat locking region configured to be disposed against the outer wall at the outer diameter, the locking surface disposed tangentially to the deformable tube, the plurality of opposing tabs movable laterally relative to the deformable tube along the outer diameter; wherein the catheter is coaxially disposed within the sheath, the opposing tabs are releasably pushed against the deformable tube at the outer diameter to collapse the deformable tube to hold the catheter in place relative to the sheath and deformable tube, the collapsed deformable tube forming an elongated opening along the inner wall and the catheter; and removing the catheter from the deformable tube, and pushing the opposing tabs releasably against the deformable tube at the outer diameter to collapse the deformable tube and seal the lumen.
30. The method of claim 29, and further comprising flowing a fluid into the elongated opening.
31. The method of claim 30, wherein, Providing the medical device includes providing the deformable tube with the inner wall having a circular cross-section, and wherein holding the catheter in place relative to the sheath includes ovalizing the cross-section to form the elongated opening.
32. The method of claim 29, comprising forming an overlap region on the deformable tube.
33. The method of claim 32, wherein, Holding the catheter in place relative to the sheath includes pinching the catheter with the inner wall associated with the overlap region.
34. The method of claim 32, wherein, Collapsing the deformable tube and sealing the lumen includes collapsing the deformable tube at the overlap region.
35. The method of claim 29, wherein, Providing the medical device includes providing a proximal hub attached to the proximal end, and further comprising guiding the catheter into the lumen via the proximal hub. Providing the medical device includes providing the deformable tube with the inner wall having a circular cross-section, and wherein holding the catheter in place relative to the sheath includes ovalizing the cross-section to form the elongated opening.
32. The method of claim 29, comprising forming an overlap region on the deformable tube. Holding the catheter in place relative to the sheath includes pinching the catheter with the inner wall associated with the overlap region. Collapsing the deformable tube and sealing the lumen includes collapsing the deformable tube at the overlap region. Providing the medical device includes providing a proximal hub attached to the proximal end, and further comprising guiding the catheter into the lumen via the proximal hub.