EP4673198A1 - Vorrichtung für einen katheter mit steuerbarer freisetzung - Google Patents

Vorrichtung für einen katheter mit steuerbarer freisetzung

Info

Publication number
EP4673198A1
EP4673198A1 EP24709521.9A EP24709521A EP4673198A1 EP 4673198 A1 EP4673198 A1 EP 4673198A1 EP 24709521 A EP24709521 A EP 24709521A EP 4673198 A1 EP4673198 A1 EP 4673198A1
Authority
EP
European Patent Office
Prior art keywords
catheter
locking mechanism
actuator
delivery catheter
protrusion
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP24709521.9A
Other languages
English (en)
French (fr)
Inventor
Erik C. GRISWOLD
Liana C. POLIKAITIS
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtronic Inc
Original Assignee
Medtronic Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medtronic Inc filed Critical Medtronic Inc
Publication of EP4673198A1 publication Critical patent/EP4673198A1/de
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0113—Mechanical advancing means, e.g. catheter dispensers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0136—Handles therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
    • A61M2025/0006—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system which can be secured against axial movement, e.g. by using a locking cuff
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M2025/0681—Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/1414—Hanging-up devices
    • A61M5/1418—Clips, separators or the like for supporting tubes or leads
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31501—Means for blocking or restricting the movement of the rod or piston

Definitions

  • the present teachings relate to a locking mechanism positioned on a controllable delivery catheter, a controllable delivery catheter system, and a method of locking a controllable delivery catheter system.
  • Accessing distal vasculature of a patient can be difficult, particularly as the anatomical pathways are delicate, tortuous and unique to each patient. Accessing the vasculature may be desirable for example, to provide therapy, such as delivering drugs, introducing an implant, balloon, or stent.
  • Delivery catheter systems are employed to access and deliver therapy to such distal vasculature. Such systems are often complex with multiple moving components to ensure transcatheter delivery of therapy, such as an implant, to a target site within a patient.
  • the delivery catheter systems are manually operated by an operator, such as a physician or clinician, to pass the catheter system through the vasculature to the desired targe site.
  • the relative positioning of catheter system components can be important to prevent unintentional patient trauma and/or damage to the delivery system. Minor shifts and changes in relative positioning is common when the catheter system is moved from a loading table to an operating table, or during handling of the system by the operator. These shifts can introduce unwanted errors, complications, or procedural delays. Maintaining the relative positioning of the catheter system components is difficult because it relies on the operator to maintain the relative positioning of the components, often within centimeters, or millimetres. This is particularly difficult as the operator manoeuvres components, such as when the operator moves parts or the whole of the catheter system towards a target site or withdraws the catheter system from the patient.
  • a locking mechanism for removably engaging with a controllable delivery catheter having at least one actuator, wherein the actuator is configured to move all or part of the delivery catheter; the locking mechanism comprising a body with at least one engagement feature, wherein the engagement feature is configured to restrict movement of the actuator to restrict movement of the delivery catheter.
  • the engagement feature comprises a first protrusion extending from the locking mechanism body, wherein the first protrusion comprises an incomplete annular sector that extends in an axial direction along a length of the locking mechanism body and is arranged to abut at least one actuator.
  • the first protrusion is arranged to snap fit or slide fit onto the controllable delivery catheter.
  • the engagement feature further comprises a second protrusion extending from the locking mechanism body, wherein the second protrusion comprises an elongate body arranged to abut at least one actuator.
  • the second protrusion is housed in an incomplete annular sector.
  • the second protrusion is removably attached to the locking mechanism body.
  • the second protrusion is spaced from the first protrusion along an axial distance along a length of the locking mechanism body, wherein the distance between the first and second protrusion is fixed.
  • the locking mechanism further comprises a third protrusion extending from the locking mechanism body, wherein the second protrusion comprises an elongate body arranged to abut at least one actuator.
  • the third protrusion is housed in an incomplete annular sector.
  • the third protrusion is removably attached to the locking mechanism body.
  • the third protrusion is spaced at an axial distance from the first and/or second protrusion along a length of the locking mechanism body, wherein the distance between the first and/or second protrusion and the third protrusion is fixed.
  • the locking mechanism further comprises a recess in the locking mechanism body.
  • the engagement feature is further configured to abut the delivery catheter to restrict movement of the delivery catheter.
  • the locking mechanism body is segmentable, such that at least one engagement feature may be selectively removed from the remaining portion of the locking mechanism body.
  • the engagement feature restricts movement of the actuator by at least partially extending around the actuator to restrict access to the actuator.
  • the actuator is a first actuator
  • the controllable delivery catheter further comprises a second actuator configured to move the delivery catheter, wherein at least one engagement feature is configured to restrict movement of the first actuator and the second actuator to restrict movement of the delivery catheter.
  • the actuator is a first actuator
  • the delivery catheter is a first catheter
  • the controllable delivery catheter further comprises a second catheter and a second actuator configured to move the second catheter, wherein the engagement feature is configured to restrict movement of the first actuator and the second actuator to restrict movement of the first and second catheter.
  • a further aspect of the invention provides an controllable delivery catheter system, comprising: a housing with a steerable delivery catheter at least partially located within a housing, the delivery catheter having a proximal portion and a distal portion, wherein the distal portion in use is positionable at a treatment site within a patient, at least one actuator on the housing, wherein the actuator is configured to move the delivery catheter; and a locking mechanism located on the housing, wherein the locking element restricts movement of the actuator to restrict movement of the delivery catheter.
  • the actuator comprises a translation mechanism that is operable to translate the delivery catheter
  • the locking mechanism comprises a body with an engagement feature that is configured to abut the translation mechanism
  • the translation mechanism comprises a shaft and a sliding element mounted on the shaft, wherein the sliding element is configured to translate longitudinally along the shaft to translate the delivery catheter.
  • the engagement feature comprises a first protrusion extending from the locking mechanism body, wherein the first protrusion is configured to be positioned on the shaft of the translation mechanism to restrict translation of the sliding element along the shaft.
  • the first protrusion comprises an incomplete annular sector that extends in an axial direction along a length of the locking mechanism body.
  • the actuator comprises a first mechanism operable to move the catheter
  • the locking mechanism engagement feature comprises a third protrusion that is configured to abut the first mechanism to restrict flexion and/or actuation of the catheter.
  • the first mechanism comprises a first annular threaded shaft and a first rotatable collar mounted on the first threaded shaft, wherein the first rotatable collar is operable to rotate along the first threaded shaft to move the first catheter and, the third protrusion abuts the first threaded shaft to restrict movement of the first rotatable collar along the first threaded shaft.
  • the third protrusion is housed in an incomplete annular sector, wherein the incomplete annular sector is configured to at least partially extend around the first threaded shaft.
  • controllable delivery catheter further comprises a rotation mechanism operable to rotate the catheter, wherein the engagement feature of the locking mechanism further comprises a cover that is arranged to extend over the rotation mechanism to restrict access to the rotation mechanism.
  • the housing further comprises a second catheter at least partially located within the housing, the second catheter at least partially located within the first catheter, the second catheter having a proximal portion and a distal portion, wherein the distal portion of the second catheter in use is positionable at a treatment site within a patient, at least one second actuator on the housing, wherein the second actuator is configured to move the second catheter, such that the first and second catheters are moveable independently from each other; and wherein the locking mechanism restricts the movement of the first actuator and the second actuator to restrict movement of the first and second catheters.
  • the second actuator comprises a second mechanism operable to move the second catheter
  • the locking mechanism engagement feature comprises a second protrusion that is configured to abut the second actuator to restrict flexion and/or actuation of the second catheter.
  • the second protrusion is housed in an incomplete annular sector, wherein the incomplete annular sector is configured to at least partially extend around the second threaded shaft.
  • the second actuator comprises a second rotation mechanism operable to rotate the second catheter
  • the engagement feature of the locking mechanism further comprises a second cover that is arranged to extend over the second rotation mechanism to restrict access to the second rotation mechanism.
  • a further aspect of the invention provides a method of locking a controllable delivery catheter system, wherein the controllable delivery catheter system comprises: a housing with a steerable delivery catheter at least partially located within a housing, the catheter having a proximal portion and a distal portion, wherein the distal portion in use is positionable at a treatment site within a patient, at least one actuator on the housing, wherein the actuator is configured to move the catheter, the method comprising: attaching a removable locking mechanism to the housing to restrict the movement of the actuator.
  • the locking mechanism is attached to the housing prior to withdrawing the distal end of the catheter from a patient.
  • controllable delivery catheter system further comprises a second catheter at least partially located within the housing, the second catheter at least partially located within the first catheter, the second catheter having a proximal portion and a distal portion, wherein the distal portion of the second catheter in use is positionable at a treatment site within a patient, at least one second actuator on the housing, wherein the second actuators are configured to move the second catheter, such that the first and second catheters are moveable independently from each other; wherein attaching the locking mechanism to the housing restricts the movement of the first and second actuator.
  • Figure 1 illustrates a diagrammatic view of a person undergoing a cardiovascular valve repair procedure, according to an example of the invention
  • Figure 2A illustrates a proximal portion of a controllable delivery catheter system
  • Figure 2B illustrates a distal portion of a controllable delivery catheter system
  • Figure 3 illustrates an exemplary locking mechanism, according to an example of the invention
  • Figure 4 illustrates a locking mechanism mounted on a proximal portion of a controllable catheter system, according to an example of the invention
  • Figure 5a illustrates a cross-sectional view of a portion of the locking mechanism mounted on a controllable catheter system, according to an example of the invention
  • Figure 5b illustrates a cross-sectional view of a portion of the locking mechanism mounted on a controllable catheter system according to an example of the invention
  • Figure 6A illustrates another exemplary locking mechanism mounted on a proximal portion of a controllable catheter system according to an example of the invention
  • Figure 6B illustrates a distal portion of the controllable catheter system
  • Figure 7A illustrates another exemplary locking mechanism mounted on a proximal portion of a controllable catheter system, according to an example of the invention
  • Figure 7B illustrates a distal portion of the controllable catheter system
  • Figure 8 illustrates a controllable catheter system mounted on a holder
  • Figure 9 schematically illustrates a method of locking a controlllable catheter system, according to an example of the invention.
  • FIG. 1 illustrates a diagrammatic view of a person undergoing an exemplary valve repair procedure.
  • a controllable delivery catheter system 20 may be inserted into an artery 6a (e.g., a femoral artery).
  • the controllable catheter system 20 in this example is steerable, but can also or additionally be controllable by sliding, driving, rotating, or the like. It is arranged to deliver an implant to a target site 80 in the patient’s body.
  • the controllable delivery catheter system 20 is formed of a proximal portion 20a and a distal portion 20b.
  • the proximal portion 20a of the delivery catheter system 20 may remain outside of the patient’s body while the distal portion 20b is advanced through the patients’ vasculature 6 towards the target site 80.
  • the target site 80 is the patient’s heart 10.
  • Figures 2A and 2B show the proximal portion 20a and the distal portion 20b of the controllable delivery catheter system 20 respectively.
  • the axes shown in Figures 2A and 2B represent the usual reference orthogonal axes of the delivery catheter system 20.
  • the X-axis defines the longitudinal direction (that extends in an axial direction lengthwise) of the system and the Y -axis defines the vertical direction (that extends width- wise) of the system 20.
  • the distal portion 20b extends from the proximal portion 20A as indicated by a break line 21.
  • Steerable delivery catheters may be operable to move in one or more degrees of freedom within a patient’s body. Steerable delivery catheters assist in navigating the patient’s vasculature because they allow operators to move one or more portions of a catheter shaft to navigate vessels and anatomical features, such as the chambers and valves of the heart. This is accomplished using an assembly of components with one or more portions of a steerable delivery catheter or shaft and at least one actuator that is operable to move the delivery catheter or shaft.
  • a controllable delivery catheter system 20 comprises two catheters 30, 40. However, any number of catheters or shafts may be arranged to extend from the controllable delivery catheter system 20.
  • controllable delivery catheter system 20 may only include a single catheter system 20 that is controlled by a first actuator 300.
  • the controllable delivery catheter system 20 may include any number of catheters or shafts with corresponding actuators to control movement of the respective catheters.
  • the distal portion of the delivery catheter system 20b defines the portion of the controllable delivery catheter system 20 that is arranged to be positioned inside the patient’s body at the treatment site 80.
  • the distal portion 20b includes a delivery capsule 100, formed of a cap 102 and an implant housed inside the cap 102.
  • the implant is a mitral, tricuspid, aortic, or pulmonary valve prosthesis that is arranged to be implanted within the heart 10.
  • the distance between the proximal portion 20a and the distal portion 20b of the controllable catheter system 20 may vary depending on a working length of the catheters 30, 40.
  • the proximal portion 20a is arranged to be manipulated by an operator, such as a physician or clinician, during a desired procedure using the delivery catheter system 20.
  • the exemplary procedure is an implant delivery procedure.
  • the delivery capsule may alternatively contain a stent, frame, annuloplasty ring, balloon, drugs fluid or any other suitable therapy or therapy component.
  • the proximal portion 20a comprises a housing 22.
  • the housing 22 is an elongate structure with a first actuator 300 and second actuator 400 which are operable to control the movement of the first and second catheters 30, 40.
  • the first housing 22 contains the inner mechanisms of the first and second actuators 300, 400, as well as the first and second catheters 30, 40.
  • the first actuator 300 is operable by the operator to control the movement of the first catheter 30.
  • the first actuator 300 may include any moveable mechanism that acts to move the first catheter 30.
  • the first actuator 300 may include any moveable mechanism that rotates, translates, actuates, or flexes the first catheter 30.
  • the first actuator 300 may include more than one moveable mechanism on the housing 22.
  • the housing 22 includes a second actuator 400 that is used to control the movement of the second catheter 40.
  • the second actuator 400 may include any moveable mechanism that acts to move the second catheter 40.
  • the second actuator 400 may be any moveable mechanism that rotates, translates, actuates, or flexes the second catheter 40.
  • the second actuator 400 may include one moveable mechanism on the housing 22, i.e., to control movement of the second catheter 40 in one manner.
  • the second catheter 400 may include more than one moveable mechanism on the housing 22.
  • the first and second actuators 300, 400 of the controllable delivery catheter system 20 may include any number of moveable mechanisms on the housing 22 depending on the desired degrees of freedom required by the first catheter 30 and second catheter 40 to enable the operator to successfully perform the desired procedure.
  • the first catheter 30 extends from a proximal portion 30A to a distal portion 30B and defines at least one first catheter lumen (not shown).
  • the proximal portion 30A is housed within the proximal portion 20a of the controllable catheter system 20A.
  • the second catheter 40 extends from a proximal portion 40A to a distal portion 40B and defines at least one second catheter lumen (not shown).
  • the proximal portion of the second catheter 40A is housed within the proximal portion 20a of the controllable catheter system 20.
  • the proximal portion 30A of the first catheter 30 and the proximal portion 40A of the second catheter 40 are mechanically connected to the housing 22 via an adhesive, welding or another suitable technique or combination of techniques.
  • the second catheter 40 is at least partially located within the first lumen of the first catheter 30.
  • the first catheter 30 and the second catheter 40 therefore form a nested arrangement.
  • the first catheter 30 and the second catheter 40 extend from a hub 310 on the housing 22 towards the distal portion 20b of the controllable delivery catheter 20. As shown, the hub 310 is located distally from the proximal portion 20a of the housing 22.
  • the distal portions 30B, 40B of the first and second catheter 30,40 extends towards to the distal portion 20b of the controllable delivery catheter system 20. In this example, the distal portion 40B of the second catheter 40 extends beyond the distal portion 30B of the first catheter 30.
  • the elongate body of the first and second catheters 30,40 are arranged to be advanced through the vasculature 6 of a patient by a pushing force applied to the proximal portion 20a of the controllable delivery catheter system 20.
  • the elongated body of the first and second catheters 30, 40 are structurally relatively flexible so they can flex and relative to the central axis 22a of the housing 22.
  • the first and second actuators 300, 400 are operable by the operator, such as a physician or clinician, to move the catheters 30, 40.
  • the actuators 300, 400 may be any suitable mechanism that moves at least a portion of the catheters 30, 40 in any degree of freedom relative to the central housing axis 22a. These may be for example, translation along the X-axis or rotating the catheters 30, 40.
  • the first and second catheters 30, 40 are arranged to move independently from each other. The operator therefore can control the catheters 30, 40 to manoeuvre through the vasculature 6 of the patient or at the target site 80.
  • the first actuator 300 comprises two exemplary moveable mechanisms 320, 330 in and on the housing 22 which are operable to enable the movement of the first catheter 30 relative to the housing 22 and/or the central axis 22a.
  • the first actuator 300 comprises a first positioner 320 and a rotator 330.
  • the first positioner 320 is arranged to move the first catheter 30, such as by flexing it. Flexing can be useful for steering and positioning the distal end 30B of the first catheter 30. e.g., The first catheter 30 is arranged to move between a neutral position (e.g., the lumen of the first catheter is parallel with the central axis 22a of the housing) and a fully flexed position (where the distal end 30B of the catheter 30 is arranged to deflect away from the central axis 22a). As shown, the first positioner 320 comprises a first annular threaded shaft 322 and a rotatable collar 324.
  • the annular threaded shaft 322 has a length and extends longitudinally along the housing 22 in an axial direction (i.e., the X- direction).
  • the rotatable collar 324 is mounted on the threaded shaft 322 and is threadingly engaged to the shaft 322. When the rotatable collar 324 is rotated (e.g., clockwise), the rotatable collar 324 translates along the length of the annular shaft 322. The rotatable collar 324 is therefore arranged to move along the length of the threaded shaft 322 towards the distal portion 20b of the controllable delivery catheter system. In other examples, the rotatable collar 324 may be arranged to move along the threaded shaft 322 towards the proximal portion 20a of the controllable delivery catheter 20.
  • the first positioner 320 comprises an inner mechanism (not shown) within the housing 22 that is arranged to control the flexing and/or actuation of the first catheter 30 when the first positioner 320 is moved by the operator.
  • the first catheter 30 includes a deformable portion 30C, which deforms in response to the movement of the rotatable collar 324 move the catheter 30.
  • the distal portion 30C When the distal portion 30C is deformed (i.e., from being actuated and/or flexed), the distal portion 30B of the first catheter 30 deviates away from the central line 22a in a pre-determined direction (not shown).
  • the distal portion 30B of the catheter 30 is arranged to move in response to the first positioner 320.
  • any length of the catheter 30 may be arranged to move in response to the movement of the rotatable collar 324.
  • the first annular thread 322 is positioned in between the rotator 330 and the hub 310.
  • the annular thread is distal from the rotator 330 and proximal to the hub 310.
  • the rotatable collar 324 is arranged to move along the threaded shaft 322 until the rotatable collar abuts the rotator 330. In this position, the catheter 30 may be fully or partly moved.
  • the first catheter 30 returns back to a neutral position (e.g., the lumen of the first catheter 30 is aligned with the a longitudinal axis of the housing 22).
  • the rotatable collar 324 is arranged to move along the threaded shaft 322 until the rotatable collar abuts against the Hub 310. In this position, the catheter 30 may be considered to be in a neutral position.
  • the controllable delivery catheter system 20 also comprises a first rotator element 330 which is arranged to rotate of the first catheter 30.
  • the rotator element 330 comprises a rotatable collar 332.
  • the rotator element 330 comprises an inner mechanism (not shown) that is arranged to control the rotation of the first catheter 30 when the rotator element 330 is moved by the operator.
  • a portion of the first catheter 30 may be secured to the rotatable collar 332, such that any rotation of the collar 332 rotates the first catheter 30.
  • any other suitable mechanism may be used.
  • the first catheter 30 may be arranged to rotate without moving via the rotator 330. This enables the operator to rotate the first catheter 30 in the vasculature 6 of the patient to orientate the first catheter 30. As described earlier, the first catheter 30 is arranged to move in a pre-determined direction (not shown) by the first actuation mechanism 320. As such, the rotator element 330 enables the operator to orientate the first catheter 30 within the vasculature 6, so that when the first catheter 30 is flexed, the catheter may flex in a desired direction.
  • the second actuator 400 comprises three exemplary moveable mechanisms 405, 410, 420, 430 in and on the housing 22 which are operable to enable the movement of the second catheter 40 relative to the housing 22 and/or the central axis 22a.
  • the second actuator 400 comprises a translator 405, 410, a second positioner 420 and a second rotator 430.
  • a translator 410 is operable by the operator to translate the catheter 40.
  • a capsule depth translator 405 with a stopping collar is located towards the proximal end 20a of the controllable delivery catheter system 20.
  • the capsule depth translator 405 also acts as a capsule depth adjustor and arranged to translate the distal portion 40B of the second catheter 40 relative to the distal portion 30B of the first catheter.
  • the second catheter 40 is arranged to move between a fully retracted position and a fully extended position relative to the catheter 30 using the translator 410.
  • the distal end 40B of the second catheter 40 is arranged to move between a fully retracted position and a fully extended position relative to the catheter 40 by using the capsule depth translator 405.
  • the translator 410 therefore translates the second catheter 40 relative to the first catheter 30 in the X direction.
  • the delivery capsule 100 is secured to the distal end 40B of the second catheter 40, so the capsule depth translator 405 may be used to translate the distal end 40B of the second catheter 40 so that the operator can position the implant at the target site 80 in the patient.
  • the translator 405 may also be used to unsheathe the delivery capsule 100 or otherwise actuate the delivery capsule 100.
  • the translator 410 may include an annular shaft 412 that extends that extends longitudinally in an axial direction along the housing 22 (i.e., along the X-axis).
  • a sliding element 412 is mounted on the shaft 412.
  • the sliding element 414 is attached to the shaft 412 so that an operator may move the sliding element 414 to cause the shaft 412 to translate relative to the catheter 30.
  • the sliding element 412 may be translated in an axial direction (i.e., in a longitudinal direction X).
  • the sliding element 414 is therefore arranged to move towards the distal portion 20b of the controllable delivery catheter system.
  • the translator 410 of this example embodiment may comprise an inner mechanism (not shown) that is arranged to control the translation of the second catheter 40 when the sliding element 414 is moved.
  • the maximum and minimum distance moveable by the second catheter 40 may be determined by the length of the shaft 412 of the translator, among other features, such as locks or stops.
  • the shaft 412 is positioned between the rotator 330 and the second positioner 420.
  • the shaft 412 is distal from the second rotator 420 and proximal from the rotator 330.
  • the sliding element 414 is arranged to move until the sliding element 414 abuts the rotator 330.
  • the second catheter 40 may be translated to a fully extended positioned a maximum distance away from the first catheter 30 and the housing 22.
  • the sliding element 414 is returned back towards the proximal portion 20a of the controllable delivery catheter system 20
  • the second catheter 40 returns to the original position (e.g., the distance between the distal end 40B of the second catheter 40 and the distance between the distal end 30B of the first catheter 30 is minimized).
  • the sliding element 414 is arranged to move until the sliding element abuts against the second positioner 420. In this position, the end of the second catheter 40B may be at a minimum distance in position in relation to the end of the first catheter 30B.
  • the second positioner 420 is arranged to move the second catheter 40.
  • the second catheter 40 is arranged to move between a neutral position (i.e., the lumen of the second catheter is aligned with a longitudinal X-axis of the housing 22) and a fully flexed position (where the distal end 40B of the catheter 40 is arranged to deflect away from the X-axis 22a).
  • the second positioner 420 comprises a second annular threaded shaft 422 and a second rotatable collar 424.
  • the annular threaded shaft 422 has a length and extends longitudinally along the housing 22 in an axial direction (i.e., along the X-axis).
  • the rotatable collar 424 is mounted on the threaded shaft 422 and is threadingly engaged to the shaft 422. When the rotatable collar 424 rotates (e.g., clockwise), the rotatable collar 424 translates along the length of the annular shaft 422. The rotatable collar 424 is therefore arranged to move along the length of the threaded shaft 422 towards the distal portion 20b (or towards the proximal portion 20a in other examples) of the controllable delivery catheter system.
  • the second positioner 420 comprises an inner mechanism (not shown) that is arranged to control the flexing and/or actuation of the second catheter 40 when the second positioner 420 is moved by the operator.
  • the second catheter 40 includes a deformable portion 40C, which deforms in response to the movement of the rotatable collar 424 move the catheter 40.
  • the distal portion 40C When the distal portion 40C is deformed (i.e., from being actuated and/or flexed), the distal portion 40B of the second catheter 40 deviates away from the central line 22a in a pre-determined direction (no shown).
  • the distal portion 40B of the catheter 40 is arranged to move in response to the second positioner 420.
  • any length of the catheter 40 may be arranged to move in response to the movement of the second rotatable collar 424.
  • the annular thread 422 is positioned in between a stopping collar on the capsule depth translator 405 and the translator 410.
  • the annular thread is distal from the second rotator 430 and proximal to the translator 410.
  • the second rotatable collar 424 is arranged to move along the second threaded shaft 422 until the rotatable collar abuts the stopping collar on translator 405. In this position, the catheter 40 may be flexed or otherwise moved.
  • the second catheter 40 When the second rotatable collar 424 is rotated back towards the proximal portion 20a of the controllable delivery catheter system 20, the second catheter 40 returns back to a neutral position (e.g., the lumen of the first catheter 40 is parallel with the centre line of the housing 22a).
  • the second rotatable collar 424 is arranged to move along the threaded shaft 422 until the rotatable collar abuts the capsule depth translator 405. In this position, the catheter 40 may be in a neutral position.
  • the controllable delivery catheter system 20 also comprises a second rotator element 430 which is arranged to rotate of the second catheter 40.
  • the rotator element 430 comprises a rotatable collar 432.
  • the rotator element 430 comprises an inner mechanism (not shown) that is arranged to control the rotation of the second catheter 40 when the rotator element 430 is moved by the operator.
  • a portion of the second catheter 40 may be secured to the rotatable collar 432, such that any rotation of the collar 432 rotates the catheter 40.
  • any other suitable mechanism may be used.
  • the second catheter 40 may be arranged to rotate without moving. This enables the operator to rotate the second catheter 40 in the vasculature 6 of the patient to orientate the first catheter 40.
  • the first catheter 40 is arranged to move in a pre-determined direction (not shown) by the first actuation mechanism 420.
  • the rotator element 430 enables the operator to orientate the second catheter 40 so that when the second catheter 40 is flexed, the catheter may flex in a desired direction.
  • Figures 2A and 2B show an exemplary catheter system 20 with a preferred arrangement of the first actuator 300 and second actuator 400 in and on the housing 22.
  • the first actuator 300 is nearer to the distal portion 20b of the controllable delivery catheter system 20, while the second actuator 400 is closer to the proximal portion 20a of the controllable delivery catheter system 20.
  • the controllable delivery catheter system 20 may be arranged in any desirable orientation.
  • the first actuator 300 may be closer to the proximal portion 20a, while the second actuator 400 may be closer to the distal portion 20b.
  • the exemplary first and second actuators 300, 400 include exemplary moveable mechanisms (i.e., first positioner 320, first rotator 330, translator 410, translator 405, second positioner 420, second rotator 430).
  • the controllable delivery catheter system 20 may include any number of moveable mechanisms to control the movement of the first and second catheters 30, 40.
  • the controllable delivery catheter system 20 may include a translator arranged to translate the first catheter 30 relative to the housing 22.
  • the controllable delivery catheter system 20 may only include a first and second moveable mechanisms 320, 420.
  • first and second actuators 300, 400 While specific examples of the first and second actuators 300, 400 are provided, it will be understood that any suitable actuator configurations may be used control the movement of the first and second catheters 30, 40.
  • the translator 410 is provided as a sliding element 414 arranged on a shaft 412.
  • the translator 410 may be a rotatable element on an annular thread. Therefore, any suitable arrangement for controlling the movement of the first and second catheters 30, 40 may be utilised.
  • the exemplary catheter system 20 described is arranged to independently move the first and second catheter 30, 40.
  • the first and second actuators 300, 400 are operable by an operator to enable precise positioning of the distal portion of the catheters 30B, 40B at a target site 80 in a patient.
  • the controllable delivery catheter system 20 is therefore operable to steer and accurately position the delivery capsule 100 (containing an implant) at a target site 80.
  • the idealised anatomy illustrated in Figure 1 is one of many possible anatomies.
  • the controllable delivery catheter system 20 may work well for one patient but then may be extremely challenging for another patient. Ensuring that the first and second catheters 30, 40 maintain their relative positioning and orientation is challenging, especially in patients who have complex narrow anatomies, or tortuous vasculature.
  • the relative positioning of the first catheter 30 and the second catheter 40 can be important to avoid damage to the vasculature 6 as the distal portion 20b of the controllable delivery catheter system 20 passes through a patient’s body towards the target site 80.
  • the distal portion 40B of the second catheter 40 may have an exposed edge or a discontinuous outer profile which may snag and damage delicate vasculature. Damage may also be caused by misalignment of first and second catheters 30, 40 and delivery capsule 100, or pinching between these components
  • the delivery capsule 100 is arranged to be deployed in an ideal configuration and alignment of the first and second actuators 300, 400.
  • the ideal configuration and alignment aids in successful implant deployment and helps mitigate against damage or snagging of the implant in the patient.
  • the first actuator 300 and the second actuator 400 are freely operable to precisely control minor movement of the first and second catheters 30, 40 (in millimetres, or to one degree of rotation). Misalignment of the actuators 300, 400 during insertion, when an operator is applying force to the proximal portion 20a of the controllable delivery catheter system 20, may damage the controllable delivery catheter system 20. This may also accidentally damage the implant in the delivery capsule 100, or accidentally deploy the implant.
  • the alignment between the first and second actuators 300, 400 can also be important when withdrawing the distal end of the first and second actuators 30B, 40B from the patient, as any misalignment may cause damage to the vasculature.
  • FIGS 3-6A and 7A show exemplary locking mechanisms 50, 50a, 50b which are arranged removably engage with the controllable delivery catheter system 20.
  • the locking mechanism 50 is arranged to be mounted onto the controllable catheter system 20, the locking mechanism 50 to engage with the catheter system 20 to restrict movement of the first catheter 30 and second catheter 40.
  • the locking mechanism 50 therefore is arranged to removably engage with the controllable delivery catheters 30,40 via the housing 22.
  • Removably engaging means that the locking mechanism 50 may be removed from the housing 22 by the operator to disengage from the first/second actuators 300, 400 and/or the first, second catheters 30, 40.
  • the locking mechanism 50 is arranged to maintain a desired distance and orientation of the first and second catheter 30, 40. In some examples, the locking mechanism 50 is arranged to engage with directly with the first and second catheters 30, 40 to restrict movement. In other examples, the locking mechanism 50 is arranged to engage with the first and second actuators 300, 400 to restrict the movement of the first and second catheters 30, 40.
  • the operator may engage the locking mechanism 50 by mounting it onto the housing 22 to engage with the first and second actuators 300, 400 and/or first and second catheters 30,40.
  • the locking mechanism 50 (or portions of the locking mechanism 50) may therefore remain on the housing 22 during different procedural steps, such as inserting the distal end of the catheters 30B, 40B into a patient, moving the distal end of the catheters 30B, 40B towards a target site, or withdrawing the distal end of the catheters 30B, 40B from a patient.
  • the locking mechanism 50 therefore may restrict movement of the catheters 30, 40 by directly engaging with the catheters 30, 40, or by engaging with the first and second actuators 300, 400.
  • Figures 3-5, 6A and 7A show exemplary locking mechanisms 50 that are mounted onto the proximal portion 20a of the controllable delivery catheter system 20.
  • the locking mechanism 50 engages with the first and second actuators 300, 400.
  • the locking mechanism 50 has a body 52.
  • the length L of the locking mechanism is larger than the width W of the locking mechanism 50.
  • the locking mechanism has an external facing profde 60a and an internal facing profde 60b.
  • the external facing profde 60a faces away from the housing 22 when the locking mechanism 50 is mounted onto the housing 22.
  • the internal facing profde 60b faces towards the housing 22 when the locking mechanism 50 is mounted onto the housing 22.
  • the internal facing profde 60b has an irregular profde that comprises at least one engagement feature 500 that is arranged to engage with the controllable delivery catheter system 20.
  • the engagement feature(s) 500 are arranged to restrict movement of the first and second actuators 300, 400.
  • the engagement feature 500 therefore restricts movement of the first and second catheters 30, 40.
  • the engagement feature 500 may be any suitable feature formed in the body 52 of the locking mechanism, and/or extending from the body 52 which restricts movement of the first and second actuators 300, 400.
  • the engagement feature 500 restricts movement of the first and second actuators 300, 400 by for example, locking the first and second actuators 300, 400 in position, or preventing the movement of the first and second actuators 300, 400.
  • the engagement feature(s) 500 may also restrict movement of the first and second actuators 300, 400 by restricting the operators’ access to the first and second actuators 300, 400, thereby preventing the ability of the operator to move the first and second actuators 300, 400.
  • the engagement feature 500 comprises a first protrusion 54, a second protrusion 60, a third protrusion 70, a first receiving portion 55, a second receiving portion 53 and a third receiving portion 63, discussed in further detail below.
  • the first protrusion 54 extends from the body 52.
  • the first protrusion 54 is used to restrict movement of the translator 410.
  • the first protrusion 54 also secures the locking mechanism 50 on to the controllable delivery catheter system 20.
  • the first protrusion 54 extends along the length L of the locking mechanism 50 in an axial direction (i.e., in the X-direction).
  • the protrusion 54 When the protrusion 54 is mounted onto the shaft 412, the protrusion 54 extends along the length of the shaft 412 to restrict the sliding element 414 from translating.
  • the receiving cavity 54b extends the entire length of the annular shaft 412. In other examples, the protrusion 54 may only extend partially along the length of the annular shaft 412.
  • the first protrusion 54 is formed as an incomplete annular sector 54a. In other examples, the first protrusion 54 may be formed as a clip or any other suitable form that prevents to sliding element 414 from translating.
  • the protrusion 54 also locks the sliding element 414 in the desired position.
  • the sliding element 414 is held is positioned adjacent to the second positioner 420.
  • the sliding element 414 is therefore held in the position nearest the proximal end 20a of the catheter system 20.
  • the distance between the distal end 40B of the second catheter 40 and the distal end 30B of the first catheter 30 is therefore at a minimum distance.
  • the sliding element 414 may be positioned at any position along the length of the shaft 412.
  • the sliding element 414 abut the protrusion 54 so that the sliding element 414 is adjacent to the first rotator 330.
  • the sliding element 414 may be positioned mid-way along the shaft 414.
  • the protrusion 54 may be arranged to selectively lock the sliding element 414 in a desired position so that the distal end 40B of the second catheter 40 extends from the distal end 30B of the first catheter 30 by a desired distance.
  • Another exemplary engagement feature 500 of the locking mechanism 50 is a second portion 53 and a third receiving portion 63.
  • the second receiving portion 53 is arranged to receive and extend over the first rotatable element 330.
  • the third receiving portion 63 is arranged to receive the second rotatable element 430.
  • the internal facing profile 60b of the receiving portions 53, 63 conforms to the profile of the rotators 330, 430.
  • the second and third receiving portions 53, 63 act as first and second covers respectively.
  • the second and third receiving portions 53, 63 prevent the operator from accessing the first and second rotatable elements 330, 430.
  • the second and third receiving portions 53, 63 therefore act as a first and second cover that extends over the first and second rotators 330, 430 to restrict access to the first and second rotatable collars 332, 432.
  • the second and third receiving portions 53, 63 therefore restrict the operator from operating the first rotatable collars 332, 432.
  • the second receiving portion 53 and the third receiving portion 63 extend of the first and second rotator 330, 430 respectively to prevent the operator from accessing the first and second rotators 330, 430. This restricts movement of the first and second rotators 330, 430.
  • the first and second receiving portions 53, 63 comprise overhanging lips 53a, 63a (shown in Figure 4). These lips 53a, 63a are arranged to at least partially extend around the rotators 330, 430 to restrict access to the rotators 330, 430.
  • the lips 53a, 63a may also include a groove that extends on the inner surface of the lips (not shown).
  • These grooves may correspond to a groove on the first and second rotator elements 330, 430 to orient the locking mechanism 50 on the handle 22.
  • the grooves may also restrict the rotator elements 330, 430 from moving.
  • the lips 53a, 63a therefore act as covers which extend over the rotators 330, 430.
  • the lips 53a, 63a also abut the first and second rotator elements 330, 430 to prevent rotation.
  • the lips 53a, 63a also help the operator position the locking mechanism 50 correctly on the handle 22 in the correct orientation.
  • Another exemplary engagement feature 500 of the locking mechanism 50 includes a second protrusion 60 and a third protrusion 70.
  • the second protrusion 60 is arranged to engage with the second annular thread 422.
  • the third protrusion 70 is arranged to engage with the first annular thread 322. This is shown more clearly in Figures 5a and 5b, which show a cross-sectional view of the second protrusion 60 and the third protrusion 70 along lines A-A.
  • the second protrusion 60 comprises an elongate body 61.
  • the elongate body 61 extends from the locking mechanism body 52 via a base 64a.
  • the elongate body 61 is generally dome shaped, but may be any suitable shape to abut the annular thread 432.
  • the elongate body may be cuboidal or a truncated cone.
  • the protrusion 60 engages with the annular thread 422 by abutting against the annular thread 422.
  • the protrusion 60 therefore prevents movement of the rotatable collar 424 along the annular thread.
  • the second protrusion 60 therefore restricts flexion and/or actuation of the catheter 40.
  • the base 64a is arranged to be removably attached to the body 52 of the locking mechanism 50. As shown in Figure 3, the base 64a is arranged to be received within a recess 64b that is formed in the body of the locking mechanism body 52.
  • the base 64a may be secured to the locking mechanism 50 by any suitable method; for example, the base 64a and the recess 64b may be arranged to form a snap fit or slide fit arrangement, as the case may be, or the base 64a may be secured by a pin or latch arrangement.
  • the operator may therefore remove the base 64a from the locking mechanism body 52. This may be advantageous during transit of the locking mechanism 50 to prevent damage to the second protrusion 60 because it extends from the locking mechanism body 52. This may also be advantageous to allow the second protrusion to be injection moulded so a different material could be used in this part of the controllable delivery catheter system 20.
  • the base 64a may be formed integrally with the locking mechanism body 52.
  • the protrusion 60 is partially housed inside a C-shaped clip 62.
  • the clip 62 is formed of an incomplete annular sector that extends around the protrusion 60.
  • the clip 62 has a receiving cavity 62b that is arranged to receive the annular threaded shaft 422.
  • the clip 62 may be dimensioned to snap fit or slide fit onto the annular threaded shaft 422 to mount the locking mechanism 50 the housing.
  • the elongate body 61 ofthe protrusion 60 may be damaged because it extends from the base 64a.
  • the clip 62 therefore helps protect the protrusion 60 from external damage.
  • the clip 62 also helps secure the locking mechanism 50 onto the delivery catheter system 20.
  • the third protrusion 70 is arranged to engage with the first annular thread 322.
  • the third protrusion 70 has an identical arrangement to the second protrusion 60.
  • the third protrusion 70 comprises an elongate body 71.
  • the elongate body 71 may be any suitable shape to abut the annular thread 322, such as a dome, cuboidal or truncated cone.
  • the elongate body 71 extends from a base 74a.
  • the base 74a is arranged to be removably attached to the body 52 of the locking mechanism 50. As shown in Figure 3, the base 74a is arranged to be received within a recess 74b that is formed in the body of the locking mechanism body 52.
  • the third protrusion 70 therefore restricts flexion and/or actuation of the first catheter 30.
  • the base 74a may be secured to the locking mechanism 50 by any suitable method; for example, the base 74a and the recess 74b may be arranged to form a snap fit or slide fit arrangement, or the base 74a may be secured by a pin or latch arrangement. The operator may therefore remove the base 74a from the locking mechanism body 52. This may be advantageous during transit of the locking mechanism 50 to prevent damage to the third protrusion 70 because it extends from the locking mechanism body 52.
  • the base 74a may be formed integrally with the locking mechanism body 52.
  • the protrusion 70 is partially housed inside a C-shaped clip 72.
  • the clip 72 is formed of an incomplete annular sector that extends around the protrusion 70.
  • the clip 72 has a receiving cavity (not shown) that is arranged to receive the annular threaded shaft 322.
  • the clip 72 may be dimensioned to snap fit or, alternatively or in combination, slide fit onto the annular threaded shaft 322 to mount the locking mechanism 50 the housing.
  • the elongate body 70a of the protrusion 70 may be damaged because it extends from the base 74a.
  • the clip 72 therefore helps protect the protrusion 70 from external damage.
  • the clip 72 also helps secure the locking mechanism 50 onto the delivery catheter system 20.
  • the bases 64a, 74a, the second and third protrusions 60, 70 and clips 62, 72 may be formed integrally with the locking mechanism body 52.
  • the engagement features 500 of the locking mechanism 50 conform to the arrangement of the first actuator 300 and the second actuator 400. It will be understood that there may be any number of engagement features 500 on the locking mechanism 50.
  • the controllable delivery catheter 20 may have a first catheter 30 that is controlled by a first positioner 320.
  • the locking mechanism 50 may therefore only include a second protrusion 60 that is arranged to restrict movement of the first positioner 330 along an annular thread 322.
  • the controllable delivery catheter 20 may have a first catheter 30 that is controlled by a translator (not shown) and a rotator 330.
  • the locking mechanism 50 may therefore include a second protrusion 60 and a receiving portion 53 to restrict the movement of the first catheter 30. Therefore, the locking mechanism 50 may be formed with any combination of engagement features 500.
  • the exemplary engagement features 500 are provided, it will be understood that any suitable engagement feature configurations may be used to restrict the movement of the first and second actuators 300, 400, and/or the first and second catheters 30, 40.
  • the second protrusion 60 is provided as an elongate body 61.
  • the second protrusion 60 may be an incomplete annular sector that extends around the annular thread 422 to restrict the operator’s access to the first/second actuators 300, 400. Therefore, any suitable arrangement for restricting the movement of the first and second moveable means 300, 400 and/or the first and second catheter 30, 40 may be utilised. This may include, clips, clamps, or pins to engage with the catheter system 20.
  • the locking mechanism 50 engagement features 500 may be in any suitable arrangement to act on the catheter delivery system 20.
  • the first protrusion is positioned between the second protrusion 60 and the third protrusion 70.
  • the receiving portion 53 is in between the third protrusion 70 and the first protrusion 54, etc.
  • the protrusions 54, 60, 70 and the receiving portions 53, 55, 63 may be in any suitable orientation and order along the length of the locking mechanism 50.
  • the engagement features 500 are arranged to position and secure the catheter system 20 in a desired orientation for inserting and/or moving the distal end 20b of the catheter system through a patient and/or withdrawing the distal end 20b of the catheter system from a patient.
  • the protrusions 54, 60, 70 are fixed in position in relation to the locking mechanism body 52. By being fixed in position, the distance between the protrusions 54, 60, 70 does not change. The protrusions 54, 60, 70 therefore cannot be displaced out of position to affect to affect the positioning of the first actuator 300 and the second actuator 400.
  • the distance between the protrusions 54, 60, 70 is pre-determined.
  • the distance between the protrusions 54, 60, 70 may be determined so that the locking mechanism 50 positions the first and second actuators 300, 400 in the desired orientation.
  • the desired orientation may be determined dependent on the type/orientation of delivery catheter system 20, the desired therapy type (e.g., implant, stent etc.) and procedural step.
  • the locking mechanism 50 may be attached to the controllable delivery catheter system 20 to maintain the positioning and distance between the first and second catheters 30, 40 in the following procedures: during insertion of the distal portion 20b into the patient, when moving the distal portion 20b towards a target site 80, or when removing the distal portion 20b from the patient. Each procedure may require the first and second catheters 30, 40 to be positioned and/or orientated in a different arrangement. Therefore, multiple locking mechanisms 50 may be used by the operator to restrict the movement of the first and second actuators 300, 400.
  • the catheter system 20 therefore may be provided with a number of locking mechanisms 50 with different arrangements of engagement features 500.
  • the operator may therefore remove and engage the appropriate locking mechanism 50 depending on which stage of the procedure they are completing, e.g., inserting, moving the distal end 20b towards a patient, or withdrawing the distal end 20b from a patient.
  • the locking mechanism 50 may also be segmentable. Portions of the locking mechanism body 52 may be removable so that the operator may freely access and move select moveable mechanisms of the first and second actuators 300, 400.
  • the exemplary locking 50a shown in Figure 6A has segmentation marks 120 which indicate areas of the locking mechanism body 52 may be removed.
  • the first protrusion 54a of the locking mechanism 50a may be removed, leaving the receiving sections 53a and protrusions (not shown) attached to the remaining portion of the locking mechanism body 52.
  • Any engagement feature 500 may be removed from the locking mechanism body 52.
  • the operator may therefore be able to selectively remove portions of the locking mechanism body 52 while leaving the remaining portions of the body 52 to engage with the catheter system 20.
  • the operator may therefore selectively inhibit and move the first and second catheters 30, 40. This is advantageous as the operator may control the movement (and the freedom of movement) of the first and second catheters 30, 40 depending on the procedural step being performed.
  • the internal facing profile 60b of the locking mechanism 50 may be adapted to accommodate the controllable delivery catheter system 20 during use.
  • the locking mechanism 50 in Figure 4 comprises a recess 80.
  • the recess 80 is adjacent to the receiving portion 55.
  • the operator may mount the controllable delivery catheter system 20 to a holder 200 (shown in Figure 8).
  • the holder 200 is arranged to secure the controllable delivery catheter system 20 and is also moveable to help position the proximal portion 20a relative to the patient.
  • the recess 80 is arranged to accommodate a holder 200 so that the locking mechanism 50 may restrict the movement of the first and second actuators 300, 400 when the controllable delivery catheter system 20 is mounted on the holder 200.
  • the locking mechanism 50 includes exemplary engagement features 500 (i.e., first protrusion 54, second protrusion 60, third protrusion 70, receiving portion 55, second receiving portion 53, third receiving portion 63, recess 80).
  • the locking mechanism 50 may include any number of engagement features 500 to restrict the movement of the first and second catheters 30, 40.
  • locking mechanism 50 may include clamps, pins or have receiving portions which extend around the actuators 300, 400 to restrict access to the actuator. While specific examples of the engagement features 500 are provided, it will be understood that any suitable engagement feature configuration may be used control the restrict the movement of the first and second catheters 30, 40.
  • the second and third protrusions 60, 70 are provided as elongate bodies (not shown) which are arranged to abut the delivery catheter system 20.
  • the second and third protrusions 60, 70 may be receiving portions which partially extend around the threaded shafts 322, 422 to restrict access to the operator.
  • the operator is unable to rotate the rotatable collars 324, 424 along the length of the threaded shafts 322, 422. Therefore, any suitable arrangement for restricting the movement of the first and second catheters 30, 40 may be utilised.
  • the locking mechanism 50 shown in Figures 3-5 may be used when an operator moves the distal portion 20b towards a target site 80, while the locking mechanism 50A shown in Figure 6A may be used while inserting the distal portion 20b of the controllable delivery catheter system 20 into the patient.
  • the locking mechanism 50B shown in Figure 7A may be used when removing the distal portion 20b of the locking mechanism 50 from the patient.
  • the locking mechanisms 50A and 50B will be discussed in greater detail below.
  • the locking mechanisms 50A and 50B have largely the same features as the locking mechanism 50 described above.
  • the reference numerals have been kept consistent to denote the same features, with a letter ‘a’ to indicate that it is in reference to the locking mechanism 50A or letter ‘b’ to indicate that it is in reference to locking mechanism 50B.
  • This locking mechanism 50a helps prevent the delivery capsule 100 from contacting the implant brim 101 during insertion, as shown in Figure 6B, which shows the distal portion 20b of the controllable delivery catheter system 20. This arrangement prevents the implant range of motion being pinched, crushed or other damaged by the capsule 100 being pushed proximally towards the catheter 40, or by the catheter 40 being pushed distally.
  • the locking mechanism 50a prevents any relative movement between the first and second catheters 30, 40 while the implant inside the delivery cap 102 is loaded onto the controllable delivery catheter system 20. Once the controllable delivery catheter system 20 is loaded onto the holder 200, the locking mechanism 50a may be easily removed by the operator because the first, second and third protrusions are snap fitted onto the proximal portion 20a of the controllable delivery catheter system 20.
  • the locking mechanism 50b includes a body 50b with a first protrusion 54b, second protrusion 60b, and a third protrusion 70b.
  • the removal locking mechanism 50b further includes a projection 82b which extends from the body 52B and abuts the rotatable element 424. The projection 82b therefore prevents any rotation of the rotatable element 424 along the annular thread 420.
  • the removal locking mechanism 50B constrains the delivery cap 100 flush to the outer cap during removal of the distal portion 20b of the catheter 20.
  • the locking mechanism 50 may be attached to the handle 22 during removal of the distal portion 20b to prevent any damage to the patient vasculature 6 during removal.
  • the locking mechanisms 50, 50a, 50b help an operator to secure the position of the first and second actuators 300, 400 and/orthe first and second catheters 30, 40. The operator therefore is free to position, insert and withdraw the catheter system 20 from a patient without worrying about maintaining the first and second actuators 300, 400 in a specific orientation and/or position. Furthermore, the locking mechanism 50, 50a, 50b provides a hands-off locking system that may be selectively engaged by the operator during different procedural steps. This not only provides the operator a repeatable method of securing the catheter system 20, but also makes the procedural steps easier to perform because they do not have to manually hold the first and second actuators 300, 400 and/or the first and second catheters 30, 40 in position.
  • an exemplary catheter system 20 is provided with a second catheter 40 arranged inside a first catheter 30.
  • the first catheter 30 is positioned relative to the second catheter 40 in an ideal orientation before the catheter system 20 is shipped to an operator.
  • the ideal orientation may be, for example, an orientation that minimises damage to the first and second catheters 30, 40 if the catheter system 20 was physically dislodged during transit.
  • a delivery locking mechanism 50a is secured to the controllable delivery catheter system 20 to maintain the ideal orientation of the first and second catheters 30, 40.
  • the delivery locking mechanism 50a is secured to the controllable delivery catheter system 20 at the point of manufacture before the controllable delivery catheter system 20 is delivered to the operator. The delivery locking mechanism 50a therefore restricts any movement of the first and second catheter 30, 40 during delivery.
  • the operator receives the catheter system 20 and positions the controllable delivery catheter system 20 so that the distal portion 20b is ready to be inserted into a patient. This may be done by placing the controllable delivery catheter system 20 on a holder 200. Alternatively, the controllable delivery catheter system 20 may not be used with a holder 200, in which case step 504 may be omitted and proceeds to step 506.
  • the locking mechanism 50 may be attached to the housing 22 prior to inserting the distal ends 30B, 40B of the catheters 30, 40 into a patient toward a target site 80.
  • the operator may place a delivery capsule 100 containing an implant at the distal end of the catheters 30B, 40B before inserting the distal ends 30B, 40B into a patient.
  • the delivery catheter system 20 may be provided with an implant already positioned at the distal end 30B, 40B of the catheters 30, 40.
  • the distal portion 20b of the controllable delivery catheter system 20 is then advanced towards the target site 80.
  • the operator may replace the locking mechanism 50a with a different locking mechanism 50.
  • the operator may choose to keep the locking mechanism 50a on the controllable delivery catheter system 20.
  • the locking mechanism 50, 50a maintain the relative positioning between the first and second catheters 30, 40, there is a reduced risk of damage to the implant and/or damage to the vasculature 6 and the catheter system 20.
  • the operator removes the locking mechanism 50a, 50 so that the first and second catheters 30, 40 may be independently moved by the first and second actuators 300, 400. This enables the operator to complete the desired procedure at a target site 80. Alternatively, the operator may remove a segmented portion of the locking mechanism if they only require to move the catheter in a specific degree of freedom.
  • a removal locking mechanism 50b is mounted to the controllable delivery catheter system 20 prior to withdrawing the distal ends 30B, 40B of the catheters 30, 40 from a patient.
  • the removal locking mechanism 50b restricts the movement of the first and second catheters 30, 40.
  • the first and second moveable means 300, 400 are positioned by the operator so that the removal locking mechanism 50b can be mounted on to the controllable delivery catheter system 20. This ensures the first and second catheters 30, 40 are positioned at the optimal distance and orientation before the removal locking mechanism 50b locks the catheters 30, 40 in position.
  • the removal locking mechanism 50b helps prevent damage to the vasculature 6 as the operator removes the distal portion 20b of the controllable delivery catheter system 20 from the patient.
  • the operator may remove the removal locking mechanism 50b from the controllable delivery catheter system 20.
  • the controllable delivery catheter system 20 is preferably provided with the locking mechanisms 50, 50A, 50B.
  • the engagement features 500, 500a, 500b of the locking mechanisms 50, 50A, 50B are therefore adapted to restrict the movement of the first and second actuators 300, 400 on the controllable delivery catheter system 20.
  • the exemplary catheter system 20 has a first catheter 30 and a second catheter 40.
  • the locking mechanism 50, 50A, 50B may be used on any number of nested catheter systems.
  • a third may be nested inside the second catheter and the locking mechanism may be configured to prevent movement of the first and third catheter.
  • the catheter system 20 may only have a single catheter.
  • the locking mechanisms 50, 50a, 50b are arranged to engage with the first and second actuators 300, 400 on the housing 22.
  • the locking mechanisms 50, 50a, 50b may also be arranged to engage directly with the first and/or second catheters to restrict movement of the catheters.
  • the second protrusion 60 of the locking mechanism 50 may abut a portion of the catheter 30 that extends distally from the hub 310.
  • the handle 22 may be arranged such that portions of the first and second catheters 30, 40 are exposed.
  • the engagement features 500 of the locking mechanism 50 may therefore be arranged to restrict movement of the first and second catheters by engaging directly with the catheters 30, 40.
  • the distal portion of the controllable delivery catheter system 20b is configured to be navigated to any suitable vascular site in a patient. While the above examples have been discussed in relation to providing a delivery capsule 100 (containing an implant) to a heart 10, it will be understood that the implant 110 may be any suitable implant that is arranged to be delivered to a desired target site 80 in the patient.
  • the first and second catheters 30, 40 are configured to access relatively distal locations in a patient including, for example, the middle cerebral artery (MCA), internal carotid artery (ICA), the Circle of Willis, and tissue sites more distal than the MCA, ICA, and the Circle of Willis.
  • MCA middle cerebral artery
  • ICA internal carotid artery
  • ICA Circle of Willis
  • tissue sites more distal than the MCA, ICA, and the Circle of Willis.
  • the MCA as well as other vasculature in the brain or other relatively distal tissue sites (e.g., relative to the vascular access point), may be relatively difficult to reach with a catheter, due at least in part to the tortuous pathway (e.g., comprising relatively sharp twists or turns) through the vasculature to reach these tissue sites.
  • tortuous pathway e.g., comprising relatively sharp twists or turns
  • catheter system 20 may also be configured to be used with other target tissue sites.
  • catheters 30,40 may be used to access tissue sites throughout the coronary and peripheral vasculature, the gastrointestinal tract, the urethra, ureters, fallopian tubes, veins and other body lumens.
  • a length of catheters 30,40 may depend on the location of the target tissue site within the body of a patient or may depend on the medical procedure for which catheters 30,40 is used. This is indicated by the break line 21.
  • an elongated body of catheters 30,40 may have a working length of about 115 centimeters (cm) to about 145 cm or more, such as about 130 cm, although other lengths may be used (e.g., in the case of a radial access catheter).
  • the distal portion may be about 5 cm to about 35 cm in length.
  • the proximal portion may be about 90 cm to about 130 cm in length, depending on the length of the distal portion.
  • Example 1 A locking mechanism for removably engaging with a controllable delivery catheter having at least one actuator, wherein the actuator is configured to move the delivery catheter; the locking mechanism comprising a body with at least one engagement feature, wherein the engagement feature is configured to restrict movement of the actuator to restrict movement of the delivery catheter.
  • Example 2 The locking mechanism of Example 1, wherein the engagement feature comprises a first protrusion extending from the locking mechanism body, wherein the first protrusion comprises an incomplete annular sectorthat extends in an axial direction along a length of the locking mechanism body and is arranged to abut at least one actuator.
  • Example 3 The locking mechanism of Example 2, wherein the first protrusion is arranged to snap fit or slide fit onto the controllable delivery catheter.
  • Example 4 The locking mechanism of Example 1, wherein the engagement feature further comprises a second protrusion extending from the locking mechanism body, wherein the second protrusion comprises an elongate body arranged to abut at least one actuator.
  • Example 5 The locking mechanism of Example 4, wherein the second protrusion is housed in an incomplete annular sector.
  • Example 6 The locking mechanism of Example 4, wherein the second protrusion is removably attached to the locking mechanism body.
  • Example 7 A locking mechanism of Example 4, wherein the second protrusion is spaced from the first protrusion along an axial distance along a length of the locking mechanism body, wherein the distance between the first and second protrusion is fixed.
  • Example 9 A locking mechanism of Example 8, wherein the third protrusion is housed in an incomplete annular sector.
  • Example 11 A locking mechanism of Example 8, wherein the third protrusion is spaced at an axial distance from the first and/or second protrusion along a length of the locking mechanism body, wherein the distance between the first and/or second protrusion and the third protrusion is fixed.
  • Example 12 A locking mechanism according to Example 1, wherein the locking mechanism further comprises a recess in the locking mechanism body.
  • Example 13 A locking mechanism according to Example 1, wherein the engagement feature is further configured to abut the delivery catheter to restrict movement of the delivery catheter.
  • Example 14 A locking mechanism according to Example 1, wherein the locking mechanism body is segmentable, such that at least one engagement feature may be selectively removed from the remaining portion of the locking mechanism body.
  • Example 15 A locking mechanism according to Example 1, wherein the engagement feature restricts movement of the actuator by at least partially extending around the actuator to restrict access to the actuator.
  • Example 16 A locking mechanism according to Example 1, wherein the actuator is a first actuator, and the controllable delivery catheter further comprises a second actuator configured to move the delivery catheter, wherein at least one engagement feature is configured to restrict movement of the first actuator and the second actuator to restrict movement of the delivery catheter.
  • Example A controllable delivery catheter system comprising: a housing with a steerable delivery catheter at least partially located within a housing, the delivery catheter having a proximal portion and a distal portion, wherein the distal portion in use is positionable at a treatment site within a patient, at least one actuator on the housing, wherein the actuator is configured to move the delivery catheter; and a locking mechanism located on the housing, wherein the locking element restricts movement of the actuator to restrict movement of the delivery catheter.
  • Example 20 A controllable delivery catheter system of Example 19, wherein the translation mechanism comprises a shaft and a sliding element mounted on the shaft, wherein the sliding element is configured to translate longitudinally along the shaft to translate the delivery catheter.
  • Example 21 A controllable delivery catheter system of Example 20, wherein the engagement feature comprises a first protrusion extending from the locking mechanism body, wherein the first protrusion is configured to be positioned on the shaft of the translation mechanism to restrict translation of the sliding element along the shaft.
  • Example 22 A controllable delivery catheter system of Example 21, wherein the first protrusion comprises an incomplete annular sector that extends in an axial direction along a length of the locking mechanism body.
  • Example 24 A controllable delivery catheter system of Example 23, wherein the first mechanism comprises a first annular threaded shaft and a first rotatable collar mounted on the first threaded shaft, wherein the first rotatable collar is operable to rotate along the first threaded shaft to move the first catheter and, the second protrusion abuts the threaded shaft to restrict movement of the first rotatable collar along the first threaded shaft.
  • Example 25 A controllable delivery catheter system of Example 23, wherein the second protrusion is housed in an incomplete annular sector, wherein the incomplete annular sector is configured to at least partially extend around the first threaded shaft.
  • Example 26 A controllable delivery catheter system of Example 18, further comprising a rotation mechanism operable to rotate the catheter, wherein the engagement feature of the locking mechanism further comprises a cover that is arranged to extend over the rotation mechanism to restrict access to the rotation mechanism.
  • Example 27 A controllable delivery catheter system according to Example 18, wherein the housing further comprises a second catheter at least partially located within the housing, the second catheter at least partially located within the first catheter, the second catheter having a proximal portion and a distal portion, wherein the distal portion of the second catheter in use is positionable at a treatment site within a patient, at least one second actuator on the housing, wherein the second actuator is configured to move the second catheter, such that the first and second catheters are moveable independently from each other; and wherein the locking mechanism restricts the movement of the first actuator and the second actuator to restrict movement of the first and second catheters.
  • Example 28 A controllable delivery catheter system of Example 27, wherein the second actuator comprises a second mechanism operable to move the second catheter, and the locking mechanism engagement feature comprises a third protrusion that is configured to abut the second actuator to restrict flexion and/or actuation of the second catheter.
  • Example 29 A controllable delivery catheter system of Example 28, wherein the second actuator comprises a second annular threaded shaft and a second rotatable collar mounted on the second threaded shaft, wherein the second rotatable collar is operable to rotate along the second threaded shaft to move the second catheter and, the third protrusion abuts the threaded shaft to restrict movement of the second rotatable collar along the second threaded shaft.
  • the second actuator comprises a second annular threaded shaft and a second rotatable collar mounted on the second threaded shaft, wherein the second rotatable collar is operable to rotate along the second threaded shaft to move the second catheter and, the third protrusion abuts the threaded shaft to restrict movement of the second rotatable collar along the second threaded shaft.
  • Example 30 A controllable delivery catheter system of Example 28, wherein the third protrusion is housed in an incomplete annular sector, wherein the incomplete annular sector is configured to at least partially extend around the second threaded shaft.
  • Example 31 A controllable delivery catheter system of Example 27, wherein the second actuator comprises a second rotation mechanism operable to rotate the second catheter, and the engagement feature of the locking mechanism further comprises a second coverthat is arranged to extend over the second rotation mechanism to restrict access to the second rotation mechanism.
  • Example 32 A method of locking a controllable delivery catheter system, wherein the controllable delivery catheter system comprises: a housing with a steerable delivery catheter at least partially located within a housing, the catheter having a proximal portion and a distal portion, wherein the distal portion in use is positionable at a treatment site within a patient, at least one actuator on the housing, wherein the actuator is configured to move the catheter, the method comprising: attaching a removable locking mechanism to the housing to restrict the movement of the actuator.
  • Example 33 The method of locking a controllable delivery catheter system of Example
  • Example 34 The method of locking a controllable delivery catheter system of Example
  • Example 35 The method of locking a controllable delivery catheter system of any Example 32, wherein the locking mechanism is attached to the housing prior to withdrawing the distal end of the catheter from a patient.
  • Example 36 The method of locking a controllable delivery catheter system of Example 33, wherein the target site is a heart.
  • Example 37 The method of locking a controllable delivery catheter system of Example 32, wherein the controllable delivery catheter system further comprises a second catheter at least partially located within the housing, the second catheter at least partially located within the first catheter, the second catheter having a proximal portion and a distal portion, wherein the distal portion of the second catheter in use is positionable at a treatment site within a patient, at least one second actuator on the housing, wherein the second actuators are configured to move the second catheter, such that the first and second catheters are moveable independently from each other; wherein attaching the locking mechanism to the housing restricts the movement of the first and second actuator.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
EP24709521.9A 2023-03-01 2024-02-28 Vorrichtung für einen katheter mit steuerbarer freisetzung Pending EP4673198A1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363449136P 2023-03-01 2023-03-01
PCT/IB2024/051922 WO2024180498A1 (en) 2023-03-01 2024-02-28 A device for a controllable delivery catheter

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EP4673198A1 true EP4673198A1 (de) 2026-01-07

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Publication number Priority date Publication date Assignee Title
US5115816A (en) * 1991-01-24 1992-05-26 Peter F. Lee, Inc. Single-hand controlled fine needle aspiration device
US7497853B2 (en) * 2005-05-05 2009-03-03 Enpath Medical Inc. Deflectable catheter steering and locking system
AU2016308017B2 (en) * 2015-08-14 2020-10-29 Caisson Interventional Llc Systems and methods for heart valve therapy
US10278852B2 (en) * 2016-03-10 2019-05-07 Medtronic Vascular, Inc. Steerable catheter with multiple bending radii via a steering mechanism with telescoping tubular components
US11446470B2 (en) * 2019-06-24 2022-09-20 Medtronic, Inc. Catheter handle with torque mechanism and valve relief component

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