Patent Application
20230321400
The present disclosure relates generally to devices for navigating passageways in a body, and in particular, to steerable tip catheters that can be used to navigate the tortuous anatomy of body lumens and to provide drug delivery to multiple areas of a target object.
Steerable or deflectable tip catheters are useful in many applications, being a marked improvement over catheters with fixed tip curves. They are especially useful in the treatment and diagnosis of disease states through transluminal access techniques. Steerable or deflectable tip catheters are particularly useful in the fields of interventional cardiology, neurology, and endovascular diagnosis and treatment of disease where access to the disease or treatment site is accomplished through the arterial or venous vasculature. However, some current steerable catheters are guided using puller wires and/or an internal stylet, which can lead to poor lateral compressive strength and transfer of torque to the tip of the catheter.
Additionally, some current steerable catheters are unable to be deflected once within a target site for drug delivery, such as a tumor. Such steerable catheters can only provide drug delivery to a single part of a target site in which it is inserted, and such catheters must be completely removed and reinserted into another target site to provide drug delivery to that target site. Thus, current steerable catheters cannot be deflected or moved once inserted into a drug delivery site, such as tumor. This can decrease the efficiency of a drug delivery to a target site during a procedure.
Accordingly, there remains a need for improved steering tips for use in deflectable tip catheters for drug delivery to target sites with a human body.
In general, methods, systems, and devices for deflectable tip catheters are provided.
In one aspect, a deflectable tip catheter is provided. The deflectable tip catheter includes a catheter body and an inner catheter body. The catheter body can include an outer surface and a smooth inner surface. The inner catheter body is coaxially disposed and slidably engaged within the catheter body. The inner catheter body includes a distal tip, a first strut member having a first proximal end and a first distal end and configured to be axially extended and retracted from the catheter body, and a second strut member having a second proximal end and a second distal end. The first strut member and the second strut member are arranged in spaced apart opposition parallel to each other. The first proximal end of the first strut member is integrally formed to the inner catheter body. The first distal end of the first strut member is integrally formed to the distal tip of the inner catheter body, and the second distal end of the second strut member is integrally formed with the tip of the inner catheter body. The second proximal end of the second strut member is integrally formed to the outer surface of the catheter body. The first strut member and the second strut member are configured to deflect while remaining parallel to each other when the first strut member is axially extended and retracted from the catheter body. The deflectable tip catheter is configured to receive a needle to effect drug delivery to a desired target site.
In another aspect, the first strut member and the second strut member of the inner catheter body can be assembled from separable component parts.
In another aspect, the first strut member and the second strut member can be configured to deflect up to about 180°.
In another aspect, the deflectable tip catheter can be configured to be rotated while the first strut member and the second strut member are bent.
In another aspect, the needle can be configured to pass through the inner catheter body while the first strut member and the second strut member are in the deflected configuration.
In another aspect, the inner catheter body can be a substantially tubular structure.
In another aspect, the first strut member and the second strut member have semicircular cross-sectional areas.
In another aspect, the distal tip can be a hollow tubular structure.
In another aspect, the distal tip can include an aperture configured to allow the needle to pass through the distal tip.
In another aspect, the distal tip can be an atraumatic distal tip.
In another aspect, a support structure can be disposed over the inner catheter body and can include a coil-like structure.
In another aspect, a support structure can be disposed over the inner catheter body and can include an axially deflectable tubular structure.
In another aspect, further including an actuator including a proximal end and a distal end, the distal end of the actuator can be fixedly secured to the inner catheter body.
In another aspect, the actuator can be a linear actuator configured to displace the inner catheter body in an axial direction.
In another aspect, the actuator and inner catheter body can be separable.
In another aspect, the actuator and inner catheter body can be made from a single piece of material.
In another aspect, the actuator and inner catheter body can be fabricated from separate component pieces mechanically fastened together.
In another aspect, further including a handle arranged on the inner catheter body, the handle includes an actuator configured to displace the inner catheter body in an axial direction.
In another aspect, the handle is attached to the proximal end of the actuator.
In one aspect, a method of delivering a drug through a deflectable tip catheter is provided. The method includes inserting a tip assembly of the deflectable tip catheter into a target site, the deflectable tip catheter having a catheter body that includes an outer surface and a smooth inner surface, with the inner catheter body being coaxially disposed and slidably engaged within the catheter body, deflecting the tip assembly to align the tip assembly with a specific region within the target site, directing the needle out of the tip assembly and into the specific region within the target site, and delivering a substance through the needle to the specific region within the target site.
In another aspect, the method can further include removing the needle from the specific region, rotating the deflectable tip catheter to arrange the needle at a second specific region within the target site, inserting the needle into the second specific region within the target site, and delivering the substance to the second specific region through the needle.
In one aspect, a method of operating a deflectable tip catheter to deliver a drug is provided. The method includes inserting a tip assembly of the deflectable tip catheter into a target site, directing a needle through the tip assembly, inserting the needle into the target site, deflecting the tip assembly to align the tip assembly with a specific region within the target site, and delivering a substance to the specific region by passing the substance through the needle inserted into the specific region.
In another aspect, the method can further include rotating the deflectable tip catheter in order to arrange the needle at a second specific region within the target site and delivering the substance to the second specific region through the needle.
The present disclosure is described by way of reference to the accompanying figures which are as follows:
Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices, systems, and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. A person skilled in the art will understand that the devices, systems, and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present disclosure is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present disclosure.
Further, in the present disclosure, like-named components of the embodiments generally have similar features, and thus within a particular embodiment each feature of each like-named component is not necessarily fully elaborated upon. Additionally, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. A person skilled in the art will recognize that an equivalent to such linear and circular dimensions can be determined for any geometric shape. A person skilled in the art will appreciate that a dimension may not be a precise value but nevertheless be considered to be at about that value due to any number of factors such as manufacturing tolerances and sensitivity of measurement equipment. Sizes and shapes of the systems and devices, and the components thereof, can depend at least on the size and shape of components with which the systems and devices will be used.
Various exemplary methods, systems, and devices for steerable catheters having a deflectable tip are provided.
The various figures show embodiments of steerable catheters having a deflectable tip of the present disclosure. The devices and related methods are described herein in connection with navigating through a body lumen, including but not limited to an airway, a duct, the GI tract, and vasculature, to gain access to a desired target site (e.g., organs, tissues, tumors, etc.) that are typically difficult to reach. The steerable catheter described herein can be used alone or, more typically, with a primary access device such as a bronchoscope, endoscope, trocar or the like. The primary access device is used to provide access to a region in proximity to the target site, however it is not possible to access the target site using the primary access device. The steerable tip catheter described herein can be used with a primary access device, such as being inserted through a working channel thereof, to reach the desired target site. Once access to the desired treatment site is obtained, a treatment or diagnostic tool can be advanced through the steerable catheter described herein to perform a treatment or provide a diagnostic procedure at the desired target site, for example, positioning a drug delivery at one or more specific locations at a target site. By way of example, the treatment or diagnostic tool can be a needle advanced through the steerable catheter to deliver a drug directly to the target site (e.g., a tumor). Alternatively, the treatment or diagnostic tool can be a biopsy needle or device, or another type of diagnostic or drug delivery tool.
The steerable catheter disclosed herein is particularly useful to provide direct access to the desired target site by a treatment or diagnostic tool that is passed through the steerable catheter. For example, the steerable catheter described herein has joined catheter sections that enable deflection of the catheter tip. The connection between the joined sections is such that the lumen of the steerable catheter is substantially smooth, enabling a treatment and/or diagnostic tool, such as a needle, to be passed through the lumen such that it does not impinge on any connection structures within the lumen. Once the steerable catheter is within the desired target site, a deflectable needle tip can be used to deliver a drug to multiple regions inside of the target site, such as a tumor. Once the deflectable needle is inserted within the tumor, the needle can be deflected in a single plane in order to perform a sweep of at least about 180° within the tumor. At any point during the sweep of the needle within the tumor, a drug can be delivered within the tumor from the needle. In addition to allowing the needle to sweep in a single plane, the steerable catheter can be rotated within the tumor such that the needle is deflected in order to perform a 360° panning of the target site. The size of the target site/tumor can determine the appropriate length of the needle.
A person skilled in the art will understand that in the case of drug delivery, a variety of drugs and/or other pharmaceutical active agents and other substances (including small and large molecules) can be delivered directly to the desired target site through the steerable catheter device described herein. Examples of such substances that can be delivered include oncolytic viruses, antibodies (such as monoclonal antibodies), hormones, antitoxins, substances for the control of pain, substances for the control of thrombosis, substances for the control of infection, peptides, proteins, human insulin or a human insulin analogue or derivative, polysaccharide, DNA, RNA, enzymes, oligonucleotides, anti-allergics, antihistamines, anti-inflammatories, corticosteroids, disease modifying anti-rheumatic drugs, erythropoietin, and vaccines.
Referring now to the figures,
The tip assembly 105 further includes an inner catheter body 111 and support structure 112 coaxially disposed over the inner catheter body 111. The inner catheter body 111 includes a strut 114 and a strut 115, as shown for example in
Deflection of the tip assembly can be effected by causing the inner catheter body 111 to deflect. As shown in
In an exemplary embodiment, the tip assembly 105 terminates with an atraumatic distal tip 117 to limit damage and trauma as the catheter assembly 100 is used to navigate the anatomy of the body. In an exemplary implementation, the atraumatic distal tip 117 includes a rounded open end member, as illustrated in
The catheter shaft 107 is a tube-like biocompatible structure substantially coaxial with catheter sheath 109, and sized such that the actuator 106 is slidably engaged with the catheter shaft 107 so that the actuator 106 can axially move the inner catheter body 111 within and relative to the catheter shaft 107 to deflect the tip assembly 105. In an exemplary implementation, the outer diameter of actuator 106 is smaller than the inner bore diameter of catheter shaft 107, allowing the actuator 106 to slide within the catheter shaft 107.
The catheter sheath 109 is the outermost elongate tube-like structure coaxial with longitudinal axis L and sized to house the tip assembly 105, catheter shaft 107, and actuator 106 during delivery. According to embodiments, a primary function of the catheter sheath 109 is to protect the catheter assembly 100, and to prevent damage to the body lumen or a bronchoscope during use. The catheter sheath 109 can be the outermost layer of a catheter assembly 100 that is inserted within a bronchoscope. When a bronchoscope is used to navigate through a body lumen, the bronchoscope can only be fed through body lumens having a certain maximum diameter, which may present size constraints that will limit the ability to deliver a drug to a specific area. In order to gain access to smaller body lumens, the catheter assembly 100 is used in combination with the bronchoscope, or a similar primary access device. The catheter assembly 100 is fed through the bronchoscope, with the catheter sheath 109 protecting the catheter assembly as it is fed through the bronchoscope. The catheter sheath 109 is operatively coupled at its proximal end to the handle 110, where the handle 110 is used to guide the catheter assembly 100 through the bronchoscope, and/or to provide any necessary manipulations. In one implementation, the catheter assembly 100 need not include the catheter sheath 109. Instead, an introducer sheath not secured to the catheter assembly 100 may be employed to assist delivery of the catheter assembly 100 into the body lumen or the bronchoscope.
In an exemplary implementation, the catheter sheath 109 can be made from various polymeric materials, or combination of polymeric materials known to one of skill in the art. In an embodiment, the outer catheter sheath 109 is constructed from polyethylenes, polyamides, polyurethanes, polytetrafluoroethylenes, or a combination of these materials. Still other polymeric materials may also be used for catheter sheath 109, including, polycarbonates and/or polyimides. In addition, embodiments of the sheath could include reinforcement materials, e.g., metallic braid and/or high tensile strength polymeric braid.
The handle 110 is manipulated by a user to advance the catheter assembly 100 and to deflect the tip assembly 105 in the desired direction. Although handle 110 is shown to be a pistol grip-type handle, a person skilled in the art will appreciate that a variety of other handle types can be used as long as they afford a user the ability to selectively control tip advancement and deflection. As such, a suitable handle will include a mechanism for receiving input from the user, such as trigger 103 shown in
The inner catheter body 111 can be a substantially rigid structure made from any one of a number of biocompatible materials known to a person skilled in the art. znon-limiting examples of such materials include surgical stainless steel, Nitinol, or cobalt-chromium alloys. The support structure may come in several forms, but it is typically a coil-like structure capable of readily bending when deflected axially, yet sufficiently rigid to resist radial expansion.
The inner catheter body 111 should have dimensions, including length and diameter, that render it suitable for an intended application. By way of example, the inner catheter body 111 can have a diameter within the range of about 0.005-0.020 millimeters, and preferably within a range of about 0.012-0.015 millimeters. The length of the inner catheter body 111 can vary depending upon the desired application, but it is typically in the range of about 150-180 cm. Additionally, the catheter shaft 107 should have dimensions, including length and diameter, that render it suitable for an intended application. The length of the catheter shaft 107 can vary depending upon the desired application, but it is typically in the range of about 100-120 cm. By way of example, the catheter shaft 107 can have a diameter within the range of about 0.5-5.0 millimeters, and preferably within a range of about 1.0-2.5 millimeters.
Referring now to
The tab 108, associated with the strut 114, is connected to the catheter shaft 107 as illustrated in
Referring now to
To deflect the tip assembly 105, the proximal inner catheter body 116 is moved in the axial direction AD within the catheter shaft 107. Since the tab 108 is fixedly secured to the catheter shaft 107, this axial movement of the proximal inner catheter body 116 causes a difference in relative positioning to occur between the strut 114 and the strut 115, with the strut 115 either being extended or retracted relative to the fixed strut 114 from the catheter shaft 107. The strut 115 is not attached to the catheter shaft 107, and is free to move within the catheter shaft 107. The strut 115 of inner catheter body 111 is rigidly attached to the distal end of the proximal inner catheter body 116 such that any movement of the proximal inner catheter body 116 is communicated directly to the strut 115. To deflect the inner catheter body 111, the actuator 106 is translated along the axial direction AD relative to the catheter shaft 107. This movement is communicated to the strut 115, which is free to move relative to the catheter shaft 107. Since the strut 114 of inner catheter body 111 is fixedly attached to the catheter shaft 107, the distal end of the catheter shaft 107 will act as the proximal end point from which the arcuate form of the inner catheter body 111 deflects. This transformation from linear motion to a curved or rotational form is directly proportional to the position of the strut 115 relative to the strut 114 that is exposed from the distal end of the catheter shaft 107. Further extending the exposed strut 115 relative to the strut 114 will deflect the distal end of the catheter assembly 100 in a first direction. Similarly, retracting the exposed length of the strut 115 relative to the strut 114 will deflect the distal end of the catheter assembly 100 in the opposite direction. When the strut 114 and the strut 115 are in a relative neutral position, the distal end of the catheter assembly 100 is substantially straight. Due to the change in relative positioning of the strut 115, a curve forms in the tip assembly 105. The tip assembly 105 curves to a deflection angle DA from the longitudinal axis L when the strut 114 and strut 115 are at different relative positions. The tip assembly 105 can curve to a deflection angle within a range of about 0°-180° for various applications of the tip assembly 105.
For example, as depicted in
Referring to
Referring now to
Referring now to
As discussed above, the catheter assembly 100 can be used in combination with a primary access device as described above, an example of which is a bronchoscope. In this example the catheter assembly 100 is inserted into a bronchoscope once the bronchoscope has already been inserted within a patient to the bronchus of a patient's lung. Once the bronchoscope is properly positioned, tip assembly 105 of the catheter assembly 100 can be passed through the bronchoscope into the smaller bronchioles of a patient's lung, which branch off from the bronchus. The exemplary implementation shown in
The needle 202 can be a flexible needle in order to follow the curvature of the tip assembly 105. Further, the tip assembly 105 and needle 202 should be sufficiently flexible so as to be able to deflect due to the curvature and limited space within the bronchioles of a lung. In addition, the needle 202 should have dimensions, including length and diameter, that render it suitable for an intended application. By way of example, the needle 202 can have a diameter within the range of 0.5-2.0 millimeters, and preferably a diameter of 1.0 millimeter, such as a 30 gauge needle.
Still referring to
In another exemplary embodiment, prior to needle 202 being inserted into the mass 200, the tip assembly 105 is deflected in order to curve the needle 202 upward or downward. Once the catheter assembly 100 is properly positioned, the needle 202 is inserted into the mass 200 in the axial direction AD. Once the needle 202 is positioned within the mass 200, a drug may be delivered within the mass 200 though the needle 202. Once the drug is delivered to a specific location within the mass 200, the needle can be retracted from the mass 200. Then, the tip assembly 105 is deflected in order to curve the needle 202 upward or downward to position the needle 202 at a different location of the mass 200. The catheter assembly 100 can also be rotated 360° in the circumferential direction CD. This allows the needle 202 to deliver a substance in a 360° arc to the mass 200. Once the tip assembly 105 is in the correct position, the needle 202 can be reinserted into the mass 200 in order to provide a drug to another location within the mass 200. This process can be repeated multiple times until the mass 200 has been fully inundated with a drug at multiple locations.
The present disclosure has been described above by way of example only within the context of the overall disclosure provided herein. It will be appreciated that modifications within the spirit and scope of the claims may be made without departing from the overall scope of the present disclosure.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2021/058034 | 9/2/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63075403 | Sep 2020 | US |
