Patent Application
20230116038
The present disclosure generally relates to minimally invasive surgical devices and, more particularly, to steerable catheters. Specifically, the disclosure relates to steerable catheters for creating openings in tissues and/or for Photobiomodulation (PBMT), during minimally invasive neurosurgical procedures, and related methods.
The present disclosure contemplates that treatments for some conditions may include surgically creating openings through tissues (e.g., biological tissue membranes). For example, for patients suffering from non-communicating hydrocephalus, the normal channel for drainage of the cerebral spinal fluid (“CSF”) from the third ventricle to the lower CSF chambers and central canal that leads to the spinal cord is blocked by an occlusion within the cerebral aqueduct. These patients, through the normal production of the CSF, experience a “rise” in the pressure of the lamina and third ventricles, causing these fluid chambers to distend. To relieve the pressure, neurosurgeons have used a procedure called a third ventriculostomy to rupture the lamina terminalis. This procedure requires creating a hole through the patient's skull and moving brain tissue to allow the introduction and navigation of an endoscope to the desired site for creation of the ventriculostomy. Once the lamina terminalis is visible in the endoscopic image, a balloon catheter (e.g., Fogarty) is advanced up to and through the membrane. Once the balloon portion of the catheter is passed through the membrane, it is inflated and then retracted through the membrane to create the fenestration (e.g., hole) between the CSF chambers. An alternative ventriculostomy procedure uses similar access through the skull and brain, but, instead of the endoscope/balloon catheter combination, a surgical instrument is used that discretely cauterizes the membrane as it is opened is utilized. While such procedures have been successfully used on patients, these procedures involve risks and disadvantages associated with surgically penetrating the skull, dura mater, and/or brain tissues.
The present disclosure further contemplates that treatments for some conditions may include Photobiomodulation (PBMT) which is the application of red and near infra-red light for medical treatment. The light can originate from a laser or a light emitting diode (LED), and can be pulsed and/or continuous. The health benefits of PBMT are well documented with the application of light typically to the exterior of the body of the patient in a non-invasive manor. Generally, transcranial PBMT procedures involve the placement of a light source, or multiple light sources, on one or more areas of the patient's head, with the goal of treating a certain part of the brain. In transcranial PBMT, light must pass through layers of tissue including the scalp, periosteum, skull bone, meninges, and dura, before reaching the cortical surface of the brain. Due to the exponential attenuation of light during the journey through the skull and brain tissues, only a small fraction of the incident light may be delivered to the intended tissue. A device and method of delivering PBMT more directly to the tissue to be treated, and specifically the brain and/or spinal tissue, may provide unique benefits.
Accordingly, and despite the various advances already made in this field, there is a need for further improvements related to steerable catheters for many desired uses during surgical procedures.
Generally, a steerable dilator is provided and includes an elongated shaft with a proximal end portion and a distal end portion, an end effector disposed at the distal end portion of the shaft, and a handle disposed at the proximal end portion of the shaft. The end effector includes a proximal dilation portion disposed proximate the distal end portion of the shaft, a transition portion disposed distally on the dilation portion, and a distal tip portion disposed distally on the transition portion. The handle includes a tip portion steering actuator disposed on the handle. The tip portion has a tip portion diameter. The dilation portion has a dilation portion diameter. The dilation portion diameter is greater than the tip portion diameter. The transition portion tapers from the tip portion diameter to the dilation portion diameter between the tip portion and the dilation portion. The tip portion is movable relative to the dilation portion, and the tip portion steering actuator enables a user to steer the tip portion by moving the tip portion with the tip portion steering actuator.
In some embodiments, the diameter of the tip portion may be equal to the diameter of the dilation portion. The transition portion may taper generally smoothly from the tip portion diameter to the dilation portion diameter. The transition portion may taper generally linearly from the tip portion diameter to the dilation portion diameter. The diameter of the shaft may be approximately equal the dilation portion diameter. As used herein, the term steerable dilator, or simply dilator, includes steerable catheters with a dilation mechanism. It should be understood that some embodiments described herein may be used with steerable catheters without a dilation mechanism.
In some embodiments, the tip portion may be steerable relative to the dilation portion in a tip portion steering plane. A first tip portion steering line may operatively connect the tip portion and the tip portion steering actuator enabling a user to steer the tip portion in a first direction in the tip portion steering plane by moving the tip portion steering actuator in a first tip portion steering actuator direction. The tip portion may include a steering ring disposed on the tip portion. The first tip portion steering line may operatively connect the tip portion steering ring and the tip portion steering actuator enabling a user to steer the tip portion in the first direction in the tip portion steering plane. The tip portion steering actuator may include a toothed portion engaged with and operative to rotate a toothed gear, and the first tip portion steering line may be coupled to the toothed gear. The dilator may include a second tip portion steering line operatively connecting the tip portion and the tip portion steering actuator enabling a user to steer the tip portion in a second direction, the second direction being generally opposite the first direction in the tip portion steering plane, by moving the tip portion steering actuator in a second tip portion steering actuator direction. The second tip portion steering line may operatively connect the tip portion steering ring and the tip portion steering actuator enabling a user to steer the tip portion in the second direction. The first tip portion steering line may be coupled to the toothed gear of the tip portion steering actuator. The first and/or second tip portion steering line may include at least one of metal wire and suture material.
In alternative or additional aspects, the dilation portion may be steerable relative to the shaft in a dilation portion steering plane. The handle may include a dilation portion steering actuator disposed on the handle. The dilation portion may include a first dilation portion steering line operatively connecting the dilation portion and the dilation portion steering actuator enabling a user to steer the dilation portion in a first direction in the dilation portion steering plane, by moving the dilation portion steering actuator in a first dilation portion steering actuator direction. The dilation portion may include a dilation steering ring disposed on the dilation portion. The first dilation portion steering line may operatively connect the dilation portion steering ring and the dilation portion steering actuator enabling a user to steer the dilation portion in the first direction in the dilation portion steering plane. The dilation portion steering actuator may include a toothed portion engaged with and operative to rotate a toothed gear, and the first dilation portion steering line may be coupled to the toothed gear. The dilator may include a second dilation portion steering line operatively connecting the dilation portion and the dilation portion steering actuator enabling a user to steer the dilation portion in a second direction, the second direction being generally opposite the first direction in the dilation portion steering plane, by moving the dilation portion steering actuator in a second dilation portion steering actuator direction. The second dilation portion steering line may operatively connect the dilation portion steering ring and the dilation portion steering actuator enabling a user to steer the dilation portion in the second direction. The first and/or second dilation portion steering line may include at least one of metal wire and suture material.
In alternative embodiments, the tip portion may be steerable relative to the dilation portion in a tip portion steering plane. The dilation portion may be steerable relative to the shaft in a dilation portion steering plane. The tip portion steering plane and the dilation portion steering plane may be substantially parallel. The dilation portion steering plane may be disposed at a steering plane angle relative to the tip portion steering plane, the steering plane angle being greater than zero. In some embodiments the steering plane angle may be about 90 degrees. The dilation portion steering plane may be substantially perpendicular to the tip portion steering plane.
In alternative or additional aspects, the dilator may include a central lumen extending longitudinally through the handle, the shaft, the dilation portion, the transition portion, and the tip portion. The central lumen may be configured to receive a guidewire therethrough. The distal end of the tip portion may be generally rounded. In alternate embodiments, the distal end of the tip portion may be generally pointed.
In some embodiments, the shaft may be generally flexible. The stiffness of the shaft may vary over a length of the shaft between the proximal end portion and the distal end portion. The stiffness of the shaft may vary in discrete intervals over the length of the shaft. The stiffness of the shaft may be greater proximate the proximal end portion than proximate the distal end portion. The shaft of the dilator may include an inner layer, an intermediate layer, and an outer layer.
The steerable dilator may include a tip portion energizing element disposed on the tip portion. The tip portion energizing element may be configured to be operatively connected to a source of electrical energy. The source of electrical energy may be configured to deliver at least one of radio frequency energy and electrocautery energy to the tip portion energizing element. The dilator may include a wiring harness extending from the tip portion energizing element, through a lumen in the shaft, and through the handle, for example. The dilator may include a dilation portion energizing element disposed on the dilation portion. The dilation portion energizing element may be configured to be operatively connected to a source of electrical energy. The source of electrical energy may be configured to deliver at least one of radio frequency energy and electrocautery energy to the dilation portion energizing element. The dilator may include a wiring harness extending from the dilation portion energizing element, through a lumen in the shaft, and through the handle, for example. The steerable dilator may be part of a dilator system, including the dilator and an electrosurgical generator, the electrosurgical generator comprising the source of electrical energy.
In some embodiments, the dilator may include an expandable element disposed on the dilation portion. The expandable element may include an inflatable element. The inflatable element may be generally toroidal when inflated. The inflatable element may be generally cylindrical when deflated, for example.
In an alternative embodiment, a steerable dilator is provided and includes an elongated shaft with a proximal end portion and a distal end portion, an end effector disposed at the distal end portion of the shaft, and a handle disposed at the proximal end portion of the shaft. The end effector includes a dilation portion disposed proximate the distal end portion of the shaft, and a distal tip portion disposed distally on the dilation portion. The handle includes a steering actuator rotatably disposed on the handle. The tip portion is movable relative to the dilation portion. The dilation portion is movable relative to the shaft. The steering actuator enables a user to steer the tip portion and the dilation portion by moving the tip portion and the dilation portion with the steering actuator.
In alternative embodiments, the steerable dilator may include a steering actuator rotatably disposed on the handle. The steering actuator includes, a yoke rotatably disposed on the handle, an actuator body rotatably disposed on the yoke, a rotational actuator rotatably disposed on the actuator body, and an actuator handle disposed on the actuator body. The actuator handle enables a user to operate the steering actuator. The steering actuator may include one or more steering line attachment points. The steering actuator may be generally configured as one or more pivoted supports that allow for the rotation of the steering actuator about a first axis of rotation and a second axis of rotation relative to the handle. Moving the actuator handle in a first actuator direction may rotate the steering actuator about a first actuator axis of rotation. Moving the actuator handle in a second actuator direction may rotate the steering actuator body about the first actuator axis of rotation, the second actuator direction being generally opposite the first actuator direction. The yoke may include a series of teeth arranged to engage an opposed series of teeth on the rotational actuator. Moving the actuator handle in a third direction may rotate the steering actuator body about a second actuator axis of rotation. Rotating the steering actuator body about a second actuator axis of rotation may cause the teeth on the yoke to apply a force to the teeth on the rotational actuator which may cause the rotational actuator to rotate about a third actuator axis of rotation. Moving the actuator handle in a fourth direction may rotate the steering actuator body about a second actuator axis of rotation, the fourth direction being generally opposite the third direction. Rotating the steering actuator body about a second actuator axis of rotation may cause the teeth on the yoke to apply a force to the teeth on the rotational actuator which may cause the rotational actuator to rotate about a third actuator axis of rotation. The rotational actuator may be configured for one handed operation where the user may grip the handle with one hand and move the actuator handle with the thumb of said hand, for example.
In some embodiments, the first tip portion steering line may be coupled to the steering actuator and moving the actuator handle in a first actuator direction may steer the tip portion in the first direction in the first tip portion steering plane. The second tip portion steering line may be coupled to the steering actuator and moving the actuator handle in a second actuator direction may steer the tip portion in the second direction in the first tip portion steering plane. The first dilation portion steering line may be coupled to the steering actuator and moving the actuator handle in a third actuator direction may steer the dilation portion in the first direction in the first dilation portion steering plane. The second dilation portion steering line may be coupled to the steering actuator and moving the actuator handle in a fourth actuator direction may steer the dilation portion in the second direction in the first dilation portion steering plane.
In alternative or additional aspects, the dilator may include an expandable element disposed on the dilation portion. The expandable element on the dilation portion may include an inflatable portion. The expandable element on the dilation portion may include a radiopaque material. The inflatable portion on the dilation portion may be generally cylindrical when not inflated and generally toroidal when inflated, for example. The inflatable portion on the dilation portion may include other shapes when inflated.
In some embodiments, the tip portion may include an expandable element disposed on the tip portion. The expandable element on the tip portion may include an inflatable element. The expandable element on the tip portion may include a radiopaque material. The inflatable element on the tip portion may generally mimic the shape of the tip when not inflated and may be generally teardrop shaped when inflated, for example. The inflatable portion on the tip portion may include other shapes when inflated. The inflatable portion on the tip portion may be used to center the tip portion during a procedure, for example. In some instances, the inflatable portion on the tip portion may be used to protect biological tissue during a procedure, for example.
In an alternative embodiment, a steerable catheter is provided and includes an elongated shaft with a proximal end portion and a distal end portion, an end effector disposed at the distal end portion of the shaft, and a handle disposed at the proximal end portion of the shaft. The end effector includes a proximal end portion disposed proximate the distal end portion of the shaft, and a distal tip portion disposed distally on the end effector. The handle includes a steering actuator rotatably disposed on the handle. The tip portion is movable relative to the shaft. The proximal end portion of the end effector is movable relative to the shaft. The steering actuator enables a user to steer the tip portion and the proximal end portion of the end effector by moving the tip portion and the proximal end portion of the end effector with the steering actuator.
In some embodiments, the diameter of the tip portion may be equal to the diameter of the end effector. In some embodiments the diameter of the end effector may be greater than the diameter of the tip portion. The diameter of the shaft may be approximately equal the end effector diameter. The tip portion may be steerable relative to the shaft in a tip portion steering plane. The handle may include a tip portion steering actuator disposed on the handle. The steerable catheter may include a first tip portion steering line operatively connecting the tip portion and the tip portion steering actuator enabling a user to steer the tip portion in a first direction in the tip portion steering plane. The tip portion may include a steering ring disposed on the tip portion. The first tip portion steering line may operatively connect the tip portion steering ring and the tip portion steering actuator enabling a user to steer the tip portion in a first direction in the tip portion steering plane. The steerable catheter may include a second tip portion steering line operatively connecting the tip portion and the tip portion steering actuator enabling a user to steer the tip portion in a second direction, the second direction being generally opposite the first direction in the tip portion steering plane. The second tip portion steering line may operatively connect the tip portion steering ring and the tip portion steering actuator enabling a user to steer the tip portion in the second direction. In alternative or additional aspects, the end effector may be steerable relative to the shaft in an end effector steering plane. The handle may include an end effector steering actuator disposed on the handle. The steerable catheter may include a first end effector steering line operatively connecting the end effector and the end effector steering actuator enabling a user to steer the end effector in a first direction in the end effector steering plane. The end effector may include an end effector steering ring disposed on the end effector. The first end effector steering line may operatively connect the end effector steering ring and the end effector steering actuator enabling a user to steer the end effector in the first direction in the end effector steering plane. The steerable catheter may include a second end effector steering line operatively connecting the end effector and the end effector steering actuator enabling a user to steer the end effector in a second direction, the second direction being generally opposite the first direction in the end effector steering plane. The steerable catheter may include a second end effector steering line operatively connecting the end effector steering ring and the end effector steering actuator enabling a user to steer the end effector in the second direction. In some embodiments, the tip portion may be steerable relative to the shaft in a tip portion steering plane, and the end effector may be steerable relative to the shaft in an end effector steering plane. The tip portion steering plane and the end effector steering plane may be substantially parallel. The end effector steering plane may be disposed at a steering plane angle relative to the tip portion steering plane, the steering plane angle being greater than zero. In some embodiments the steering plane angle may be about 90 degrees. The end effector steering plane may be substantially perpendicular to the tip portion steering plane. It is understood that the steerable catheter may include any element or elements, method or methods, or combination thereof as disclosed herein.
A method of creating an opening in a biological tissue membrane is provided. The method may include advancing an end effector of a dilator to proximate a biological tissue membrane, creating an initial opening through the membrane by advancing a tip portion of the end effector through the membrane, expanding the initial opening to an expanded opening by advancing at least a portion of a dilation portion of the end effector through the membrane, and withdrawing the end effector from the expanded opening. In some embodiments, creating the initial opening may include energizing a tip portion energizing element of the tip portion. Energizing the tip portion energizing element may include supplying at least one of radio frequency energy and electrocautery energy to the tip portion energizing element. Energizing the tip portion energizing element may include energizing the tip portion energizing element before advancing the tip portion through the membrane. The method of energizing the tip portion energizing element may include energizing the tip portion energizing element while advancing the tip portion through the membrane. Advancing the end effector of the dilator to proximate the biological tissue membrane may include advancing the dilator on a guidewire extending through a central lumen of the dilator.
In some embodiments, expanding the initial opening may include energizing a dilation portion energizing element of the dilation portion. Energizing the dilation portion energizing element may include supplying at least one of radio frequency energy and electrocautery energy to the dilation portion energizing element. Energizing the dilation portion energizing element may include energizing the dilation portion energizing element before advancing at least the portion of the dilation portion through the membrane. Energizing the dilation portion energizing element may include energizing the dilation portion energizing element while advancing at least the portion of the dilation portion through the membrane. Energizing the dilation portion energizing element may include energizing the dilation portion energizing element after advancing at least the portion of the dilation portion through the membrane.
In alternative or additional aspects, the method of creating an opening in a biological tissue membrane may include at least partially expanding an expandable element disposed on the dilation portion of the end effector. At least partially expanding the expandable element may include at least partially inflating an inflatable element. At least partially inflating the inflatable element may include injecting a fluid into the inflatable element. The method may include advancing the at least partially expanded expandable element through the membrane. The method may include withdrawing the at least partially expanded expandable element through the membrane. Expanding the expandable element may include expanding the expandable element while the expandable element is at least partially in contact with the membrane.
In some methods, advancing the end effector may include steering the tip portion in a tip portion steering plane. Advancing the end effector may include steering the dilation portion in a dilation portion steering plane. The tip portion steering plane may be substantially parallel with the dilation portion steering plane. In alternative embodiments the tip portion steering plane may be disposed at a steering plane angle relative to the dilation portion steering plane, the steering plane angle being greater than zero.
In alternative or additional aspects, the biological tissue membrane may include a lamina terminalis and advancing the end effector of the dilator to the biological tissue membrane may include advancing the end effector of the dilator to the lamina terminalis through one of a lumbar puncture and a C1-C2 puncture. The method may include at least partially expanding an expandable element disposed on the tip portion of the end effector. At least partially expanding the expandable element may include at least partially inflating an inflatable element. At least partially inflating the inflatable element may include injecting a fluid into the inflatable element. The method may include advancing the at least partially expanded expandable element through the membrane. The method may include withdrawing the at least partially expanded expandable element through the membrane. Expanding the expandable element may include expanding the expandable element while the expandable element is at least partially in contact with the membrane.
In some embodiments, the steerable catheter or dilator may include a stent portion disposed on the end effector. The stent portion may be used in some procedures. The stent portion may be generally cylindrical. The stent portion may be generally flexible. The stent portion may be generally tapered at the distal end of the stent and the stent portion may have a stent diameter and distal end diameter. The stent diameter may be greater than the tip portion diameter and the dilation end diameter may be less than the tip portion diameter which may allow the stent portion to be directed to a location by a user using the dilator. The stent portion may be disposed on the dilation portion of the end effector. The dilator may be withdrawn from the stent portion leaving the stent portion in the location. A method of using a dilator may include advancing an end effector, with a stent portion installed on the end effector, to a location and withdrawing the end effector from the stent portion, leaving the stent in the location.
In alternative embodiments, the steerable catheter or dilator may include a light element disposed on the tip portion, and the light element may be configured to be operatively connected to a source of light. The source of light may be configured to deliver light to the light element. The source of light may produce red and near infra-red light for medical treatment, for example. Other types of light may be used as well. The light may originate from a laser or a light emitting diode (LED), and may be pulsed and/or continuous, for example. It should be understood that other sources of light may be used. The catheter may include a fiber optic harness extending from the light element, through the shaft, and through the handle. The steerable catheter may be part of a catheter system, the system including the catheter (such as a dilator, or more generally another catheter) and a light generator, the light generator comprising the source of light.
A method of applying light to the brain and/or spinal cord is provided, the method including advancing an end effector of a catheter to proximate a biological tissue, and applying light to the biological tissue. Applying light to the biological tissue may include energizing a light element of the tip portion. Energizing the light element may include supplying light to the light element. The source of light may produce red and near infra-red light for medical treatment, for example. Other types of light may be used as well. The light may originate from a laser or a light emitting diode (LED), and may be pulsed and/or continuous, for example. It should be understood that other sources of light may be used.
Additional features, options or aspects of the invention will become more apparent through a review of a detailed description of various illustrative embodiments described in more detail herein, taken in conjunction with the accompanying drawings of these illustrative embodiments.
Illustrative embodiments according to at least some aspects of the present disclosure are described and illustrated below and include devices and methods relating to surgical procedures. Of course, it will be apparent to those of ordinary skill in the art that the embodiments discussed below are examples and may be reconfigured without departing from the scope and spirit of the present disclosure. It is also to be understood that variations of the exemplary embodiments contemplated by one of ordinary skill in the art shall concurrently comprise part of the instant disclosure. However, for clarity and precision, the illustrative embodiments as discussed below may include optional steps, methods, and features that one of ordinary skill should recognize as not being a requisite to fall within the scope of the present disclosure.
The present disclosure includes, among other things, steerable dilators. As used herein, the term steerable dilator, or simply dilator, includes steerable catheters with a dilation mechanism. It should be understood that some embodiments described herein may be used with steerable catheters without a dilation mechanism. Some illustrative embodiments according to at least some aspects of the present disclosure may be used in connection with creating openings in tissues during minimally invasive neurosurgical procedures. For example, illustrative apparatus and methods disclosed herein may be utilized in connection with minimally invasive surgical treatment of hydrocephalus involving creation of an opening through the lamina terminalis. Some illustrative apparatus and methods disclosed herein may be utilized in connection with PBMT, for example. While the present detailed description of illustrative embodiments focuses on minimally invasive neurosurgical procedures, it will be appreciated that various embodiments according to at least some aspects of the present disclosure may be utilized in connection with other procedures. Additionally, although some features may be described herein in connection with particular exemplary embodiments, one of skill in the art will appreciate that any features described herein may be used alone or in any combination within and between various embodiments.
In some embodiments, the tip portion steering plane 14 and the dilation portion steering plane 18 are substantially parallel, such as substantially coplanar. Such an embodiment is shown in
Referring to
Similarly, the dilation portion 202 is steerable in the dilation portion steering plane 18 by the selective distal pulling of a first dilation portion steering line 218 and a second dilation portion steering line 220 on a dilation portion steering ring 222. Specifically, pulling distally on the first dilation portion steering line 218 pulls on the dilation portion steering ring 222 so as to cause the dilation portion 202 to flex in the direction of arrow 20a. Pulling distally on the second dilation portion steering line 220 pulls on the dilation portion steering ring 222 so as to cause the dilation portion 202 to flex in the direction of arrow 20b. The direction of arrow 20a and the direction of arrow 20b may be generally opposite directions. The dilation portion steering lines 218, 220 may be connected to the dilation portion steering ring 222 by a weld or solder joint, or a mechanical fastener, for example. In some embodiments, the dilation portion steering ring 222 may be constructed of a radiopaque material, which may facilitate visualization of the dilator 100 using various medical imaging modalities.
As described below, the tension elements (e.g., steering lines 212, 214, 218, 220) are tensioned by one or more actuators disposed on the handle 300. Generally, the tension elements (e.g., steering lines 212, 214, 218, 220) may be constructed of any materials capable of transmitting a tensile force from the actuators to the steering rings 216, 222. For example, the steering lines 212, 214, 218, 220 may comprise metal wires and/or various suture materials.
In the illustrative embodiment, the distal end of the tip portion 206 is defined at least partially by the tip energizing element 224. The tip energizing element 224 is shaped to facilitate passage of the tip portion 206 through a biological tissue membrane. The tip energizing element 224 may include a radiused shape (e.g., generally rounded) as shown and/or other shapes, such as bevels and/or tapers (e.g., generally pointed).
Referring to
In this illustrative embodiment, a guidewire lumen 120 extends longitudinally through the end effector 200, shaft 102, and handle 300, and is configured to slidably receive a guidewire therethrough. In the illustrative embodiment, the guidewire lumen 120 is substantially centrally located in the shaft 102 and the end effector 200. The tip portion power wire 122 extends through a tip portion power wire lumen 126 and the dilation portion power wire 124 extends through a dilation portion power wire lumen 128.
The shaft 102 may be constructed from one or more layers. For example, this illustrative embodiment includes an inner layer 130, an intermediate layer 132, and an outer layer 134. In some embodiments, the layers 130, 132, 134 are formed separately and are then joined, such as using a thermal bonding process and/or a chemical bonding process. Alternatively, two or more of the layers 130, 132, 134 may be formed together.
In this illustrative embodiment, the inner layer 130 comprises a polymer, such as a polymer extrusion. The inner layer 130 may be substantially uniform over the length of the shaft 102, or some characteristics may vary over the length of the shaft 102. For example, in the illustrative embodiment, the inner layer 130 comprises a plurality of extruded segments facilitating a differing stiffness over the length of the shaft 102. As used herein, “stiffness” may refer to the resistance of an object to deformation under an applied force. In this exemplary embodiment, the stiffness of the inner layer 130 decreases from proximal to distal so that the shaft 102 is generally stiff proximally for pushability (e.g., relatively high buckling strength) and/or is generally softer distally for flexibility and atraumatic contact with tissue. In the illustrative embodiment, the inner layer 130 extends substantially from the handle 300 to the tip portion 206 of the end effector 200. The stiffness changes may occur in discrete intervals. The distal portion (e.g., near the tip portion 206) may comprise a polymer having a stiffness of about Shore 80A or less. The proximal portion (e.g., near the handle 300) may comprise a polymer having a stiffness of about Shore 75D or higher, which may approximately match the stiffness of the handle 300 material. In some embodiments, various intermediate segments (e.g., between a distal-most segment and a proximal-most segment) may vary in stiffness, such as in a stepwise fashion. For example, some intermediate segments may increase in Shore 10D to Shore 15D increments (e.g., 25D, 40D, 55D, 65D) from distal to proximal. In some embodiments, the outer diameter of the inner layer 130 may be about 0.7 mm to about 1.7 mm. Different diameters may be useful when different anatomy will be traversed and/or to accommodate different sized guidewires, for example.
In this illustrative embodiment, the intermediate layer 132 comprises a structural reinforcing layer, such as a polymer (e.g., Nylon, Kevlar) or metal (e.g., stainless steel, nickel titanium) coil and/or braided structure. In the illustrative embodiment, the intermediate layer 132 is configured to resist kinking of the shaft 102 and/or to increase the torsional strength of the shaft 102. In some embodiments, some characteristics of the intermediate layer 132 may vary over the length of the shaft 102. For example, the pitch and/or pick rate of a coil and/or braided intermediate layer 132 may vary over the length of the shaft 102. In one exemplary embodiment, the braid and/or coil may be more open (providing better pushability due to the pattern extending more axially) toward the proximal end portion 104 of the shaft 102 and/or the braid and/or coil may be more closed (providing better flexibility due to the pattern being positioned more radially) toward the distal end portion 106 of the shaft 102. Various shapes of filaments and/or wires may be utilized. For example, a filament or wire may have a generally round cross section, or it may have a generally rectangular cross section, such as in devices requiring a smaller tip portion diameter 208. Some illustrative embodiments may not include a structural reinforcing layer (e.g., intermediate layer 132). For example, a device configured for use where the pathway from the access site to the treatment site is not tortuous may not require the torsional stiffness and/or kink resistance provided by such an intermediate later 132. In the illustrative embodiment, the intermediate layer 132 extends substantially from the proximal side of the tapered transition portion 204 to the distal side of the handle 300.
In this illustrative embodiment, the outer layer 134 comprises a polymer, such as a polymer extrusion. The outer layer 134 may be substantially uniform over the length of the shaft 102, or some characteristics may vary over the length of the shaft 102. For example, in the illustrative embodiment, the outer layer 134 comprises a plurality of extruded segments facilitating a differing stiffness over the length of the shaft 102. In this exemplary embodiment, the stiffness of the outer layer 134 decreases from proximal to distal so that the shaft 102 is generally stiff proximally for pushability (e.g., relatively high buckling strength) and/or is generally softer distally for flexibility and atraumatic contact with tissue. The outer layer 134 extends substantially from the distal side of the handle 300 to the tapered transition portion 204 of the end effector 200. In this illustrative embodiment, the outer layer 134 is thermally formed to at least partially define the tapered transition portion 204. The stiffness changes may occur in discrete intervals. The dilation portion 202 of the end effector may comprise a polymer having a stiffness of about Shore 25D or less. The proximal portion (e.g., near the handle 300) may comprise a polymer having a stiffness of about Shore 75D or higher. In some embodiments, various intermediate segments (e.g., between a distal-most segment and a proximal-most segment) may vary in stiffness, such as in a stepwise fashion. For example, some intermediate segments may increase in Shore 10D to Shore 15D increments (e.g., 40D, 55D, 65D) from distal to proximal. In some embodiments, the segments of the inner layer 130 may be positioned to overlap the segments of the outer layer 134, which may provide generally smoother transitions over the length of the shaft 102. In some embodiments, the outer diameter of the outer layer 134 may be about 2.3 mm to about 3.0 mm. Different diameters may be useful for creating different opening sizes at the treatment site, for example.
Referring to
The tip portion steering actuator 304 is coupled to the first tip portion steering line 212 and the second tip portion steering line 214. In this illustrative embodiment, the tip portion steering lines 212, 214 are coupled to the tip steering actuator 304 such that rotating the tip portion steering actuator 304 clockwise is operative to tension the first tip portion steering line 212. Likewise, rotating the tip steering actuator 304 counter-clockwise is operative to tension the second tip portion steering line 214. Similarly, the dilation portion steering actuator 306 is coupled to the first dilation portion steering line 218 and the second dilation portion steering line 220. The dilation portion steering lines 218, 220 are coupled to the dilation portion steering actuator 306 such that rotating the dilation portion steering actuator 306 clockwise is operative to tension the first dilation portion steering line 218. Likewise, rotating the dilation portion steering actuator 306 counter-clockwise is operative to tension the second dilation portion steering line 220. Generally, in this illustrative embodiment, the respective diameters of the steering actuators 304, 306 where the steering lines 212, 214, 218, 220 are attached determine the degree of “pull” on the respective steering lines 212, 214, 218, 220 and, thus, the resultant deflection of the tip portion 206 and/or the dilation portion 202.
In this illustrative embodiment, the tip portion steering lines 212, 214 are individual, discrete lengths that are individually attached to opposite, lateral sides of the tip portion steering actuator 304. In alternative embodiments, both tip portion steering lines 212, 214 may be provided as part of a continuous length that extends from the tip portion steering ring 216, around the tip portion steering actuator 304, and back to the tip portion steering ring 216. In some such embodiments, the tip portion steering lines 212, 214 may be secured to the tip portion steering actuator 304 at one location, such as on a proximal aspect of the tip portion steering actuator 304. Generally, the tip portion steering lines 212, 214 may be secured to the tip portion steering actuator 304 by the engagement of one or more raised features on the tip portion steering lines 212, 214 with a corresponding recess on the tip portion steering actuator 304. Alternatively, the tip portion steering lines 212, 214 may be welded or soldered to the tip portion steering actuator 304. The dilation portion steering lines 218, 220 and the dilation portion steering actuator 306 may be configured in a similar manner.
Referring to
Referring to
Referring to
The proximally extending portion of the wiring harness 108 is positioned in the handle 300 to avoid conflicting with the guidewire lumen 120. In some embodiments, the various wires 122, 124 of the wiring harness 108 may be color-coded to correspond to the steering actuators 304, 306, which may reduce the risk of user confusion.
In various embodiments according to at least some aspects of the present disclosure, various combinations of energizing elements 224, 226 and power circuits 400, 450 may be provided. For example, some embodiments may include no energizing elements 224, 226 and/or no power circuits 400, 450. Other embodiments may include only the RF power circuit 400, which may be configured to supply RF energy to one or both of the tip portion energizing element 224 and/or the dilation portion energizing element 226. Some embodiments may include only the electrocautery power circuit 450, which may be configured to supply electrocautery energy to one or both of the tip portion energizing element 224 and/or the dilation portion energizing element 226. Alternative embodiments may include both the RF power circuit 400 and the electrocautery power circuit 450. In some such embodiments, the RF power circuit 400 may be configured to provide RF energy to only the tip portion energizing element 224 or the dilation portion energizing element 226, and the electrocautery power circuit 450 may be configured to provide electrocautery energy to only the other of the tip portion energizing element 224 and the dilation portion energizing element 226.
RF energy produces a high frequency vibration of the RF element, while electrocautery (EC) energy will produce heat. Therefore, the RF element will remain cooler and essentially act as a dottering instrument. With EC, the tissue is heated and slightly burned. Generally, RF energy causes tissue to also vibrate at high frequency and may cause tissue scarring as a result. RF is typically used for passing an instrument through thin tissue membranes. EC energy is essentially used to stop bleeding during surgery and can also be used to cut and stop bleeding at the same time. Relative to the present disclosure, EC may be used for “fixing” the tissue (where the hole through the tissue is created by the proximal element). Using RF to scar and therefore fix the tissue surrounding the hole may be effective as well.
This illustrative dilator 100a includes an elongated shaft 102a having a proximal end portion 104a and a distal end portion 106a. The illustrative dilator 100a includes an end effector 200a disposed at the distal end portion 106a of the shaft 102a and a handle 300a disposed at the proximal end portion 104a of the shaft 102a. The illustrative end effector 200a includes a proximal dilation portion 202a disposed proximate the distal end portion 106a of the shaft 102a, a transition portion 204a disposed distally on the dilation portion 202a, and a distal tip portion 206a disposed distally on the transition portion 204a. The tip portion 206a has a tip portion diameter 208a and the dilation portion 202a has a dilation portion diameter 210a.
In this illustrative embodiment, the dilation portion 202a includes an expandable element 203a, such as an inflatable element, which is selectively expandable from approximately the dilation portion diameter 210a to a fully expanded diameter 211a. The expandable element 203a is configured to be selectively expanded and/or contracted, such as by injecting or withdrawing fluid (e.g., a liquid or a gas) via an inflation connection 303a. The inflation connection 303a is provided on a connection hub 301a at the proximal end of the handle 300a, such as on a dedicated branch of the connection hub 301a. In one exemplary embodiment, the expandable element 203a may comprise a generally toroidal inflatable element configured to have an expanded diameter 211a. A hole is formed in the tissue in a somewhat constricted, non-circular anatomy. For example, the third ventricle is flat like a pancake and only a few mm (3-4 mm max) thick but may be 1-2 cm long or more depending upon the severity of the hydrocephalus. Therefore, the dilation may be more “oval” as opposed to “circular” but could be either shape, or even another shape. A balloon-like expansible element used for dilation should be highly compliant to conform to the anatomy during the procedure. In an uninflated state the balloon may have a diameter of approximately 2 mm. The balloon may be filled with a suitable fluid to inflate and create a fenestration in the tissue of between approximately 2 mm to approximately 10 mm in diameter. In some embodiments, the expandable element 203a comprising an inflatable element may be generally in the form of a compliant balloon having a hardness of about Shore 60A to about Shore 25D. Expandable elements 203a, such as inflatable elements, may be fully inflated or partially expanded, such as by injecting and/or withdrawing fluid to achieve a desired partially or fully expanded diameter, for example.
In this illustrative embodiment, the tip portion 206a comprises a tip portion energizing element 224a and/or the dilation portion 202a may not include an energizing element (e.g., similar to dilation portion energizing element 224 described above). A wiring harness 308a operatively connected to the tip portion energizing element 224a may extend proximally through the connection hub 301a of the handle 300a, such as through a dedicated branch of the connection hub 301a. The tip portion energizing element 224a includes the distal end opening of a guidewire lumen 120a, which extends longitudinally through the handle 300a, shaft 102a, and end effector 200a. The guidewire lumen 120a may be accessed proximally via a mechanical coupling 324a, which may be provided on a dedicated branch of the connection hub 301a.
In this illustrative embodiment, the handle 300a includes a tip portion steering actuator 304a and a dilation portion steering actuator 306a. In this exemplary embodiment, each steering actuator 304a, 306a is generally in the form of a roller that is rotatably disposed on the handle 300a for operation by the user. More specifically, in this embodiment, each steering actuator 304a, 306a is rotatable about a respective axis 308a, 310a that is substantially parallel to the portion of the handle 300 where the respective steering actuator 304a, 306a is exposed. Each steering actuator 304a, 306a is exposed on two opposite faces of the handle 300a. Each steering actuator 304a, 306a comprises at least one grip element, such as upstanding tabs 312a, 312b, 314a, 314b. Each steering actuator 304a, 306a comprises a toothed portion 315a, 317a, which is operatively engaged with a respective toothed gear 319a, 321a. Each toothed gear 319a, 321a comprises at least one post 323a, 323b, 325a, 325b, which is connected to a respective steering line 212, 214, 218, 220. Rotation of a steering actuator 304a, 306a in one direction causes the respective toothed gear 319a, 321a to rotate in the opposite direction. Rotation of the toothed gear 319a, 321a moves the respective posts 323a, 323b, 325a, 325b, thereby tensioning and/or slacking the respective steering lines 212, 214, 218, 220.
Exemplary methods of using an illustrative steerable dilator 100 according to at least some aspects of the present disclosure are described below and may include optional and/or alternative structures and/or operations. Although the following description focuses on the steerable dilator 100 of
Generally, some exemplary methods of creating an opening in a biological tissue membrane (e.g., performing a ventriculostomy) may include accessing the lamina terminalis 508 in a minimally invasive manner, such as via a lumbar puncture or a C1-C2 puncture into the CSF system. Accordingly, the lamina terminalis 508 may be accessed from “below” (e.g., from the central canal), rather than from “above” as in the endoscopic third ventriculostomy procedures described in the Background section.
A surgical device (e.g., dilator 100) may be introduced into the CSF space using a modified Seldinger technique. For example, an initial lumbar or C1-C2 puncture may be made with a hollow needle. Then, a guidewire may be advanced through the lumen of the needle. The needle may be removed and other devices (e.g., dilator 100) may be passed over the guidewire.
Once access to the CSF space is obtained, the dilator 100 may be directed to the desired treatment site (e.g., lamina terminalis 508), such as using fluoroscopic and/or computed tomography imaging techniques. The dilator 100 may be steered as necessary to navigate to the ventriculostomy site and/or to avoid injury to other anatomical structures along the pathway 510 (e.g., blood vessels and/or nerve structures). For example, the tip portion 206 may be steered in the tip portion steering plane 14 and/or the dilation portion 202 may be steered in the dilation portion steering plane 18, such as using steering actuators 304, 306. In some circumstances, it may be advantageous to advance the dilator 100 along a guidewire in a stepwise manner, such as in connection with imaging guidance.
After positioning of the dilator 100 at the desired puncture site is confirmed, such as by “tenting” the lamina terminalis membrane 508, the dilator 100 may be used to create the opening through the membrane 508.
Referring to
Illustrative methods employing a surgical device comprising an expandable element (e.g., dilator 100a comprising the expandable element 203a) may include expanding and/or retracting the expandable element.
Referring to
Illustrative methods of manufacturing a steerable dilator 100 may include assembling a steerable dilator 100 from a handle 300, a shaft 102, and an end effector 200. Illustrative methods may include constructing the handle 300, the shaft 102, and the end effector 200. Illustrative methods may include routing steering lines steering lines 212, 214, 218, 220 and/or power wires 122, 124 between the end effector 200 and the handle 300 through the shaft 102. Illustrative methods may include operatively connecting steering lines 212, 214, 218, 220 to steering actuators 304, 306 and/or steering rings 216, 222. Illustrative methods may include operatively connecting power wires 122, 124 to energizing elements 224, 226.
The present disclosure generally discloses “over-the-wire” techniques for performing a catheter based procedure. It will be understood that other catheter based techniques may be used instead for delivering instruments and components as generally described. These techniques may include, for example, “rapid exchange” techniques in which a catheter includes a short guide wire receiving sleeve or inner lumen extending through the distal portion of the catheter. The sleeve or inner lumen extends from a distal guide wire port in the distal end of the catheter to a proximal guide wire port spaced proximal to the proximal end of the dilation balloon. The proximal guide wire port is usually located between about 10 cm and about 50 cm from the distal guide wire port. A slit is provided in the catheter wall which extends from the second guide wire port, to a location proximal to the proximal end of the inflatable balloon to aid in the removal of the catheter from a guide wire upon withdrawal of the catheter from the patient. The structure of the rapid exchange catheter allows for the quick exchange of the catheter without the need for the use of an exchange wire or adding a guide wire extension to the proximal end of the guide wire. This type of catheter system may be used for similar benefits in procedures as generally shown and described in this disclosure.
Referring to
In some embodiments, the first dilation portion steering plane 1054 is disposed transversely relative to the first tip portion steering plane 1050. As used herein, “transverse” may refer to relative angular orientations that are non-parallel (e.g., perpendicular or oblique). For example, the first dilation portion steering plane 1054 may be disposed at a steering plane angle 1060 of about 90 degrees relative to the first tip portion steering plane 1050 as shown in
Referring again to
Similarly, the dilation portion 1302 is steerable in the first dilation portion steering plane 1054 by the selective proximal pulling of a first dilation portion steering line 1120 and a second dilation portion steering line 1122 connected to a dilation portion steering ring 1306. Specifically, pulling proximally on the first dilation portion steering line 1120 pulls on the dilation portion steering ring 1306 so as to cause the dilation portion 1302 to flex in the direction of arrow 1020a. Pulling proximally on the second dilation portion steering line 1122 pulls on the dilation portion steering ring 1306 so as to cause the dilation portion 1302 to flex in the direction of arrow 1020b. The direction of arrow 1020a and the direction of arrow 1020b may be generally opposite directions. The dilation portion steering lines 1120, 1122 may be connected to the dilation portion steering ring 1306 by a weld or solder joint, or a mechanical fastener, for example. In some embodiments, the dilation portion steering ring 1306 may be constructed of a radiopaque material, which may facilitate visualization of the dilator 1100 using various medical imaging modalities.
As described below, the tension elements (e.g., steering lines 1112, 1114, 1120, 1122) are tensioned by one or more actuators disposed on the handle 1400. Generally, the tension elements (e.g., steering lines 1112, 1114, 1120, 1122) may be constructed of any materials capable of transmitting a tensile force from the actuators to the steering rings 1306, 1350. In some embodiments, the steering lines 1112, 1114, 1120, 1122 may comprise metal wires and/or various suture materials.
Referring to
Referring to
Referring to
In the illustrative embodiment, the distal end of the tip portion 1350 is defined at least partially by the tip energizing element 1356. The tip energizing element 1356 is shaped to facilitate passage of the tip portion 1350 through a biological tissue membrane. The tip energizing element 1356 may include a beveled shape (e.g., generally beveled) as shown and/or other shapes, such as radiuses and/or tapers (e.g., generally rounded or pointed).
Referring to
In this exemplary embodiment, the steering actuator 1500 includes an actuator body 1510, a yoke 1540, a rotational actuator 1560, and an actuator handle 1580. The actuator body 1510 includes a yoke shaft portion 1512 and yoke retainer portion 1514. The yoke 1540 includes a round hole 1542. The actuator body 1510 is rotatably mounted to the yoke 1540 with the yoke shaft portion 1512 passing through the hole 1542 and the actuator body 1510 is secured to the yoke 1540 by means of the yoke retainer portion 1514. The yoke 1540 includes a pair of pivot shafts 1544, 1546. The pivot shafts 1544, 1546 of the yoke 1540 are rotatably mounted on the handle 1400. The actuator body 1510 includes a rotational actuator shaft portion 1516 and a rotational actuator retainer portion 1518 for rotatably mounting the rotational actuator 1560. The rotational actuator 1560 includes a round hole 1562. The rotational actuator 1560 is rotatably mounted to the actuator body 1510 with the rotational actuator shaft portion 1516 passing through the hole 1562 and the rotational actuator 1560 is secured to the actuator body 1510 by means of the rotational actuator retainer portion 1518. The actuator body 1510 includes an actuator handle shaft portion 1522 for mounting the actuator handle 1580. The yoke 1540 includes a tooth portion 1554 arranged to engage an opposed tooth portion 1572 on the rotational actuator 1560. In this illustrative embodiment, the tooth portions 1554, 1572 act as a matched pair of beveled gears.
In this illustrative embodiment, the steering actuator 1500 is disposed on the handle 1400 such that the actuator handle 1580 may be moved by the user about the two axis of rotation 1502, 1504 by moving the actuator handle 1580 in the directions defined by the arrows 1014a, 1014b and 1016a, 1016b respectively. Moving the actuator handle 1580 in the direction of arrows 1014a and 1014b rotates the steering actuator 1500 about the axis of rotation 1502 with the pivot shafts 1544, 1546 of the yoke 1540 rotating relative to the handle 1400. Moving the actuator handle 1580 in the direction of arrows 1016a and 1016b rotates the actuator body 1510 about the axis of rotation 1502 with the yoke shaft portion 1512 rotating in the yoke 1540. Further, moving the actuator handle 1580 in the direction of arrows 1016a and 1016b causes the tooth portion 1554 on the yoke 1540 to apply a force to the tooth portion 1572 on the rotational actuator 1560 causing the rotational actuator 1560 to rotate on the rotational actuator shaft portion 1518 of the actuator body 1510 about an axis of rotation 1506.
In this illustrative embodiment, the steering actuator 1500 includes four steering line attachment points 1520, 1552, 1564, 1566. The actuator body 1510 includes steering line attachment point 1520. The yoke 1540 includes steering line attachment point 1552. The rotating actuator includes steering line shafts 1568, 1570 which include steering line attachment points 1564, 1566 respectively.
Referring to
In this illustrative embodiment, the actuator handle 1580 may be moved by the user about the axis of rotation 1502 by moving the actuator handle 1580 in the directions defined by the arrows 1014a and 1014b, see
Referring to
In this illustrative embodiment, the actuator handle 1580 may be moved by the user about the axis of rotation 1504 by moving the actuator handle 1580 in the directions defined by the arrows 1016a and 1016b, see
Referring to
The proximally extending portion of the wiring harness 1130 is positioned in the handle 1400 to avoid conflicting with the guidewire lumen 1250 and the one or more mechanical couplings 1412, 1414. In some embodiments, the wires 1132, 1134 of the wiring harness 1130 may be color-coded, which may reduce the risk of user confusion. In this illustrative embodiment, a guidewire lumen 1250 extends longitudinally through the end effector 1300, shaft 1200, and handle 1400, and is configured to slidably receive a guidewire therethrough. In the illustrative embodiment, the guidewire lumen 1250 is substantially centrally located in the shaft 1200 and the end effector 1300.
Illustrative methods of employing a surgical device comprising an stent 1380 disposed on the end effector 1300 may include guiding the end effector 1300 to a location by the user utilizing the dilator 1100. Once in a location determined by the user, the dilator 1100 may be withdrawn from the stent 1380 leaving the stent 1380 in said location.
Referring to
In the illustrative embodiment, the distal end of the tip portion 1350a is defined at least partially by the light element 1356a. The light element 1356a is shaped to facilitate passage of the tip portion 1350a through a biological tissue membrane. The tip portion 1350a may include a beveled shape (e.g., generally beveled) as shown and/or other shapes, such as radiuses and/or tapers (e.g., generally rounded or pointed).
Illustrative methods employing a surgical device comprising a light element 1356a, which forms the distal end of the tip portion 1350a may include guiding the tip portion 1350a to a location by the user utilizing the dilator 1100a. Once in a location determined by the user, the light element 1356a may be energized by the user to apply light therapy to biological tissues such as for instance brain or spinal tissue.
Referring to
While the present invention has been illustrated by the description of specific embodiments thereof, and while the embodiments have been described in considerable detail, it is not intended to restrict or in any way limit the scope of the appended claims to such detail. The various features discussed herein may be used alone or in any combination within and between the various embodiments. Additional advantages and modifications will readily appear to those skilled in the art. The invention in its broader aspects is therefore not limited to the specific details, representative apparatus and methods and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the scope or spirit of the general inventive concept.
This application is a continuation of PCT Application Ser. No. PCT/US2021/037803 filed Jun. 17, 2021, which claims the priority of U.S. Provisional Patent Application Ser. No. 63/041,395 filed Jun. 19, 2020, the disclosures of which are incorporated herein by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63041395 | Jun 2020 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2021/037803 | Jun 2021 | US |
| Child | 18080995 | US |
