Indexing cell delivery catheter

An insertion device and method of using and manufacturing an insertion device is shown, wherein the insertion device is capable of distributing a media over a large distribution volume inside a patient while reducing the amount of tissue disturbed by the procedure. Also shown is a computer-readable medium with instructions stored thereon, the instructions when executed operable to cause generation of a set of data for use with an insertion device. An insertion device and methods are shown that allows a series of iterations to be performed within a single insertion procedure that distributes media, such as cells for cell therapy, over a large volume.

BACKGROUND

1. Field of the Invention

This invention relates to medical devices. Specifically, but not by way of limitation, this invention relates to medical devices for introduction of a media such as cells into a body cavity, such as within the human brain.

In this document, the medical device that is described is inserted within a body cavity. While the insertion procedure could be directed at any of several locations within a patient, for the discussion in this document, a neurosurgical procedure will be used as an example. Assisting devices may also be used in combination with the present insertion device in a neurosurgical procedure. Such devices may include, but are not limited to, a stereotactic headframe, a trajectory guide, electronic tissue imaging equipment, and frameless reference systems.

A common surgical technique inserts a medical device into a patient to a targeted area through a small opening that is surgically opened in the patient. Inserting a device to the targeted area of the patient and disturbing as little tissue as possible is a high priority. Small openings are desirable because they are less invasive and less traumatic to the patient. A catheter is a broad category of medical devices that can be inserted into a patient through small openings. The term catheter could include several configurations of devices. In one basic form, a catheter includes a hollow tube, or passage to deliver a media such as a drug or other treatment media to a selected location in the patient. Included in the general definition of catheters are multiple tube devices. Multiple tube configurations typically include an outer tube, and an inner tube, where one of the tubes is moveable with respect to the other tube.

In this document, references to coordinates with respect to catheters or insertion devices will refer to axial or longitudinal locations and radial locations. Axial or longitudinal locations are typically locations with reference to an insertion axis. Radial locations will use the conventional 2-dimensional radial coordinates (r, θ) in a circle that is normal to the insertion axis. By combining an axial coordinate with the radial coordinates, a point can be located in three dimensional space relative to a given reference frame, such as the patient. Descriptions of the insertion axis in this document will generally refer to depth inside a patient along a line. It should be noted that although catheters need not be inserted along a straight line, a generally linear depth model will be used for ease of discussion. Also, the axial end, or tip of the catheter that is inserted into a patient is referred to herein as the distal end of the catheter, while the axial end of the catheter that remains toward the outside the patient is referred to as the proximal end.

In some medical procedures, it is desirable to distribute a media over a large target area within a patient. One procedure that utilizes a large distribution target area is neurosurgical cell therapy. Several prior approaches have been used to accomplish a large distribution target area. In one approach, a relatively small catheter, such as a single lumen catheter, is inserted into a patient several consecutive times. In this procedure, a measured amount of media, or dose, is delivered at one location, and then the catheter is withdrawn and re-inserted at a nearby location to deliver another dose. This process is repeated a number of times until the entire target area has received the desired dose. A problem with this approach is that multiple insertions disturb a large amount of tissue in the patient. Each time that tissue is disturbed, there is a chance for tissue damage.

Some catheters utilize a single lumen host catheter that houses a delivery catheter having a deflected distal tip. The deflected distal tip exits the single lumen host catheter in a direction chosen by the orientation of the single lumen host catheter upon insertion. The deflected distal tip slightly increases the distribution of a single insertion and dose, however larger target area coverage is still needed. Steerable catheters exist, where the orientation and location of the distal tip can be changed while the distal tip is inserted in the patient, however, moving the distal tip while it is within the patient further disturbs tissue, which again, can lead to tissue damage. Also, steerable catheters are typically more complex and expensive to manufacture.

Another approach has been to insert a relatively large host catheter, the host catheter incorporating a number of internal passages for micro-catheters. The internal passages exit a distal end of the large host catheter at a distribution of locations around the distal end. Using this approach, the large host catheter is inserted in a center of the target area. Micro-catheters are then inserted in the various internal passages, and a dose is delivered at each of the distribution of locations. In this way a larger target area is covered without the need for multiple host catheter insertions. A problem with this approach is that the large host catheter displaces a large amount of tissue, even though the number of insertions is reduced.

What is needed is a device and method for distributing a media over a large target area. What is further needed is a device and method that disturbs a lower amount of tissue.

SUMMARY OF THE INVENTION

An insertion device is shown, the insertion device being adapted for delivery of a media inside a patient. The insertion device shown includes an insertion axis. One embodiment of the insertion device includes a first tube that is substantially coaxial with the insertion axis. Also included is a second tube substantially contained within the first tube, the second tube having a first range of motion with respect to the first tube. Also included is a third tube located at least partially within the second tube, the third tube having a second range of motion with respect to the first tube.

A method of introducing a media into a body cavity is shown, the method in one embodiment includes inserting an insertion device into the body cavity along an insertion axis. In this method, the insertion device includes a first tube that is substantially coaxial with the insertion axis, and a second tube substantially contained within the first tube the second tube having an angular range of motion with respect to the first tube. The insertion device in this method also includes a third tube at least partially within the second tube, the third tube having an axial range of motion with respect to the first tube. The method further includes rotating the second tube to a first position within the angular range of motion while the first tube remains stationary. The method includes advancing the third tube into the body cavity along the axial range of motion to a first location, and introducing the media to the first location through the third tube.

A method of manufacturing an insertion device is shown that includes forming a first tube with an axis that defines an insertion axis. The method also includes placing a second tube substantially contained within the first tube. The method also includes defining a first range of motion of the second tube with respect to the first tube; placing a third tube substantially contained within the second tube; and defining a second range of motion of the third tube with respect to the first tube.

A further method of introducing a media into a body cavity is shown that includes inserting an insertion device into the body cavity along an insertion axis. The insertion device in this method embodiment includes a first tube that is substantially coaxial with the insertion axis and a second tube substantially contained within the first tube, the second tube having an angular range of motion with respect to the first tube and an axial range of motion with respect to the first tube. The method includes rotating the second tube to a first position within the angular range of motion while the first tube remains stationary. The method further includes advancing the second tube into the body cavity along the axial range of motion to a first location, the first location being radially spaced at least partially radially outward from the insertion axis, and a radial component of the first location with respect to the insertion axis being determined by the first position within the angular range of motion. The method further includes introducing the media to the first location through the second tube.

An insertion device with an insertion axis is shown, the insertion device including an axial actuator that controls relative motion along the insertion axis. The insertion device further includes a first tube coupled to the axial actuator wherein the first tube is movable along the insertion axis in response to the axial actuator and a second tube having a radially biased distal end. In this embodiment, the second tube is substantially contained within the first tube in a first state. In this embodiment, the second tube is rotatable with respect to the first tube. In this embodiment, the second tube is axially movable to a second state, a portion of a distal end of the second tube being exposed from a distal end of the first tube in the second state.

A method of manufacturing an insertion device is shown, the method including defining an insertion axis and forming an axial actuator that controls relative motion along the insertion axis. The method also includes coupling a first tube to the axial actuator wherein the first tube is movable along the insertion axis in response to the axial actuator. The method also includes forming a second tube having a radially biased distal end. The method includes placing the second tube in a way that the second tube is substantially within the first tube in a first state; the second tube is rotatable with respect to the first tube; and the second tube is axially movable to a second state. In the second state, a portion of a distal end of the second tube is exposed from a distal end of the first tube.

A computer-readable medium is also shown with instructions stored thereon, the instructions when executed operable to cause location of a target volume in three dimensional space. The instructions, when executed, are also operable to cause plotting of a trajectory from an external point on a patient to the target volume and generation of a set of data corresponding to locations within the target volume. The set of data in one embodiment includes at least one axial position of a first tube along an insertion axis; at least one axial position of a second tube with respect to the first tube; and at least one rotational position of the second tube with respect to the first tube.

Although specific embodiments have been illustrated and described herein, it will be appreciated by those skilled in the art that any arrangement which is calculated to achieve the same purpose may be substituted for the specific embodiment shown. This document is intended to cover any adaptations of variations of the present invention. It is to be understood that the above description is intended to be illustrative, and not restrictive. The scope of the invention includes any other applications in which the above structures and fabrication methods are used. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

DETAILED DESCRIPTION

FIG. 1ashows a insertion device100according to one embodiment. The insertion device100inFIG. 1ais further shown in a sectional view asFIG. 1b,the section being taken along line1b-1b.

The insertion device100includes a first tube110, the first tube having a distal end112and a proximal end114. Located on an upper surface of the proximal end114are a number of first indexing bumps116. A central axis102is shown inFIG. 1b.The central axis102in this figure represents a central axis of the first tube. In one embodiment, the central axis102of the first tube is the same axis as an insertion axis of the insertion device100.

The insertion device100further includes a second tube130. The second tube130includes a distal end132and a proximal end134. The proximal end134of the second tube130includes a knob portion136, an indexing indicator138with a first index engaging recess140, and a number of friction bumps142. The proximal end134of the second tube130also includes a recess portion144that contains a number of second indexing bumps146. The second tube130includes a first range of motion148with respect to the first tube110as shown by the arrows148. In one embodiment, the friction bumps142interact with a surface of the first tube110to provide a designed level of resistance to rotation within the first range of motion148. In one embodiment, a central axis of the second tube130is coaxial with the central axis102.

The first range of motion148is adjustable to select a radial direction, theta (θ). The second tube130is rotatable about the first range of motion148with respect to the first tube110. In one embodiment, the second range of motion is indexed by elements such as first indexing bumps116, which interact with the first index engaging recess140of the indexing indicator138. Non-indexed embodiments of the first range of motion are also contemplated within the scope of the invention. An indicating scale may also be included on the insertion device100to indicate the position of the third tube150, or second tube130, or both within the first range of motion148. In one embodiment, the indexing indicator138and its associated first index engaging recess140combine with the first indexing bumps116to serve as an indicator scale in addition to serving an indexing function.

The insertion device100further includes a third tube150. The third tube150includes a distal end152and a proximal end154. The distal end152of the third tube150includes a tip portion156, and a number of distribution holes157. In one embodiment, the tip portion156is blunt to protect tissue during insertion of the insertion device100. Along a sidewall of the third tube150is a second index engaging bump158. At the proximal end154of the third tube150is a connector160, which in one embodiment includes a luer hub configuration. The connector160is adapted for connection to a media source. The third tube150includes a second range of motion162with respect to the first tube110as shown by the arrows162. In one embodiment, a central axis of the third tube150is coaxial with the central axis102.

In one embodiment the third tube includes a coating (not shown) on an inner surface. The coating may include, but is not limited to a hydrophobic material, a hydrophilic material, or a biological agent. The biological agent may include a substance that promotes cell viability. In one embodiment where the media includes cells, the viability promoting biological coating helps to keep the cells alive for effective treatment at a target location within a patient.

FIGS. 1aand1billustrate the insertion device100in a configuration with the third tube150in a retracted state along the second range of motion162. In the retracted state along the second range of motion162, the second index engaging bump158is in an upper location within the number of second indexing bumps146.FIG. 1cshows the insertion device100with the third tube150in an extended state along the second range of motion162. In the extended state along the second range of motion162, the second index engaging bump158is in a lower location within the number of second indexing bumps146.

Although only two positions of the third tube150in the second range of motion162are shown, any of a number of locations along the second range of motion162are possible. Although in one embodiment, a feature such as second indexing bumps146indexes the second range of motion162, non-indexed embodiments are also contemplated within the scope of the invention. An indicating scale may also be included on the insertion device100to indicate the position of the third tube150within the second range of motion162. One example would include a series of marks on the side of the third tube to indicate a position along the second range of motion.

The distal end152of the third tube150extends radially as well as axially in the extended state. A magnitude of radial extension in one embodiment is controlled by position of the third tube150along the second range of motion162. In one embodiment a magnitude of axial extension is also controlled by position of the third tube150along the second range of motion162. InFIG. 1c,a configuration of the distal end152of the third tube150controls both the axial and radial components of the extension of the distal end152.

In one embodiment, the distal end152extends in an arc. One skilled in the art will recognize that shapes other that an arc would also be within the scope of the invention. The radial extension component of the distal end152can be measured in part by an angle162. Angle162is defined as the internal angle between the central axis102and the distal end152of the third tube150as shown inFIG. 1c.In one embodiment the arc at the distal end152of the third tube150is biased or molded permanently into the third tube. In one embodiment, the bias of the third tube is overcome by a stiffness of the second or first tube6r both when the third tube is in its retracted state as shown inFIGS. 1aand1b.In one embodiment, the third tube150is therefore coaxial with the central axis102in the retracted state, while exhibiting a radial component outward from the central axis102in the extended state. Other embodiments that impart a radial component to the distal end152of the third tube150in an extended state are also contemplated within the scope of the invention. For example, the second tube could include a deflecting tip to impart a radial component to the distal end152.

In the extended state shown inFIG. 1c,the number of distribution holes157are exposed from the distal end132of the second tube and the distal end112of the first tube. This allows distribution of a media such as cells in a region that is axially spaced and radially spaced from the distal ends of the first and second tubes.

In one embodiment, the tip portion156is visible to the use of an electronic imaging system. During a procedure such as neurosurgery, an electronic imaging system such as magnetic resonance imaging (MRI), or computed tomography (CT), radio wave imaging, or other imaging system may be used to image the patient. With the tip portion156of the third tube150of the insertion device100visible to the selected imaging technique, it is possible for the surgeon to see more accurately the placement of the distal end152of the third tube. This makes delivery of the selected media more accurate.

In one embodiment, the insertion device100may be adjusted in two ranges of motion. While the second range of motion selects magnitude of extension, the first range of motion148is adjustable to select a radial direction, theta (θ). The second tube130is rotatable about the first range of motion148with respect to the first tube110. In one embodiment, the second range of motion is indexed by elements such as first indexing bumps116, which interact with the first index engaging recess140of the indexing indicator138. Non-indexed embodiments of the first range of motion are also contemplated within the scope of the invention. An indicating scale may also be included on the insertion device100to indicate the position of the third tube150, or second tube130, or both within the first range of motion148. In one embodiment, the indexing indicator138and its associated first index engaging recess140combine with the first indexing bumps116to serve as an indicator scale in addition to serving an indexing function.

FIGS. 2a-2cshow an embodiment of a insertion device200in operation. The insertion device200in inserted into a patient270through an opening271. The insertion device200is inserted along an insertion axis202to a target location280within the patient. Upon insertion, the insertion device200is in a retracted state as shown inFIG. 2a.Once the target location280is reached, an operator gripping a knob portion236and rotating a second tube230within a first tube210makes a radial selection within a first range of motion248. In one embodiment, a third tube250also rotates with the second tube230.

As shown inFIG. 2b,once the radial selection is made the third tube250is extended along a second range of motion262. Extension of the third tube reveals a distal end252of the third tube. The distal end252in this embodiment is biased in an arcuate shape, therefore directing the distal end252of the third tube250outward from the insertion axis202in a radial direction in addition to an axial direction. Extension of the distal end252along the second range of motion262, at the radial selection along the first range of motion248, directs the distal end252to a first location272. The extended distal end252of the third tube also exposes a number of distribution holes257. A media source that is connected to a connector260such as a luer hub is then actuated to dispense a media such as cells into the patient270adjacent to the first location272.

Because the distal end252of the third tube250is extended at least partially in a radial direction, rotation of the third tube250about the first range of motion248while the distal end252is extended could cause tissue damage. In one embodiment, the insertion device200includes a mechanism to prevent rotation about the first range of motion248while the distal tip252is extended. Rotation in the first range of motion248would be permitted once the distal end252is in a retracted position, and coaxial with the insertion axis202.

After the media has been delivered to the first location272, the third tube250is withdrawn back into the retracted state as shown inFIG. 2a.This is accomplished by withdrawing the third tube250along the second range of motion262. The second tube is then rotated to a second radial selection within the first range of motion248. The third tube may then be re-extended to a second location274within the patient270as shown inFIG. 2c.Once extended at the second location274, the number of distribution holes257are used to distribute media such as cells to an area adjacent the second location274.

The above detailed procedure of selection of direction, extension, distribution of media, and retraction can be repeated several times to fully cover a large area of distribution within a patient. Advantageously, the large area within the patient is covered with a single insertion of the insertion device200. The first tube210in this embodiment remains stationary, and does not rotate during the procedure, while elements such as other tubes substantially contained within the first tube210are allowed to rotate. Thus surrounding tissue is protected during rotation from damage due to friction between surrounding tissue and the first tube210, which is in direct contact with the surrounding tissue on a substantial portion of its side surfaces.

Although an infinite number of radial locations can be covered with this novel insertion device200, the first tube210in this embodiment need only be large enough to accommodate the second and third tubes230and250. The need for a large host catheter with a large number of internal passages for micro-catheters is thus eliminated. In one embodiment, when the distal end252of the third tube250is integrally molded with a bias, the need for complicated and expensive steerable catheters is also eliminated.

Indexing of the first and second ranges of motion248and262is advantageous because is allows the operator to easily adjust the various tubes of the insertion device within the first and second ranges of motion. A predetermined interval of adjustment is allocated for each index, and the operator need only adjust a number of indices for each iteration of extension/retraction as described above. In addition, the inclusion of a visible indicator scale allows the operator to see exactly where in the ranges of motion the distal end252of the third tube250is located.

The inclusion of an electronically imageable tip256allows the operator to use the insertion device200in conjunction with an imaging system such as a magnetic resonance imaging (MRI) system, or similar imaging system. Features such as indexing, visible indicator scales, and imageable tips make locating and adjusting the insertion device200easier, more accurate, and safer for the patient270.

Components that are included in a further embodiment of an insertion device are shown inFIGS. 3-5b.FIG. 3shows a microcatheter300. The microcatheter300includes a proximal end portion310and a tube portion330. A fitting340is attached to one end of the proximal end portion310. The fitting is adapted for connection to additional devices, such as a media supply line, etc. In one embodiment, the fitting340includes a female luer lock fitting.

In one embodiment, a depth adjustment region312is included. In the embodiment shown inFIG. 3, the depth adjustment region312includes a number of slots314at varying locations along a longitudinal axis of the proximal end portion310. One of ordinary skill in the art, with the benefit of having read the present disclosure, will recognize that alternative depth adjustment regions312are within the scope of the present disclosure, such as bumps, other notch profiles, or a smooth surface with a set screw, etc.

In one embodiment, an indicator scale320is included on the proximal end portion310. In the embodiment shown inFIG. 3, the indicator scale320includes a number of marks322that are used to indicate a longitudinal position of the microcatheter300in relation to other elements of the insertion device. One of ordinary skill in the art, with the benefit of having read the present disclosure, will recognize that alternative indicator scales, including electronic position scales, etc. are within the scope of the present disclosure. In one embodiment, a rotational marker318is included on the proximal end portion310. The rotational marker318will be described in more detail in discussion of later figures. Further included in one embodiment, an index engaging feature316is attached to the proximal end portion310. The index engaging feature316will also be described in more detail in discussion of later figures.

FIGS. 4aand4bshow a cannula400. The cannula400includes a proximal end portion410and a tube portion430. In one embodiment, the proximal end portion410includes an inner diameter large enough to telescope with the proximal end portion310of the microcatheter300. In one embodiment, the tube portion430includes an inner diameter large enough to telescope with the tube portion330of the microcatheter300.

The cannula400, in one embodiment, includes an index housing420that includes a number of index slots422(FIG. 4b). One of ordinary skill in the art, with the benefit of having read the present disclosure, will recognize that any of a number of indexing devices such as ratchet shaped teeth, bumps, etc. can also be used. Also included in one embodiment of the cannula400, is a depth adjustment actuator feature412. The depth adjustment actuator feature412will be discussed in more detail in discussion of later figures.

FIGS. 5aand5bshow an axial actuator500. The axial actuator includes a main body510and a stem portion530. Coupled to the stem portion530is a fitting532that is adapted for connection to additional devices that will be discussed in more detail in later figures.

In one embodiment, the main body510includes a first portion514and a second portion524. In the embodiment shown inFIGS. 5aand5b,the first portion is axially movable with respect to the second portion524. The relative axial motion is controlled by a user control520. In the embodiment shown, the user control520includes a thumb wheel. The user control520includes inner threads522that engage a number of outer threads526on the second portion524. When the user control520is turned, the inner threads522drive the outer threads526and the second portion524axially with respect to the first portion514. The first portion514may in this manner be moved axially with respect to the second portion along direction516either apart or together depending on the direction of rotation of the user control520. One of ordinary skill in the art, with the benefit of having read the present disclosure, will recognize that alternate axial actuator mechanisms such as a ratchet, worm thread, etc. are possible within the scope of the present disclosure.

In one embodiment, the axial actuator500includes a fixing device512, such as a set screw. The fixing device512, in one embodiment, is used to secure the proximal end portion410of the cannula400within the first portion514of the main body510. In this way, the cannula400is axially movable by adjusting the axial actuator500as described above.

FIG. 6ashows the elements fromFIGS. 3-5bcoupled together in one possible configuration of an insertion device600. The proximal end portion310of the microcatheter300is located within the proximal end portion410of the cannula400. The proximal end portion410of the cannula400is further located within the main body510of the axial actuator500.

A depth adjustment actuator610is shown adjacent to the depth adjustment actuator feature412of the cannula400. The depth adjustment actuator610includes an engagement feature614and a biasing device612in the embodiment shown. In one embodiment, the biasing device612includes an elastic O-ring that fits within the depth adjustment actuator feature412. The biasing device612urges the engagement feature614into one of the slots314of the microcatheter300. As discussed above, other depth adjustment designs are also contemplated within the scope of the invention.

The fixing device512is shown engaging the cannula400through a bushing618. The bushing618is included on some embodiments to further fix a maximum depth of the insertion device600during initial setup of the insertion device600in a medical procedure.

In one embodiment, the microcatheter300is rotatable about the insertion axis601, and the rotation is indexed. In the embodiment shown, the index engaging feature316of the microcatheter engages the number of index slots422of the cannula400. Rotation of the microcatheter300, is thus divided into discrete steps in embodiments that include the indexing feature.

The tube330of the microcatheter is shown passing along an insertion axis601of the insertion device600. The microcatheter travels inside the tube430of the cannula400as both tubes330and430exit the insertion device600towards a distal end602. The tubes330and430at their distal end602are the portions of the insertion device that are actually placed inside a patient for a procedure such as delivery of a media.

FIGS. 6band6cfurther show elements of the insertion device600from FIG.6a.FIG. 6bshows the fitting532of the stem portion530attached to a portion of a trajectory device that will be discussed in later figures.FIG. 6cshows an indicator scale620that indicates a rotational position of the microcatheter300with respect to the cannula400. A rotational range of motion of the microcatheter300with respect to the cannula400is shown by arrows630. The indicator scale620includes a number of markings622that define exact angles of position. The rotational marker318is coupled to the microcatheter300, while the indicator scale620is coupled to the cannula400. In this way, the relative position of the microcatheter300with respect to the cannula400is shown. One of ordinary skill in the art, with the benefit of having read the present disclosure, will recognize that alternative indicator scales, including electronic position scales, etc. are within the scope of the present disclosure.

FIG. 7ashows an embodiment of a trajectory guide700. The trajectory guide700includes a stem portion720. The stem portion further includes a fitting adaptor724such as a male luer lock, and a multi axis joint722, such as a ball joint. The multi axis joint722allows adjustment of a trajectory axis726. The trajectory guide700further includes a base710with at least one securing device712such as a screw.

In operation, the base710is attached to a patient using the securing devices712. An example of a location on a patient includes mounting the base710directly to the skull of a patient. The stem720is then adjusted to point the trajectory axis726to a desired location within the patient.FIG. 7bfurther shows a fixing device730such as a lockring that is used to fix the trajectory axis726once targeting of the desired location is complete.

The trajectory guide700as shown inFIGS. 7aand7bis used in one possible embodiment an insertion device from previous figures. For example, inFIG. 6b,the fitting532is shown secured to a stem such as found in the trajectory guide700. Other embodiments do not include the trajectory guide700, and use other means to adjust a trajectory before performing an insertion procedure.

In embodiments that include a trajectory guide700, the axial actuator500is secured to the trajectory guide700with the insertion axis601substantially coaxial with the trajectory axis of the trajectory guide700. A starting condition is set by adjusting a pair of variables. The microcatheter tube330is secured substantially within the cannula tube430using the depth adjustment actuator610, and a desired slot314. An axial starting depth of the two tubes330and430is then set by using the fixing device512to secure the cannula400to the axial actuator500.

The insertion microcatheter tube330and the cannula tube430are inserted into a patient through an opening or incision. The microcatheter tube330and cannula tube430are inserted along the insertion axis601to a target location within the patient. Insertion is accomplished by actuation of the axial actuator500with the user control520. During insertion, the microcatheter tube330is substantially contained within the cannula tube430. Similar to previously described embodiments, the distal end of the microcatheter tube330may include a blunt tip to prevent tissue damage during insertion. Once the target location is reached, an operator makes a beginning radial selection using the indicator scale620shown inFIG. 6c.The microcatheter tube330is allowed to rotate substantially within the cannula tube430without rotation of the cannula tube430. Tissue surrounding the cannula tube430is not subject to any rotational friction from sidewalls of the cannula tube430.

Once the radial selection is made, the microcatheter tube330is extended along the insertion axis601by itself, leaving the cannula tube430in place. This is accomplished by actuating the depth adjustment actuator610, and moving to another selected slot314. The depth of the microcatheter330, as extended separate from the cannula tube430, is indicated by the indicator scale320. Again, very little tissue is disturbed due to the stationary position of the cannula tube430.

Extension of the microcatheter tube330reveals a distal end of the microcatheter tube330with a bias as described in other embodiments above. The distal end in one embodiment is biased in an arcuate shape, therefore directing the distal end of the microcatheter tube330outward from the insertion axis601in a radial direction in addition to an axial direction.

Extension of the distal end of the microcatheter tube330, at the beginning radial selection, directs the distal end to a first location. The extended distal end of the microcatheter tube330also exposes a number of distribution holes as described in embodiments above. A media source that is connected to the fitting340such as a luer lock hub is then actuated to dispense a media such as cells into the patient adjacent to the first location.

Because the distal end of the microcatheter tube330is extended at least partially in a radial direction, rotation of the microcatheter tube330while the distal end is extended could cause tissue damage. In one embodiment, the insertion device600includes a mechanism such as a selectively keyed slot, etc. to prevent rotation while the distal tip of the microcatheter tube330is extended.

After the media has been delivered to the first location, the microcatheter tube330is withdrawn substantially within the cannula tube430. This is accomplished by using the depth adjustment actuator610, and moving to another selected slot314.

The microcatheter tube330is then rotated to a second radial selection using the indicator scale620shown inFIG. 6c.The microcatheter tube330may then be re-extended to a second location within the patient. Once extended at the second location, the number of distribution holes are used to distribute media such as cells to an area adjacent the second location.

Several iterations of moving to a new radial selection and extending the microcatheter tube330can be performed to reach numerous locations within the patient. Advantageously, the cannula tube remains stationary during all iterations. One depth of the cannula tube430along the insertion axis601is described in the example above, however the iterations described above can be performed at multiple cannula tube430depths along the insertion axis601to accomplish a further distribution of media. Once the media has been delivered to the desired number of locations, the microcatheter tube330and the cannula tube430are withdrawn together by actuating the user control520of the axial actuator500.

Although the description of operation steps above is described in an order, other orders of operations are also possible within the scope of the invention. One of ordinary skill in the art, with the benefit of having read the present disclosure, will recognize alternative orders to accomplish the same objective.

FIG. 8shows a flowchart for a method of operation of an insertion device as described in embodiments above. First the patient is imaged in three dimensions using any of a number of tissue imaging techniques such as MRI, CT, PET, etc. A target volume such as a tumor, or other target volume is then identified. Boundaries of the target volume are identified and marked using, for example, computer software that interfaces with the imaging device. A trajectory is then plotted to intersect with the target volume as identified. In one embodiment, the trajectory is plotted as a part of the imaging procedure. In one embodiment the trajectory is plotted as a part of the insertion procedure. In another embodiment, imaging, plotting the trajectory, and insertion are all performed in a single procedure. One method of plotting the trajectory includes imaging an actual trajectory of a trajectory guide such as the trajectory guide shown inFIGS. 7aand7b,the trajectory guide being mounted directly to a patient.

Using geometry, in conjunction with known values such as a starting tip location of a microcatheter, a starting tip location of a cannula, amount of bias or arc shape at a distal tip of the microcatheter, desired dose of media to be introduced, etc. a set of data can be generated for use in a procedure to introduce media to the target volume. In one embodiment, a table of instructions is generated that determines a number of steps in media delivery iterations.

By following the table of instructions for one iteration, or a number of iterations, a media concentration or concentration gradient can be effectively delivered over the target volume. A location of a distal tip of the microcatheter is determined by sets of data points in the table. For a larger target volume, a number of locations are determined by the table of instructions, and a dose of media is delivered at each of the locations. In this way a dose of media can be delivered to a large volume target area using a single insertion. In one embodiment, the table of instructions includes variables such as axial depth of the cannula, axial depth of the microcatheter, and rotational angle of the microcatheter.

CONCLUSION

Thus has been shown an insertion device and method of using and manufacturing a insertion device, wherein the insertion device is capable of distributing a media over a large distribution area inside a patient while reducing the amount of tissue disturbed by the procedure.

Although specific embodiments have been illustrated and described herein, it will be appreciated by those skilled in the art that any arrangement which is calculated to achieve the same purpose may be substituted for the specific embodiment shown. This document is intended to cover any adaptations of variations of the present invention. It is to be understood that the above description is intended to be illustrative, and not restrictive. The scope of the invention includes any other applications in which the above structures and fabrication methods are used. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.