WO2001005450A1

WO2001005450A1 - Multi-channeled insertion system for simultaneous delivery of biologically active elements to multiple organ sites

Info

Publication number: WO2001005450A1
Application number: PCT/US2000/019219
Authority: WO
Inventors: Hoi Sang U; James Peter Amis
Original assignee: Macropore, Inc.; The Regents Of The University Of California
Priority date: 1999-07-14
Filing date: 2000-07-14
Publication date: 2001-01-25
Also published as: AU6098500A; EP1218041A1

Abstract

A multi-channeled insertion system (10) includes a longitudinal structure (12) having a proximal end, a distal end, and an axis extending between the proximal end and the distal end. The multi-channeled insertion system further includes a plurality of channels (18), with each of the plurality of channels beginning at an entry port, extending distally therefrom and terminating at an exit port which is disposed distally of the entry port. Each of the plurality of channels being is constructed to accommodate a tubular structure therethrough, wherein the tubular structures exit the exit ports at different angles relative to one another.

Description

MULTI-CHANNELED INSERTION SYSTEM FOR SIMULTANEOUS

DELIVERY OF BIOLOGICALLY

ACTIVE ELEMENTS TO MULTIPLE ORGAN SITES

This application claims the benefit of U.S. Provisional Application No. 60/143,789, filed July 14, 1999, the contents of which are expressly incorporated herein by reference.

Background of the Invention

1. Field of the Invention

The present invention relates generally to surgical devices and, more particularly, to catheters and needles for insertion into organs.

2. Description of Related Art

Needles have existed in the prior art for facilitating insertion of catheters into fluid spaces such as the blood stream or the subarachnoid space. Each catheter so introduced followed the direction of the axis of the needle through which the catheter was inserted, and thus the catheter was targeted to a region aligned with and distal of the needle.

In order to target specific areas within a solid organ, typical prior art procedures inserted single delivery or visualization devices, usually consisting of needles, to each independent target. Thus, when multiple target sites were required, multiple insertions of the needles were required, consequently increasing tissue damage and the risk of hemorrhage.

Summary of Invention

The multi-channeled insertion system of the present invention enables numerous points of interest within an organ to be marked, diagnosed and treated through only a single incision into the organ. The multi-channeled insertion system of the present invention includes a number of channels for facilitating the insertion of various devices therethrough. In accordance with one aspect of the present invention, the multi-channeled insertion system is initially inserted into an organ and, subsequently, two or more needles are inserted into the organ through the channels of the multi-channeled insertion system. At least one of the two or more needles will typically diverge from an axis of the multi-channeled insertion system as the needle is further inserted into the organ.

The multi-channeled insertion system thus facilitates the introduction of various delivery and/or visualization devices to different areas within a region of interest, through a single insertion of the multi-channeled insertion system. The locations of the various delivery and/or visualization devices can be verified anatomically using magnetic resonance (MR) scanning, and can further be defined physiologically using one or more data recorders incorporated into the inserted devices.

In accordance with a method of the present invention, the multi-channeled insertion system is first introduced into proximity of a region of interest. This step can be performed through the use of stereotaxy as in the case of the brain or the use of MR guidance. The precise location of the multi-channeled insertion system can then be verified with MR scanning and, subsequently, the relationships between the device and the region of interest determined. Multiple smaller tubular structures, e.g., needles, catheters, electrodes, assay devices, or endoscopes, can be directed to desired regions of interest through specifically designed channels of the multi-channeled insertion system. The channels are specifically designed to have the smaller tubular structures exit at predetermined angles, to thereby direct the smaller tubular structures to various components or sub-regions of the region of interest. The locations of the smaller tubular components can then be verified using MR scanning. The smaller tubular components can comprise electrodes for monitoring and recording parameters relating to different brain regions. Biologically active elements, such as cells, genetic elements, proteins or other biologically active elements, to be delivered to each region can be inoculated through the lumens of the smaller tubular components of the multi-channeled insertion system.

Brief Description of the Drawings Figure 1 is a longitudinal cross-sectional view of the multi-channeled insertion system of the present invention;

Figure 2 is an axial cross-sectional view of the multi-channeled insertion system, taken along the line 2-2 of Figure 1 ;

Figure 3 is a side-elevation view of the multi-channeled insertion system of the present invention;

Figure 4 is an end view of the multi-channeled insertion system of the present invention;

Figure 5 is a side-elevation view of the support structure of the multi- channeled insertion system in accordance with the present invention; Figure 6 is an end view of the support structure, taken along line 6-6 of

Figure 5;

Figure 7 illustrates a multi-channeled insertion system, inserted through an aperture in a skull and having two needles extending therefrom into close proximity of a target; Figure 8 illustrates a multi-channeled insertion system, inserted through an aperture in a skull and having five needles extending therefrom into close proximity of a target;

Figure 9 illustrates another multi-channeled insertion system, inserted through an aperture in a skull and having at least one needle formed of a memory material;

Figure 10 illustrates a multi-channeled insertion system having alignment structures on at least one of the channels thereof;

Figure 11 illustrates a multi-channeled insertion system having a central delivery needle and a single side delivery needle for application about an axis of the multi-channeled insertion system;

Figure 12 illustrates two target sites disposed within the cranium of a patient at coordinates determined by stereotaxic procedures; and

Figure 13 illustrates two needles extending from a multi-channeled insertion system to the two target sites in accordance with the present invention.

Detailed Description of the Presently Preferred Embodiments

The multi-channeled insertion system of the present invention is adapted for insertion into body cavities and tissue, such as an organ. Organs can include the brain, liver, kidneys, prostate, etc. The multi-channeled insertion system preferably comprises: (1 ) a non-scatterable metal, such as titanium, (2) a plastic, or (3) other alloy metals that will not scatter a Magnetic Resonance Imaging

(MRI) or other viewing beam. Alternatively, the multi-channeled insertion system may be constructed of scatterable materials.

A longitudinal cross-sectional view of the multi-channeled insertion system 10 is shown in Figure 1. An axial cross-sectional view, taken along the line 2-2 of Figure 1 , is shown in Figure 2. The multi-channeled insertion system 10 comprises a tubular structure 12, a channel support structure 14 holding or forming a central channel 16, and a plurality of additional channels 18. In the illustrated embodiment, the spaces between the channels 18 and the channel support structure 14 are operated as pressure release channels. Figure 3 is a side-elevation side-elevation view of the multi-channeled insertion system 10, and Figure 4 is an end view of the multi-channeled insertion system 10. Figure 5 is a side-elevation side-elevation view of the support structure 14, and Figure 6 is an end view of the support structure 14.

Each of the channels 18 preferably is configured to accommodate a delivery needle 20 or other object therethrough. The delivery needle 20 preferably comprises titanium, but may be formed of a plastic or other alloy metals or materials that will not scatter or otherwise interfere with an MRI or other viewing beam.

The multi-channeled insertion system 10 can be used to precisely target a specific area with only a single incision, for example. The single insertion of the multi-channeled insertion system 10 into the organ can reduce a possibility of hemorrhaging. The specific area can be targeted with up to 4 delivery needles, in the illustrated embodiment. In modified embodiments, the target area can be targeted with up to 6 or 8, or more, delivery needles.

In accordance with a method of the present invention, the target, in this case the brain, is located and identified through stereotaxic procedures incorporating CAT, MRI, or other scanning protocols. A benefit of forming the multi-channeled insertion system 10 of non-scatterable material is the ability of viewing the multi-channeled insertion system 10 in real time after insertion into the patient. The brain is then plotted 3-dimensionally, relative to a halo device secured to the scull of the patient. The words "halo device" are intended to refer to any device for holding the skull for imaging. Such devices will typically operate by identifying a non-visible target, such as the brain, through interpolation of three axes, for example. The target site within the brain is triangulated with needles. When the skull is opened (with a drill, for example), the brain typically will move slightly. Consequently, the 3-dimensional plotted location of the target site, relative to the halo, may be off. The multi-channeled insertion system of the present invention is preferably formed of a non-scatterable material to facilitate the collection of MRI data, for example, subsequent to the slight movement of the target (brain). The multi-channeled insertion system 10 of the present invention can be moved closer to the target site, based upon image data (such as MRI) collected subsequent to the insertion of the multi-channeled insertion system 10. In the illustrated embodiment, an endoscope housed within the central channel 16 provides real-time visual information for accurate placement of the multi- channeled insertion system 10 and subsequent placement of the delivery needles. As mentioned, post-insertion MRI data can be collected, due to the fact that the multi-channeled insertion system 10 is formed of non-scatterable material. In accordance with one preferred embodiment, the halo is also formed of non-scatterable metal. In accordance with the present invention, the delivery needles are inserted through the channels and near to or into the tissue of the target in order to reach targeted site locations on or within the target. As shown in Figure 1 , a delivery needle 21 is output at an angle 22 from a distal end 24 of a channel 18 of the multi-channeled insertion system 10. The angle 22, which is measured relative to an axis 27 of the multi-channeled insertion system 10, can be calculated by the surgeon or other user, to ensure that the ultimate destination of the delivery needle 21 coincides with the targeted site location to be marked or treated. Treatment can include, for example, chemotherapy injections, application of electrical stimulus, or injection of cellular structure such as fetal stem cells, proteins, genetic materials. The same or similar procedures can be implemented for the other channels 18 of the multi-channeled insertion system 10.

In the illustrated example of Figure 1 , the exit angle 22 is measured from the axis 27 in a direction radially outwardly from the axis 27. In addition to the exit angles having different magnitudes, they may also be configured to have different measured directions. For example, instead of the exit angle 22 being measured from the axis 27 in a direction radially outwardly from the axis 27, the exit angle 22 may be measured in a direction perpendicular to a plane containing both the illustrated direction and angle and the axis 27. In this example, the delivery needle shown in Figure 1 would extend at an angle out of the paper, instead of extending at an angle toward the top of Figure 1. Put another way, with reference to Figure 2, instead of the delivery needle 21 extending away from the central channel 16 (toward the top of the figure), the delivery needle could extend in a direction to the right of the figure. If one were to superimpose a clock onto the axis of the delivery needle 21 , the illustrated direction of extension is 12 o=clock, and the suggested other possibility would be 3 o'clock. Of course, any other direction of extension would also be possible, as would any other magnitude of the angle formed by the extension, for the delivery needle 21 or for any of the other delivery needles. Moreover, a delivery needle could be formed to extend from the central channel 16 (and the endoscope placed in one of the other channels or omitted altogether), at any direction of extension and at any angle magnitude. The distal end 24 of the channel 18 (Figure 1 ) is preferably shaped or curved to transition the inserted delivery needle 21 from alignment with the axis 27 to the exit angle.

In accordance with one aspect of the present invention, the user determines the number, nature and coordinates of targeted site locations to be marked or treated and, further, determines a configuration and implementation of the multi-channeled insertion system 10 that can be used to achieve the placement of the delivery needles 21 at the required locations. The determined solution will often be one of many possible solutions, and may be a function of, inter alia, the equipment on-hand, the trauma to be incurred by the patient and the available time and subsequent procedures to be conducted. As an example, Figure 12 illustrates two target sites T1 and T2 to be treated. Using conventional means, the surgeon determines that the first target site T1 is located a distance D1 below the cranium surface and a distance D2 to the left. Similarly, in the example the second target site T2 is determined to be located a distance D1 below the cranium surface and a distance D3 to the right , or 180 degrees, from T1. As illustrated in Figure 13, the surgeon obtains a multi- channeled insertion system 110 having two channels, each exiting at 45 degrees from the longitudinal axis of the multi-channeled insertion system 110. The two channels are configured to have components of travel that are 180 degrees away from each other (i.e., as shown in Figure 13, one channel points left toward the first target site T1 and the other channel points right toward the second target site T2). In accordance with the illustrated solution, the surgeon advances the multi- channeled insertion system 110 a depth D4 below the surface of the cranium 35 to a point 112 above and between the two target sites T1 and T2. A first needle 114 is then advanced through the first channel to the D4 depth below the cranium 35, and advanced an additional distance D5 at an angle of 45 degrees from the axis of the multi-channeled insertion system 110 toward the target site T1. Similarly, a second needle 116 is advanced through the second channel to the D4 depth below the cranium 35; and then advanced an additional distance D6 at an angle of 45 degrees from the axis of the multi-channeled insertion system 110 toward the target site T2. When D1 , D2 and D3 are 8 cm, 1 cm and 1 cm, respectively, D4, D5 and D6 will be 7 cm, 1.4 cm, and 1.4 cm, respectively, in the illustrated example. Of course, many other solutions are possible for achieving a single insertion through the aperture 33 and a subsequent branching to the target sites T1 and T2. In a situation wherein it is desirable to disrupt the tissue between the two target sites T1 and T2, rather than the tissue at the point 112, the multi-channeled insertion system 110 can be advanced to a depth of 8 cm and the two needles 114, 116 branched left and right 1 cm each to the target sites T1 and T2. In other embodiments, it may be preferred to insert the multi- channeled insertion system 110 to a depth less than 7 cm, and to branch the two needles toward the two target sites T1 and T2 at the appropriate distances and angles accordingly. In yet another embodiment, it may be preferred to insert the multi-channeled insertion system 110 closer to the target site T1 than the target site T2, and to branch the second needle 116 a greater distance toward the second target site T2 than the first needle 114 is advanced toward the first target site T1. Various factors may influence the solution to reaching the targets T1 and T2, such as types of tissues, the density of vessels in the various tissues surrounding the targets T1 and T2, the equipment on hand, the surgical procedures to be implemented. In the the presently preferred embodiment, the multi-channeled insertion system 110 and the needles 114, 116 comprise non- scatterable materials to enable an imaging scan for verification that the needles 114, 116 are properly placed in the correct proximities to the two target sites T1 and T2.

For example, when the angle 22 is prefabricated into the channel fewer possibilities for implementing a viable solution are possible. In such a circumstance, a multi-channeled insertion system may be prefabricated having the illustrated four (or five) channels, with at least one of the channels having a different exit angle. A user may have a selection of different multi-channeled insertion systems 10 on hand, and may select, from the inventory of multi- channeled insertion systems 10, a multi-channeled insertion system 10 that will provide the proper solution. In accordance with another aspect of the present invention, a computer program or other procedure may be implemented to assist the user in selecting the proper procedure. In a scenario where the multi- channeled insertion systems 10 are prefabricated with predetermined exit angles, the computer program may have the user input information including the desired target site locations and the inventory of multi-channeled insertion systems 10 on hand. In accordance with another aspect of the present invention, the configuration of the multi-channeled insertion system 10 can be generated on- site, in a matter of minutes or hours. In accordance with yet another aspect of the present invention, the configuration of the multi-channeled insertion system 10 is generated off-site, in a matter of hours or days, and is over-nighted or hand delivered to the user upon the user=s submission of the desired specifications for the multi-channeled insertion system 10. The specifications may include information pertaining to the number of channels; from 1 to 10 channels, for example, the placement of an endoscope, if any; and the exit angles and directions of the channel or channels, for example . A computer program or other procedure may be implemented to assist the user in selecting the proper custom configuration and preferred implementation of the multi-channeled insertion system 10. The computer program may have the user input information including the desired target site locations, the trauma to be incurred by the patient and the available time and subsequent procedures to be conducted. The computer program would then generate, in accordance with one embodiment, both specifications for the fabrication of a multi-channeled insertion system 10 and detailed instructions for using the fabricated multi-channeled insertion systems 10 in a procedure to target the desired target site locations.

Figure 7 illustrates a multi-channeled insertion system 10, inserted through an aperture 33 in a skull 35 and into close proximity of a target 38. A central delivery needle 41 extends from the central channel 16 (Figure 2), and a side delivery needle 43 extends from one of the additional channels 18. The multi- channeled insertion system 10 is illustrated inserted a predetermined distance from the target 38, with the central delivery needle 41 and the side delivery needle 43 extending predetermined distances at predetermined angles to the axis 27 (Figure 1 ) of the multi-channeled insertion system 10. In the illustrated embodiment, the central delivery needle 41 and the side delivery needle 43 are advanced from the distal end of the multi-channeled insertion system 10 to locations 45, 47 on or close to the target 38 for marking and/or delivery procedures. The central delivery needle 41 is shown having an angle of zero, relative to the axis 27 of the multi-channeled insertion system 10. In modified embodiments, however, the central delivery needle 41 can form an angle other than zero with the axis 27 of the multi-channeled insertion system 10. In other modified embodiments, a viewing device such as an endoscope may be placed within the central channel 16 or, alternatively, within the additional channel 18 which in the illustrated embodiment would otherwise have housed the side delivery needle 43. Subsequently, the central delivery needle 41 and the side delivery needle 43 can be advanced further into the target 38 for additional marking and/or delivery functions. For example, the central delivery needle 41 and the side delivery needle 43 can be advanced to the phantom locations 49 and 51 and, subsequently, advanced to the phantom locations 53 and 55.

Figure 8 illustrates a multi-channeled insertion system 10, inserted through an aperture 33 in a skull 35 and into close proximity of a target 74. A central delivery needle 60 extends from the central channel 16 (Figure 2), and a plurality of side delivery needles 63, 65, 69 and 71 extend from a corresponding plurality of channels of the multi-channeled insertion system 10. The central delivery needle 60 and the plurality of side delivery needles 63, 65, 69 and 71 extend predetermined distances at predetermined angles to a plurality of locations on or close to the target 74 for marking and/or delivery procedures. The central delivery needle 60 is shown having an angle of zero, relative to the axis 27 of the multi-channeled insertion system 10. In modified embodiments, however, the central delivery needle 60 can form an angle other than zero with the axis 27 of the multi-channeled insertion system 10. In other modified embodiments, a viewing device such as an endoscope may be placed within the central channel 16 or, alternatively, within one or more of the channels housing the side delivery needles 63, 65, 69 and 71.

In accordance with one aspect of the present invention, one or more of the delivery needles can be formed of a memory material or memory metal, such as a Nitenol material comprising Nickel Titanium alloy. The memory metal is preferably formed of a non-scatterable material. The side delivery needle 71 of Figure 8 is shown comprising a memory metal, which in the instant application is formed to curve in a proximal direction.

Figure 9 illustrates a multi-channeled insertion system 10 positioned near a target 89. The side delivery needle 91 comprises a memory metal, which in the instant application is advanced to mark or treat a first location 93 of the target 89. The side delivery needle 91 may later be advanced to a second location 95 of the target 89. Subsequently, the side delivery needle 91 may be retracted and advanced between the first location 93 and the second location 95 on the target 89. In modified embodiments, the side delivery needle 91 may be moved through the target 89 between two or more locations. Any one or more of the other delivery needles 60, 63, 65 and 69 may be formed of memory metals, as well. Moreover, any given delivery needle may be formed to bend in a proximal, distal, or any other direction.

As shown in Figure 10, one or more ribs 111 and/or one or more slots 113 may be formed on one or more of the channels 16 and/or 18, with complementary slots and/or ribs being formed on the endoscope or delivery needles, for preventing rotation of the endoscope or delivery needles. The formation of the ribs and/or slots can be especially beneficial when the delivery needles comprise memory metals. In Figure 10, the channel 18 comprises a slot 111 for accommodating a rib of a delivery needle, and further comprises a rib 113 for accommodating a slot of the delivery needle. In a modified embodiment, the delivery needle is configured to abut directly and be held by the support structure 14 and the tubular structure 12. A slot may be formed, for example, on the support structure 14 for directly accommodating a rib of a delivery needle. Similarly, a rib may be formed, for example, on the tubular structure 12 for directly accommodating a slot of a delivery needle. Combinations of ribs and slots may be used. Only a single slot or rib, or a combination thereof, may be placed only on the tubular structure 12 and/or the support structure 14. In embodiments wherein the ribs and/or slots are formed directly into the tubular structure 12 or the support structure 14, the tubular structure 12 or the support structure 14 may be advantageously formed to be slightly thicker and/or the delivery needle may be advantageously formed to be slightly thicker.

In a modified embodiment, one or more of the channels 18 can be removed from and reinserted into the multi-channeled insertion system 10, either in vitro or in vivo, regardless of whether slots or ribs are formed on the removable channels. Figure 11 shows a multi-channeled insertion system 10 having a central delivery needle 60 and a single side delivery needle 101. After the location 104 is marked or treated, the side delivery needle 101 is retracted, and the multi- channeled insertion system 10 is rotated about its axis in the direction of the arrow A1. The side delivery needle 101 is extended for marking or treating of a second location 106 of the target. In accordance with one aspect, the central needle 60 helps to stabilize the side delivery needle 101 as it is rotated. This procedure may be repeated for various angular positions and various lengths of the side delivery needle 101. In a modified embodiment, an endoscope is used instead of the central needle 60. In other modified embodiments, a plurality of side needles are controlled similarly to the side delivery needle 101.

It is preferred in one embodiment that the tubular structure 12 (Figure 2) comprise titanium or other non-scattering metal, in order to provide sufficient rigidity to the multi-channeled insertion system 10. The internal star shaped structure 14 may be formed of plastic when the tubular structure 12 is formed of a non-scattering metal. In another embodiment, the tubular structure 12 is formed of plastic and the internal star shaped structure 14 is formed of a non- scatterable metal. Both the internal star shaped structure 14 and the tubular structure 12 can be formed of a non-scatterable metal for maximum rigidity, or both the internal star shaped structure 14 and the tubular structure 12 can be formed of plastic for maximum flexibility. Chemical markers may be placed on or formed into parts of the multi-channeled insertion system 10 for enhancing visibility of the parts to imaging operations, such as MRI. The multi-channeled insertion system 10 and/or one or more of the channels 16, 18 may be shaped to have cross sections other than circular, such as rectangular, and may be formed of other materials such as stainless steel that will scatter an MRI beam. Similarly the delivery needles may be shaped to have cross sections other than circular, such as rectangular, and may be formed of other materials such as stainless steel.

In the illustrated embodiment, the diameter of the tubular structure 12 is preferably 2 to 3 mm, the diameter of the central channel 18 is preferably about .5 mm, and the diameter of the central channel 16 is preferably about .5 mm. Fluids may be aspirated through one or more of the channels (or devices inserted within the channels), and/or a tissue collection devices or microelectrodes can be inserted through one or more of the channels, for performing various assays and the assay information recorded. Thus, the region or regions of interest may be characterized physiologically, diagnosed, treated, and monitored. The multi-channeled insertion system 10 may thus be left in an organ on a prolonged basis or permanently for the administration of drugs and/or the measurement of parameters of the organ.

Claims

CLAIMS:

1. A multi-channeled insertion system, comprising: a longitudinal structure having a proximal end, a distal end, and an axis extending between the proximal end and the distal end; and a plurality of channels, each of the plurality of channels beginning at an entry port, extending distally therefrom and terminating at an exit port which is disposed distally of the entry port; each of the plurality of channels being constructed to accommodate a tubular structure therethrough; wherein at least one of the plurality of channels has an exit port that is constructed to route a tubular structure in a first direction that is not parallel to the axis of the longitudinal structure.

2. The multi-channeled insertion system as set forth in Claim 1 , wherein: a second one of the plurality of channels has an exit port that is constructed to route a tubular structure in a second direction that is not parallel to the axis of the longitudinal structure.

3. The multi-channeled insertion system as set forth in Claim 2, wherein the first direction is not parallel to the second direction.

4. The multi-channeled insertion system as set forth in Claim 3, wherein: a third one of the plurality of channels has an exit port that is constructed to route a tubular structure in a third direction that is not parallel to the axis of the longitudinal structure.

5. The multi-channeled insertion system as set forth in Claim 4, wherein the third direction is parallel to neither the first direction nor the second direction.

6. The multi-channeled insertion system as set forth in Claim 1 , wherein the longitudinal structure comprises a tubular structure.

7. The multi-channeled insertion system as set forth in Claim 6, wherein: the tubular structure comprises a lumen extending between the proximal end and the distal end; and the plurality of channels is formed within the lumen.

8. The multi-channeled insertion system as set forth in Claim 1 , wherein at least one of the plurality of channels is formed on the longitudinal structure.

9. The multi-channeled insertion system as set forth in Claim 1 , wherein the multi-channeled insertion system comprises a non-scatterable material.

10. The multi-channeled insertion system as set forth in Claim 1 , wherein the plurality of channels comprises a plurality of channels surrounding a central channel.

11. The multi-channeled insertion system as set forth in Claim 10, wherein the central channel is constructed to house an endoscope.

12. A multi-channeled insertion system, comprising: a longitudinal structure having a proximal end, a distal end, and an axis extending between the proximal end and the distal end, the longitudinal structure comprising at least one longitudinally extending channel; and at least one needle disposed within the at least one longitudinally extending channel, the at least one needle comprising a memory material and being constructed to extend through the at least one longitudinally extending channel and to exit the at least one longitudinally extending channel at a different angle relative to the axis.

13. The multi-channeled insertion system as set forth in Claim 12, wherein: the at least one longitudinally extending channel comprises a plurality of longitudinally extending channels; and the at least one needle comprises a plurality of needles disposed within the plurality of channels, the plurality of needles comprising memory materials and being constructed to extend through the plurality of channels and to exit the plurality of channels at different angles relative to one another and the axis.

14. The multi-channeled insertion system as set forth in Claim 13, wherein the longitudinal structure comprises a tubular structure.

15. The multi-channeled insertion system as set forth in Claim 14, wherein: the tubular structure comprises a lumen extending between the proximal end and the distal end; and the plurality of longitudinally extending channels are formed within the lumen.

16. The multi-channeled insertion system as set forth in Claim 13, wherein at least one of the plurality of longitudinally extending channels are formed on an outer surface of the longitudinal structure.

17. The multi-channeled insertion system as set forth in Claim 13, wherein the multi-channeled insertion system comprises a non-scatterable material.

18. The multi-channeled insertion system as set forth in Claim 13, wherein the plurality of longitudinally extending channels comprises a plurality of longitudinally extending channels surrounding a central channel.

19. The multi-channeled insertion system as set forth in Claim 18, wherein the central channel is constructed to house an endoscope.

20. The multi-channeled insertion system as set forth in Claim 13, wherein the memory materials comprise memory metals.

21. A method of accessing at least one target site within an organ, the method comprising the following steps: inserting a multi-channeled insertion system through a single incision in the organ, the longitudinal structure comprising at least one longitudinally extending channel; inserting at least one needle through the longitudinally extending channel and into the organ, the at least one needle exiting the longitudinally extending channel and traveling to the at least one target site at an angle relative to the axis, wherein the angle is not equal to zero.

22. The method of accessing at least one target site according to Claim

21 , wherein the step of inserting at least one needle through the longitudinally extending channel comprises a step of inserting a plurality of needles through the longitudinally extending channel.

23. The method of accessing at least one target site according to Claim

21 , wherein: the at least one target site comprises a plurality of target sites; and the step of inserting at least one needle through the longitudinally extending channel comprises a step of inserting a plurality of needles through the longitudinally extending channel, wherein the plurality of needles exit the longitudinally extending channel and travel to the plurality of target sites at angles relative to the axis, wherein the angles are not equal to zero.

24. The method of accessing at least one target site according to Claim 23, wherein the multi-channeled insertion system and the needles comprise non- scatterable materials.

25. The method of accessing at least one target site according to Claim 23, wherein at least one of the plurality of needles comprises a memory material.

26. The method of accessing at least one target site according to Claim

21 , wherein: the step of inserting a multi-channeled insertion system comprises a step of inserting a multi-channeled insertion system having a plurality of longitudinally extending channels; and the step of inserting at least one needle through the longitudinally extending channel comprises a step of inserting a plurality of needles through the plurality of longitudinally extending channels.

27. The method of accessing at least one target site according to Claim 26, wherein: the at least one target site comprises a plurality of target sites; and the step of inserting a plurality of needles through the plurality of longitudinally extending channels comprises a step of inserting a plurality of needles through the plurality of longitudinally extending channels so that the plurality of needles exit the longitudinally extending channels and travel to the plurality of target sites at angles relative to the axis, wherein the angles are not equal to zero.