Abstract:
Described is a medical assembly and delivery devices for performing minimally invasive medical procedures. In particular, described is a controllable articulating directional tip assembly consisting of interlocking segments creating an articulating directional tip and various components utilized with the directional tip for various tissue alterations and/or viewing within a tissue cavity such as, for example, non-soft tissue alterations such as bone within a non-soft tissue cavity. In particular, the disclosed device could be utilized as an osteotome device for altering, such as cutting, bone.

Description:
FIELD 
       [0001]    Described herein is a medical assembly and delivery devices for performing minimally invasive medical procedures. In particular, described is a controllable articulating directional tip assembly consisting of interlocking segments creating an articulating directional tip and various components utilized with the directional tip for various implant delivery, tissue alterations and/or viewing of tissue within a tissue cavity such as, for example, alterations of non-soft tissue such as bone within a non-soft tissue cavity. In particular, the disclosed device could be utilized as an osteotome device for altering tissue, such as cutting or crushing bone. 
       BACKGROUND 
       [0002]    Currently, there are a multitude of various directional tip medical devices available for use in surgical procedures on mammals. Many of them are utilized to position certain devices such as endoscopes, orthoscopes, probes, catheters, and similar devices in specific locations within a body tissue. Procedures include tissue repair, tissue cutting, tissue removal or imaging. Most of these devices, however, are flimsy and lack the robustness and strength to be utilized for the objectives of altering, preparing and/or removing tissue, and in particular, non-soft tissue such as bone tissue. There exists a need for an articulating directional tip devices and assemblies that can be precisely placed within a tissue cavity, and in particular, a non-soft tissue cavity, for altering non-soft tissue such as bone tissue to accomplish desired objectives such as tissue alteration, preparation, cutting, compacting, removal, suctioning, and viewing, and devices and assemblies that have sufficient strength to accomplish the desired goal. 
       SUMMARY OF INVENTION 
       [0003]    Described herein is an articulating directional tip assembly consisting of interlocking segments that are connected by a flexible linking guidance wire and can be articulated through the use of a tensioning wire component that can cause the articulating directional tip be precisely manipulated within a tissue cavity while delivered through minimally invasive surgical procedure. In an alternative embodiment, the articulating            
     
    
     
         [0004]      FIG. 1  shows a preferred embodiment of an articulating directional tip assembly with a directional articulating tip device. 
           [0005]      FIG. 2  shows a side view of an articulating directional tip assembly. 
           [0006]      FIG. 3   a  shows a cutaway view of an articulating directional tip assembly with a flexible linking guidance wire and a tensioning wire component. 
           [0007]      FIG. 3   b  shows a close up view of a cutaway of an articulating directional tip assembly. 
           [0008]      FIGS. 4   a - c  show various views of an articulating directional tip assembly consisting of multiple angled interlocking segments. 
           [0009]      FIGS. 5   a - d  show various views of a preferred embodiment of an interlocking segment. 
           [0010]      FIGS. 6   a - b  show two perspectives of an articulating tip of an osteotome assembly with a distal cutting tip. 
           [0011]      FIGS. 7   a - d  show various views of an alternative designed interlocking segment. 
           [0012]      FIGS. 8   a - d  show various views of a distal cutting tip. 
           [0013]      FIG. 9  shows an alterative articulating directional tip assembly design. 
           [0014]      FIG. 10  shows a cutaway of a directional articulating tip assembly shaft. 
           [0015]      FIG. 11  shows an articulated articulating directional tip assembly. 
           [0016]      FIG. 12   a - e  show various alternative applicators for use with an articulating directional tip assembly. 
           [0017]      FIG. 13  shows an imaging applicator. 
           [0018]      FIG. 14   a  shows a cutaway of a double lumen shaft. 
           [0019]      FIG. 14   b  shows a side view of a double lumen shaft. 
           [0020]      FIG. 15  shows a side view of double lumen shaft with a scissor applicator. 
           [0021]      FIG. 16  shows a side view of a double lumen shaft with a bone crusher applicator. 
           [0022]      FIG. 17  shows a side view of a double lumen shaft with an imaging applicator. 
           [0023]      FIG. 18  shows a suctioning lumen with suction applicator. 
           [0024]      FIG. 19  shows a delivery device with a straight articulating directional tip assembly. 
           [0025]      FIG. 20  shows a delivery device with an articulating directional tip assembly. 
       
    
    
     DETAILED DESCRIPTION 
       [0026]    In the drawings reference numeral  10  generally denotes an exemplary embodiment of an articulating directional tip assembly  201  as shown in  FIG. 2 . 
         [0027]      FIGS. 1 and 2  show an articulating directional tip assembly  201  that consist of two or more interlocking segments  203  that are connected with a flexible linking guidance wire  301 . As shown in  FIG. 3  the flexible linking guidance wire  301  would connect to the distal tip  205  of the articulating directional tip assembly  201  and connect to or run through a passage within the interlocking segments  203  to the distal end  207  of a delivery cannula  209 . A tensioning wire component  305  would also connect to or run through a passage in the interlocking segments then runs through the interior of the delivery cannula  209  to a point where is exits the proximal end of the delivery cannula  211  At the proximal end of the tensioning wire component  305  a tensioning component (not shown) could be connected. That would allow the tensioning wire component  305  to be tensioned proximally through the delivery cannula  209 . With the proximal movement of the tensioning wire component  305  the proximal tension of the wire causes the articulation of the directional tip  201  in a desired direction  303 . The amount of articulation that can be caused would be correlated to the number of interlocking segments  203  that make up the articulating tip  201  and to the angle  401  of the termination of each interlocking segment based of the design of the segment. In the preferred embodiment the maximum angle would be 15%  403 . With this example an articulating tip  201  consisting of six interlocking segments  203  could achieve a 90° angle or articulation  405  with the tensioning of the tensioning wire component  305  by the tensioning component (not shown). 
         [0028]    Each interlocking segment  203  would consist of one or more protruding or male components  407  which would interlock with one or more corresponding recessed or female slot  409  on the adjacent segment.  FIG. 5   a - d  shows a preferred embodiment of an interlocking segment with four protruding or male components  407  and four recessed or female slots  409 . Within the interior of the segment in the preferred embodiment there would be one more lumen passages  411  which would allow a flexible linking guidance wire  301  to pass through the interior  501  of the segment from a proximal entry  503  to a distal exit  505 . The flexible linking guidance wire  301  and/or the tensioning wire component  305  could be connected anywhere on the interlocking segments however, that would allow for the connecting of the segments and for the articulation of the directional tip. 
         [0029]    In  FIGS. 4   a - b  and  5   a  and  d  three lumen passages are shown that allow for the passage of a flexible linking guidance wire  301 , a tensioning wire component  305 , and a rigid straightening component, for example, a pin. (not shown.) This rigid straightening component might be utilized to straighten out the articulated directional tip once the tissue altering action within a space is completed to ensure a smooth exit of the assembly from the space. While the preferred embodiment disclosed has four protruding or male components  407  and four recessed or female slots  409 , any number of male components and female slots could be utilized that allows the interlocking segments  203  to angle or articulate to the desired angle. 
         [0030]    While in the preferred embodiment the angle of the segment termination is 15°, any angle per segment and number of segments utilized could be used that would achieve the maximum desired articulation angle desired. For example,  FIG. 6  shows nine interlocking segments  203  that each have a 10° angle  601  on one of the termination end of the respective interlocking segments  203  achieving a 90° articulation upon tensioning of the tensioning wire component  305 . 
         [0031]      FIGS. 7   a - d  show an alternative interlocking segment where the passage  701  that passes through the interior of the segment  203  is rectangular in shape with the width of the passage  701  wider than the height. This would allow for a wide flexible linking guidance wire  301 , such as, for example, a band, to pass through proximally to distally and provide a different type of directional control when articulating the articulating tip  201  within a tissue cavity. It also might allow a narrower flexible linking guidance wire  301  that could be moved laterally as well as proximally and distally within the passage  701 .  FIGS. 7   a, b  and  d  also show an alternative embodiment where the interlocking segment  203  has two protruding or male components  703  and two recessed or female slots  705  rather than four. 
         [0032]      FIG. 8  shows a cutting interlocking segment  801  that is located at the distal end  105  of the articulating tip  201  of the articulating directional tip assembly  201 . In the preferred embodiment the cutting mechanism  803  is spaced distally  805  from the base of the segment  807  for cutting purposes. Any cutter design could be utilized that would allow for the cutting of material such as for example, body tissue. The cutting interlocking segment  801  would include one or more protruding or male components  407  for interlocking with its proximal interlocking segment  203 , it would not include any recess or female slots at its distal end. In one alternative embodiment the osteotome assembly might include a passage through the interior of the delivery cannula  109  and the articulating tip  103  that would exit on the cutting tip as shown in  FIG. 8   a . This passage might be utilized for providing suction from the cutting tip for the removal of fluids and/or material such as severed body tissue, or for the delivery of materials such as biologic or non-biologic materials or implants. While  FIG. 8  shows one example of a cutting mechanism, any mechanism could be utilized with the tip that would accomplish the objective of the user once the articulating tip is delivered into a space such as a tissue cavity and then the articulating tip  203  is rotated or articulated by the tensioning component to its desired placement within the cavity. 
         [0033]      FIG. 9  shows an alternative embodiment of an articulating directional tip assembly  901 , whereby the device consists of a shaft  903  made of a strong but deformable material such as a semi-rigid braided stainless steel guidance wire  904 . Any structure or material might be utilized that is deformable and has sufficient strength to prepare and/or cut non-soft tissue such as bone tissue. 
         [0034]    In an alternative embodiment surrounding the center shaft  903  are guidance wire retaining rings  905  that contain a tensioning wire component  907  that runs parallel to the shaft  903  as shown in  FIGS. 9-11 . In this alternative embodiment, the tensioning wire might be contained in small wire holders attached to the side of the shaft. Any method of connecting the tensioning wire component  907  to the shaft of the articulating directional tip assembly could be utilized, however, that would cause the shaft to bend when the tensioning wire component is tensioned proximally away from the distal tip such as is shown in  FIG. 11 . 
         [0035]    As shown in  FIG. 10  in the preferred embodiment, the shaft  903  contains a lumen  1001  for a straightening ram (not shown) that ensures the shaft  903  will only bend as desired when pressure is applied through the tension of the tensioning wire component  907 . This straightening ram  911  might be adjustable either outward distally or proximally within the shaft  903  thereby determining the length of movement of the distal end of the shaft  903  depending on the desired result. For example, the portion of the distal end of the shaft  909  might be a ½ inch. In another use, it might be 1½ inch. Any length of shaft could be utilized for bending the tip by sliding the straightening ram  911  distally or proximally within the shaft  903 . Once tension is applied on the tensioning wire component  907 , the tip  909  is pulled inwardly and directionally  1101  to a desired location as shown in  FIG. 11 . The tension could be achieved by any mechanism that would pull the tensioning wire component  907  proximally away from the tip  909  causing the bending  1103  shown in  FIG. 11 . 
         [0036]    In one embodiment at the end of the articulating directional tip shaft  909 , the tip might be configured for use with a specific application. In an alternative embodiment, the tip  909  might include a connector mechanism to allow for the attachment of a variety of applicators as described below. In one variation, two or more applicators might be attached to the tip  909 . 
         [0037]    Applicators might include a scoop  1201  as shown in  FIG. 12   a , a cutter  1203  such as, for example, a knife as shown in  FIG. 12   b , scissors  1205  as shown in  FIG. 12   e , or any other tissue separation component. In one variation as shown in  FIG. 12   d , the applicators might include a non-soft tissue scraper  1206  such as, for example, a bone scraper. In another variation, the applicator might be a bone crusher  1207  as shown in  FIG. 12   e . Any applicator capable of preparing and/or the removal of non-soft tissue such as bone might be utilized, however. In one variation, the applicators utilized with the directional tip device might include an imaging device such as a camera lens  1301  as shown in  FIG. 13 . Any imaging or data collecting device might be utilized, however. 
         [0038]    The shaft  903  of the device might contain a secondary lumen  1401  as shown in  FIG. 14  that might house a tensioning wire component  1403  for manipulating applicators such as, for example, tissue scissors  1205  as shown in  FIG. 15  or a bone crusher  1207  as shown in  FIG. 16 . In that embodiment, the secondary guidance wire  1403  could be tensioned and untensioned allowing for the opening and closing of the scissors  1205 . In an alternative embodiment as shown in  FIG. 17 , the wire contained within the secondary lumen  1401  might be a data wire  1701  allowing data transfer such as, for example, for imaging to be transferred from an imaging lens  1301 . Any data transfer mechanism might be utilized. 
         [0039]    In another embodiment, the secondary lumen might be a hollow pathway allowing for the suctioning of tissue and/or fluids from a cavity as shown in  FIG. 18 . In that embodiment, the tip  909  might include a suctioning tip  1801  with an opening  1803  that connects to the secondary lumen  1401  within the shaft  903 . A suctioning collector device (not shown) would be connected to the secondary lumen at the proximal end of the shaft. A control device might be included for regulating the suction force as needed. A collection vessel might be utilized to collect the tissue and/or fluid. In alternative embodiment materials such as, for example, biologic or non biologic materials and/or implants could be delivered through a secondary lumen, surrounding The articulating tip or via the tip itself. 
         [0040]      FIG. 19  shows an alternative embodiment of a delivery device for an articulating directional tip assembly  1901 . The delivery device would consist of a delivery cannula  1903  containing an articulating directional tip assembly  1901 . The proximal end of the alternative delivery cannula  1902  is contained in a delivery housing  1909 . The proximal end of the tensioning wire component  305  passes through the delivery housing  1909  to a tensioning housing  1911  where it is secured  1913 . When tension is desired on the tensioning wire component  305 , the user would move the flexible handle  1915  inwardly towards the static handle  1917 . This would pull the tensioning wire component  305  distally away from the directional tip  901  causing the tip to articulate  2001  as shown in  FIG. 20 . In one variation, the squeezable handle  1915  could be locked into position once the desired articulation on the articulating directional tip  901  is achieved. This might be accomplished with a locking mechanism that consist of a guidance wire  1919  connected to the static handle  1917  with a tensioning component  1921  located on the proximal side of the squeezable handle  1915 . 
         [0041]    It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the described device as specifically shown here without departing limn the spirit or scope of that broader disclosure. The various examples are, therefore, to be considered in all respects as illustrative and not restrictive.