Patent Publication Number: US-2018042590-A1

Title: Percutaneous Cannula Assembly

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. application Ser. No. 15/606,641 filed May 26, 2017, U.S. application Ser. No. 15/502,814 filed Feb. 9, 2017, PCT Application Serial No. PCT/US2015/039833 filed Jul. 9, 2015, U.S. Provisional Application Ser. No. 62/092,022 filed Dec. 15, 2014, and U.S. Provisional Application Ser. No. 62/022,511 filed Jul. 9, 2014, which are all incorporated by reference herein. 
    
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     Not applicable. 
     1. Field of the Invention 
     The present invention relates to the field of medical devices, specifically syringes and aspirating cannulas. 
     2. Background of the Related Art 
     Autologous stem cell transplant generally occurs in a highly sterile environment such as available in an operating room or ambulatory surgical center. One of the common methods to obtain stem cells is through the use of aspirating cannulas. However, cannulas require a second instrument to access the interior of the body for collection of the stem cells. For example, extraction of bone marrow stem cells generally requires the insertion of a trocar and the cannula after the trocar is in place. Similarly, extraction of stem cells from adipose tissues generally requires a scalpel incision into the patient before insertion of the aspirating cannula. Moreover, once the desired cells and tissues are harvested by the cannula, the cells or tissues are then transferred to syringes or test tubes. These transfers significantly increase the opportunity for sterile breaks through introduction of manual transfers. An invention and method is desired to simply extract and collect desired cells from a patient in a sterile closed system and then reintroduce the concentrated cells for therapeutic purpose. 
     The present invention simplifies the process for autologous stem cell transplant by utilization of a dual syringe with percutaneous aspirating cannula that safely harvests cells and tissues without the need for a surgical procedure and by minimizing the opportunity for a sterile break. The percutaneous aspirating cannula utilizes a needle and a tapered edge cannula wherein the needle and tapered edge allow for the percutaneous aspirating cannula to be inserted directly into a patient without the need of surgical incision or insertion of a trocar. The dual syringe is a closed system that allows for the harvesting syringe to harvest the cells/tissue which is then centrifuged to aggregate the cells wherein the isolated cell pellet is then transferred to a second syringe where it can then be reinjected to the patient for a desired therapeutic purpose. 
    
    
     
       BRIEF SUMMARY OF THE DRAWINGS 
         FIG. 1  is a side profile of the harvesting syringe. 
         FIG. 2  is a front profile of the harvesting syringe. 
         FIG. 3  is an isometric view showing the bottom of the dual syringe. 
         FIG. 4  is an isometric view showing the bottom of the dual syringe with the transfer covering removed. 
         FIG. 5  is a cross section of the side profile of the harvesting syringe. 
         FIG. 6  is a close-up cross section of the side profile of the lower end of the harvesting syringe. 
         FIG. 7  is a profile view of the needle hub assembly. 
         FIG. 8  is a profile view of the cannula. 
         FIG. 9  is a profile view of the percutaneous cannula. 
         FIG. 10  is a close-up cross section of the side profile of the needle hub assembly. 
         FIG. 11  is an isometric view of the dual syringe with a standard hypodermic needle. 
         FIG. 12  is an isometric view of the dual syringe with the percutaneous cannula assembly. 
         FIG. 13  is an isometric view of the dual syringe with the cannula. 
         FIG. 14  is an isometric view of the transfer syringe with a standard hypodermic needle. 
         FIG. 15  is a flow chart of the method of autologous stem cell transplant. 
     
    
    
     DETAILED DESCRIPTION OF THE VARIOUS EMBODIMENTS 
     As seen in  FIGS. 1 through 6 and 12 , the dual syringe  1  comprises a harvesting syringe  10  and a transfer syringe  100 . The harvesting syringe  10  comprises a barrel  20 , spacer  70 , and harvesting plunger  90 . The barrel  20  comprises a partially cylindrical sidewall  21  and bottom wall  30  that define an interior cavity  60 . The side wall  21  is shaped so that it forms a hemi-cylindrical groove  22  that extends from the top end  23  of the harvesting syringe  10  to the bottom end  24 . The preferred embodiment of the groove is hemi-cylindrical but other shapes such as triangular or rectangular are envisioned. On the opposing end of the barrel  20  from the bottom wall  30  is an opening  40 . Handles  25  extend perpendicularly from the cylindrical sidewall  21  and away from the opening  40  at the top end  23  of the barrel  20 . The handles  25  are positioned  90  degrees from the hemi-cylindrical groove  22 . 
     The interior surface  26  is of the cylindrical sidewall  21  is generally smooth and corresponds in shape to the exterior surface  27  which includes the hemi-cylindrical groove  22 . A ridge  28  is located along the interior surface  26  of the cylindrical sidewall  21  near the top end  23 . The cylindrical sidewall  21  is generally translucent and contains identifying markings  29  to indicate the volume of material within the interior cavity  60 . 
     Still referring to  FIGS. 1 through 6 and 12 , a tubular shaped spacer  70  having a cylindrical sidewall  71 , a bottom wall  72 , and top wall  73  is positioned within the hemi-cylindrical groove  22  such that the bottom wall  72  of the spacer  70  and bottom wall  30  of the harvesting syringe  10  are aligned. The top wall  73  of the spacer  70  is positioned approximately at the midpoint of the hemi-cylindrical groove  22  of the harvesting syringe  10 . An interior channel  74  extends from the top wall  73  to the bottom wall  72  of the spacer  70 A top port  75  is positioned on the top wall  73  which creates a fluid pathway with channel  74 . A syringe locking mechanism  76  having a channel  78  through its center is positioned on the top wall  73  above the top port  75 . The syringe locking mechanism  76  may be female luer taper connection. A bottom port  77  is positioned on the bottom wall  72 . A fluid pathway exists from the bottom port  76 , through the channel  74 , through the top port  75  and through the channel  78  of the syringe locking mechanism  76 . The spacer  70  may be bonded, glued, or welded onto the barrel  20 . Alternatively, the spacer  70  and barrel  21  may be integral. 
     The harvesting syringe  10  has an outflow port  31  positioned approximately in the middle of the of the bottom wall  30  and an inflow port  32  positioned in a portion of the bottom wall  30  opposite from the spacer  70  and aligned with the bottom port  77  and the outflow port  31 . Both the inflow port  31  and outflow port  31  create a fluid pathway into the interior cavity  60  of the barrel  20 . A needle attachment  34 , positioned on the exterior surface  33  of the bottom wall  30 , has a channel  41  through its center such that a fluid pathway exists with the inflow port  32 . The needle attachment  34  may be a male luer taper connection. On the exterior surface  33  of the bottom wall  30  a transfer wall  35  is formed around the outflow port  31  and transfer port  77 . A transfer cover  36  is attached to the transfer wall  35  and covers the outflow port  31  and transfer port  77 . The transfer wall  35  and transfer cover  36  create a pathway  38  between the outflow port  31  and transfer port  77 . 
     As seen in  FIGS. 5 and 6 , the interior surface  37  of the bottom wall  30  is sloped such that the interior surface  37  is shaped to funnel contents into the outflow port  31 . The exterior surface  33  of the bottom wall  30  corresponds to the same slope of the interior surface  37 . The pathway  38  may be selectively closed by a valve  39 . 
     The harvesting plunger  90  has a stopper or harvesting plunger head  91  connected to one end of a shaft  92 . The opposing end of the shaft  92  has a handle  93  which is shaped to generally correspond with the interior surface  26  of the cylindrical sidewall  31 , including the hemi-cylindrical groove  22 . The harvesting plunger head  91  is shaped to correspond with the interior surface  26  of the cylindrical sidewall  31  including the hemi-cylindrical groove  22 . The shaft  92  is screwed into the plunger head  91  and the friction created by the plunger head  91  and the interior surface  26  generally holds the plunger head  91  in place which allows the shaft  92  to be screwed in or out. The harvesting plunger head  91  is made of a malleable material such as a hard rubber to create a seal between the interior cavity  60  of the barrel  20  and the atmospheric environment existing above the plunger head  91 . The ridge  28  on the interior surface  26  inhibits removal of the harvesting plunger head  91  from the interior cavity  60  of the barrel  20 . 
     As seen in  FIG. 12 , the transfer syringe  100  comprises a barrel  101  and a transfer plunger  110 . The barrel  101  is translucent and contains identifying markings  102  to indicate the volume of material within the barrel  101 . The transfer syringe barrel  101  comprises a cylindrical sidewall  103  having an open top end  104  and a closed bottom end  105 . A handle  106  extends from the barrel  101  at its top end  104 . A port  107  is positioned in the bottom end  105  of the syringe barrel  101  to allow access into the interior cavity  108  of the barrel  101 . A needle attachment  109  having a channel through its center is affixed to exterior surface of the bottom end  105 . The needle attachment  109  may be a male luer taper connection. A fluid pathway exists between the channel of the needle attachment  109 , port  107 , and interior cavity  108 . 
     As seen in  FIGS. 9 and 12 , the percutaneous cannula assembly  200  is composed of a needle hub  210 , a needle  201 , and a removable cannula  250 . As seen in  FIGS. 7 and 10 , the hollow tubular needle  201  is comprised of cylindrical sidewall  202  having a beveled point  203  on one end and an opening  204  on the opposing end. A cavity  205  is formed by the cylindrical sidewall  202  and extends from the beveled point  203  to the opening  204 . 
     As seen in  FIGS. 7, 9, 10, and 12 , the needle hub  210  contains a syringe connecting portion  211  and a cannula connecting portion  230 . The syringe connecting portion  211  consists of a cylindrical sidewall  212  having a connecting outlet  213  on one end and a needle receiving outlet  214  on the opposing end. A radial flange  217  is positioned around the connecting outlet  213  on the exterior face  216  of the cylindrical sidewall  212 . The radial flange  217  may be consistent with a female luer taper connection. A cavity  215  is formed by the cylindrical sidewall  212  and extends from the connecting outlet  213  on one end and a needle receiving outlet  214 . The needle  201  is permanently affixed to at least a portion of the interior face of the cylindrical sidewall  212 . Two wings  218  extend radially away from the exterior face  216  of the cylindrical sidewall  212 . The wings  218  permit a user to grip and rotate the needle hub  210 . The wings  218  are positioned on the exterior face  216  of the cylindrical sidewall  212  at a sufficient distance away from the radial flange  217  to allow the radial flange  217  to connect to the needle attachment  34  and be screwed or positioned into place. A fluid communication pathway exists from the connecting outlet  213  to the beveled point  203  of the needle  201 . 
     As seen in  FIG. 8 , the cannula connecting portion  230  consists of a cylindrical sidewall  231  having a connecting end  232  on one end and a cannula receiving end  233  on the opposing end. The diameter of the cylindrical sidewall  231  of the cannula connecting portion  230  is greater than the cylindrical sidewall  212  of the syringe connecting portion  211 . The connecting end  232  is attached to the exterior face  216  of the cylindrical sidewall  212  of the syringe connecting portion  211  at the approximate midpoint of the cylindrical sidewall  212  of the syringe connecting portion  211 . Threads  234  are positioned on the interior face  234  of the cylindrical sidewall  231  of the cannula connecting portion  230 . Threads  234  may be consistent with a male luer lock taper connection. Radial ridges  236  are positioned on the external face  237  of the cylindrical sidewall  231  of the cannula connecting portion  230 . The radial ridges  236  assist in gripping the needle hub  210 . 
     The distance between the interior face  234  of the cylindrical sidewall  231  of the cannula connecting portion  230  and the exterior face  216  of the cylindrical sidewall  212  of the syringe connecting portion  211  is of sufficient distance that a cannula or other syringe may be removably attached to the needle hub  210 . 
     As seen in  FIG. 8 , the cannula  250  is comprised of a tubular shaft  251  attached to a cannula hub  252 . The cannula hub  252  is tubular in shape with a generally cylindrical sidewall  253  with a cannula receiving portion  254  on one end and outlet  255  on the opposing end. A radial flange  256  is positioned around the outlet  255  of the cylindrical sidewall  253 . The radial flange  256  may be consistent with a female luer taper connection. One end of the tubular shaft  251  is attached to the cannula hub  252  at the cannula receiving portion  254 . The other end of the tubular shaft  251  is a tapered outlet  258 . The cylindrical sidewall  253  and cannula shaft  251  form a cavity  257  between the outlet  255  and the tapered outlet  258 . The cannula shaft  251  and the tapered outlet  258  have an inner diameter large enough to allow the needle  201  to pass through. Ports  259  extend longitudinally through the sidewall of the tubular shaft  251 . Ports  259  may have smooth edges for minimal tissue cleavage or sharp skived edges for maximum tissue recovery depending on the desired use and desired tissue and/or cells to harvest. Ports  259  may be oriented on one side or may extend generally around the circumference of the tubular shaft  251 . Depth markings  260  are positioned along the outer face of the cannula shaft  251  that indicate the distance from the respective marking to the tapered outlet  258 . 
     As seen in  FIGS. 11 through 14 , the transfer syringe  100  is attached to the harvesting syringe  10  through attachment of the needle attachment  109  to the syringe locking mechanism  76  of the spacer  70 . The barrel  101  of the transfer syringe  100  partially fits within the hemi-cylindrical groove  22  of the harvesting syringe  10 . The harvesting plunger head  91  is shaped to not interfere with the transfer syringe  100  or to prohibit the screwing in of the transfer syringe  100  onto the syringe locking mechanism  76 . A pathway is created between the interior cavity  60  of the harvesting syringe  10  and the interior cavity  108  of the transfer syringe  100  by the outflow port  31 , pathway  38 , bottom port  77 , interior cavity  74  of the spacer  70 , top port  75 , needle attachment  109 , and port  107 . The pathway  38  may be selectively closed by a valve  39 . Valve  39  may designed as a pressure sensitive valve which seals with positive pressure from outflow port  31  but opens upon negative pressure from the bottom port  77 . 
     As seen in  FIG. 12 , the needle hub  210  may attach to the dual syringe  1  through mating of needle attachment  34  of the dual syringe  1  and ridge  217  of the needle hub assembly  210 . The cannula  250  may attach to the needle hub  210  through mating of the cannula connecting portion  230  and radial flange  256  of the cannula  250 . As seen in  FIGS. 9 and 12 , the needle  201  extends out the tapered outlet  258  of the cannula  250  when the cannula  250  is attached to the needle hub  210 . As seen in  FIG. 13 , the cannula  250  may also attach to the dual syringe  1  through mating of needle attachment  34  of the dual syringe  1  and radial flange  256  of the cannula  250 . In the preferred embodiment, the attachments are luer lock taper connections although alternative embodiments may use a luer slip taper connection. 
     Referring to  FIG. 15 , the broad process  300  of operation of the dual syringe  1  comprises the following steps: 
     Anesthetize the patient generally or locally where cells are to be harvested. Anesthetization may occur through use of the dual syringe  1  with a standard hypodermic needle  50  attached as seen in  FIG. 11 , or through the percutaneous adipose aspirating cannula  200  as seen in  FIG. 12 . Anesthetizing agent is drawn into the harvesting syringe  10  by pulling on the harvesting plunger  90 . The anesthetizing agent is drawn through the standard hypodermic needle  50  or percutaneous adipose aspirating cannula  200 . The anesthetic agent is then applied locally at the site of cell harvesting. 
     The dual syringe  1 , with the attached transfer syringe  100  (with the transfer plunger  110  fully depressed) and the percutaneous cannula assembly  200 , is inserted into tissue or bone of a patient to harvest the desired cells. The beveled point  203  of the needle  201  along with the cannula  250  inserts percutaneously through patient&#39;s skin and advanced into the patient until the appropriate depth as indicated by the depth markings  260  on the cannula  250 . The tapered outlet  255  of the cannula  250  assists insertion into the patient&#39;s skin to reduce any catching or blunt trauma. 
     Once the desired depth is obtained, the cannula  250  is unmated from the needle hub assembly  210  which allows for the removal of the dual syringe  1  (with the needle hub assembly  210  still attached) from the cannula  250 . The needle hub assembly  210  is unmated from the harvesting syringe  10 . The harvesting syringe is then attached to the cannula  250  through mating the needle attachment  34  of the dual syringe  1  and ridge  256  of the cannula  250 . This establishes a fluid communication pathway from the tapered outlet  258  and ports  259 , through the tubular shaft  251 , through the cannula hub  252 , through the outlet  255 , through the inflow port  32 , and into the barrel  20  of the harvesting syringe  10 . 
     The cannula  250  may then be used as a standard aspirating cannula to harvest the desired cells. The user creates negative pressure within barrel  20  by pulling on the harvesting plunger  90  to draw in cells and tissues while simultaneously moving the cannula within the patient&#39;s body at the desired location. As the cannula  250  is moved back and forth while inside the patient, the ports  259  and tapered outlet  258  shear and collect cells/tissue which are then drawn into the cannula  250  and are ultimately drawn into the barrel  20 . 
     Once the desired volume of cells and/or tissues are harvested, the harvesting syringe  10  (with the cannula  250  still attached) is removed from the patient. 
     The cannula  250  is removed  270  from the harvesting syringe  10 . The shaft  92  is unscrewed from the plunger head  91  and removed from the harvesting syringe  10 . A standard syringe port cap is attached to the needle attachment  34  to seal inflow port  32 . The cap ensures sterility and prevents migration of the cell pellet into the inflow port  32 . 
     The dual syringe  1  is placed in a centrifuge and spun at approximately 500 to 2000 g forces for a period of 3 to 20 minutes. Centrifugation causes the aspirated cells to separate from the aspirated fluid. As a result of the funnel shape of the bottom wall  30 , the cells, denser than the fluid, form a pellet on the bottom wall  30  near the outflow port  31 . The valve  39  remains closed due to the positive pressure exerted from the outflow port  31  which prevents any of the contents of the barrel from migrating through pathway  38  and/or through the bottom port  77  of the spacer  70 . 
     The dual syringe  1  is removed from the centrifuge. The transfer plunger  110  is pulled away from the bottom end  105  which creates negative pressure within the interior cavity  108  of the transfer syringe  100 . This negative pressure opens the valve  39  to allow cells of the pellet to move through the outflow port  31 , through the pathway  38 , through the interior cavity  74  of the spacer  70 , through the top port  75 , through the port  107  of the transfer syringe and into the interior cavity  108  of the transfer syringe  100 . To adjust for the varying hydraulic pressure within the interior cavity  60  of the harvesting syringe  10 , if necessary, the harvesting plunger may be manually depressed, after reattachment of the shaft  92 , by the user in conjunction with user&#39;s pulling of the transfer plunger  110 . 
     Once the cell pellet is fully transferred to the transfer syringe  100 , the transfer syringe  100  is removed from the syringe locking mechanism  76  and a standard hypodermic needle is attached to the transfer syringe  100  at the needle attachment  109  as seen in  FIG. 14 . The gauge and design of the needle for the transfer syringe may depend on the type of tissue delivered, the tissue the needle needs to penetrate to deliver the cells and the volume of the cells to be delivered. Saline and/or other chemicals may be added to reconstitute the cell pellet in the transfer syringe  100 . 
     The transfer syringe  100  is then inserted into a patient in a specific location for delivery of the harvested cells for therapeutic purposes. 
     A person of ordinary skill in the art would appreciate the number, gauge, and design of the ports  259  may vary depending on the type of tissue harvested, the tissue the needle needs to penetrate to acquire the tissue, and the volume of the tissue needed. 
     The dual syringe may be used with a standard aspirating cannula as well with traditional access to the cells created through trocar use or surgical incision. Once the cells are harvested, the dual syringe is removed from the patient. The standard aspirating cannula is removed  270  from the harvesting syringe  10 . The shaft  92  is unscrewed from the plunger head  91  and removed from the harvesting syringe  10 . A standard syringe port cap is attached to the needle attachment  34  to seal inflow port  32 . The dual syringe  1  is placed in a centrifuge and spun at approximately 500 to 2000 g forces for a period of 3 to 20 minutes. Centrifugation causes the aspirated cells to separate from the aspirated fluid. As a result of the funnel shape of the bottom wall  30 , the cells, denser than the fluid, form a pellet on the bottom wall  30  near the outflow port  31 . The valve  39  remains closed due to the positive pressure exerted from the outflow port  31  which prevents any of the contents of the barrel from migrating through pathway  38  and/or through the bottom port  77  of the spacer  70 . The dual syringe  1  is removed from the centrifuge. The transfer plunger  110  is pulled away from the bottom end  105  which creates negative pressure within the interior cavity  108  of the transfer syringe  100 . This negative pressure opens the valve  39  to allow cells of the pellet to move through the outflow port  31 , through the pathway  38 , through the interior cavity  74  of the spacer  70 , through the top port  75 , through the port  107  of the transfer syringe and into the interior cavity  108  of the transfer syringe  100 . To adjust for the varying hydraulic pressure within the interior cavity  60  of the harvesting syringe  10 , if necessary, the harvesting plunger may be manually depressed, after reattachment of the shaft  92 , by the user in conjunction with user&#39;s pulling of the transfer plunger  110 . Once the cell pellet is fully transferred to the transfer syringe  100 , the transfer syringe  100  is removed from the syringe locking mechanism  76  and a standard hypodermic needle is attached to the transfer syringe  100  at the needle attachment  109  as seen in  FIG. 14 . The gauge and design of the needle for the transfer syringe may depend on the type of tissue delivered, the tissue the needle needs to penetrate to deliver the cells and the volume of the cells to be delivered. Saline and/or other chemicals may be added to reconstitute the cell pellet in the transfer syringe  100 . The transfer syringe  100  is then inserted into a patient in a specific location for delivery of the harvested cells for therapeutic purposes. 
     The above device may be used for autologous stem cell transplantation in an office setting as described in  FIG. 15 . A healthcare provider may utilize local anesthetic at the specific harvesting site or general anesthetic for the harvesting of stem cells. Stem cell harvesting may occur through adipose tissue in a patient&#39;s abdominal region, or through adipose tissue in another adipose-rich region such as the inner thigh or through a patient&#39;s bone marrow. The healthcare provider utilizes the sterile dual syringe and attaches the percutaneous cannula  200 . The healthcare provider inserts the dual syringe  1  with the percutaneous cannula  200  as described in  FIG. 15  into the patient&#39;s abdomen and aspirates 50 to 60 milliliters of adipose tissue into the harvesting syringe  10 . Centrifugation separates a cellular pellet rich in mesenchymal stem cells from the stromal vascular fraction. The mesenchymal stem cells are then transferred to the transfer syringe  100  as described in  FIG. 15 . The transfer syringe is removed from the harvesting syringe, a needle is attached as shown in  FIG. 11 , and then the mesenchymal stem cells are transplanted into the same patient for treatment of osteoarthritis, for assistance in wound healing, or for one or more of many other regenerative medicine uses. The procedure is accomplished in the same office visit for the patient. 
     In a preferred embodiment the harvesting syringe  10 , transfer syringe  100 , percutaneous cannula assembly  200 , syringe port cap, and hypodermic needle  50  are sterile and stored in a single use sterile packaging kit. The packaged unit is designed for singular use for a single patient for transplantation of autologous tissue.