Patent Publication Number: US-2022233334-A1

Title: Hydraulic implant introducer

Description:
FIELD OF DISCLOSURE 
     The present disclosure relates generally to orthopedic implants, and more specifically, to an instrumentation and system for introducing a hydrogel implant into an implant site. 
     BACKGROUND 
     Hydrogel implants can be used to replace deteriorated or otherwise damaged cartilage within a joint. Such implants can be used to treat osteoarthritis, rheumatoid arthritis, other inflammatory diseases, generalized joint pain, and joint damages. 
     Particularly, hydrogel implants are useful in replacing deteriorated or damaged portions of cartilage within a joint with more specificity in terms of ability to repair areas of varying sizes. Advantageously, hydrogel implants having a body consisting essentially of hydrogel material that can be compressed and inserted into a receiving hole or a recess prepared in a bone being repaired results in the hydrogel implants with good stability and longevity. 
     A variety of types of introducer devices may be used to introduce or implant such hydrogel implants into the receiving hole in the bone. These introducer devices operate by squeezing a hydrogel implant into and through a tube-like body while holding the discharge end of the introducer device in a receiving hole or a recess in a bone until the hydrogel implant is pushed out into the recess in the bone. However, this operation exerts some amount of force on the bone as the operator pushes out the hydrogel implant through the introducer device. In situations where the repair site is located in a joint associated with relatively small bones, such as the joints in a hand (e.g. the joints between carpal bones and metacarpal bones, the joints between metacarpal bones and phalanges bones, or the joints between different phalangeal bones), the force transmitted to the bone via the operation of the introducer device can be too much to safely complete the procedure. Therefore, an improved introducer device for implanting a hydrogel implant is desired. 
     SUMMARY 
     Disclosed herein is a hydraulic implant delivery system according to an embodiment. The implant delivery system comprises, a main body extending from a first end to a second end and a channel defined therein for delivering a supply of saline solution therethrough, a nozzle removably attached to the second end of the main body, and a syringe for holding and delivering a supply of saline solution to the main body. In this embodiment, the nozzle extends away from the second end of the main body and terminates with a neck portion. The nozzle comprises a lumen extending therethrough and in fluid communication with the main body&#39;s channel. The nozzle further comprising a hydrogel implant in a compressed state pre-loaded and positioned in the lumen and the lumen forms a dispensing opening at the neck portion for dispensing the pre-loaded hydrogel implant and a nozzle input opening at the end opposite from the dispensing opening. The hydrogel implant has a leading end, a trailing end, and an exterior sidewall extending between the leading end and a trailing end. The lumen of the nozzle has a generally frusto-conical shape, whereby the dispensing opening has a smaller diameter than the nozzle input opening. The dispensing opening has a smaller diameter than the leading end of the hydrogel implant, whereby in the compressed state inside the lumen, the hydrogel implant has the same diameter as the lumen. The syringe is connected to the first end of the main body and in fluid communication with the cavity of the main body. 
     A hydraulic implant delivery system according to another embodiment is also disclosed. The implant delivery system comprises a main body extending from a first end to a second end and a channel defined therein for delivering a supply of saline solution therethrough, a nozzle removably attached to the second end of the main body, and a syringe for holding and delivering a supply of saline solution to the main body. In this embodiment, the nozzle extends away from the second end of the main body and terminates with a neck portion and the nozzle comprises a lumen extending therethrough and in fluid communication with the main body&#39;s channel. The lumen forms a dispensing opening at the neck portion, for dispensing a hydrogel implant that is positioned in the lumen, and a nozzle input opening at the end opposite from the dispensing opening. The lumen of the nozzle has a generally frusto-conical shape, whereby the dispensing opening has a smaller diameter than the nozzle input opening. The syringe is connected to the first end of the main body and in fluid communication with the cavity of the main body. 
     The hydraulic implant delivery system of the present disclosure provides an improved way to deliver hydrogel implants into a joint repair site compared to the existing implant delivery devices. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The inventive hydraulic implant delivery system of the present disclosure will be described in more detail in conjunction with the following drawing figures. The structures in the drawing figures are illustrated schematically and are not intended to show actual dimensions. 
         FIG. 1  is an exploded view illustration of an embodiment of the hydraulic implant delivery system according to the present disclosure. 
         FIG. 2  is a detailed view illustration of the main body of the hydraulic implant delivery system of  FIG. 1 . 
         FIG. 3  is a cross-section view illustration of the main body shown in  FIG. 2  taken through the section line A-A shown in  FIG. 2 . 
         FIG. 4  is an exploded view illustration of another embodiment of the hydraulic implant delivery system according to the present disclosure. 
         FIGS. 5 and 6  are detailed view illustration of the main body and the handle piece of the hydraulic implant delivery system of  FIG. 4 . 
         FIG. 7  is a cross-section view illustration of the structure shown in  FIG. 5  taken through the section line B-B shown in  FIG. 6 . 
         FIG. 8  is a perspective view of an example of a nozzle portion of the hydraulic implant delivery system. 
         FIG. 9A  is an illustration showing the orientation of a hydrogel implant being loaded into the nozzle portion of the hydraulic implant delivery system. 
         FIGS. 9B and 9C  are illustrations showing the shapes of different examples of the hydrogel implant. 
         FIG. 10  is a longitudinal cross-section view illustration of the exemplary nozzle portion of the hydraulic implant delivery system shown in  FIGS. 8 and 9 . 
         FIG. 11  is the longitudinal cross-section view of the nozzle in  FIG. 10  that is pre-loaded with a hydrogel implant. 
     
    
    
     DETAILED DESCRIPTION 
     This description of the exemplary embodiments is intended to be read in connection with the accompanying drawings, which are to be considered part of the entire written description. The drawing figures are not necessarily to scale and certain features may be shown exaggerated in scale or in somewhat schematic form in the interest of clarity and conciseness. In the description, relative terms such as “horizontal,” “vertical,” “up,” “down,” “top” and “bottom” as well as derivatives thereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should be construed to refer to the orientation as then described or as shown in the drawing figure under discussion. These relative terms are for convenience of description and normally are not intended to require a particular orientation. Terms including “inwardly” versus “outwardly,” “longitudinal” versus “lateral” and the like are to be interpreted relative to one another or relative to an axis of elongation, or an axis or center of rotation, as appropriate. Terms concerning attachments, coupling and the like, such as “connected” and “interconnected,” refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise. When only a single machine is illustrated, the term “machine” shall also be taken to include any collection of machines that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methodologies discussed herein. The term “operatively connected” is such an attachment, coupling or connection that allows the pertinent structures to operate as intended by virtue of that relationship. In the claims, means-plus-function clauses, if used, are intended to cover the structures described, suggested, or rendered obvious by the written description or drawings for performing the recited function, including not only structural equivalents but also equivalent structures. 
     Referring to  FIGS. 1-3 , an implant delivery system  100  according to an embodiment of the present disclosure is disclosed. The implant delivery system  100  comprises a main body  120  having a first end  121  and a second end  122 . At the first end  121 , a nozzle  110  pre-loaded with a hydrogel implant  500  (see  FIG. 11 ) is removably connected to the main body  120 . The first end  121  of the main body  120  is connected to a syringe  140  via a flexible tubing  130 . The syringe  140  comprises a syringe body  142  and a plunger  144 . The flexible tubing  130  provides a connection providing fluid communication between the syringe  140  and the main body  120  and to the nozzle  110  when the nozzle  110  is connected to the main body  120 . The fluid communication allows the system to be filled with a fluid, preferably saline solution, for delivering hydraulic pressure to the hydrogel implant  500  pre-loaded in the nozzle  110  for pushing the hydrogel implant  500  out of the nozzle and into the intended joint repair site. 
     The main body  120  extends from a first end  121  to a second end  122 . The main body  120  has a channel  127  defined therein extending through the main body&#39;s full length for delivering a supply of the saline solution therethrough. The nozzle  110  is removably attached to the second end  122  of the main body  120 . As shown in  FIGS. 1 and 3 , the nozzle  110  is configured with a male threaded portion  111  and the main body  120  is configured with a female threaded opening  129  at its second end  122  for receiving the nozzle&#39;s threaded portion  111  for removably connecting to the nozzle  110 . 
     The nozzle  110  extends away from the second end  122  of the main body  120  and terminates with a neck portion  119 . 
     Referring to  FIGS. 8-11 , the nozzle  110  comprises a lumen  116  extending therethrough and in fluid communication with the main body&#39;s channel  127 . The nozzle  110  further comprises a hydrogel implant  500  that is pre-loaded and positioned in the lumen  116 . The pre-loaded configuration is shown in the cross-sectional view in  FIG. 11 . 
     The lumen  116  extends through the full length of the nozzle  110  and forms a nozzle input opening  112  at one end through which the hydrogel implant  500  is inserted into its pre-loaded position. The lumen  116  also forms a dispensing opening  118  at the neck portion  119 , which is at the end opposite from the nozzle input opening  112 , for dispensing the pre-loaded hydrogel implant  500 . 
     The hydrogel implant  500  used in the implant delivery system disclosed herein has a leading end  510 , a trailing end  520 , and an exterior sidewall  530  extending between the leading end and a trailing end.  FIGS. 9B and 9C  show exemplary embodiments  500 A,  500 B of the hydrogel implant in their uncompressed at-rest state before they are inserted into the nozzle  110 .  FIG. 9B  shows a hydrogel implant embodiment  500 A that has a cylindrical shape with the leading end  510  and the trailing end  520  having the same diameter.  FIG. 9C  shows a hydrogel implant embodiment  500 B that has a generally frusto-conical shape with the leading end  510  having a larger diameter than the trailing end  520 . 
     The lumen  116  of the nozzle  110  generally comprises three main sections: the nozzle input opening  112  section formed by a first straight sidewall section  112 A; the dispensing opening  118  section formed by a second straight sidewall section  118 A; and a frusto-conical shaped middle portion formed by a frusto-conical shaped sidewall section  116 A connecting the first straight sidewall section  112 A and the second straight sidewall section  118 A. The first straight sidewall section  112 A has a diameter d 1 , and the second straight sidewall section  118 A has a diameter d 2 , where d 1  is larger than d 2 . The frusto-conical shaped middle portion formed by the sidewall section  116 A has a generally frusto-conical shape so that the end that is connected to the first straight sidewall section  112 A has the same diameter d 1  as the first straight sidewall section. The end that is connected to the second straight sidewall section  118 A has the same diameter d 2  as the second straight sidewall section  118 A, whereby the input opening  112  is larger than the dispensing opening  118 . 
     The nozzle input opening  112  has a substantially the same diameter as the leading end  510  of the hydrogel implant  500  allowing the hydrogel implant  500  to be inserted into the nozzle input opening  112 . When the hydrogel implant  500  is fully inserted into the nozzle  110  into its pre-loaded position shown in  FIG. 11 , the leading end  510  of the hydrogel implant extends into the frusto-conical shaped middle portion of the lumen  116  and the leading end  510  is in a compressed state. This height of the compressed portion of the hydrogel implant  500  is identified in  FIG. 11  as portion C. The full height (or length depending on one&#39;s perspective) of the hydrogel implant  500  is identified in  FIG. 11  as portion H. In order to accommodate cartilage repairs that require a range of different sizes of hydrogel implants, the hydrogel implant  500  can be provided in a variety of sizes in terms of its diameter and height and the nozzle  110  can be provided in a variety of sizes where the dimensions of the lumen  116  are different in each nozzle types to match the different size hydrogel implants. 
     For a given hydrogel material for the hydrogel implant, it becomes progressively more difficult to radially compress the implant as the size of the implant becomes smaller. In some embodiments, the hydrogel implants can be provided in 5.0 mm diameter, 6.0 mm diameter, 8.0 mm diameter, and 10.0 mm diameter. Therefore, the taper angle θ of the sidewall section  116 A of the lumen  116  can be varied in order to accommodate the varying degrees of compressibility among the different sizes of the hydrogel implants  500 . The taper angle θ of the sidewall section  116 A can vary from about 3.98° for the 5.0 mm diameter implant to 5.71° for the 10.0 mm diameter implant. The taper angle θ of the sidewall section  116 A is identified in the cross-sectional view in  FIG. 12 . 
     Additionally, the ratio of the height of the compressed portion C to the full height H of the hydrogel implant, C/H, can be adjusted along with the size of the hydrogel implant in order to account for the varying degree of compressibility mentioned above. The ratio C/H can vary from about 0.2 for the 5.0 mm diameter implant to 0.4 for the 10.4 mm diameter implant. 
     In the compressed state, the leading end  510  of the hydrogel implant is radially compressed and forms an intimate contact with the interior surface of the lumen  116 . The quality of this intimate contact is liquid tight and prevents any liquid such as the saline solution used in the implant delivery system from passing between the hydrogel implant  500  and the interior surface of the lumen  116 . 
     The implant delivery system  100  further comprises a syringe  140  for holding and delivering a supply of saline solution to the main body  120  and the nozzle  110  for dispensing the pre-loaded hydrogel implant  500 . The syringe  140  is connected to the first end  121  of the main body  120  and is in fluid communication with the cavity  127  of the main body  120 . 
     According to the disclosed embodiment, a flexible tubing  130  connects the syringe  140  to the first end  121  of the main body  120 . In some embodiments, the flexible tubing  130  is removably connected to the syringe  140  and the first end  121  of the main body  120 . The removable connections can be made by the use of Luer lock structures found in medical syringe structures. For example, the flexible tubing  130  can be configured with a female Luer lock connector  134  at the end that connects to the syringe  140  and the syringe  140  would be configured accordingly with a male Luer lock connector structure to connect to the female Luer lock connector  134 . The other end of the flexible tubing  130  can be configured with a male Luer lock connector  132  and he first end  121  of the main body  120  can be configured with a corresponding female Luer lock connector  125  to connect to the flexible tubing  130 . 
     The flexible tubing  130  can be any suitable tubing such as polymer tubing used in medical applications sufficient to withstand the static pressure generated by the saline solution while the hydrogel implant  500  is being pushed through the nozzle  110  during the implant delivery operation. 
     Referring to  FIGS. 4-7 , another embodiment of the implant delivery system  200  is disclosed. In this embodiment  200 , the main body  220  which has the same structures as the main body  120  in the first embodiment  100 , comprises a handle piece  228  extending from the main body  220  at an angle for allowing a user to hold the handle piece  228  and manipulate the neck portion  119  of the nozzle  110  into a desired location for dispensing the hydrogel implant  500 . The desired location would be bone in a joint that has been prepared with a recess for receiving the hydrogel implant  500 . 
     As shown in  FIG. 4 , the main body  220  in this embodiment comprises a first end  221  and a second end  222  and is configured with a female Luer lock connector  225  at its first end  221  for removably connecting to the male Luer lock connector  132  of the flexible tubing  130 .  FIG. 5  shows a perspective view of the handle piece  228  and the main body  220  from the second end  222  side.  FIG. 6  is another view of the main body  220  and the handle piece  228  from an angle looking directly into the second end  222  and the channel  227 .  FIG. 7  is a cross-sectional view of the main body  220  and the handle piece  228  taken through the section line B-B in  FIG. 6 . The channel  227  can be seen extending through the main body  220 . The first end  221  of the main body  220  is configured with the female Luer lock connector  225 . The second end  222  of the main body  220  is configured with a female threaded opening  229  for threadably connecting to the nozzle  110 . 
     The implant delivery system  100 ,  200  can be pre-filled with saline solution and packaged in a sterile packaging to be provided to a surgeon in an operating room. The syringe  140 , the flexible tubing  130 , and the main body  120 ,  220  would be connected and filled with saline solution so that the surgeon just has to attach a pre-loaded nozzle  110  to the main body  120 ,  220  to deliver a hydrogel implant to a cartilage repair surgery site. A plurality of pre-loaded nozzles can be provided, each pre-loaded with a different size hydrogel implant. The surgeon just has to select a nozzle holding an implant of the desired size, attach the nozzle to the main body  110 ,  220 , and operate the hydraulic implant delivery system to deliver the hydrogel implant to the cartilage repair site. The pre-loaded nozzles can be individually packaged in sterile packages or packaged in groups of desired implant sizes. 
     After the pre-loaded nozzle  110  is attached to the main body  120 ,  220 , the neck portion  119  of the nozzle  110  is positioned in a previously prepared recess in a bone for receiving the hydrogel implant  500 . Then, while the user is holding the main body  120 ,  220  in position, the plunger  144  is pressed into the syringe body  142  with sufficient force to generate enough hydraulic pressure within the implant delivery system  100 ,  200  for the saline solution to push the pre-loaded implant  500  through the lumen  116  of the nozzle  110  and out through the dispensing opening  118  and into the recess in the bone. Because the tapered portion of the lumen  116  and the dispensing opening  118  have smaller diameter than the hydrogel implant  500 , the hydrogel implant  500  gets compressed throughout its travel through the lumen and remains in a radially-compressed state until it exits the nozzle  110  and into the recess in the bone. The recess in the bone has been prepared to have a diameter that is appropriately sized (slightly smaller than the initial diameter of the hydrogel implant) so that when the hydrogel implant  500  decompresses and tries to return to its initial diameter, a snug interference fit is created between the hydrogel implant  500  and the recess in the bone. This holds the hydrogel securely in its place. 
     In other examples, the hydraulic implant delivery system  100 ,  200  can be packaged and provided without being filled with saline solution. The surgeon would need to fill the syringe  140  with saline solution in the operating room to use the implant delivery system. 
     Although the devices, kits, systems, and methods have been described in terms of exemplary embodiments, they are not limited thereto. Rather, the appended claims should be construed broadly, to include other variants and embodiments of the devices, kits, systems, and methods, which may be made by those skilled in the art without departing from the scope and range of equivalents of the devices, kits, systems, and methods.