Patent Publication Number: US-2022218401-A1

Title: Systems and methods for treating pyronies disease

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims benefit of priority to U.S. Provisional Patent Application No. 63/136,034 filed Jan. 11, 2021, the content of which is incorporated herein by reference in its entirety. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to medical devices and methods, and more particularly to cryotherapy devices for remodeling tissues to treat Peyronie&#39;s disease. Devices and methods of the invention are adapted for cryogenic cooling of targeted plaque in a male penis to selectively remodel such targeted tissue. 
     BACKGROUND OF THE INVENTION 
     Peyronie&#39;s disease is a condition resulting from fibrous scar penile tissue that causes curved, painful erections. Peyronie&#39;s disease causes a significant bend or pain in some men and can interfere or prevent maintaining an erection leading to erectile dysfunction. 
     Typically, Peyronie&#39;s disease does not go away on its own. In most men having Peyronie&#39;s disease, the condition remains or worsens. 
     SUMMARY OF THE INVENTION 
     The techniques described herein relate to methods for cryogenically treating Peyronie&#39;s disease, including providing a cryogenic device including at least one tissue-penetrating needle with a cooling tip; advancing the cooling tip into plaque in a subject&#39;s penile shaft; and cooling the plaque with the cooling tip thereby inducing a cooling injury to the plaque to achieve a therapeutic effect. 
     The techniques described herein can relate to a method wherein cooling the plaque with the cooling tip maintains the cooling tip at a targeted cooling temperature for at least 5 seconds. This targeted cooling temperature can be lower than −10 degrees Celsius and, in some variations, is between −10 and −80 degrees Celsius. 
     In additional variations, the techniques described herein relate to a method wherein cooling the plaque with the cooling tip includes maintaining the cooling tip in a stationary position in the plaque. In additional variations, the therapeutic treatment allows the plaque to be absorbed by a body of a patient. 
     The treatments described herein can result in reduced penile curvature. 
     Variations of the method can include imaging the plaque to provide a 3-dimensional map of the plaque. For example, such imaging can include the use of an ultrasound device. In additional aspects, the techniques and methods described herein relate to imaging during advancing the cooling tip. 
     In some aspects, the techniques described herein relate to a method further including a controller operatively coupled to the cryogenic device and the ultrasound device. Additional variations include methods wherein the controller is configured to modulate cooling the plaque in response to imaging signals from the ultrasound device. 
     In additional variations, the methods and techniques described herein include a controller that is configured to (i) record a 3-dimensional map of the plaque provided by the ultrasound device, (ii) monitor location of one or more cooling tips within the plaque with the ultrasound device; and (iii) actuate the cryogenic device to cool the plaque; and (iv) terminate cooling with the cryogenic device in response imaging with the ultrasound device. 
     Variations of the systems and methods can include a warming system with at least one warming needle with a warming tip and introducing a warming tip into tissue adjacent to the plaque. In some aspects, the methods can further include warming an adjacent tissue with the warming tip to thereby prevent a cooling injury to the adjacent tissue. 
     The warming can be performed prior to cooling the plaque, contemporaneous with cooling the plaque, and/or after cooling the plaque. 
     Additionally, the warming tip can be operatively coupled to the controller, and the controller is configured to modulate warming the adjacent tissue. In addition, or as an alternative, the method can include modulating warming of the adjacent tissue in response to signals from a temperature sensor carried by the warming tip. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a schematic elevational view of a cryogenic probe and system corresponding to the invention with a needle assembly detachably coupled to a handpiece component together with an optional controller component. 
         FIG. 2  is an enlarged cut-away schematic view of the cryogenic probe of  FIG. 1 , showing a cooling fluid injector tube in relation to the lumen in the needle. 
         FIG. 3  is an illustration of a variation of the cryogenic probe of  FIG. 1  with a needle assembly consisting of a plurality of tissue-penetrating needles. 
         FIG. 4  illustrates a penile shaft of a subject with Peyronie&#39;s disease wherein the needle of the probe of  FIG. 1  is shown after penetration into the plaque for providing cryogenic treatment together with ultrasound apparatus positioned to image the formation of an ice-ball in the plaque. 
         FIG. 5  is another view of a penile shaft with Peyronie&#39;s disease a probe with a plurality of cryogenic needles introduced into plaque in a penile shaft. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring now to  FIG. 1 , a cryogenic treatment system  100  for cryogenic treatment of tissue is shown, which comprises a cryogenic probe  105  with a proximal handle or handpiece  106  coupled to a tissue-penetrating cryogenic needle  110 . The handpiece  106  is adapted for gripping by human hand or can be configured for attachment to a robotic assembly as is known in the art. The cryogenic system optionally includes a controller  112  coupled to the probe  105  as will be described further below. 
     As shown in  FIG. 1 , a cryogenic cooling fluid assembly is carried within the handpiece  106 , which typically consists of a single-use cooling cartridge  115  with and valve mechanism  116  operatively coupled to an electrical power source  120  adapted to open and close the valve mechanism  116 . The electrical power source  120  further is coupled to a processor or subcontroller  125  for controlling flows of a cooling fluid  126  from the cartridge  115  to the tissue-penetrating needle  110 . In one variation, the subcontroller  125  may be carried on a single processor board in the handpiece  106  and is adapted to perform one or more selected programs. The subcontroller  125  can comprise a programmable microprocessor that carries computer code or programming instructions for a treatment cycle, wherein such a treatment cycle typically comprises an on/off interval which delivers the cooling fluid  126  at a predetermined flow rate for a predetermined time interval which then provides a treatment of a predetermined volume a tissue which comprises the creation of an ice-ball in the targeted tissue or plaque as will be described below. 
     The power source  120  and valve mechanism  116  are typically activated manually by a switch  128  in the handpiece  106  that triggers the controller  125  to control a treatment cycle. The power source  120  can comprise a rechargeable battery or single-use battery that actuates, for example, a solenoid-type of valve mechanism  116 . 
     Referring to  FIGS. 1 and 2 , in one variation, the cryogenic probe  105  carries a single hollow, tissue-penetrating needle  110  that may be detachably coupled to the handpiece  106  with coupling  132 . A cooling fluid path  140  is shown in  FIG. 1  that extends from cooling fluid source or cartridge  115  to the distal region  142  of the needle  110 . 
     In a variation, still referring to  FIGS. 1 and 2 , the needle  110  can consist of a 30-gauge hollow hypotube having a sharpened, closed-end distal tip  145 . The needle  110  can have any suitable axial length between the handpiece  106  and the distal tip  145  of the needle  110  ranging from 5 mm to 50 mm. Typically, the needle has a length from about 5 mm to about 20 mm although any length is possible. Such a needle  110  can be straight or have a curved distal portion. Such a needle  110  can comprise a stainless-steel material with an inner diameter of about 0.005″ and an outer diameter of about 0.010″ to 0.015″. Alternative probes can carry multiple needles having other outer diameters from about 0.006 inches to about 0.100 inches (see  FIG. 3 ). Typically, the needles will be a 16 gauge or smaller. 
     Referring to  FIG. 1 , in one variation, the exemplary cooling fluid supply or cartridge  115  contains a liquid cooling fluid  126  under high pressure, wherein the liquid preferably has a boiling temperature that is lower than body temperature (37° C.). Thus, when the cooling fluid  126  is delivered through the tissue-penetrating needle  110  when penetrated into targeted tissue, the heat from the targeted tissue will evaporate the liquid cooling fluid  126  within the needle  110 , resulting in cooling the target tissue typically with the formation of an ice-ball  150  in the targeted tissue or plaque  155  (see  FIG. 4 ). The valve  116  is provided within the handpiece  106  in the cooling fluid flow pathway  140  between the cartridge  115  and needle tip  145 . Typically, the subcontroller  125  is configured to limit the cooling fluid flow rate and cooling fluid volume in a treatment cycle, which in turn controls the rate of temperature change the targeted tissue, and thereby controls the dimensions of the ice-ball  150  that is formed in the targeted tissue or plaque  155  ( FIG. 4 ). The subcontroller  125  thus controls the pressure of the cooling fluid  126  delivered into the needle  110  and the temperature of the needle tip in contact the targeted tissue thus can be controlled. A mechanical pressure relief valve  156  also may be used to control the pressure within the lumen  158  of the needle  110  ( FIG. 2 ). 
     In  FIG. 1 , the cooling fluid  126  is carried in a single-use cartridge  115  with a metal cap or seal, and in one variation, the cartridge contains liquid N2O. Other cooling fluids also can be used, where exemplary cooling fluids include fluorocarbon refrigerants and/or carbon dioxide. The volume of cooling fluid  126  contained by cartridge  115  typically is adequate to treat plaque  155  in a Peyronie&#39;s disease patient in a single procedure. An exemplary liquid N2O cartridge can contain, for example, a cooling fluid volume in a range of 10 grams to 100 grams of a cooling liquid. 
     Referring now to  FIG. 2 , the flow of cryogenic cooling fluid  126  from the cartridge  115  is controlled by the valve  116 , which can comprise an electrically actuated solenoid valve or the like operating in response to control signals from the subcontroller  125  ( FIG. 1 ). A typical valve  116  can be adapted for on/off operation and may provide for venting of the cooling fluid path downstream from the valve  116  after the valve is closed, which can limit residual cryogenic fluid vaporization and cooling. 
     In  FIG. 2 , the cryogenic cooling fluid  126  is released via valve  116  to flow through an injection tube  165  that communicates with the cooling fluid path  140  in the handpiece  106 . The injection tube  165  is carried within the lumen  166  of the needle  110  and wherein the distal end  168  of the injection tube  165  extends close to the distal end  170  of the lumen  166  in the needle  110 . The injection tube  165  can comprise a metal or polymer material or a combination thereof. The injection tube  165  has an outer diameter that is less than the diameter of the lumen  166  in the needle  110  such that outflows of a cooling fluid  126  (at least partly comprising a gas in the outflow) will be accommodated in the annular space  172  between the injection tube  165  and the wall of the needle  110 . As an example, the injection tube  165  can have an inner lumen diameter ranging between 10 μm and 100 μm. An outer diameter of the injection tube  165  will typically be less than about 1000 and often being less than about 500 μm. 
     Referring now to  FIGS. 2 and 3 , it can be understood that the cooling fluid  126  is injected into lumen  166  of needle  110  and as the liquid cooling fluid vaporizes within the needle  110 , such vaporization will cool and freeze the tissue or plaque  155  in contact with the needle  110 . 
     Referring now to  FIG. 3 , an alternative embodiment of a cryogenic system  100 ′ and cryogenic probe  105 ′ is shown that is similar to that of  FIG. 1  except that the fluid path  140 ′ from the cooling fluid cartridge  115  communicates with a plurality of needles and in this variation consist of two spaced-apart tissue-penetrating needles  175   a  and  175   b . It should be appreciated that the number of such needles can range from 1 to 6 and operate as described above. In all other respects, the variation of  FIG. 3  operates as described previously. 
     Referring back to  FIGS. 1 and 2 , the cartridge  115  can be initially inserted into the handpiece  106  and be adapted for use by piecing a metal cap of the cartridge  115  as is known in the art. Further, one or more filters (not shown) can be provided in the fluid path  140 . 
     It should also be appreciated that the proximal portion  176  of the needle  110  ( FIG. 1 ) can be supported and surrounded by an insulator member  177  adapted to limit heat transfer from the proximal portion  176  of the needle  110  to the environment. In other variation, the needle or needles can have flat or oval cross-sectional shapes which can be desirable for creating suitable ice-balls in tissue. 
     Referring now to  FIG. 4 , a method of treating Peyronie&#39;s disease is shown using the probe  105  of  FIG. 1  where the objective is to cryogenically treat plaque  155  in a penile shaft  182  of the patient. In one method variation, the needle  110  is penetrated into the plaque  155  in an orientation that is generally perpendicular to the axis  185  of the penile shaft  182 . In this variation, first and second ultrasound transducers  188 A and  188 B (also shown in  FIG. 1 ) are positioned approximately 90° apart from another to provide for bi-planar views of the plaque  155  to optimally position the needle  110  in the plaque  155 . 
     The ultrasound transducers  188 A and  188 B are subsequently used for observing the formation of the ice ball  150  in the plaque  155 . During such a procedure, the physician would penetrate the needle  110  into the plaque  155  sequentially in multiple locations under ultrasonic monitoring and actuate the subcontroller  125  ( FIG. 1 ) to deliver a predetermined cooling dose, which would be selected based on evaluation of the dimensions of the plaque prior to insertion of the needle  110 . Following treatment, the patient would optionally tension the penile shaft  182  in a straightened position with traction devices that are known in the art. Within about two to six weeks following the procedure, the patient&#39;s immune system would absorb or resorb the treated plaque  155  and would reduce the volume of the plaque  155  in the range of 70% to 90%. With a reduction in the volume of the plaque  155 , the penile shaft  182  would be straightened. The use of traction on the penile shaft  182  can be used for any suitable time interval post-treatment, for example, one to two weeks. 
       FIG. 5  illustrates another method of the invention for treating Peyronie&#39;s disease wherein the probe  100 ′ has two needles  190   a  and  190   b  that are similar to the variation of  FIG. 3 . In the method shown in  FIG. 5 , it can be seen that the two needles  190   a  and  190   b  can be introduced from a lateral side of the plaque  155  rather than directly into the plaque from a superior position as shown in  FIG. 4 . In this case, dual ultrasound transducers  188 A and  188 B again can be positioned such that the needles  190   a  and  190   b  can be inserted into the plaque  155  prior to performing a treatment cycle. In this case, the dual needles  190   a  and  190   b  are adapted to create a more planar ice-ball  150 ′ for ablating the plaque  155 , which typically may form as a somewhat flat layer in the penile shaft  182 . 
     In general, a method corresponding to the invention for cryogenically treating Peyronie&#39;s disease comprises providing a cryogenic device including at least one tissue-penetrating needle with a cooling tip, advancing the cooling tip into plaque in a subject&#39;s penile shaft, and cooling the plaque with the cooling tip thereby inducing a cooling injury to the plaque to achieve a therapeutic effect. Typically, the cooling step of the method maintains the cooling tip at a targeted cooling temperature for at least 5 seconds. The targeted cooling temperature is lower than −10 degrees Celsius and typically the temperature is between −10 degrees Celsius and −80 degrees Celsius. 
     In one variation, the cooling step of the method includes maintaining the cooling tip  145  in a stationary position in the plaque. Alternatively, the cooling step includes moving the cooling tip  145  in the plaque  155 . Following the cooling step, the therapeutic result is achieved wherein the plaque is absorbed or resorbed by the patient&#39;s body and can reduce penile curvature. 
     In a variation, the method can include imaging the plaque to provide a 3-dimensional map of the plaque, typically with one or more ultrasound devices or transducers such as ultrasound transducers  188 A and  188 B shown in  FIGS. 4 and 5 . Such an imaging step can be used as the needle(s) and cooling tip  145  are advanced into the plaque  155  and during the cooling step to observe formation of the ice-ball  150  in the plaque  155 . 
     In another variation of a treatment system and method, the system controller  112  is operatively coupled to the cryogenic probe  105  and the ultrasound devices or transducers  188 A and  188 B. In this variation, the system controller  112  is configured to modulate the cooling step in response to imaging signals from the ultrasound transducers  188 A and  188 B. Typically, the system controller  112  is configured to (i) record a 3-dimensional map of the plaque provided by the ultrasound system, (ii) monitor a location of one or more cooling tips within the plaque with the ultrasound system, (iii) actuate the cryogenic device to cool the plaque, and (iv) terminate cooling with the cryogenic device in response imaging with the ultrasound system. 
     In another variation, the treatment method further comprises the use of a tissue-warming system  200  with at least one warming needle  210  with a warming tip  215 , wherein the warming tip  215  is introduced into tissue adjacent the plaque  155  to thereby prevent a cooling injury or freezing of such adjacent tissue. Such a method of warming tissue can be performed (i) prior to the step of cooling the plaque, (ii) contemporaneous with the step of cooling the plaque, and/or (iii) after the step of cooling the plaque. Such a warming system can be operatively coupled to the system controller  112  and such a controller can be configured to modulate the warming step. In one variation, the warming step is modulated in response to signals from a temperature sensor  218  carried by the warming tip  215  of the at least one warming needle  210 .