CRYOTHERAPY DEVICE WITH CRYOPROTECTION AND METHODS FOR PERFORMING CRYOTHERAPY WITH CRYOPROTECTION

Abstract

A method for preventing damage to adjacent tissue at a surgical site includes locating the tissue to be protected, placing a cryoprotective device at the tissue to be protected, injecting a cryoprotective substance (CPS) through the cryoprotective device at the tissue, at least one of positioning a temperature sensor at the CPS and positioning a temperature sensor at the tissue, monitoring a temperature of at least one of the CPS and the tissue with the temperature sensor, and carrying out cryotherapy at the surgical site without harm to the tissue.

Claims

1. A method for preventing damage to adjacent tissue at a surgical site, which comprises: locating the tissue to be protected: placing a cryoprotective device at least one of at and adjacent the tissue to be protected; injecting a cryoprotective substance (CPS) through the cryoprotective device at least one of at and adjacent the tissue; at least one of: positioning a temperature sensor at least one of at and adjacent the CPS; and positioning a temperature sensor at least one of at and adjacent the tissue; monitoring a temperature of at least one of the CPS and the tissue with the temperature sensor; and carrying out cryotherapy at the surgical site without harm to the tissue.

2. The method according to claim 1, wherein the CPS comprises a rapid transition polymer.

3. The method according to claim 1, wherein the CPS comprises an anesthetic.

4. The method according to claim 1, wherein the CPS comprises dehydrated cells.

5. The method according to claim 4, wherein the dehydrated cells comprise dehydrated amniotic tissue allograft membranes.

6. The method according to claim 1, which further comprises repeating the locating, placing, injecting, positioning and monitoring steps for each area of different tissues to be protected.

7. The method according to claim 1, which further comprises injecting further CPS through the cryoprotective device if a preset temperature limit is exceeded.

8. A method for preventing damage to adjacent tissue at a surgical site, which comprises: locating the tissue to be protected; placing a cryoprotective device adjacent the tissue to be protected; injecting a cryoprotective substance (CPS) through the cryoprotective device adjacent the tissue; at least one of: positioning a temperature sensor adjacent the CPS; and positioning a temperature sensor adjacent the tissue; monitoring a temperature of at least one of the CPS and the tissue with the temperature sensor; and carrying out cryotherapy at the surgical site without harm to the tissue.

9. The method according to claim 8, wherein the CPS comprises a rapid transition polymer.

10. The method according to claim 8, wherein the CPS comprises an anesthetic.

11. The method according to claim 8, wherein the CPS comprises dehydrated cells.

12. The method according to claim 11, wherein the dehydrated cells comprise dehydrated amniotic tissue allograft membranes.

13. The method according to claim 8, which further comprises repeating the locating, placing, injecting, positioning and monitoring steps for each area of different tissues to be protected.

14. The method according to claim 8, which further comprises injecting further CPS through the cryoprotective device if a preset temperature limit is exceeded.

15. A method for preventing damage to adjacent tissue at a surgical site, which comprises: locating the tissue to be protected; placing a cryoprotective device at the tissue to be protected; injecting a cryoprotective substance (CPS) through the cryoprotective device at the tissue; at least one of: positioning a temperature sensor at the CPS; and positioning a temperature sensor at the tissue; monitoring a temperature of at least one of the CPS and the tissue with the temperature sensor; and carrying out cryotherapy at the surgical site without harm to the tissue.

16. The method according to claim 15, wherein the CPS comprises a rapid transition polymer.

17. The method according to claim 15, wherein the CPS comprises an anesthetic.

18. The method according to claim 15, wherein the CPS comprises dehydrated cells.

19. The method according to claim 18, wherein the dehydrated cells comprise dehydrated amniotic tissue allograft membranes.

20. The method according to claim 15, which further comprises repeating the locating, placing, injecting, positioning and monitoring steps for each area of different tissues to be protected.

21. The method according to claim 15, which further comprises injecting further CPS through the cryoprotective device if a preset temperature limit is exceeded.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0056] The accompanying figures, where like reference numerals refer to identical or functionally similar elements throughout the separate views, which are not true to scale, and which, together with the detailed description below, are incorporated in and form part of the specification, serve to illustrate further various embodiments and to explain various principles and advantages all in accordance with the present invention. Advantages of embodiments of the present invention will be apparent from the following detailed description of the exemplary embodiments thereof, which description should be considered in conjunction with the accompanying drawings in which:

[0057] FIG. 1 is a photograph of a fragmentary, perspective view of a prior art cryotherapy needle template and cryotherapy needles from above a front side thereof;

[0058] FIG. 2 is a photograph of a fragmentary, perspective view of a prior art ultrasonic probe from above a top side thereof;

[0059] FIG. 3 is a photograph of a fragmentary, perspective view of the ultrasonic probe of FIG. 1 from above a right side thereof;

[0060] FIG. 4 is a photograph of a fragmentary, perspective view of the ultrasonic probe of FIG. 1 and a probe attachment from below a right side thereof;

[0061] FIG. 5 is a photograph of a fragmentary, perspective view of the attachment and probe of FIG. 4 in an attached configuration from above a distal end thereof;

[0062] FIG. 6 is a photograph of a fragmentary, perspective view of the attachment and ultrasonic probe of FIG. 5 from above a proximal end thereof:

[0063] FIG. 7 is a photograph of a fragmentary, perspective view of the attachment and ultrasonic probe of FIG. 5 from above a proximal end thereof with a needle catheter inserted through a guide of the attachment;

[0064] FIG. 8 is a photograph of a fragmentary, perspective view of the attachment and probe of FIG. 7 from above a right side thereof;

[0065] FIG. 9 is a photograph of a fragmentary, perspective view of the attachment and probe of FIG. 8 with a cryotherapy needle inserted into the needle catheter from above a left side thereof;

[0066] FIG. 10 is a photograph of a fragmentary, perspective view of a cryotherapy pretreatment device in accordance with an exemplary embodiment;

[0067] FIG. 11 is a sagittal, cross-sectional view through a cryotherapy treatment area of a prostate and with the probe of FIG. 2 inserted in the anus for ultrasonic visualization of the treatment area;

[0068] FIG. 12 is a transverse, cross-sectional view through the cryotherapy treatment area of FIG. 11; and

[0069] FIG. 13 is a block diagram of a method for protecting nerves during a cryotherapy procedure.

DETAILED DESCRIPTION OF THE INVENTION

[0070] As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which can be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure. Further, the terms and phrases used herein are not intended to be limiting; but rather, to provide an understandable description of the invention. While the specification concludes with claims defining the features of the invention that are regarded as novel, it is believed that the invention will be better understood from a consideration of the following description in conjunction with the drawing figures, in which like reference numerals are carried forward.

[0071] Alternate embodiments may be devised without departing from the spirit or the scope of the invention. Additionally, well-known elements of exemplary embodiments of the invention will not be described in detail or will be omitted so as not to obscure the relevant details of the invention.

[0072] Before the present invention is disclosed and described, it is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. The terms a or an, as used herein, are defined as one or more than one. The term plurality, as used herein, is defined as two or more than two. The term another, as used herein, is defined as at least a second or more. The terms including and/or having, as used herein, are defined as comprising (i.e., open language). The term coupled, as used herein, is defined as connected, although not necessarily directly, and not necessarily mechanically.

[0073] Relational terms such as first and second, top and bottom, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. The terms comprises, comprising, or any other variation thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by comprises . . . a does not, without more constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises the element.

[0074] As used herein, the term about or approximately applies to all numeric values, whether or not explicitly indicated. These terms generally refer to a range of numbers that one of skill in the art would consider equivalent to the recited values (i.e., having the same function or result). In many instances these terms may include numbers that are rounded to the nearest significant figure.

[0075] It will be appreciated that embodiments of the systems and methods described herein may be comprised of one or more conventional processors and unique stored program instructions that control the one or more processors to implement, in conjunction with certain non-processor circuits and other elements, some, most, or all of the functions of the powered injector devices described herein. The non-processor circuits may include, but are not limited to, signal drivers, clock circuits, power source circuits, and user input and output elements. Alternatively, some or all functions could be implemented by a state machine that has no stored program instructions, or in one or more application specific integrated circuits (ASICs) or field-programmable gate arrays (FPGA), in which each function or some combinations of certain of the functions are implemented as custom logic. Of course, a combination of these approaches could also be used. Thus, methods and means for these functions have been described herein.

[0076] The terms program, software, software application, and the like as used herein, are defined as a sequence of instructions designed for execution on a computer system. A program, software, application, computer program, or software application may include a subroutine, a function, a procedure, an object method, an object implementation, an executable application, an applet, a servlet, a source code, an object code, a shared library/dynamic load library and/or other sequence of instructions designed for execution on a computer system.

[0077] Herein various embodiments of the present invention are described. In many of the different embodiments, features are similar. Therefore, to avoid redundancy, repetitive description of these similar features may not be made in some circumstances. It shall be understood, however, that description of a first-appearing feature applies to the later described similar feature and each respective description, therefore, is to be incorporated therein without such repetition.

[0078] Described now are exemplary embodiments of the present invention. Referring now to the figures of the drawings in detail and first, particularly to FIG. 10, there is provided a cryotherapy pretreatment device 1005. Like FIG. 9. FIG. 10 shows the ultrasonic probe 200, the attachment 400, and the cryotherapy catheter 705. In contrast to the cryotherapy injection needle 905, however, is the presence of the cryotherapy pretreatment device 1005, which is inserted through the catheter 705 before cryotherapy begins. It is noted that, the probe 200 and attachment 400 is only one exemplary use of the cryoprotective systems and methods described herein and these systems and methods can uses any ultrasonic visualization device and associated cryotherapy aligning device (such as the template 100), and, in addition, provide the cryotherapy pretreatment device 1005.

[0079] The cryotherapy pretreatment device 1005 includes a proximal connector 1010 and a hollow needle shaft 1015 that terminates in a distal tip 1020. In use, the needle shaft 1015 is inserted into a proximal end of the catheter 705 through the connector 710 and, thereby, through the channel 610 of the attachment 400. In this way, when the channel 610 is aligned with the surgical site, the needle shaft 1015 can be pushed through the catheter 705 and into the patient for administering the cryotherapy pretreatment.

[0080] In particular regard to administering cryotherapy to a prostate, the distal end 225 of the probe 200 is placed through the anus and adjacent the prostate as shown in FIG. 11. With use of the probe 200 (e.g., with doppler ultrasound), the neuro-vascular bundle and/or the nerves of the prostatic plexus adjacent the prostate are located; these structures are close to or adjacent the seminal vesicle. In particular, the bundle 1200 including the arteries 1205, the veins 1206, and the nerves 1207 are shown in FIG. 12 on both the left and right sides of the prostate.

[0081] The distal tip 1020 of the cryotherapy pretreatment device 1005 is guided trans-rectally alongside the nerves (bilaterally) up to and adjacent the prostatic plexus with an obturator therein to protect the CPS injection channel. When placed adjacent the prostatic plexus as shown in FIG. 11, the obturator is removed and the CPS 1105 is injected through the proximal connector 1010 under visualization through the cryotherapy pretreatment device 1005 to form a liquid space surrounding the entirety of the prostatic plexus or at least the side of the prostatic plexus facing the prostate. Ideally, both the left and right sides are injected with the CPS 1105 at the locations shown in FIG. 12 and identified with numeral 1210. As the CPS 1105 fills up the space at locations 1210, the bundle 1200 is both moved away from the prostate and protected from cryotherapy to be performed on the prostate with the antifreezing properties of the CPS 1105. If desired, the CPS 1105 can also be injected at other areas surrounding the prostate, such as area 1110 shown in FIG. 11.

[0082] The cryotherapy pretreatment device 1005 also has an integral temperature sensor 1025 adjacent the distal tip 1020. In an exemplary embodiment, the integral temperature sensor 1025 can be a single temperature sensor or a set of spaced apart independent temperature sensors (not illustrated) located and extending away from the distal tip 1020. In such a configuration, when pretreatment using CPS is finished, the cryotherapy pretreatment device 1005 can be left at the prostatic plexus to place the temperature sensor near the prostatic plexus and monitor temperature at and/or near the CPS protective space. One exemplary embodiment of a cryotherapy pretreatment device 1005 with an integral temperature sensor 1025 has the temperature sensor as a fiberoptic sensor(s) having a hollow injection channel with a distal injection port. The sensor(s) is(are) used to determine temperature of the area around the prostatic plexus during the cryotherapy procedure. During the cryotherapy procedure, the freeze ball will penetrate through the capsule of the prostate and then encounter the CPS 1105. Because the CPS 1105 surrounds the nerves 1207 (as well as the vessels 1205, 1206), these structures will be protected and preserved. Additionally, because the cryotherapy pretreatment device 1005 has an integral injection channel, any sensing of lowered temperature beyond a pre-set floor can be counteracted by manually or automatically placing more CPS 1105 in the target area.

[0083] At the termination of the procedure, the cryotherapy pretreatment device 1005 is removed, its temperature monitor/sensor having insured that the targeted tissue (e.g., nerves) have not been exposed to temperature that would crystallize the respective tissue.

[0084] In an exemplary embodiment, the cryotherapy pretreatment device 1005 is approximately 6 mm or 18-French.

[0085] There are several different methods of injecting the CPS 1105. For example, the CPS 1105 can be injected using a standard transrectal doppler ultrasound probe with a guidance apparatus attached to the probe. The transrectal doppler ultrasound probe with the guidance apparatus is placed in the rectum prior to initiating the cryosurgery. The neuro-vascular bundle 1200 is identified at its usual location, which is at the apex of the prostate on both the right and left side of the prostate. An injection needle, usually 22 gauge, is placed through the guidance apparatus. Then the injection needle is guided to the space 1210 between the neuro-vascular bundle 1200 and the prostate. The CPS 1105 is injected through the needle, thus creating a protective space between the neuro-vascular bundle 1200 and the prostate. This process is performed on both the right and left sides of the prostate. Afterwards, the cryosurgical procedure can be initiated in the usual fashion.

[0086] Alternatively, the cryosurgical procedure can be initiated first. In this exemplary method, a cryogrid (e.g., template 100) is attached to a stabilizing device. The grid has holes that are used to stabilize both the cryoprobes and the temperature sensors. The cryogrid has both an X axis (letters) and a Y axis (numbers), which gives every hole a specific coordinate. The exact coordinates of the locations of both the cryoprobes and the temperature sensors will vary from patient to patient depending on the specific three-dimensional geometry of the prostate. A transrectal doppler probe is placed in the rectum and attached to the same stabilizing unit. The neuro-vascular bundles 1200 are identified using doppler. A 20-gauge needle is placed through one of the holes in the grid and is directed to the neuro-vascular bundles 1200 on one side of the prostate. The CPS 1105 is injected in the space 1210 between the neuro-vascular bundle 1200 and the prostate. If a temperature sensor is provided at the distal end thereof, the needle is left in a position to monitor the temperature of the CPS 1105 or adjacent the neuro-vascular bundle 1200. This process is repeated for the neuro-vascular bundle 1200 on the other side of the prostate. Likewise, the CPS 1105 can also be injected at space between the rectum and the prostate (Denonvilliers Fascia). The latter will provide protection of the rectum from thermal injury.

[0087] By having a probe that contains both an injection port for the CPS and thermal sensors alongside the neuro-vascular bundles and the prostate, as well as in the space between the rectum and the prostate, the operating surgeon has the advantage of knowing the temperature of these critical spaces during cryotherapy, as well as having the ability to inject more CPS if the temperature of any becomes too low or if the space becomes too small. This probe also can be repositioned if necessary without affecting the surgical procedure. In an exemplary embodiment where the probe is provided with multiple temperature sensors, the probe will have the unique ability to measure the temperatures at multiple critical locations (e.g., in the CPS and outside the CPS) in order to prevent injury along the entire length of the neuro-vascular bundle and/or the rectum. After this cryoprotection is performed, standard cryoprobes are placed through the grid at the appropriate coordinates to completely ablate the entire prostate or just the cancerous lesions (focal therapy).

[0088] At the termination of the procedure, all of the probes are removed and discarded. Doppler ultrasound is then used to document the integrity of the neuro-vascular bundles by measuring blood flow.

[0089] FIG. 13 is a block diagram of using the inventive systems and methods to prevent the freezing of nerves in a neuro-vascular bundle (e.g., prostatic plexus) during the removal of cancerous cells from a prostate using cryotherapy. At block 1305, the neuro-vascular bundle near the prostate is located. In one exemplary embodiment, the neuro-vascular bundle(s) is(are) located using doppler ultrasound. At block 1310, once the neuro-vascular bundle(s) has(have) been found, the cryotherapy pretreatment device 1005 is placed trans-rectally alongside each neuro-vascular bundle and, in particular, the cryotherapy pretreatment device 1005 is placed alongside the nerves bilaterally.

[0090] At block 1315, the CPS is injected through the cryotherapy pretreatment device 1005. The CPS (e.g., RTP or saline) can be initially placed through the cryotherapy pretreatment device 1005 and alongside the nerves after an obturator is removed from the needle. In an exemplary embodiment, the CPS can comprise RTP, an anesthetic, and/or dehydrated cells such as dehydrated amniotic tissue allograft membranes.

[0091] At block 1320, the cryotherapy pretreatment device 1005 positions the temperature sensor adjacent the bundle protected by the CPS. In an exemplary embodiment, the temperature sensor is a fiber optic sensor. It is noted that such temperature sensors are valuable but are not required for use of the instant systems and methods for cryotherapy protection.

[0092] At block 1325, a temperature of the area near the neuro-vascular bundle is monitored using the sensor.

[0093] Steps 1305 to 1320 are repeated (indicated with dashed line) for each area of tissue to be protected, which can include multiple sites at a particular area of tissue.

[0094] At block 1330, cryotherapy begins and, if a preset temperature limit is exceeded, then further CPS is injected to prevent freezing. During the cryotherapy procedure, a freeze ball produced by the procedure will penetrate through the capsule of the prostate and encounter the CPS. If the CPS is RTP, the RTP gel will liquefy and insulate the protected space from the damaging cold. Due to the unique properties of the ethylene glycol and the additional space created by injecting the RTP around the nerves, these structures are preserved and are not damaged by the adjacent cryotherapy procedure. Similar protection is provided by other forms of CPS as described herein. The inventive probe is removed once the cryotherapy procedure is terminated.

[0095] In an alternative embodiment where the cryotherapy pretreatment device 1005 has a separate fiber optic sensor as the temperature sensor, then, at block 1320, a catheter is threaded through the cryotherapy pretreatment device 1005 to lay alongside the neuro-vascular bundle.

[0096] Another exemplary embodiment of a method for protecting tissue during cryotherapy includes placement of a bi-planer trans-rectal doppler probe in a properly prepared rectum. Using doppler ultrasound the nerves are identified by locating the neuro-vascular bundles in both the sagital and transverse planes. The CPS is prepared pursuant to the manufacturer's instructions, if any. The cryotherapy pretreatment device 1005 (e.g., a 6-French needle) is placed through a guidance apparatus. The cryotherapy pretreatment device 1005 is guided to the/each neuro-vascular bundle using doppler ultrasound. If RTP is the CPS, then approximately 5cc of the RTP is injected alongside the neuro-vascular bundle. This injection is repeated on the contralateral side. The cryotherapy pretreatment device 1005 is retracted and repositioned in a space between the prostate and the rectum (Denonvilliers Fascia) if desired and approximately 5cc of the RTP is injected into this space as well. The doppler ultrasound probe is removed and the cryosurgical procedure is initiated in the typical fashion. If desired, one or more cryotherapy pretreatment devices 1005 have the integral temperature probes placed adjacent or in tissue desiring to be protected and the temperature of those tissues are monitored during the cryotherapy procedure. Upon termination of the cryosurgical procedure, the neuro-vascular bundles are rescanned to document acceptable blood flow and, therefore, identify lack of injury.

[0097] Even though RTP has been described herein as the measures by which insulation and physical protection of targeted tissue occurs, saline, which could also contain an anesthetic, can be infused alternatively and/or additionally during the protective procedure.

[0098] It is noted that various individual features of the inventive processes and systems may be described only in one exemplary embodiment herein. The particular choice for description herein with regard to a single exemplary embodiment is not to be taken as a limitation that the particular feature is only applicable to the embodiment in which it is described. All features described herein are equally applicable to, additive, or interchangeable with any or all of the other exemplary embodiments described herein and in any combination or grouping or arrangement. In particular, use of a single reference numeral herein to illustrate, define, or describe a particular feature does not mean that the feature cannot be associated or equated to another feature in another drawing figure or description. Further, where two or more reference numerals are used in the figures or in the drawings, this should not be construed as being limited to only those embodiments or features, they are equally applicable to similar features or not a reference numeral is used or another reference numeral is omitted.

[0099] The phrase at least one of A and B is used herein and/or in the following claims, where A and B are variables indicating a particular object or attribute. When used, this phrase is intended to and is hereby defined as a choice of A or B or both A and B, which is similar to the phrase and/or. Where more than two variables are present in such a phrase, this phrase is hereby defined as including only one of the variables, any one of the variables, any combination of any of the variables, and all of the variables.

[0100] The foregoing description and accompanying drawings illustrate the principles, exemplary embodiments, and modes of operation of the invention. However, the invention should not be construed as being limited to the particular embodiments discussed above. Additional variations of the embodiments discussed above will be appreciated by those skilled in the art and the above-described embodiments should be regarded as illustrative rather than restrictive. Accordingly, it should be appreciated that variations to those embodiments can be made by those skilled in the art without departing from the scope of the invention as defined by the following claims.