Patent Application
20210299358
This patent specification pertains to cannulas used primarily in medical instruments and procedures although they may have non-medical uses as well.
Flexible cannulas are widely used in medical procedures to pass through cannula lumens in instruments such as endoscopes and introducers and treat internal patient sites, for example to inject a substance in an internal organ, to deliver a substance to an internal site, to apply electrical current or other energy to an internal site, to view an internal organ, and to extract tissue samples or fluids from an internal site, to name a few. Such cannulas may also find use in fields other than medicine, for example to access internal regions in objects that are not otherwise easily reachable.
One condition treated with injections in the bladder Overactive Bladder (OAB). In about 2013, the FDA approved treatment of OAB by periodically injecting OnabotulinumtoxinA (Botox) at sites in a pattern along the inner wall of the patient's bladder. Previous methods of delivering OnabotulinumtoxinA to the bladder have involved inserting a cystoscope in the bladder through the urethra, passing a long metal needle through a lumen or working channel in the cystoscope, and manipulating the entire assembly both laterally and along the axis of the urethra as a unit to inject medication at numerous injection sites in the bladder. Such previous devices and methods have resulted in significant patient discomfort and hold the danger of damage to the urethra and surrounding tissue.
A desired placement and pattern of the multiple injections in the bladder are associated with significantly improved treatment outcomes. It is important that devices and methods of injecting OnabotulinumtoxinA into the bladder offer physicians performing the procedure precise control. However, it had been difficult to create precise injection patterns using such previous devices and methods when the scope moves with the needle when aiming for a new injection site. Moreover, said devices are usually not disposable, and must be disassembled and sterilized after each use, making them difficult to maintain and increasing the risk of contamination or infection. More recently, disposable cannulas with integrated video camera and injection needles have been discussed. See for example US Published Application 2016/0367119 A1 and U.S. Pat. No. 10,278,563.
There are proposals to use cannulas made of shape memory metals that change shape after emerging from lumens in devices such as introducers. See Sachveda U.S. Pat. No. 5,607,435 illustrating in
According to some embodiments, a medical device for insertion into a patient's body comprises: an elongated hollow cannula made of a biocompatible, non-metallic material; said cannula having a first shape when confined by first external forces acting thereon; said cannula having a distal portion that reverts to a second shape when free of said first external forces, and said distal portion having a distal end; said second shape having a predetermined curvature defined by an inverse tangent function and comprising two bends in different directions; whereby said distal end of the cannula is radially spaced from an axis of said first shape when said distal portion of the cannula has reverted to said second shape; and wherein said cannula is sufficiently flexible to assume said first shape when in a working channel of an introducer or endoscope but at least said distal portion of the cannula has a flexural modulus that is sufficiently high when in said second shape to force said distal end against tissue for selected medical action on said tissue when a selected distal force is exerted on a proximal portion of the cannula of the introducer or endoscope. The device can further include an injection needle protruding from said distal end of the cannula, wherein and said distal portion of the cannula has a sufficiently high flexural modulus for inserting said needle into patient tissue after the distal portion of the cannula has reverted to said second shape. The needle has a beveled distal portion with a distal end that is sharpened to make a hole in tissue and a proximal portion that is sufficiently dull to dilate rather than cut tissue at the hole as said proximal portion of the bevel is inserted in said hole. The needle can protrude distally a distal end of the cannula by roughly 3 mm and said distal end of the cannula surrounds the needle and acts as a stop limiting the needle penetration depth in said tissue. The cannula and injection needle can be configured to limit depth of penetration into tissue to inject medication in submucosa rather than underlying muscle. The injection needle can be shaped and configured to form a hole in tissue by a distal tip of the needle and to dilate rather than cut tissue around the hole as a portion of an injection needle portion that is proximal from said distal tip penetrates the issue. The device can comprise an electrode rather than a needle protruding distally from the cannula and an electrical connection from the electrode to a proximal portion of the cannula, or another surgical device protruding distally from said cannula. The device can comprise a guide wire in said cannula configured for motion relative to the cannula along a length of the cannula. The distal portion of said cannula has a flexural modulus of about 595,000 psi, and the entire cannula can comprise a single hollow tube made of PEEK. The two bends of the distal portion of said cannula can be spaced from each other by a straight portion of the cannula, and the two bends can be in opposite directions.
According to some embodiments, a method comprises: inserting an elongated hollow cannula made of a biocompatible, non-metallic material into a passage in a patient's body while confining at least a distal portion of said cannula to a first shape by first external forces acting thereon; thereafter gradually moving a distal end of said cannula distally from said confining to thereby cause said distal portion of said cannula to gradually revert to a second shape that has a predetermined curvature defined by an inverse tangent function and comprises two bends in different directions and cause said distal end to move radially from an axis of said first shape; and applying medical action at selected sites of internal tissue of said patient with device protruding distally from a distal end of said cannula; wherein said injection sites are spaced from each other by distances that depend on a distal distance of said device from said first external forces. The cannula can be confined by enclosing it in a working channel of an introducer or endoscope. The medical action can comprise injecting medication at said sites or applying electromagnetic or ultrasound energy or heat to patient tissue.
A detailed description of examples of preferred embodiments is provided below. While several embodiments are described, the new subject matter described in this patent specification is not limited to any one embodiment or combination of embodiments described herein, but instead encompasses numerous alternatives, modifications, and equivalents. In addition, while numerous specific details are set forth in the following description in order to provide a thorough understanding, some embodiments can be practiced without some or all these details. Moreover, for the purpose of clarity, certain technical material that is known in the related art has not been described in detail in order to avoid unnecessarily obscuring the new subject matter described herein. Individual features of one or several of the specific embodiments described herein can be used in combination with features of other described embodiments or with other features. Further, like reference numbers and designations in the various drawings indicate like elements.
This patent specification describes special, hollow, biocompatible polymer cannulas configured to pass through lumens or working channels of a variety of devices and revert to desired predefined curvatures after distally exiting. The lumens of channels can be straight or curved differently from the predefined curvatures to which the polymer cannulas revert when out of those lumens or channels. The lumens or channels can be in any one of a great variety of instruments, including without limitation cystoscopes and other endoscopes of introducers. The curvatures to which the cannulas revert can be as suitable for a specific need or application. The curvature to which a cannula reverts can have a single bend of any desired angle up to 180 degrees relative to a long axis of the cannula, and in some cases can exceed 180 degrees. Another curvature to which a cannula reverts can have two bends in opposite direction, i.e., the curvature can conform to an inverse tangent function. Other curvatures also are possible, e.g., more than two bends, or bends in different planes, etc. The cannulas typically have a distal portion that reverts to the predefined curvatures while the rest of the cannulas are straight or have different curvatures. The cannulas typically have proximal ends that are accessible, for example to inject fluids or other substances into the proximal end of the cannulas or to withdraw substances through the proximal ends. For example, the proximal ends of the cannula can extend proximally from the lumens or working channels for such access.
For use of such cannulas to inject substances at an internal site in a patient, injection needles can be secured to distal tips of the cannulas. For other purposes, such as infusing a substance into or withdrawing a substance from an internal site, the distal tips of the cannulas may be simply open or may be shaped as desired or needed. A cannula that is open at its distal end can be used to pass a guide wire therethrough, and once the guide wire is in place the cannula can be withdrawn, leaving the guide wire in the patient such than additional devices or instruments can be passed over the guide wire to a desired anatomical location. The cannulas can be tipped with electrodes that can be flexible or can be Bugbee type. The entire cannula or a portion of a cannula can be opaque to x-rays to be visible in x-ray imaging.
The lumens or working channels through which the cannulas pass can be in instruments such as endoscopes, introducers, and other devices that can guide cannulas and allow them to protrude distally from the device. Such devices can include viewing components, such as a video camera and a light source at a distal end, or a scope channel in which a viewing device can be inserted and may include one or more lumens in addition for the lumen or working channel for the cannulas, e.g., fluid passages or working channels for surgical instruments. Alternatively, the devices guiding the cannulas can be simply guides, with no viewing facilities and may or may not have any additional lumens or channels.
One example of such cannulas, as used to inject Botox or other medication into a pattern of injection sides at the inner wall of a patient's bladder, is described in commonly owned U.S. patent application Ser. No. 15/697,640, now U.S. Pat. No. 10,286,159, to which this patent specification claims priority. This patent specification recapitulates that example as illustrative of one use of such cannulas and adds disclosure of other examples of uses of such cannulas. In other examples, the cannulas can be used to access other organs such as the uterus, the ureters, and the kidneys. In still other examples, the cannulas can be tipped with an electrode rather than an injection needle, or can be open at the distal end to allow guide wires or other surgical devices or instruments to be passed through the cannulas.
In the example of treating a patient's bladder with Botox (for OAB) or other medication for other medical conditions, this patent specification highlights the discovery that certain biocompatible polymers can be advantageously configured to inject medication in a desired pattern of sites over a relatively wide area in the interior wall of a bladder with little or no lateral movement of an introducer. This is made possible in part by using a memory shape, biocompatible polymer cannula with a distal portion that revert to a predetermined curvature after exiting a cannula lumen. One particularly important predetermined curvature has two bends in opposite directions. While it may have seemed counterintuitive that such curvatures of a thin, non-metal cannula would provide enough support for a needle to be pushed into tissue and maintain a desired orientation, this curvature has been proved highly useful and has been particularly helpful in injecting at sites arranged over a relatively large area by only rotating and advancing the cannula, with no or only slight side-to-side motion that can harm tissue. Another significant benefit is that the memory shape polymer used for the cannulas described in this patent specification is much less expensive than the metals such as Nitinol that have been traditionally used as memory shape devices. Other benefits are discussed in said patent and further below.
In the example of using a cannula tipped with an injection needle, the needle can be beveled such that only a distal portion of the bevel is sharpened and cuts a small hole in tissue while a proximal portion of the bevel is less sharp and tends to spread and stretch (dilate), rather than cut tissue around that small hole. This needle shape and structure have the important benefit of allowing tissue at the injection site to contract and close the small hole after the injection needle is withdrawn, to thereby keep the injected medication where it is intended to stay and thereby provide the intended medical benefit and to thereby keep expensive medication from wastefully leaking out of the injection site. In addition, the portion of the injection needle that protrudes distally from the cannula can be shorter than common, and the cannula distal end than surrounds the needle can serve as a penetration depth stop, such that the medication is injected only or to a large extent in the submucosa rather than all the way into the underlying muscle or other tissue. It has been found that the medical benefit of injecting in the submucosa compares favorably with injecting in the underlying muscle or other tissue.
The inside diameter of the scope lumen 103 preferably fits industry standard cystoscopes known in the art. In preferable embodiments, the scope lumen 103 preferably has an inside diameter of about 4 mm to about 5 mm.
The cannula lumen 104 preferably has an inner diameter of about 1 mm to about 2 mm. The inner diameter or lumen 104 is only slightly more than the outside diameter of cannula 109. The walls of sheath 102 preferably are thin to reduce the outer diameter of the sheath and thereby facilitate passage through a patient's urethra while maintaining strength and rigidity. In preferred embodiments, the sheath walls may have a thickness of about 0.1 mm to about 0.4 mm. The sheath 102 may be comprised of polyether block amides, polyethylene, or other materials with similar rigidity characteristics.
Cannula 109 is a hollow tube made of a biocompatible thermoplastic polymer such as polyether ether-ketone (PEEK), with an outside diameter about 1-2 mm. At least a distal portion of cannula 109 is a shape memory, biocompatible material that reverts to a predetermined curvature after it projects distally from cannula lumen 104. The material and the inside and outside diameters of cannula 109 are carefully selected to meet two mutually exclusive requirements” one is to make the distal portion of cannula 109 stiff so it can help push an injection needle into the inner wall of a patient's bladder when said distal portion is curved, for example in an S-shape, and the other is to make that distal portion of cannula 109 flexible so it can be straight when inside a cannula lumen 104. Preferably, the polymer of cannula 109 has a flexural modulus of about 595,000 psi. Notably, such a flexural modulus allows the user of the device to insert the needle into bladder tissue without causing the cannula to bend or deform in a clinically significant manner. To a skilled person such as a urologist, this means that when injecting in the bladder, the needle would not harm bladder tissue more than has been acceptable in standard-of-care medical practice for conventional injections in the bladder wall and that the visible part of the needle would generally stay in the field of view of a typical endoscope viewing. The bladder wall of adults typically is about 3.5-5.0 mm thick, or an injection needle about 3.0 mm thick would stay in the bladder wall. Some deviation in the needle trajectory during insertion is common and is clinically insignificant so long as it leaves only a temporary tissue disruption, i.e., a disruption that typically clears in a few days, as distinguished from a disruption that punctures the bladder wall or interferes with bladder function for more than a few days. For example, if the cannula deforms so much that the needle cannot penetrate into the bladder wall at a desired injection site or if the cannula bends or deforms so much that the tissue is disrupted to the point of not containing the medication being injected, or if the cannula bends or deforms so much that the needle being forced into tissue opens a slot in tissue rather than a hole about the diameter of the needle, this can be considered a medically significant deformation of the cannula. For example, for a typical adult with a bladder wall thickness about 35-5.0 mm, and a 23-gauge injection needle (about 0.58 mm diameter, typically used to inject medication in the bladder wall) that is 3 mm long from the distal tip of the cannula to the sharp point of the needle (again, typical needle length), a deviation in trajectory within 15-20 degrees from the orientation at the start of insertion would not be clinically significant.
In each of
The cannula 109 that has been used in a medical procedure typically is discarded as medical grade waste rather than being sterilized and used in another procedure to thereby eliminate or reduce the danger of possible contamination in other procedures.
The predefined curvatures discussed above exist when the cannula is free of external forces that would prevent it from assuming such curvatures. When subjected to external forces, such as when confined in a straight lumen or working channel, the cannula would extend along a straight axis if the lumen or channel is straight or would assume the curvature of the lumen or channel that is not straight.
Returning to the example of using the cannula to inject medication in a patient's bladder,
The cannula lumen 104 extends from a proximal end of the handle 101 and is configured to receive cannula 109 from a proximal end of the handle 101. A cannula seal 113 is at a proximal end of the handle 101 to engage cannula 109. The cannula seal 113 preferably is made of a material with an appropriate coefficient of friction to hold a cannula 109 in place. The material of the cannula seal 113 preferably comprises silicone. The handle 101 further comprises a fluid line 105 in fluid communication with the scope lumen 103. The distal end of the fluid line 105 connects to the scope lumen 103 via a watertight fluid connector. In yet other embodiments, the distal end of the fluid line 105 may be integrated directly into the scope lumen 103 via known manufacturing methods such as various molding techniques, welding, 3D printing, adhesives, etc. The fluid line 105 may comprise a second fluid connector 106. In preferred embodiments, the second fluid connector 106 may be a Luer lock. The fluid line 105 may further comprise a pinch valve 107. The pinch valve 107 may control the flow of fluid form a fluid source through the fluid line 105 and into the scope lumen. A port at the distal end of the scope lumen can be provided for outflow or inflow of fluid.
The needle 114 may be a commercially available hypodermic needle suitable for performing injections of OnabotulinumtoxinA or other desirable medication. The outer diameter of the needle 114 is slightly less than the diameter of the cannula 109, so that the needle can be friction-fitted in the cannula. For example, the needle 114 may be a 23-gauge needle and may extend past the cannula 109 about 1.0 mm to about 3.0 mm in length. In such configurations, the distal tip of the cannula 109 acts as a circumferential wall that helps keep the needle 114 from penetrating into the target tissue past the distal tip of the cannula 109.
The vertical distance between the distal tip of cannula 109 and a long axis of cannula lumen 104 changes in the course of movement of cannula 109 distally out of cannula lumen 104. This distance is relatively small in
A method for treating overactive bladder comprises inserting an endoscope 110 into a scope lumen 103 of an introducer 100, according to some embodiments. The method may further comprise inserting a cannula 109 into a cannula lumen 104 of the introducer 100, the cannula 109 configured such that the distance between the distal tip of the cannula 109 and the axis defined by the sheath 102 of the introducer 100 increases as the cannula 109 is moved in a distal direction out of the introducer, wherein a syringe 111 filled with OnabotulinumtoxinA or other medication is coupled to the proximal end of the cannula 109. The method may further comprise guiding the introducer 100 through the urethra of a patient to the patient's bladder. The method may further include extending the distal portion of the cannula 109 past the distal end of the introducer 100 until a needle 114 attached to the distal end of the cannula 109 is placed at a desired radial distance from the long axis defined by the sheath of the introducer. The method may further comprise rotating the introducer 100 and/or cannula 119 to position the needle 114 at a desired position. The method may further comprise moving the introducer and/or the cannula in a distal direction to insert the needle 114 into the bladder. The method may further include activating the syringe 111 to inject OnabotulinumtoxinA or other medication into the bladder. The method may further include moving the introducer 100 and/or the cannula 109 in a proximal direction to withdraw the needle 114 from the bladder. The method may further include repeating the extending, rotating, moving distally, activating, and moving proximally steps until a therapeutically effective amount of OnabotulinumtoxinA or other medication has been injected in a therapeutically effective pattern into the bladder.
An alternative method comprises enclosing a cannula 109, with or without an injection needle 114, in a sterile pouch and delivering the pouch to a user. The method further comprised opening the sterile pouch and passing the cannula through an lumen or channel of a device such as an introducer, endoscope or some other guide that may or may not be already inserted into a patient's cavity. The method further comprises advancing the cannula distally until a distal portion thereof starts protruding distally from such lumen or channel and begins to revert to its predetermined curvature. The method further includes advancing the cannula distally even more relative to a distal end of the lumen or channel, so more of the distal portion of the cannula reverts to its predetermined shape and using the cannula such as to inject a substance into a patient's bladder or deliver or inject a substance into another body cavity. The cannula is them withdrawn from the patient, alone or together with the instrument through which it passed, and the cannula 109 is discarded along with any needle 114 as medical grade waste.
In use to inject medication in tissue such as a bladder wall, it has been observed that injecting medication such as Botox with a needle such as 90, which makes a small hole with its tip and dilates tissue as the remainder of the bevel enters tissue, results in a well-defined bleb (a fluid-containing, elevated lesion or blister) that does not leak out the injected medication after the needle is withdrawn, or leaks significantly less than a case of an injection that is otherwise the same but uses a needle with a bevel that cuts rather than dilates tissue.
In the example of using a cannula such as 94 or 109 with an injection needle such as 90 or 114, the curve at the distal portion of the cannula provides a well-controlled injection angle such that the injection needle can be perpendicular or close to perpendicular to the wall of the tissue at the injection site or another device such as an ablation electrode also can be oriented at a preferred angle. The curve at the distal portion of the cannula has a further benefit—it allows a viewing device such as an endoscope through which the cannula passes to observe a greater viewing field of motion of the needle compared with conventional injection needles, and to require no or minimal motion of the endoscope or introducer relative to the patient, thus providing greater patient comfort because of less torquing or other motion relative to the patient.
The distal portion of the cannula, with two bends in opposite directions, preferably is sufficiently stiff for the intended medical procedure. For example, if the cannula is used to inject medication in tissue, the stiffness should be enough to make the injection needle penetrate the type of tissue at the injection site when pressed against the tissue by action on a portion of the cannula that is proximal to the distal portion with the two bends. The selected stiffness may differ for different types of tissue at the intended injection sites. In another example, where an ablation electric stylet is used rather than an injection needle, the distal portion of the cannula (with the two bends) may be less stiff as the medical procedure may require less pressure of the stylus on tissue. When yet different devices protrude from the distal end of the cannula, different stiffness parameters may be selected for the cannula's distal portion, appropriate for the intended medical procedure.
Although the foregoing has been described in some detail for purposes of clarity, it will be apparent that certain changes and modifications may be made without departing from the principles thereof. There can be many alternative ways of implementing both the processes and apparatuses described herein. Accordingly, the present embodiments are to be considered as illustrative and not restrictive, and the body of work described herein is not to be limited to the details given herein, which may be modified within the scope and equivalents of the appended claims. Numerous specific details are described to provide a thorough understanding of the disclosure. However, in certain instances, well-known or conventional details are omitted to avoid obscuring the description.
This application is a continuation-in-part of U.S. patent application Ser. No. 16/564,668 filed Sep. 9, 2019 and scheduled to issue as U.S. Pat. No. 10,953,159 on Mar. 23, 2021, which is a continuation-in-part of each of (a) U.S. patent application Ser. No. 15/722,168 filed Oct. 2, 2017, (b) U.S. patent application Ser. No. 15/834,333 filed Dec. 7, 2017, and (c) International Patent Appl. No. PCT/US18/50087 filed Sep. 7, 2018 published as WO 2019/051315 on Mar. 14, 2019. Said International Patent Appl. claims priority to said U.S. patent application Ser. No. 15/834,333 as well as to U.S. patent application Ser. No. 15/722,168 filed Oct. 2, 2017, and said U.S. patent application Ser. No. 15/834,333 is a continuation-in-part application of U.S. patent application Ser. No. 15/697,640 filed Sep. 7, 2017 and issued as U.S. Pat. No. 10,286,159 on May 14, 2019. This application incorporates by reference and claims the benefit of the filing date of each of the above-identified patent applications, as well as of the applications that they incorporate by reference, directly or indirectly, and the benefit of which they claim.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15834333 | Dec 2017 | US |
| Child | PCT/US18/50087 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16564668 | Sep 2019 | US |
| Child | 17208955 | US | |
| Parent | 15722168 | Oct 2017 | US |
| Child | 16564668 | US | |
| Parent | 15834333 | Dec 2017 | US |
| Child | 15722168 | US | |
| Parent | PCT/US18/50087 | Sep 2018 | US |
| Child | 15834333 | US | |
| Parent | 15697640 | Sep 2017 | US |
| Child | 15834333 | US |
