LASER FIBER INTEGRATED MORCELLATOR

Various examples disclosed relate to treatment of BPH with an integrated device for both tissue treatment and removal. The present disclosure includes a device including a sheath for partial insertion into a patient, a laser fiber actuatable for laser enucleation of tissue, an elongated member, and a tissue engagement tool on the elongated member.

BACKGROUND

Benign Prostatic Hyperplasia (BPH) increasingly affects men as they age. BPH can cause enlarged prostate tissue. This enlarged prostate can cause a number of uncomfortable urinary conditions, including significantly restricting urine flow, urethra stricture, frequent urination, inability to urinate, difficulty in starting urination, or loss of bladder control, and other complications.

SUMMARY OF THE DISCLOSURE

The present disclosure provides devices and methods for treating BPH. The devices can include a multi-use tool for urology. The tool integrates a laser fiber with a morcellator. This can allow for enucleation and morcellation to be combined in a single step procedure. This can shorten procedure time and improve safety.

A variety of techniques are used to medically address BPH. These can include observation, dietary, medicinal, and minimally invasive surgical techniques. Medicinal approaches can include alpha blockers, 5-ARI or PDE-51, while minimally invasive techniques can include TUMT, TUNA, steam vapor, and others. In some cases, invasive surgeries are used, such as TURP, TUIP, HoLAP, green light, HoLEP, or prostatectomy. Certain techniques are useable for prostates of particular sizes. Some of these surgical techniques can used plasma energy, bipolar energy, or laser energy, to trim, cut, or reduce enlarged prostate tissue.

In some cases, prostate tissue is removed through enucleation or resection methods, where the trimmed or cut away tissue is directed into the bladder. In this case, a separate tool, such as a morcellator, can then be used to remove the tissue from the bladder.

However, these types of surgical techniques rely on two distinct steps, with multiple tools, for full removal of prostate tissue. The discrete steps include first severing targeted prostate tissue (e.g., with plasma energy, bipolar energy, or laser energy), moving that resected tissue to the bladder, and then using a separate device (e.g., a morcellator) to further cut and retrieve the tissue from the bladder.

Such multi-step and multi-instrument techniques take a significant amount of time to perform. Additionally, complications can occur at multiple steps. For example, anatomy can be damaged, such as causing urethral sphincter. This can occur where the field of vision is blocked by the resected prostate tissue itself, obscuring a view of anatomical landmarks.

A reduction in surgery times, hospital stays, and post-procedure catheterization would be beneficial. Additionally, methods that allow for better safety by maintain the field of vision are desired. The single tool, combined methodology discussed herein can allow for contemporaneous resection and cleaning of prostate tissue.

In an example, a device for at least partial insertion into a patient can include an elongated sheath having a proximal portion, a distal portion and a lumen, the sheath for partial insertion into a patient, a laser fiber extending longitudinally within the lumen of the elongated sheath, the laser fiber actuatable for laser enucleation of tissue at the distal portion of the elongated sheath, an elongated member extending longitudinally within the lumen of the elongated sheath, the elongated member extending concurrently with the laser fiber and a tissue engagement tool at a distal portion of the elongated member, the tissue engagement tool actuatable for removal of tissue. The laser fiber and the elongated member can be configured for concurrent insertion into or removal from the lumen of the sheath.

In an example, a method of treating prostate tissue can include enucleating the prostate tissue with a laser fiber and morcellating the prostate tissue with a tissue removal device, wherein the laser fiber and the tissue removal device are integrated into a single medical instrument.

DETAILED DESCRIPTION

The present disclosure describes, among other things, a single device or tool for surgical treatment of BPH by resection and removal of prostate tissue in a single surgical step. In an example, the device can include a laser fiber and a morcellator. This can allow for the two steps of enucleation and morcellation to be combined into a single step procedure, shortening procedure time. This can additionally improve safety and reduce the chance of damage to the bladder during the procedure.

FIGS.1A-1Cillustrate an example multi-use device100for resection and clearing of prostate tissue in different operations. The device100can include an elongated sheath110having a proximal portion112, a distal portion114, and a lumen116, a laser fiber120, and a tissue engagement tool130extending from an elongated member132. Shown inFIG.1C, the device100can further include a distal segment140.

In device100, the lumen116of the elongated sheath110can host both the laser fiber120and the elongated member132. The laser fiber120and the elongated member132can extend longitudinally at least partially within the lumen116of the sheath110, such that the laser fiber120can extend out the distal portion114of the sheath110to allow for laser enucleation of tissue. Similarly, the elongated member132can extend out the distal portion114of the sheath110and terminate with the tissue engagement tool130to allow for grasping of tissue at the distal portion114.

The elongated sheath110, extending between the proximal portion112and the a distal portion114, can be a sheath or shaft shaped and sized for at least partial insertion into a patient, such as laparoscopically or through the urethra, for treatment of BPH by enucleation and removal of excess prostate tissue. The sheath110can include a central longitudinal lumen116, through which both the laser fiber120and the tissue engagement tool shaft132can extend. During operation, a surgeon can grasp or hold the sheath110near the proximal portion112, such a at a handpiece or handle (not shown) and manipulate the device100into the patient. For example, the surgeon can manipulate the device100up through the surgical pathway towards the prostate to enucleation and remove enlarged prostate tissue.

The laser fiber120can run through the lumen116of the sheath110, such as from a laser source (not shown) attached to the proximal portion112, towards the opening of the lumen116at the distal portion114. InFIG.1A, the laser fiber120is shown along the body of the sheath110. In some cases, a groove can be provided in the sheath110along the side of the lumen116for placement of the laser fiber120. In contrast, the example shown inFIG.1B, the laser fiber120is situated adjacent the tissue engagement tool130elongated member132extending down the center of the sheath110lumen116.

In the example ofFIGS.1A-1C, a laser fiber is shown for treatment of enlarged prostate tissue. Various endoscopic surgical methods can be used in treatment of BPH, and variants on the laser fiber120can be substituted. The laser fiber120, depending on its configuration, can be actuatable for enucleation, resection, or vaporization of prostate tissue. In enucleation methods, the laser fiber120can be an end-firing laser used to peel the entire prostate adenoma from the prostate capsule. In some vaporization cases, the laser fiber120can eb replaced with a designed bipolar loop. In resection, the prostate tissue can be moved piece by piece, and the laser fiber120can be replaced by a mono-polar or bi-polar resection loop. In vaporization, the laser fiber120can be a side firing laser fiber to vaporize the enlarged prostate adenoma, or alternatively the laser fiber120can be replaced with a mushroom-like bipolar electrode.

In an example, the laser fiber120can be a laser fiber configured for holmium laser enucleation of the prostate (HoLEP), or alternatively a laser configured for laser vaporization of the prostate. In the case of HoLEP, the laser is used to cut and remove the bulky prostate tissue that is blocking the flow of urine. Specifically, HoLEP can include cutting a short surgical horizontal incision to exposed the surgical capsule of the prostate before the apex. The surgeon can dig a tunnel from the apex to the bladder neck beneath the median lobe along the surgical capsule. The surgeon can then enucleate the prostate adenoma in a counterclockwise manner in the first lobe, then clockwise in the second lobe. The surgeon can then push the entire prostate off the prostatic wall and into the bladder.

Once prostate tissue is removed, whether by enucleation, resection, vaporization, or other methods using the laser fiber120, the tissue engagement tool130can be used to remove the tissue. In conventional methods, this would require a separate tool, such as an independent morcellator. Morcellation of tissue can include “mincing” of tissue to smaller pieces of tissue, or remnants, for removal from the body.

However, the device100is an integrated device with both the laser fiber120to treat prostate tissue and the tissue engagement tool130to remove the treated tissue. The device100can combine both tissue treatment (e.g., enucleation or vaporization) and tissue removal (e.g., morcellation) steps into a single-step procedure, shortening the procedure time. This can help avoid bladder damage and improve safety by keeping the field of view open.

The tissue engagement tool130can extend distally from the elongated member132. In some cases, the tissue engagement tool130is a morcellator configured to collect, digest, and remove prostate tissue that has been treated with the laser fiber120.

In some cases, the tissue engagement tool130can be a morcellator. In this case, the morcellator tissue engagement tool130can include a shaft having a blade (seeFIGS.4A-4C) that is configured to further chew up tissue. In this case, the laser120can be actuated to enucleation prostate tissue, which is then sucked into the shaft of the morcellator tissue engagement tool130and cut up before disposal. Such a morcellator can be a bipolar, a monopolar, or a mechanical morcellator.

Where the tissue engagement tool130is a morcellator, the distal segment140can be included. The distal segment140can, for example, be a flexible segment covering the tissue engagement tool130. The distal segment140can be configured to deflect against tissue to improve access to the tissue.

In some cases, the tissue engagement tool130can instead be a forceps jaw for mechanically grasping the prostate tissue. In this case, the forceps tissue engagement tool130can be moved and clamped around tissue to be removed. The forceps tissue engagement tool130can hold the tissue in place, while the laser120is actuated to vaporize or enucleate the tissue. The forceps tissue engagement tool130can then be moved to another portion of tissue. As needed, the forceps tissue engagement tool130can be used to pull remainder tissue out.

In the case of a forceps tissue engagement tool130, the laser fiber120can be integrated into the tissue engagement tool130, such that the forceps tissue engagement tool130and the laser fiber120work in conjunction for enucleation and vaporization of tissue.

A variety of examples of the integrated device100are shown inFIGS.1A-1C.

For instance,FIG.1Adepicts an example where the laser fiber120is positioned along the sheath110, which may be positioned in a groove to protect the fiber. In this case, the tissue engagement tool130can be a morcellator integrated into the sheath110, such that the laser fiber120sits within the morcellator itself. InFIG.1A, the laser fiber120can be used to cut prostate tissue, with the morcellator130further severing tissue if needed, and removing the prostate tissue.

By comparison,FIG.1Bdepicts an example where the laser fiber120is positioned on the back of the forceps tissue engagement tool130. In this manner, the laser fiber120can be used to cut/resect tissue, and forceps tissue engagement tool130can remove tissue pieces as needed.FIG.1Cdepicts a flexible morcellator tip140used in combination with forceps tissue engagement tool130, thereby improving access, and improving visibility during the procedure and allowing tracking of anatomical landmarks.

In some cases, the tissue engagement tool130can be a morcellator. In an example, it can be a bipolar morcellator. Such a bipolar morcellator can include a jaw for grasping tissue and at least two electrodes. The two electrode can provide radio frequency (RF) energy for morcellation. In some cases, the morcellator can be a monopolar morcellator. In some cases, the tissue engagement tool130can be a forceps jaw with a vaporization feature. In some cases, the morcellator can be a mechanical morcellator, such as a blade, screw, or teeth.

FIGS.2A-2Cillustrate an example multi-use device200for resection and clearing of prostate tissue. The device200is similar to device100, and contains similar components. The device200specifically depicts an example forceps tissue engagement tool130working with a laser fiber120to enucleate and vaporize tissue. The device200uses a bipolar morcellator for the tissue engagement tool130, compared to the examples of device100above.

InFIG.2A, the laser fiber120can be used to resect or enucleate tissue. Then, inFIG.2B, the forceps tissue engagement tool130can secure pieces of tissue. InFIG.2C, the forceps tissue engagement tool130can be retracted with the pieces of tissue to electrically morcellate the tissue.

The multi-use device200can include a bipolar arrangement for the forceps tissue engagement tool130, where a first electrode133is on a jaw131of the forceps tissue engagement tool130. A second electrode135can be on the sheath110. The first and second electrodes133,135, can be of opposing polarities. Thus, when the forceps tissue engagement tool130is retracted through the sheath110(FIG.2C), the forceps tissue engagement tool130first electrode133and the second electrode135can create an electrical path. The electrical path can be sufficient to electrically morcellate the secured tissue pieces. The remnants of the morcellated tissue can be drawn out through the sheath110or by further retraction of the forceps tissue engagement tool130. In some cases, the remnants of the morcellated tissue can be pushed into a holding area in the device200. In some cases, suction can be used to draw the remnants out of the body.

FIG.3illustrates an example multi-use device300for resection and clearing of prostate tissue. The device300is similar to device100, and contains similar components, except where otherwise noted. The device300specifically depicts an example forceps tissue engagement tool130working with a laser fiber120to enucleate and vaporize tissue. The device300uses a vaporizing laser fiber125.

In device300, instead of using bipolar energy to morcellate the tissue, a separate laser fiber125can be used to vaporize grasped tissue. The laser fiber125can be positioned at the pivot point136of the forceps jaw131, and extend distally between the jaws. When tissue is grasped between the forceps jaws131, the laser fiber125can be used to vaporize the tissue. Thus, device300does not include a separate morcellator.

FIGS.4A-4Cillustrate an example multi-use device400for resection and clearing of prostate tissue.FIGS.4A-4Cdepict examples of the tissue engagement tool130that include mechanical morcellators. Such a mechanical morcellator tissue engagement tool130can reside partially or fully within the sheath110. The mechanical morcellator tissue engagement tool130can be configured to receive enucleated tissue, such as that treated with the laser fiber120, and further morcellate the tissue.

InFIG.4A, the mechanical morcellator tissue engagement tool130can include a blade with a number of teeth. InFIG.4B, the mechanical morcellator tissue engagement tool130can include a screw-like blade. InFIG.4C, the mechanical morcellator tissue engagement tool130can include plurality of blades. These mechanical morcellator tissue engagement tools130can be configured to rotate, so as to further mince or chew up received tissue.

Each of the devices shown inFIGS.4A-4Ccan involve a laser fiber being provided through a central lumen of the mechanical morcellator. The laser fiber may alternatively be provided elsewhere such as along an edge of the morcellator, or in any other non-central location capable of receiving the laser fiber therethrough.

Each of the devices100,200,300,400, can combine the two steps of tissue treatment (e.g., enucleation or vaporization) with tissue removal (e.g., morcellation), into a one-step procedure, with optional continuous removal of tissue during the operation. This can aid in shortening procedure times.

FIGS.5A-5Dillustrate an example device500for medication of treated prostate tissue. Another example involves controlling strictures and facilitating healing after the procedure, as depicted inFIGS.5A-5D. One example involves using a medicated gel. For example, a bristled device may be delivered such that its bristles collapse during delivery, and expand to a gel delivery shape upon exiting the delivery device.

The device500can include the sheath110extending between the proximal portion112and the distal portion114with the lumen116. The device500can further include a tube510with bristles512for carrying a medicated gel. The device500can be inserted into the prostate cavity520along the urethra522towards the bladder524.

InFIG.5A-5D, the sheath110can include the lumen116, and the medication delivery tube510can be used to deliver medicated gel along the length of the lumen116to the prostate cavity520. The tube510can be sized and shaped for insertion down the lumen116towards the prostate tissue and cavity520. The tube510can optionally include bristles512, which can flex along the length of the lumen116during delivery.

The bristles512can be on the tube510and straighten when they are pushed into the prostate cavity520. The bristles can serve several functions, including serving as a conduit for the mediated gel to move from the tube into the cavity, and as a brush to spread the gel on the cavity. The bristles512can, for example, include lumens or hollow portions to allow spreading of gel therethrough, When the bristles512reach the cavity520, the bristles512can vertically expand, and the medicated gel can be dispersed through the bristles. The tube510can be moved forward and back and rotated, helping to spread the medicated gel along the walls of the prostate cavity520.

Specifically, the prostate cavity520can be treated by a medicated gel with device500following laser enucleation or vaporization. In this case, the tube510can be inserted down the lumen116of the sheath110either contemporaneously with the laser fiber120and/or the tissue capture device130, or after the laser fiber120and/or the tissue capture device are retracted along the sheath110. In some cases, the tube510can be inserted separately up the endoscope after the multi-use device is used for treatment.

FIGS.6A-6Billustrate an example device600for medication of treated prostate tissue. The device600can be used, for example, to provide a medicated spray to the prostate cavity630.

The device600can include a tube610with a plurality of spray holes612. In this case, the tube610can be inserted along the sheath110lumen116or other endoscope after use of the multi-use device for treatment and removal of prostate tissue. Once inserted into the prostate cavity630, a medicated spray can be released along the length of the tube610and through the spray holes612to spray along the interior surface of the prostate cavity630. In some cases, the spray can be originally in a liquid state for delivery, and can be configured to change to a gelatinous state when the temperature of the spray changes as a result of being applied to the prostate.

FIG.7illustrates an example method700for resection and clearing of prostate tissue. The method700can include blocks710and720. At block710, the prostate tissue can be enucleated with a laser fiber. At block720, the prostate tissue can be morcellated with a tissue removal device. The laser fiber and the tissue removal device can be integrated into a single medical instrument. Morcellating the prostate tissue can include application of radio frequency energy with a bipolar morcellator. Morcellating the prostate tissue can include mechanical morcellation of the tissue.

Various Notes & Examples

Example 1 can include a device for at least partial insertion into a patient, the device comprising: an elongated sheath having a proximal portion, a distal portion and a lumen, the sheath for partial insertion into a patient; a laser fiber extending longitudinally with the elongated sheath, the laser fiber actuatable for laser enucleation of tissue at the distal portion of the elongated sheath; an elongated member extending longitudinally within the lumen of the elongated sheath; and a tissue engagement tool at a distal portion of the elongated member, the tissue engagement tool actuatable for morcellation of tissue.

Example 2 can include Example 1, wherein the laser fiber and the elongated member are configured to move together relative to the sheath.

Example 3 can include Example 1, wherein the laser fiber is located on an outer surface of the elongated sheath.

Example 4 can include Example 3, wherein the outer surface of the sheath comprises at least one groove for engaging with the laser fiber.

Example 5 can include Example 1, wherein the tissue engagement tool is a morcellator.

Example 6 can include Example 5, wherein the morcellator comprises a bipolar morcellator comprising jaws actuatable for grasping tissue and at least two electrodes actuatable for providing radio frequency energy to the tissue.

Example 7 can include Example 6, wherein the laser fiber extends between the jaws.

Example 8 can include Example 5, wherein the morcellator comprises a mechanical morcellator.

Example 9 can include Example 8, wherein the morcellator comprises one or more blades with teeth, a rotatable screw, or a plurality of rotatable blades.

Example 10 can include Example 1, wherein the tissue engagement tool comprises a mechanical jaw.

Example 11 can include Example 10, wherein the mechanical jaw is actuatable for blunt dissection of tissue.

Example 12 can include Example 10, wherein the mechanical jaw and the laser fiber are actuatable for vaporizing tissue.

Example 13 can include Example 1, further comprising a deflected segment on the distal portion of the elongated sheath.

Example 14 can include Example 1, further comprising a delivery tube configured to delivery of a medicated gel, the delivery tube situated within the lumen of the elongated sheath.

Example 15 can include Example 14, wherein the delivery tube further comprising a plurality of bristles extending laterally outward actuatable for dispersing the medicated gel.

Example 16 can include Example 1, further comprising a delivery tube configured to delivery of a medicated spray, the delivery tube situated within the lumen of the elongated sheath.

Example 17 can include Example 16, wherein the delivery tube further comprises a plurality of spray holes actuatable for dispensing the medicated spray.

Example 18 can include a method of treating prostate tissue, comprising: enucleating the prostate tissue with a laser fiber; and morcellating the prostate tissue with a tissue removal device, wherein the laser fiber and the tissue removal device are integrated into a single medical instrument.

Example 19 can include Example 18, wherein morcellating the prostate tissue comprises application of radio frequency energy with a bipolar morcellator.

Example 20 can include Example 18, wherein morcellating the prostate tissue comprises mechanical morcellation of the prostate tissue.