JP5025269B2 - Noninvasive arthroscopy instrument sheath - Google Patents

Description

  The invention described below relates to the field of arthroscopic surgical instruments.

  In the arthroscopic surgery, an optical instrument such as an arthroscope is used in order to visualize a surgical region in or near a patient's joint. In performing a surgical operation, the same instrument or different instruments may be used. In general, the instruments used in addition to the arthroscope include a trimming instrument used for cutting tissue and a cleaning instrument used for cleaning an operation area. In order to insert instruments into the surgical area, an incision must be made for each instrument. Therefore, many surgeons prefer to use only trimming instruments and arthroscopes in arthroscopic surgery.

  Since the arthroscope is more fragile than the force used in arthroscopic surgery, a stiff cannula is placed over the arthroscope to strengthen it. A stiff cannula has a pointed tip and is usually sharp and may scratch or scrape soft tissue in the surgical area. A stiff cannula can get caught between bones and cartilage during surgery. The stiff cannula can damage the metal prosthesis used for joint replacement and shortens the service life of the prosthesis, so that correction requires the patient to undergo another painful operation.

  Another problem associated with arthroscopic surgery is maintaining a clear surgical field during surgery. Blood and debris can cloud the field of view and impair the surgeon's ability to visualize tissue. One way to solve this problem is to clear the surgical area with saline using a cleaning instrument. However, many surgeons wish to avoid having another trauma caused by inserting a third instrument. Such a surgeon performs arthroscopic surgery even if there is a problem with the visualization of the surgical field. Accordingly, there is a need for an apparatus and method that uses only two instruments while maintaining a sharp surgical field while reducing accidents to the patient.

  The devices and methods described below provide a soft non-invasive disposable sheath made of plastic that slides over a rigid cannula of an arthroscope.

The end of the non-invasive sheath is slightly beyond the end of the rigid cannula and provides a soft and unsharp cushion on the end of the rigid cannula. Thus, the non-invasive sheath protects surrounding tissue or objects from accidental accidents while handling the arthroscope within the surgical area.
The non-invasive sheath may function as an inflow / outflow sheath. The surgeon can allow fluid to flow out of or into the surgical area. The inflow / outflow sheath is a multi-lumen tube into which the arthroscope is inserted. The proximal portion of the sheath is provided with a fluid inlet / outlet, a manifold, and other means for controlling the flow of fluid within the sheath. A plurality of holes are provided in the distal portion of the inflow / outflow sheath. Each of the holes communicates with one or more lumens in the tube so that fluid can flow between the surgical area and a source or sink external to the patient. Thus, the surgeon can use the inflow / outflow sheath to maintain a clear surgical area, protect the patient from accidents, and eliminate the need for a third cleaning instrument.

  FIG. 1 illustrates a method for performing arthroscopic surgery on a patient using an arthroscopic instrument housed in a non-invasive introducer sheath. The arthroscopy instrument may be an arthroscope, endoscope, awl, pick, shaver, or the like. The arthroscopy instrument 2 shown in FIG. 1 is an arthroscope. (The various parts of the arthroscope are modeled to show their position within the sheath.) For reference, several anatomical structures of the patient's knee are shown, including the femur 5, patella 6, This includes the posterior cruciate ligament 7, the anterior cruciate ligament 8, the meniscus 9, the tibia 10 and the ribs 11. During the operation, the surgeon inserts the arthroscope 2 into the knee through the first incision 12 to visualize the surgical area. Trimming instrument 13 is inserted through the second incision to remove or cut tissue that the physician has determined should be removed or cut. A cleaning instrument 15 may optionally be inserted through the third incision 16 to clean the surgical area and maintain a clear field of view. As shown below, the cleaning instrument may be replaced with a composite of an arthroscope and an inflow / outflow non-invasive sheath. This can reduce the number of incisions required for surgery.

  The arthroscope 2 is an optical instrument 17 surrounded by a rigid cannula 18 having a distal edge that is usually cut obliquely. An arthroscope is inserted into a resilient external introducer sheath or non-invasive sheath 3 extending from a rigid cannula to protect the patient from accidental injury or trauma. The distal tip 19 of the non-invasive sheath extends distally through the distal end of the arthroscope and the rigid cannula to further protect the patient.

  A non-invasive sheath 3 is shown in FIGS. A non-invasive sheath is a tube made of a resilient material such as soft plastic or rubber. The inner diameter of the non-invasive sheath is on the outer diameter of the arthroscopic instrument and is dimensioned to closely match it. The distal end 19 of the non-invasive sheath is shaped very closely to the shape of the distal tip of the arthroscope and / or rigid cannula. A flange 30 disposed around the distal end of the sheath prevents the distal tip of the rigid cannula from scavenging the patient's tissue. The flange is integral with the sheath wall and extends inward toward the sheath axis. Dimensioned to prevent the distal tip of the rigid cannula from accidentally sliding distally during surgery. In some non-invasive sheaths, an opening 36 is provided. This is because the surgeon can insert an endoscope or other instrument into the space of the surgical site through the opening. 3 and 4 show a lens 31 at the end of the optical instrument for reference.

  The proximal end 32 of the non-invasive sheath is provided with a tab 33 so that medical personnel can easily pull the non-invasive sheath away from rigid cannulas, arthroscopes and / or arthroscopic instruments. At the proximal end of the non-invasive sheath, an attachment part for fixing the non-invasive sheath is also provided. Such as a locking hub or snap latch connected to an attachment or opening located on an arthroscope or other instrument.

  Tab 33 is dimensioned to divert fluid away from devices adjacent to the non-invasive sheath, such as cameras, optics, motors, and other devices sensitive to liquids and moisture. The liquid leaving the surgical site and flowing on the outer surface of the sheath is redirected by the tab. The tabs are larger than the lumen of the sheath and extend radially.

  FIG. 2a shows a non-invasive sheath 3 having two tabs 33 arranged along the longitudinal direction of the sheath. An additional tab ensures that the liquid does not approach the sensitive device at the proximal end of the sheath, even if a large volume of liquid spill is expected during the surgical procedure. Additional tabs may be placed along the longitudinal direction of the sheath.

  The outer surface of the non-invasive sheath may be provided with a smooth coating so that the arthroscope and rigid cannula can more easily move within the surgical site. For example, Teflon (registered trademark) (PTFE or expanded polytetrafluoroethylene) may be applied to the sheath, or it may be covered with a water injection type lubricant. In contrast, the inner surface of the non-invasive sheath (the wall that forms the lumen of the tube) may be provided with a non-slip coating or other high coefficient of friction coating. For example, the inner surface of a non-invasive sheath may be coated with an adhesive coextruded thermoplastic elastomer (TPE). The non-slip coating prevents the sheath from slipping over the rigid cannula or arthroscope and can prevent the non-invasive sheath from bending or sliding over the arthroscope.

  3 and 4 show a non-invasive sheath used for an arthroscopic instrument or endoscope or arthroscope 2 placed in a non-invasive sheath. The non-invasive sheath shown in FIG. 3 is provided with a balloon 34 at the distal end of the sheath. (The balloon may be molded integrally with the sheath.) The balloon allows the surgeon to open a space in the tissue and cut through the surgical area. Next, the arthroscope is extended from the opening 36 in the distal direction, and the space of the surgical site is visualized. Furthermore, a spoon protruding in the distal direction or another object protruding in the distal direction may be provided at the distal end of the sheath to open a space in front of the arthroscope. Thus, the balloon and the distally projecting spoon provide a means to incise or remove tissue to form a small surgical space.

  FIG. 4 shows a non-invasive sheath 3 having a second working tube 35. The actuation tube allows cleaning fluid, fiber optics, sutures, needles, probes or surgical tools to pass through the lumen. The non-invasive sheath shown in FIG. 4 may be combined with the non-invasive sheath shown in FIG. 3 to provide a non-invasive sheath with both a balloon and a working tube.

  FIG. 5 shows a cross section of the non-invasive sheath 3 shown in FIG. 2 and the arthroscopy instrument 2 placed in the sheath. To facilitate the removal of the sheath from the arthroscope, the non-invasive sheath is provided with a tab 33 at the proximal end of the sheath. The distal end of the sheath is provided with an opening 36 so that light can pass between the arthroscope and the space at the surgical site, and in some cases, additional instruments can enter the surgical area through or along the arthroscope. It is done. The wall 37 of the sheath distal end 19 is thicker than the rest of the sheath and a flange 30 is formed at the sheath distal end. (The flange may be another ring of material that contacts the inside of the sheath.) The flange covers the sharp end of the arthroscopic instrument and prevents the instrument from sliding distally through the opening 36. The remaining walls of the non-invasive sheath are thin to minimize the thickness of the entire sheath and arthroscopic instrument.

  A non-invasive sheath is prepared at the time of use and is placed over the arthroscopic instrument. (You may consider inserting the instrument into the sheath.) The arthroscopic instrument covered with the sheath is then inserted into the surgical site, where the surgeon performs the medical procedure. If a balloon is provided, the balloon is used to incise tissue and an arthroscope extends distally from the opening 36 to help visualize the space at the surgical site.

  6 and 7 show the inflow / outflow non-invasive sheath 50 and the arthroscope 2 placed within the sheath. The inflow / outflow non-invasive sheath 50, like the sheath shown in FIG. 2, is made of a resilient material that protects the patient from accidental trauma even when the arthroscope strikes or scratches the tissue. . The material of the sheath may be a radio park. The preferred durometer hardness of the sheath material is in the range of about 40 Shore D to about 90 Shore D. This hardness range is elastic enough to protect the patient from accidental trauma and is also hard enough to prevent the lumen within the sheath from collapsing.

  Inflow / outflow sheath 50 is a multi-lumen tube into which an arthroscope is inserted. Each lumen extends from a distal portion 51 of the sheath to a proximal portion 52 of the sheath. The proximal portion of the sheath includes one or more fluid ports such as first port 53 and second port 54, one or more stopcocks 55 or fluid switches, check valves, etc. One or more valves, manifold 56, or other means of controlling fluid flow within the sheath are provided. The distal portion 51 of the inflow / outflow sheath is provided with a plurality of holes 57. Each of the holes leads to one or more lumens in the tube so that fluid can flow between the surgical site and the lumen in the sheath.

  Prior to surgery, medical personnel or device manufacturers insert the arthroscope into the inflow / outflow non-invasive sheath and secure the set screw, snap-on attachment, or other removable attachment or sheath to the arthroscope Other means 58 secure the sheath to the arthroscope. In use, as shown by the inflow arrow 60, the surgeon can flow fluid, preferably saline, from the fluid source 59 through the arthroscope to the surgical area. (The arthroscope is provided with one or more lumens, ports or working tubes so that fluid can flow through the arthroscope to the surgical area.) Blood and other fluids and debris are As indicated by the outflow arrow 61, it flows from the surgical area through the hole 57 and through one or more lumens of the sheath. With clear saline inflow and turbid fluid and debris outflow, the surgeon can maintain a clear surgical field with one instrument. As a result, the use of a cleaning tool is not necessary. Therefore, the surgeon can perform an arthroscopic operation with only two incisions while maintaining a clear visual field.

  FIG. 7 illustrates a non-invasive sheath for fluid inflow / outflow using a vacuum source 70 or a gravity drain operably attached to a fluid port such as port 53 connected to a sheath manifold 56. It also shows how it flows through. Fluid is passed from the fluid source 59 (using a pump or gravity feed) operably attached to a fluid port such as the third port 72 or the fourth port 73 connected to the arthroscope, through the arthroscope. Provided. Depending on the performance of the arthroscope or the needs of the surgeon, the vacuum source and fluid source may be connected in different combinations to various ports on the inflow / outflow non-invasive sheath or arthroscope. For example, a vacuum source may be connected to port 73 of the inflow / outflow sheath and a fluid source connected to port 72. In this case, the surgeon can use only the inflow / outflow non-invasive sheath to introduce fluid into or out of the surgical site. Thus, even if the arthroscope does not have the ability to introduce fluid into or out of the surgical site, the surgeon can eliminate the need for a cleaning instrument by using an inflow / outflow sheath. In any case, a pressure sensor, a flow rate control system, and a feedback control system may be provided to automatically monitor and control the flow rate of fluid flowing into and out of the surgical site.

  FIG. 8 is a cross-sectional view of the distal portion of the inflow / outflow sheath 3 shown in FIG. The inflow / outflow sheath 50 has a central lumen 80 bordering the inner wall 81 into which the arthroscope is inserted. The sheath has four outer lumens: a first outer lumen 82, a second outer lumen 83, a third outer lumen 84, and a fourth outer lumen 85, which are an inner wall 81, an outer wall 86 and an inner wall. It borders on a relatively hard rib 87 extending between the outer walls and extending along the longitudinal direction of the sheath. The outer lumen is annular. The distal end of the sheath is sealed at the outer lumens 82, 83, 84, and 85, and is rounded to prevent trauma to the patient. (To accommodate the arthroscopy instrument, the central lumen is a cavity.) A hole 57 or opening located in the outer wall allows fluid to flow into and out of the outer lumen. For example, the lumens 82 and 84 may be used as passages through which fluid is introduced into the surgical site, and the lumens 83 and 85 may be used as passages through which fluid flows out of the surgical site. In another surgical procedure, all four lumens may be used to flush or introduce fluid. Thus, the surgeon is given the option of using the inflow / outflow non-invasive sheath in various ways. (After the sheath and arthroscope have been inserted into the surgical site, the sheath should have more or less than four ribs as long as at least one outer lumen is hollow for fluid flow. It doesn't matter.)

  Figures 9 through 16 show cross sections of the distal portions of various inflow / outflow non-invasive sheaths. FIG. 9 shows an inflow / outflow non-invasive sheath having a second set of inner lumens, a first inner lumen 100, a second inner lumen 101, a third inner lumen 102, and a third inner lumen. 103 is included in it. In this design, all of the inner lumen is used to introduce fluid into the surgical site and all of the outer lumens 82, 83, 84, and 85 are used to drain fluid from the surgical site (or vice versa) The surgeon can increase the fluid exchange rate.

  FIG. 10 shows an inflow / outflow sheath without an inner wall. When the arthroscope is inserted into the sheath instead of having an inner wall, the outer surface of the arthroscope 2 functions as the inner wall of the sheath. Four relatively stiff ribs 87 are in intimate contact with the outer surface 88 of the arthroscope, resulting in the formation of four outer lumens 82, 83, 84 and 85. The rib end 104 may be provided with a resilient flange or extension to further enhance the tight contact between the rib and the arthroscope. With this configuration, the dimensions of the inflow / outflow sheath and the arthroscopic complex can be reduced as a whole. (If the outer wall 86 is made of an elastomeric material, the tube will extend radially to match the various dimensions of the arthroscope.)

  As shown in FIG. 10, the arthroscope 2 is inserted into the sheath 50 through the central lumen 80. The arthroscope 2 may or may not be covered with a second protective sheath before insertion. Once inserted, the outer surface 88 of the arthroscope 2 contacts the flange or extended portion of the rib 87. If the rib 87 does not have a flange or extension, it may be used to contact the land of the rib with the outer surface of the arthroscope 2. The rib 87 and the outer surface 88 of the arthroscope 2 are brought into close contact with each other by the force that the outer surface 88 of the arthroscope 2 presses against the rib 87 and the rib flange or rib extension portion. The outer lumens 82, 83, 84 and 85 are formed by ribs, the outer surface of the endoscope 88 and the inner surface 89 of the outer wall 86 of the inflow / outflow sheath. The ribs act as vertical struts that prevent the sheath from collapsing and support the sheath under pressure. The ribs reduce the span in the lateral direction of the unsupported thin outer wall. Accordingly, the sheath can be further prevented from being crushed. A close contact state is formed by the contact between the rib 87 and the outer surface 88 of the arthroscope, thereby preventing fluid from flowing between the outer lumens 82, 83, 84, and 85. The outer lumens 82, 83, 84, and 85 facilitate a continuous operation that allows fluid to flow into or out of the surgical site from outside the patient 1. In order to prevent spilled fluid from returning to the surgical site and spilled fluid from escaping from the proximal end of the sheath, check valves or gates are flowed into / out of the outer lumens 82, 83, 84 and 85. You may connect with the inner wall of the outflow sheath 50. FIG.

  The outer diameter of the inflow / outflow sheath shown in FIG. 10 is typically about 5 to 7 mm when a sheath for an arthroscopy instrument is manufactured for a large joint, but this dimension is the size of the arthroscopy instrument. It may be different depending on the diameter. When a sheath for an arthroscopy instrument is manufactured for a smaller joint, the outer diameter of the sheath 50 is about 2 to 3 mm. The thickness of the outer wall 86 of the inflow / outflow sheath 50 depends on the expanded portion and the material constituting the tube, but is usually 1 mm or less. The inflow / outflow sheath 50 can be adapted to an arthroscope in the range of +/− 10% of the nominal diameter of the sheath. The ribs 87 extend inward from the inner surface of the inflow / outflow sheath, and are brought into close contact when the arthroscope is inserted.

  An inflow / outflow sheath 50 having a small outer diameter is particularly useful in arthroscopic surgery. Because of its uniqueness, the inflow / outflow sheath 50 achieves a 30% reduction in diameter compared to a multi-lumen cannula where the inner wall of the cannula needs to contact the outer wall of the arthroscope. Currently, arthroscopic surgery techniques use standard three incision techniques. For the first incision, an inflow cannula is inserted to expand the joint. The inflow cannula is used to fill the joint with sterile fluid, widen the joint, and create a space for the surgeon to observe and work with. In the second incision, an arthroscope is inserted to view the patient's surgical site. In the third incision, the surgeon inserts a special surgical instrument to correct the trauma or abnormality. After surgery, the joint is flushed with fluid, the instrument is removed, and the incision is closed with sutures, staples or taping. Surgeons have recently begun moving towards a two-incision technique using an arthroscope. The surgeon inserts an arthroscope at the first incision and a special surgical instrument at the second incision. With this technique using an arthroscope with an inflow / outflow sheath, a third incision is not necessary. However, in the sheath currently used for inflow / outflow, the inflow of fluid to the operation site and the outflow of fluid from the operation site cannot be performed simultaneously and the sheath having a small diameter is used. not. Current sheaths only alternately flow fluid into and out of the surgical site and are large in diameter and require large incisions. In Applicant's inflow / outflow sheath 50, the outer lumens 82, 83, 84, and 85 can be used to substantially simultaneously flow fluid into and out of the surgical site, Moreover, a small incision is sufficient. By performing the inflow / outflow substantially simultaneously, the surgeon can keep the surgical site clean and maintain a clear field of view.

  A unique feature of Applicant's inflow / outflow sheath 50 is the tolerance that the outflow exceeds the inflow of the sheath 50. If the amount of outflow is large, the removal of debris and body fluid from the surgical site is promoted. The fluid pressure supplied to the inflow / outflow sheath 50 is an arthroscopic standard dilation pressure, typically about 6 to 8 feet of pressure head, but this may vary depending on the surgical method. The suction force used for the inflow / outflow sheath 50 is about 0 to 250 mm / Hg, although it varies depending on the size of the sheath and the surgical method. When an inflow / outflow sheath is used with a 5.7 mm arthroscope, fluid inflow to the surgical site occurs at a rate of 800 ml / min with 6 feet of water, and outflow from the surgical site is 21 mm / Hg. Suction is performed at 850 ml / min. A large spill can eliminate both the irrigation fluid and any additional debris and fluid drained from the patient during surgery.

  FIG. 11 shows an inflow / outflow non-invasive sheath 50 similar to that shown in FIG. Although the relatively hard rib 87 is pleated, it is also in close contact with the outer wall of the arthroscope 2, so that once the arthroscope is inserted into the sheath, outer lumens 82, 83, 84 and 85 are formed. . The sheath of FIG. 11 can accommodate various sizes of arthroscopes because the pleated ribs bend to the extent necessary to accommodate a large arthroscope, as shown in FIG.

  FIG. 13 shows an inflow / outflow non-invasive sheath 50 similar to that shown in FIG. The ribs of the sheath are elastic tubes that are in close contact with the outer wall of the arthroscope 2. Once the arthroscope is inserted into the sheath, outer lumens 82, 83, 84, and 85 are formed. As shown in FIG. 14, the sheath of FIG. 13 is compressed to the extent necessary to accommodate the large arthroscope, so that various sizes of arthroscopes can be accommodated.

  FIG. 15 shows a C-shaped or scoring inflow / outflow sheath 50. Similar to the sheath of FIG. 8, four outer lumens 82, 83, 84 and 85 are provided and border the three ribs 87, inner wall 81 and outer wall 86. When the arthroscope 2 is inserted into the sheath, a small gap 105 is formed between the respective tips of the arcuate first segment and the arcuate second segment. (When the arthroscope is inserted into the surgical site space, the tissue 108 closes the gap and prevents fluid from leaking out of the surgical site space out of the body.) The sheath of FIG. When a large arthroscope is inserted into the sheath, the arcuate segments move radially outwards, so that various sizes of arthroscopes can be stored.

  The protrusion or guide rail 109 may be arbitrarily extended from the arthroscope or the sheath. The guide rail helps the sheath align with the arthroscope when the user inserts the arthroscope into the sheath. The guide rail also prevents the sheath from unintentionally rotating or bending over the arthroscope during surgery.

  17 and 18 show the inflow / outflow non-invasive sheath 50 and the arthroscope 2 inserted into the sheath. In contrast to the inflow / outflow sheaths shown in FIGS. 6-16, the outer wall 86 of the distal end portion 51 of the sheath is made of a continuous tube (ie, there are no holes in the distal end portion of the sheath). . However, like the sheath of FIG. 8, the sheath of FIG. 17 has an inner lumen for accommodating the arthroscope, and a first outer lumen 82, a second outer lumen 83, a third outer lumen 84, and a fourth outer lumen. It has four outer lumens for inflow and outflow of fluid including the cavity 85. The outer lumen borders the inner wall 81, the outer wall 86 and the support rib 87. The instrument shown in FIG. 17 assists in the flow of fluid into and out of the distal end 110 of the sheath.

  FIG. 19 shows an inflow / outflow non-invasive sheath 50 having an end portion 111 that fits snugly. The distal portion has an inner diameter that closely matches the outer diameter of the distal portion of the arthroscope 2. A sheath portion 112 that directs the fluid is located proximally from the distal end portion 111 of the closely-fitting sheath. The outer diameter of the fluid introduction portion 112 and the outer diameter of the closely-fitting end portion 111 may be integrally formed so as to be part of the same sheath. A hole 57 in the fluid introduction portion 112 near the proximal direction of the distal portion 111 communicates with one or more lumens in the sheath so that the surgeon can use it to introduce fluid into the surgical site or there. Fluid can be drained from. The sheath shown in FIG. 19 has a relatively small radius distal portion 111 because the sheath fits closely to the arthroscope at the distal portion of the arthroscope. Thus, the surgeon can insert the arthroscope into a narrow surgical site. In addition, the fluid introduction portion allows the surgeon to clean the surgical area using the sheath / arthroscope complex.

  20 and 21 show a non-invasive sheath 3 disposed on the arthroscope 2 and a resilient grip 120 disposed on the proximal portion 121 of the sheath. A hollow ergonomic cylinder made of a resilient material (e.g., a thermoplastic elastomer) is preferred, with a grip 120 that is dimensioned to allow easy manipulation of the arthroscope and sheath even if the surgeon's hands are wet. The grip extends in the proximal direction of the proximal end 32 of the sheath such that the proximal portion 122 of the grip extends over the arthroscope 2 disposed within the sheath 3. (The sheath proximal end portion 121 in FIG. 20 is shown as a model to show the position in the grip.) The grip design has a shape with an inner diameter smaller than the outer diameter of the arthroscopy instrument. And preferably is biased into a shape having an inner diameter smaller than the inner diameter of the inner lumen of the sheath. Accordingly, as shown by arrow 123 in FIG. 21, the grip emits a radial force inwardly with respect to the instrument disposed in the sheath.

  In use, the proximal portion 122 of the grip 120 grips the arthroscope 2 disposed within the sheath 3. When the hand on the proximal side of the grip is released, the grip is biased to return to its original shape. Therefore, even if the arthroscope or the sheath is operated during the operation, the arthroscope can exist stably in the sheath.

  FIG. 22 shows the crossing of the non-invasive sheath 3 placed on the arthroscope 2, the resilient grip 120, and the levers 124 and 125 placed in the grip for the purpose of widening the proximal opening of the grip. Shows the surface. The grip shown in FIG. 22 is provided with a first channel 126 and a second channel 127 used to insert the first lever 124 and the second lever 125, respectively. The lever is provided with barbs, tongues or other means for securing the lever within each channel. The end portion of the lever is shaped so as to be bent away from the sheath while bowing.

  In use, the user compresses the end portion of the lever. When the distal end portion of the lever moves radially inward, the proximal end portion of the lever applies a force that radially directs the corresponding segment of the proximal end portion of the grip outward, and the proximal end portion of the grip radially Bent outward. As a result, the opening at the proximal end of the grip expands. If the opening at the proximal end of the grip expands, the user can easily insert and remove the arthroscope from the sheath. A fulcrum 128 located at the end of the lever prevents the lever from moving radially inward beyond a predetermined distance. With the fulcrum, the user can apply a stronger force to the corresponding segment of the proximal end portion of the grip, further facilitating instrument insertion.

  FIGS. 23 and 24 show the end of the grip 120 and the levers 124 and 125 extending from the end of the grip. In FIG. 23, the sheath 3 extending from the grip in the distal direction is shown for reference. Channels 126 and 127 disposed within the grip extend longitudinally (or partially through) the grip to accommodate the lever. In use, the user compresses the lever and widens the proximal end portion of the grip. The user then inserts and removes the arthroscope from the sheath.

  FIG. 25 shows the distal portion of the non-invasive sheath 3 and the arthroscope 2 extending distally from the distal end 140 of the sheath 3. A hole 57 is provided in the end portion of the sheath. The hole communicates with one or more lumens of the sheath. The lumen leads to a vacuum source, a fluid source, a therapeutic agent source, or a complex thereof. Thus, the holes assist fluid inflow / outflow during surgery.

  The distal end 141 on the distal end side of the sheath is made of an elastic material having an elastic coefficient larger than that of the material on the proximal end side portion of the sheath. In another embodiment, a single polymer that is flexible and sterilizable may be used to fabricate the sheath and distal tip 141. Furthermore, the distal tip of the sheath has an inner diameter that is slightly smaller than the outer diameter of most arthroscopes. In another embodiment, the sheath and distal tip 141 may be manufactured using a single polymer that is flexible and sterilizable.

  In use, the user inserts the arthroscope into the sheath. The distal tip of the sheath expands as the distal end of the arthroscope slides past the distal tip. Since the inner diameter of the tip is smaller than the outer diameter of the arthroscope, the tip is in close contact with the arthroscope so as not to pass fluid.

  FIG. 26 shows the arthroscope 2 extending distally through the non-invasive sheath 3 and the distal end 140 of the sheath. Since the sheath is provided with a hole 57, fluid can flow in and out during surgery. The distal end 141 on the distal end side of the sheath is made of an elastic material having a hardness smaller than the hardness of the proximal end side portion of the sheath. Since the front end is provided with a cut 142, it can be expanded toward the distal end portion of the sheath. In use, the tip expands as the user inserts the arthroscope into the tip. Thus, the sheath can also accommodate large arthroscopes and other medical instruments.

  FIGS. 27 and 28 show a continuous inflow / outflow non-invasive sheath 50 having a tissue storage function 113. The outer surface of the proximal portion 52 of the sheath is corrugated to prevent accidental removal of the sheath or instrument from the surgical area. Alternatively, a thread 114 is provided. The thread 114 of the tissue storage function 113 is disposed around the sheath. As shown in FIG. 27, it may be a series-shaped thread extending radially outward. The thread 114 of the tissue storage function 113 may be a threaded screw type as shown in FIG.

  FIGS. 29 and 30 show a state in which the tissue storage function is incorporated into a separate tissue storage sleeve 115 that is used on the non-invasive sheath 50 without the tissue storage function 113. In this embodiment, the tissue storage sleeve is sized to fit over the non-invasive sheath. The tissue storage sleeve is manufactured using an elastomer that has a coefficient of friction such that once the part is slid over the outer surface of the non-invasive sheath and placed in place, it cannot be moved any further. Sleeve friction is compatible with surgical instruments and non-invasive sheaths. Elastomers can be sterilized for patients. The outer surface of the tissue storage sleeve is corrugated to prevent the sheath or instrument from accidentally falling out of the surgical area when the tissue storage sleeve is used in a sheath or instrument. Alternatively, a thread is provided. The threads 114 on the sleeve are arranged around the outer surface of the sleeve 115, but may be series threads extending radially outward. The thread 114 may be a threaded screw type.

  The non-invasive sheath configuration may be designed or dimensioned to accommodate different shaped instruments. The sheath of the present invention is also useful for other medical instruments and surgical procedures where the surrounding tissue needs to be protected from accidental trauma. For example, a non-invasive sheath may be placed on a trimming instrument during surgery using an arthroscope or using an energy delivery medical instrument such as a laser or RF energy instrument. Other techniques that benefit from a non-invasive sheath include surgery using a laparoscope and surgery using other endoscopes. Furthermore, other types of sheaths for instruments may be formed by combining the sheaths of various configurations shown in the present application. Although only preferred method embodiments are shown in this application in the context of the developed environment, they are merely illustrative of the principles of the present invention. Other embodiments and configurations may be devised without departing from the spirit of the invention and the scope of the appended claims.

Figure 3 shows how to perform arthroscopic surgery on a patient. 1 shows a non-invasive sheath used in an arthroscopy instrument. Figure 2 shows a non-invasive sheath with two tabs. 1 shows a non-invasive sheath used in an arthroscopy instrument and an arthroscope placed within the non-invasive sheath. Figure 2 shows a non-invasive sheath used for an arthroscopy instrument, an arthroscopy instrument placed inside the non-invasive sheath, and a irrigation tube placed on the sheath. FIG. 3 shows a cross-section of the non-invasive sheath shown in FIG. 2, with the arthroscopy instrument positioned within the non-invasive sheath. Figure 3 shows an inflow / outflow non-invasive sheath for an arthroscopy instrument. Figure 2 shows an inflow / outflow non-invasive sheath for an arthroscopy instrument and an arthroscope positioned within the non-invasive sheath. Figure 8 shows a cross section of the distal portion of the inflow / outflow non-invasive sheath of Figure 7; Figure 3 shows a cross section of the distal portion of an inflow / outflow non-invasive sheath. Figure 3 shows a cross section of the distal portion of an inflow / outflow non-invasive sheath. Figure 3 shows a cross section of the distal portion of an inflow / outflow non-invasive sheath. Figure 3 shows a cross section of the distal portion of an inflow / outflow non-invasive sheath. Figure 3 shows a cross section of the distal portion of an inflow / outflow non-invasive sheath. Figure 3 shows a cross section of the distal portion of an inflow / outflow non-invasive sheath. Figure 3 shows a cross section of the distal portion of an inflow / outflow non-invasive sheath. Figure 3 shows a cross section of the distal portion of an inflow / outflow non-invasive sheath. Figure 3 shows an inflow / outflow non-invasive sheath for an arthroscopy instrument. Figure 18 shows a cross section of the distal portion of the inflow / outflow non-invasive sheath of Figure 17; Fig. 5 shows an inflow / outflow sheath having an inner diameter end portion very close to the outer diameter of the arthroscopic end portion. Fig. 5 shows a non-invasive sheath and a resilient grip disposed on the proximal portion of the sheath. FIG. 6 shows a cross-section of a non-invasive sheath placed over an arthroscope and a resilient grip placed on the proximal portion of the sheath. Fig. 5 shows a cross section of a non-invasive sheath placed over an arthroscope, a resilient grip and a lever placed in the grip. The end portion of the grip is shown. Fig. 5 shows a lever extending in a distal direction from a grip end portion and a grip opening. FIG. 6 shows a distal portion of a non-invasive sheath and a distal arthroscope extending distally of the sheath. FIG. 6 shows a distal portion of a non-invasive sheath and a distal arthroscope extending distally of the sheath. Fig. 5 shows a continuous inflow / outflow non-invasive sheath with a radially extending thread-type tissue storage function. Fig. 5 shows a continuous inflow / outflow non-invasive sheath with threaded screw-type tissue storage. Fig. 3 shows a tissue storage component placed over a non-invasive sheath. A tissue storage ring is shown.

Explanation of symbols

2 ... Arthroscopy instrument 3 ... Non-invasive sheath 13 ... Trimming instrument 15 ... Cleaning instrument 17 ... Optical instrument 18 ... Cannula 19 ... Tip or distal end 30 ... Flange 31 ... Lens 32 ... Base end 33 ... Tab 34 ... Balloon 35 ... Second working tube

Claims (10)

A system for performing a surgical operation using an arthroscope,
An arthroscopic instrument suitable for performing arthroscopic surgery,
A non-invasive sheath comprising a proximal portion and a tube characterized by a proximal end, the sheath having an inner diameter that is very close to the outer diameter of the arthroscopic instrument and removable on the arthroscopic instrument A non-invasive sheath placed in a state;
A cylindrical grip disposed on the proximal portion of the sheath, characterized by the proximal portion;
With
A proximal end portion of the grip extends in a proximal direction beyond the proximal end of the sheath;
The material of the proximal end portion of the grip and the dimensions of the proximal end portion of the grip are selected to be biased into a shape having an inner diameter that is smaller than the outer diameter of the arthroscopic instrument, whereby the grip The proximal end portion of can be used to grab the arthroscopy instrument,
A first lever and a second lever that are attached to the grip in an operable state, and that can radially move the first portion and the second portion in the circumferential direction of the proximal end portion of the grip further outward. Including the system. The first lever and the second lever extend in a distal direction from the grip,
Before SL-terminal portion of the first lever and the second lever system of claim 1, wherein it contains an arcuate segment extending radially outwardly from the sheath. The system according to claim 2 , further comprising a first fulcrum disposed at an end portion of the first lever and a second fulcrum disposed at an end portion of the second lever.   Further comprising a first tab disposed on the sheath, wherein the first tab prevents fluid disposed outside the sheath from moving in a proximal direction of the tab. The system according to claim 1. The apparatus further includes a second tab disposed on a distal side of the first tab on the sheath, and the second tab moves a fluid disposed outside the sheath toward a proximal direction of the second tab. 5. The system of claim 4, wherein The tip of the front Symbol distal consists of a material having a softer hardness than the hardness of the sheath,
The system of claim 1, wherein the distal tip has an inner diameter that is smaller than an inner diameter of the sheath. 7. The system of claim 6 , wherein the tip has a tear at at least one location of the tip. Before SL sheath further having a terminal portion disposed holes of the sheath, the hole is in communication with lumen disposed within the sheath from the outer diameter of the sheath, thereby the fluid is surgery through the hole The system of claim 1, wherein the system is adapted to be sent to a site or sucked from a surgical site. Before SL sheath further has a hole disposed at the end portion of the sheath, the hole is in communication with lumen disposed within the sheath from the outer diameter of the sheath, is thereby fluid surgical through said hole 5. The system of claim 4 , wherein the system is adapted to be sent to a surgical site or sucked from a surgical site. Before SL sheath further has a hole disposed at the end portion of the sheath, the hole is in communication with lumen disposed within the sheath from the outer diameter of the sheath, is thereby fluid surgical through said hole The system according to claim 6 , wherein the system is adapted to be sent to a surgical site or sucked from a surgical site.

Images