USRE33258E - Irrigating, cutting and aspirating system for percutaneous surgery - Google Patents

Abstract

A percutaneous discectomy system 10 includes a discectomy device 12 having a needle 16 with a port 48 and a flared cutting edge 44 which is actuated past the port 48 to sever tissue provided adjacent thereto. An irrigation device is 18 are provided for irrigating the area adjacent the tip 46 of the needle 16 to assist a vacuum device 22 in aspirating the severed tissue away from the disc. The discectomy system 10 assists in the removal of herniated disc tissue in order to relieve pressure on the nerves located adjacent thereto. In addition, the needle 16 is flexible so that it can be temporarily or permanently bent around other body tissues such as the pelvis in order to access discs which are surgically hard to reach otherwise.

Description

TECHNICAL FIELD

The present invention relates to a surgical cutting device and, in particular, to a percutaneous discectomy device for removing nucleus pulposus from a herniated spinal disc.

BACKGROUND ART

An estimated eight million Americans suffer chronic low back pain due to disc problems requiring a total disability health care expenditure of over twenty billion dollars. The interverebrate disc can be looked upon as an osmotic system. .[.Bacuse.]. .Iadd.Because .Iaddend.of a breakdown of macromolecules as a person ages, the number of particles in the internal softer tissue of the disc, known as nucleus pulposus, increases and causes a rise in osmotic pressure, which in turn causes a fluid influx into the disc and raises the intradisc pressure. Concomitantly, fissures begin to form in the fibrous annulus, which defines the outer periphery of the disc, because of the biomechanical forces placed upon it. Accordingly, the intervertebral disc may extend through the annulus thereof and compress nerve roots, causing great pain. The remedy has been in the past to reduce the mechanical forces that were causing the increase in disc pressure by placing the patient in bed. When such conservative therapy failed, the surgical approach was followed.

A current surgical approach aims at a total disc removal through a partial hemilaminectomy and thus entails the risks that are associated with major surgery and general anesthesia. In addition, costs of this surgery and the in-hospital convalescence required are large.

Chemonucleolysis has been tried to avoid these problems. The intradiscal pressure is decreased by the percutaneous introduction of chymopapain into the intervertebral disc to dissolve it. Such an approach is effective in the majority of patients but does has some side effects, as some patients are hypersensitive to the drug.

SUMMARY OF THE INVENTION

The present invention is directed to overcoming all of the problems associated with prior surgical and drug treatments by providing a percutaneous discectomy system which can selectively remove herniated disc tissue in a surgical procedure which does not have the traumatic effect on the patient associated with prior surgical procedures. The guillotine type cutting action of the system can effectively cut the herniated disc tissue into small portions while the irrigation and vacuum means of the system can efficiently aspirate the severed herniated disc material and remove same from the disc, decompressing the disc so as to relieve the pressure. Such a procedure can allow the patient to be up and about almost immediately after the procedure has been performed.

The present invention includes a percutaneous discectomy system for removing intervertebral disc tissue which comprises a probe including an elongate tubular member with an elongate central bore and port communicating through the tubular member with the central bore. The device further includes means for cutting the nucleus pulposus of the intervertebral disc, said means including another elongate tubular member having another central bore and a flared cutting edge. The another elongate tubular member is inserted into the central bore of the elongate tubular member and substantially spaced from said central bore of the needle, with the flared cutting edge contacting the central bore of the needle and positioned adjacent the port. The another elongate tubular memeber includes a slot provided through the flared cutting edge so that the space between the central bore and said another elongate tubular member communicates with the another central bore.

In another aspect of the invention, means are provided for communicating internal irrigating fluid in the space defined between the central bore of the needle and the another elongate tubular member of the cutting means. This fluid is used to irrigate the area around the port and the flared cutting edge and to act as a vehicle for the removal of the severed tissue. The general prior art includes probe type guillotine cutters which have a source of irrigating fluid provided externally to the needle adjacent a port. Such probes with external irrigation have not proven successful for aspirating disc tissue.

Additionally, to facilitate the removal of the severed tissue, a source of vacuum is adapted to communicate with the another central bore of the cutting means so as to aspirate the severed tissue.

Still further means are provided for driving the flared cutting edge past the port of the needle in a pulsed manner.

Accordingly, the present invention provides for a percutaneous discectomy device which allows the selected removal of herniated disc tissue without the major surgical implications of standard back surgery and without the side effects of chemical surgery. This system allows the surgery to occur rapidly without the trauma to the patient which is characteristic of other surgical techniques. The invention provides a guillotine cutting arrangement, irrigation system and vacuum or aspiration system which addresses the problem of cutting and removing disc tissue, which is often dry and tough.

In another aspect of the invention, both the needle and the cutting means are flexible so that if the disc tissue is difficult to reach, the needle and cutting means can be bent to curve around bone and tissue structures and address the proper disc without the requirement to drill through, for example, the pelvic bone. This is particularly important for the disc located between the fifth lumbar vertebra and the first sacroiliac vertebra. It is to be understood that the teachings of the present invention can be applied to other than percutaneous discectomy and fall within the scope of the claimed invention.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a partial schematic, partial section view of an embodiment of the invention.

FIG. 2 depicts a cross-sectional view of the tip of the needle of the embodiment of the invention of FIG. 1.

FIG. 3 depicts a cross-sectional view similar to FIG. 2 with the cutting edge of the embodiment positioned midway through a cut.

FIG. 4 is a figure similar to FIG. 2 with the cutting edge all of the way through a cut.

FIG. 5 is a cross-sectional view taken .[.throuh.]. .Iadd.through .Iaddend.theline 5--5 in FIG. 2.

FIG. 6 is an alternative embodiment of the invention.

FIG. 7 is yet another alternative embodiment of the invention.

FIG. 8 is a schemiatic view of the needle positioned within a curved cannula sleeve, with the operative end of the needle exposed to remove disc tissue.

FIG. 9 is a view similar to FIG. 8 showing the cannula sleeve straight instead of being curved.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

With respect to the figures and in particular to FIG. 1, an embodiment of the percutaneous discectomy system of the invention is depicted and identified by the numeral 10. This descectomy system includes a hand-heldpercutaneous discectomy probe 12 which has aprobe body 14 and aprobe needle 16. The system further includes in a preferred embodiment adevice 18 for providing and controlling internal irrigation fluid under pressure, a device 20 for providing a pulsed source of positive pressure to drive the system and adevice 22 for providing a source of vacuum and collection means for aspirating cut disc tissue.Devices 18, 20, 22 can be included in a single control device console if desired.

Thebody 14 is comprised of acylindrical housing 24 which has acentral bore 26 and a backpressure relief vent 27. Disposed at one end of thecentral bore 26 is aplug 28 which has abore 30 provided therethrough. At the front end of thebody 14 is acap 32 which is secured to thebody 14 with glue or other appropriate means. Thecap 32 includes abore 34.Needle 16 is partially inserted intobore 34 and, in a preferred embodiment, glued in place. Anirrigation passage 36 communicates withbore 34 at a point adjacent the end ofneedle 16. Thisirrigation passage 36 also communicates with theirrigation fluid device 18. Theneedle 16 defines acentral bore 40. Located inside of thecentral bore 40 ofneedle 16 and thebore 30 ofplug 28 and also thecentral bore 26 ofcylindrical housing 24 is an elongatetubular cutting member 42 which has a flaredcutting edge 44 located adjacent theblunt end 46 of theneedle 16. An O-ring 38, located in a groove defined bycap 32 and located adjacent theplug 28, provides a seal abouttubular member 42.

As will be described more fully hereinbelow, the flaredcutting edge 44 is positioned to pass acrossport 48 located adjacentblunt end 46 and provided through theneedle 16. The flaredcutting edge 44 has aslot 50 therethrough which provides communication between acentral bore 52 of the elongatetubular cutting member 42 and the space located between thecentral bore 40 of theneedle 16 and the elongatetubular cutting member 42. The flaredcutting edge 44 is compressed when it is inserted in thecentral bore 40 ofneedle 16 in order to increase the effectiveness of the guillotine cutting action ofdevice 12. The fact that the rest of thetubular cutting member 42 is spaced from thecentral bore 40 ofneedle 16 not only allows the flow of irrigating fluid, as described below, but also reduces friction between theneedle 16 andmember 42.

Provided in thecentral bore 26 and located about the cuttingmember 42 is aspring 54. Secured to elongate tubular cuttingmember 42, at the opposite end fromcap 32, is a piston 56. Secured to piston 56 is a flexible diaphragm 58. Diaphragm 58 includes aperipheral lip 60 which is seated in annular groove 62 defined bycylindrical housing 24.

Aring member 64 is disposed against theperipheral lip 60 and held in place by a threadedring 66. This allows the threadedring 66 to be tightened against thering 64 which holds theperipheral lip 60 of the diaphragm 58 in place without causing the diaphragm to be pinched or twisted from its position. It is to be understood that upon .[.assemble.]. .Iadd.assembly.Iaddend., the diaphragm is positioned so that theslot 50 in the flared cuttingedge 44 is located opposite theport 48 at theblunt end 46 of theneedle 16.

Anothercap 68 is provided adjacent the piston 56 and includes a threaded portion which can be threaded to thebody 14 adjacent the threadedring 66. Achamber 74 is defined between thecap 68 and the diaphragm 58. Thecap 68 includes acentral bore 70 which guides a portion of the piston 56 and cuttingmember 42 and which provides a position to seat an O-ring 72, which provides a seal between the elongatetubular cutting member 42 and the anothercap 68. Thespring 54 biases the piston 56 and the cuttingmember 42 against thecap 68 so as to keep the flared cuttingedge 44 in a first position located adjacent theport 48 as shown in FIG. 2.

Thevacuum source device 22 is provided in communication with thecentral bore 52 of the elongatetubular cutting member 42 .Iadd.by .Iaddend.aspiration line 55, and the pulsed pressure device 20 is provided in communication with thechamber 74 through apassage 76 provided in the anothercap 68.

The various positions which thecutting edge 44 can occupy relative to theport 48 are shown in FIGS. 2, 3, 4. In FIG. 2, a first position is shown with theport 48 fully open. In FIG. 3, thecutting edge 44 is urged toward theblunt end 46 by pulsed pressure provided to thechamber 74 from the pressure device 20 to capture and sever a piece ofdisc tissue 78. In FIG. 4, thecutting edge 44 has passed completely by theport 48 and has severed thetissue 78 whereby, with the aid of the irrigating fluid shown by the arrows and the vacuum provided bydevice 22, the severed tissue is aspirated into a collection bottle of thedevice 22. A cross-sectional view of the needle including the slot of thecutting edge 44 is depicted in FIG. 5.

In a preferred embodiment, thehousing 14 can be comprised of plastic or other suitable materials, and theneedle 16 and thetubular cutting member 42 can be comprised of flexible stainless steel tubing with the elongate tubular cutting member .[.44.]. .Iadd.42 .Iaddend.chrome-plated to prevent galling. The needle and cuttingmember 42 can be permanently bent to a fixed orientation if desired or can be temporarily bent if it is provided through a bent sleeve as will be described hereinbelow.

In a preferred embodiment, the diameter of theneedle 16 is 0.084 inches, or approximately 2 millimeters, while the internal diameter of thecentral passage 40 of theneedle 16 is approximately 0.073 inches with the outer diameter of thetubular cutting member 42 being approximately 0.059 inches. This spacing provides for sufficient irrigating fluid to be provided to slot 50 in order to provide irrigation adjacent theport 48.

It is to be understood that other types of cutting arrangement such as rotating cutters can be used and be within the scope and spirit of the invention.

Alternate embodiments of the invention are depicted in FIGS. 6 and 7. In FIG. 6, an additionalelongate tube 80 is provided inside thecentral bore 52 of thetubular cutting member 42. Irrigation fluid can be provided therethrough into the area adjacent theport 48. In the other embodiment depicted in FIG. 7,apertures 86 are provided through the flared portion ofmember 42adjacent cutting edge 44.Apertures 86 provide internal irrigation fluid communication and allow for astrong cutting edge 44.

It is to be understood that with internal irrigation as provided by the present invention, irrigation fluid tends not to pass throughport 48 and thus does not interfere with the sucking of tissue intoport 48.

It is also to be understood that in addition to pulsing the source of positive pressure to drive diaphragm 58 and thus to drive the cuttingedge 44, the irrigation fluid fromdevice 18 as well as the vacuum fromdevice 22 is also pulsed as follows. The irrigation fluid is periodically pulsed off or to a reduced flow with theport 48 open so as not to reduce the .[.vacuuum.]. .Iadd.vacuum .Iaddend.and the efficiency thereof in pulling tissue into the port. As cutting is completed and thecutting edge 44 closesport 48, the irrigation fluid is pulsed on to assist in removing the severed tissue throughaspiration line 55. The vacuum is pulsed to prevent clogging of tissue inaspiration line 55 by providing an impulse to such tissue.

It is further to be understood thatdevice 18 can also control the irrigation fluid flow rate independently of the above periodic pulsed flow rate. This second control can be adjusted by the operator by observing the flow of irrigation fluid and tissue in theaspiration line 55 which in a preferred embodiment is substantially clear. If the operator observes a fast irrigation fluid flow with little tissue, the operator can decrease generally the flow rate independently of the first periodic pulsed flow rate so that the vacuum can be more efficient in aspirating tissue. If the operator observes a slow irrigation flud flow rate with much tissue, the operator can generally increase the fluid flow rate as a preventative measure so that tissue clogging does not occur.

INDUSTRIAL APPLICABILITY

The operation of the percutaneous discectomy system 10 is as follows. Using CT scan techniques and the like, theneedle 16 can be inserted straight-in between the appropriate vertebra and into the herniated disc. Prior to the insertion of theneedle 16, a small hole can be prepared through the fibrous annular ring which defines the outer periphery of the disc. The needle is then inserted through this opening.

As theneedle 16 is inserted through the hole drilled in the periphery of the disc, the irrigation device, the suction device, and positive pressure device are turned on to operate the guillotine cutting action of the flared cuttingedge 44 relative to theport 48 and to aspirate tissue. As the needle is inserted further into and through the disc, additional tissue is severed and aspirated. Also as the needle is rotated in place, theport 48 is exposed to different portions of the disc and additional tissue is severed and aspirated. Once the required amount of tissue is removed, the needle can be moved from the disc.

It is to be understood that if the disc is located in a hard-to-reach area such as between the fifth lumbar and the first sacroiliac vertebrae, then instead of cutting through part of the pelvis or other tissues or bone structures, an introduction and delivery system which includes a curved sleeve or cannula .Iadd.90 .Iaddend.as shown in FIG. 8 can be inserted using known techniques, such as with the aid of the CT scan so as to avoid the bone obstacles. Such an introduction and delivery system using astraight sleeve 92 as shown in FIG. 9 can also be used, if desired, in the above described straight-in procedure. Once thecannula 90,92 is positioned, the flexible needle can be inserted through the cannula into the disc so as to remove disc tissue along a linear path. It is to be understood that theport 48 can also be rotated throughout 360° in order to extract additional tissue. Further it is to be understood that if desired, theneedle 16 can be permanently bent, and without the use of a sleeve or cannula .Iadd.90, 92 .Iaddend.can be inserted into this position. However, there is then no opportunity to rotate theport 48 located in theneedle 16 in order to sever and aspirate tissue on a 360° basis. It is also to be understood that such an introduction and delivery system can be used generally with this invention and can also include devices for precisely maintaining the position of the probe relative to the body.

From the above it can be seen that the present invention provides for a system for removing tissue from a herniated disc without causing undue trauma to the patient. Additionally the system is flexible so that it can be positioned in otherwise surgically hard to reach areas, plus it provides for irrigation of the severed material to facilitate the aspiration thereof to the collection vessel. The pulsed vacuum creates impulses in the line which act as shock waves to further facilitate the aspiration of the tissue and prevent it from clogging in theneedle 16.

Other advantages of the invention can be obtained from a review of the figures and the appended claims. It is to be understood that although the present invention was described relative to a percutaneous discectomy procedure, that a similar system can be used to remove tissue from other portions of the body or for other unrelated purposes and fall within the scope of the invention and the appended claims.

Claims (13)

I claim:

1. A surgical instrument comprising:

a housing;

a needle supported by said housing, said needle having a forward portion extending distally of said housing;

said needle including a first elongated tubular wall member defining a first bore, and having a port formed entirely within the sidewall of the forward portion of said first tubular wall member;

said needle including a second elongated tubular wall member defining a second bore sized to permit passage of tissue therethrough when said second tubular wall member is connected to a source of suction, .Iadd.the passage within said second bore being unobstructed, .Iaddend.said second tubular wall member having a forward portion extending radially outwardly and terminating in a cutting edge;

said second tubular wall member being positioned within said first tubular wall member with said cutting edge in contact with the sidewall defining said first bore, the forward portion of said first bore adjacent said port defining a tissue receiving portion communicating with said second bore;

said first and second tubular wall members being the only tubular wall members in said forward portion of said needle;

the wall of said second tubular wall member spaced inwardly from the wall of said first tubular wall member to define the opposing walls of an annular passageway adapted to be connected to a source of irrigating fluid, said annular passageway being the sole annular chamber in said forward portion of said needle;

said second tubular wall member being disposed for movement within said first tubular wall member to cause said cutting edge to move from a first position where tissue is drawn through said port into said tissue receiving portion of said first bore under suction to a second position where said cutting edge traverses said port to sever the tissue drawn therethrough, and to permit the severed tissue to be captured in said tissue receiving portion;

said second tubular wall member having an opening formed in its sidewall .[.adjacent.]. .Iadd.extending to .Iaddend.said cutting edge to provide internal communication between said annular passageway and said second bore to permit direct passage within said needle of irrigating fluid between said annular passageway .Iadd.and said tissue receiving portion .Iaddend.and said second bore;

the forward portion of the sidewall of said first tubular wall member having no opening rearward of said cutting edge of said second tubular wall member when said cutting edge is in its first position;

whereby the severed tissue is evacuated through said second bore with the aid of the irrigating fluid.

2. The surgical instrument of claim 1 wherein said first tubular wall member has a cylindrical surface defining said sidewall and a blunt end wall, said port in said sidewall located adjacent said blunt end.

3. The surgical instrument of claim 1 further comprising means for moving said cutting edge of said second tubular wall member between its first and second positions.

4. The surgical instrument of claim 3 wherein said moving means includes a diaphragm associated with said second tubular wall member, and means for exposing said diaphragm to a source of pulsating positive pressure.

5. The surgical instrument of claim 1 further comprising means for providing the irrigating fluid to said annular passageway.

6. The surgical instrument of claim 5 further comprising means for regulating the flow of the irrigating fluid.

7. The surgical instrument of claim 1 further comprising means for providing the source of suction to said second tubular wall member.

8. The surgical instrument of claim 1 wherein the flow of irrigating fluid is "off" when said cutting edge is in its first position and "on" when said cutting edge is in its second position.[.;.]. .Iadd.. .Iaddend.

9. The surgical instrument of claim 1 further comprising a cannula adapted to receive said first tubular wall member.

10. The surgical instrument of claim 9 wherein said cannula is curved, said first and second tubular wall members being sufficiently flexible to fit within said curved cannula.

11. The surgical instrument of claim 1 .[.whereinn.]. .Iadd.wherein .Iaddend.said instrument is a percutaneous discectomy device.

12. A percutaneous discectomy surgical instrument comprising:

a housing;

a needle supported by said housing, said needle having a forward portion extending distally of said housing;

said needle including a first elongated tubular wall member defining a first bore, and having a port formed within the sidewall of the forward portion of said first tubular wall member;

said needle including a second elongated tubular wall member defining a second bore sized to permit passage of tissue therethrough when said second tubular wall member is connected to a source of suction, .Iadd.the passage within said second bore being unobstructed, .Iaddend.said second tubular wall member having a forward portion extending radially outwardly and terminating in a cutting edge;

said second tubular wall member being positioned within said first tubular wall member with said cutting edge in contact with the sidewall defining said first bore, the forward portion of said first bore adjacent said port defining a tissue receiving portion communicating with said second bore;

said first and second tubular wall members being the only tubular wall members in said forward portion of said needle;

the wall of said second tubular wall member spaced inwardly from the wall of said first tubular wall member to define the opposing walls of an annular passageway adapted to be connected to a source of irrigating fluid, said annular passageway being the sole annular chamber in said forward portion of said needle;

said second tubular wall member being disposed for movement within said first tubular wall member to cause said cutting edge to move from a first position where tissue is drawn through said port into said tissue receiving portion of said first bore under suction to a second position where said cutting edge .[.tranverses.]. .Iadd.traverses .Iaddend.said port to sever the tissue drawn therethrough, and to permit the severed tissue to be captured in said tissue receiving portion;

means for moving said cutting edge of said second tubular wall member between its first and second positions;

said second tubular wall member having an opening formed in its sidewall .[.adjacent.]. .Iadd.extending to .Iaddend.said cutting edge to provide internal communication between said annular passageway and said second bore to permit direct passage within said needle of irrigating fluid between said annular passageway .Iadd.and said tissue receiving portion .Iaddend.and said second bore;

the forward portion of the sidewall of said first tubular wall member having no opening rearward of said cutting edge of said second tubular wall member when said cutting edge is in its first position;

means for providing the irrigating fluid to said annular passageway; and

means for providing the source of suction to said second tubular wall member;

whereby the severed tissue is evacuated through said second bore with the aid of the irrigating fluid.

13. A percutaneous discectomy surgical instrument comprising:

a housing;

a needle supported by said housing, said needle having a forward portion extending distally of said housing;

said needle including a first elongated tubular wall member defining a first bore, and having a port formed entirely within the sidewall of the forward portion of said first tubular wall member;

said needle including a second elongated tubular wall member defining a second bore sized to permit passage of tissue therethrough when said second tubular wall member is connected to a source of suction, said second tubular wall member having a forward portion extending radially outwardly and terminating in a cutting edge;

said second tubular wall member being positioned within said first tubular wall member with said cutting edge in contact with the sidewall defining said first bore, the forward portion of said first bore adjacent said port defining a tissue receiving portion communicating with said second bore;

the wall of said second tubular wall member being spaced inwardly from the wall of said first tubular wall member to define the opposing walls of an annulus, said annulus providing the spacing for the forward portion of said second tubular wall member to extend radially outward and provide a cutting edge, said annulus being the sole annular space in said forward portion of said needle.[.,.]. .Iadd.; .Iaddend.

a third elongated tubular wall member positioned in said second bore and defining a passageway adapted to be connected to a source of irrigating fluid, said passageway being in communication with said second bore.Iadd., said third tubular wall member being the sole element in said second bore.Iaddend.;

said third elongated tubular wall member terminating approximately at said cutting edge of said second tubular wall member to provide direct passage within said needle of fluid between said third tubular wall member and said second bore;

said second tubular wall member being disposed for movement within said first tubular wall member to cause said cutting edge to move from a first position where tissue is drawn through said port into said tissue receiving portion of said first bore under suction to a second position where said cutting edge traverses said port to sever the tissue drawn therethrough, and to permit the severed tissue to be captured in said tissue receiving portion;

the forward portion of the sidewall of said first tubular wall member having no opening rearward of said cutting edge of said second tubular wall member when said cutting edge is in its first position;

whereby the severed tissue is evacuated through said second bore with the aid of the irrigating fluid.

Images