Patent Grant
8029495
The present invention relates generally to the field of surgical instruments and methods, and more particularly to an intrathecal catheter having a stylet with a curved forward end.
Human and animal subjects suffering from chronic pain have several options available to help alleviate the pain. One option is intrathecal drug delivery, in which a low dose of a medication, typically a narcotic such as morphine, is delivered to the intrathecal space (i.e., within the spinal canal). A typical system for intrathecal drug delivery includes a drug delivery pump implanted in the patient's abdomen, which has a reservoir for the medication, and a catheter leading from the pump into the intrathecal space. The pump releases the medication at a set rate, and the medication flows from the pump, through the catheter to the site of delivery in the intrathecal space. Intrathecal drug delivery is beneficial because typically smaller doses of the medication can be used, as compared to the dosages of those same medications taken orally.
However, implanting the device is not without risk. Inadvertently implanting the catheter into the spinal cord can result in permanent injury to the spinal cord, potentially resulting in irreversible paralysis. For example, there is some risk that the practitioner, when placing the guide needle or the styletted catheter within the spinal canal, might puncture the spinal cord with the sharp tip of the guide needle and/or the styletted catheter and subsequently accidentally thread the styletted catheter into the substance of the spinal cord. And since typically, most practitioners choose to perform this operation under general anesthesia in which the patient is completely unaware of the procedure, the patient will not know something is wrong until he or she wakes up, and in a more egregious case, the patient may wake up paralyzed from the waist down.
Therefore, a need exists for an apparatus and method that allows a catheter for an intrathecal drug delivery system to be guided more safely into proper placement within the intrathecal space.
Advantageously, the present invention provides an intrathecal catheter having a curved forward end for placement in the intrathecal space. The intrathecal catheter includes a guide wire or a stylet, within the catheter, that has a curved tip, and the tip of the catheter itself conforms to the shape of the stylet tip. Thus, the catheter provides a blunt forward end, which minimizes the likelihood of puncturing tissue, such as the spinal cord.
In an example form, the present invention provides an apparatus including a catheter for an intrathecal drug delivery system and a stylet, wherein the stylet has a curved forward end. Thus, the catheter has a tip that can conform to the curved forward end of the stylet. Preferably, the curved forward end of the stylet is in the shape of a “J” or a “C.” Also preferably, the curved forward end of the stylet is formed of a resilient and flexible material.
In one embodiment, the catheter has a single lumen for housing the stylet and for carrying a fluid from a fluid source to target tissue. Preferably, the catheter has a biocompatible body with at least one opening extending along the body near its distal end for drug delivery to target tissue.
In another form, the present invention provides a method for introducing a catheter for an intrathecal drug delivery system into the intrathecal space. The method includes the steps of inserting a stylet having a curved forward end into an intrathecal catheter; inserting the intrathecal catheter into an incision in the body; and guiding the intrathecal catheter into the intrathecal space by manipulation of the combination of the stylet and the catheter. The method can further include the steps of removing the stylet from the intrathecal catheter such that the catheter tip straightens out in the intrathecal space; anchoring the intrathecal catheter to adjacent tissue; and connecting the intrathecal catheter to a drug delivery pump.
In yet another example form, the present invention includes a kit for intrathecal drug delivery. The kit can include one or more of the following items packaged in a single kit: an intrathecal catheter, a stylet having a curved forward end, a drug delivery pump, a guide needle, an insertion device, a tunneling tool, and suturing supplies.
These and other aspects, features and advantages of the invention will be understood with reference to the drawing figures and detailed description herein, and will be realized by means of the various elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following brief description of the drawings and detailed description of the invention are exemplary and explanatory of preferred embodiments of the invention, and are not restrictive of the invention, as claimed.
The present invention may be understood more readily by reference to the following detailed description of the invention taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this invention is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of the claimed invention. Also, as used in the specification including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment.
Referring to
In an example embodiment, the catheter 10 has a length of about 60 to about 90 cm, an internal diameter in the range of about 0.4 to about 0.6 mm and more preferably in the range of 0.5 mm to 0.6 mm. In an example embodiment, the catheter 10 has an internal diameter of about 0.53 mm. The external diameter can be about 1.0 to about 3.0 mm, and more preferably from about 1.4 mm to about 2.0 mm, though those skilled in the art will understand that the dimensions can be larger or smaller. Preferably, the catheter 10 has a distal portion or tip 17 with a closed end 19. The distal portion 17 also preferably includes at least one and preferably a plurality of lateral (e.g., transverse to the catheter longitudinal axis) openings, slots, or holes 18 in the body 14 of catheter 10. The medication can be pumped through the lumen 16 forward to the distal portion 17 and then transversely out through the lateral openings and into the intrathecal space. As shown in the figures, the catheter 10 has three such openings 18, though those skilled in the art will understand that the catheter can have more or fewer openings. Those skilled in the art will also understand how to determine the placement of the openings and the spacing between the openings 18.
Also, a fitting 19, such as a conventional fitting as shown in
The stylet 12 has a tip or portion 20 at its distal end and a handle 21 at its proximal end for manipulating the stylet. Those skilled in the art will understand that the handle 21 shown in
Preferably, the stylet 12 is constructed of a resilient and flexible material that allows the tip 20 to resiliently deflect and adjust from a curved position in its neutral state to a straight position when being inserted through a guide needle or when being retracted from the catheter 10. Thus, at least the curved tip 20 of the stylet 12 is springy or flexible in the sense that when the stylet is being retracted from the catheter 10, the curved tip of the stylet straightens out within the confines of the lumen 16 as it is being pulled therethrough, and with the stylet distal tip removed then the distal portion 17 of the catheter 10 is allowed to also straighten out, so that removal from the catheter is made easier and minimizes the chances of tearing the catheter. The tip 20 of the stylet 12 can be constructed of a spring or coil material. Additionally, the entire stylet 12 can be a unitary piece that is constructed of a resilient, flexible, and biocompatible material, such as a plastic or a metal. Upon removal from the catheter 10, the flexible distal tip 20 of the stylet 12 resiliently returns to its neutral curved shape.
The size of the stylet 12 can vary, but in an example embodiment, the diameter of the stylet is smaller than the internal diameter of the catheter 10 and is about 0.46 mm. Those skilled in the art will understand that the stylet 12 can have a larger or smaller diameter, such as in the range of about 0.2 mm to about 0.52 mm and more preferably in the range of about 0.4 mm to about 0.5 mm. The length of the stylet 12 is preferably similar to the length of the catheter 10, and can be about 38 cm to about 89 cm, though those skilled in the art will understand that the dimensions can be larger or smaller.
The practitioner inserts the catheter 10 with the stylet 12 through a guide needle previously inserted through an incision in the patient's back and into the intrathecal space. Those skilled in the art will understand where and how to insert the guide needle. To facilitate threading the styletted catheter 10 into the needle, an insertion device 22, as depicted in
The guide needle or sheath generally deflects the curved tip 20 of the stylet 12 to at least a somewhat straight position so that the catheter and stylet can be threaded through the needle or sheath. Thus, while the styletted catheter 10 is threaded through he needle, the tip 20 of the stylet 12, and hence the distal portion 17 of the catheter 10, temporarily straighten out. Once the styletted catheter 10 is threaded through the needle, the tip 20 of the stylet 12 springs back into its curved shape (i.e., back to its neutral position), which causes the distal portion 17 of the catheter 10 to curve in shape. Alternatively, the curved tip of the catheter 10 can be threaded through a needle or sheath of a diameter sufficient to accommodate the diameter of the catheter in its curved tip position. Thus, the catheter 10 has a blunt forward end that can be manipulated through the intrathecal space.
The practitioner advances the catheter 10 into the intrathecal space, as pictorially shown in
Optionally, the tools that the practitioner uses to implant the catheter 10 into the patient can be assembled into a single kit 30. For example, the kit 30 can include a catheter 10 with a stylet 12 having a curved tip 20, a pump 13, a guide needle 32, an insertion device 22, a tunneling tool 36, an anchor (not shown), a sterile drape (not shown), and suturing supplies 34.
While the invention has been described with reference to preferred and example embodiments, it will be understood by those skilled in the art that a variety of modifications, additions and deletions are within the scope of the invention, as defined by the following claims.
This application is a divisional of U.S. patent application Ser. No. 11/424,126, filed Jun. 14, 2006, now abanoned which claims priority to U.S. Provisional Patent Application Ser. No. 60/690,253, filed Jun. 14, 2005. The disclosures of application Ser. Nos. 11/424,126 and 60/690,253 are hereby incorporated herein by reference in their entireties for all purposes.
| Number | Name | Date | Kind |
|---|---|---|---|
| 2118631 | Charles | May 1938 | A |
| 3128769 | Scislowicz | Apr 1964 | A |
| 3867945 | Long | Feb 1975 | A |
| 4811743 | Stevens | Mar 1989 | A |
| 4813929 | Semrad | Mar 1989 | A |
| 4813938 | Raulerson | Mar 1989 | A |
| 4834709 | Banning et al. | May 1989 | A |
| 5003989 | Taylor et al. | Apr 1991 | A |
| 5045065 | Raulerson | Sep 1991 | A |
| 5250038 | Melker et al. | Oct 1993 | A |
| 5304140 | Kugo et al. | Apr 1994 | A |
| 5484419 | Fleck | Jan 1996 | A |
| 5807324 | Griffin, III | Sep 1998 | A |
| 6477402 | Lynch et al. | Nov 2002 | B1 |
| 6512957 | Witte | Jan 2003 | B1 |
| 20040073197 | Kim | Apr 2004 | A1 |
| 20040220543 | Heruth et al. | Nov 2004 | A1 |
| 20050107861 | Harris et al. | May 2005 | A1 |
| Number | Date | Country | |
|---|---|---|---|
| 20100179509 A1 | Jul 2010 | US |
| Number | Date | Country | |
|---|---|---|---|
| 60690253 | Jun 2005 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 11424126 | Jun 2006 | US |
| Child | 12731966 | US |
