BRACED BRACHYTHERAPY NEEDLE
Braces to reduce bending of a brachytherapy needle during insertion into a patient, as well as methods of using the needle braces and kits useful therefor.
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This application is a continuation of U.S. Non-Provisional patent application Ser. No. 13/515,375 titled Braced Brachytherapy Needle, filed on Jun. 12, 2012, which claims the benefit of International Patent Application PCT/US10/61764 filed on Dec. 22, 2010, which claims priority to U.S. Provisional Application 61/289,492, filed Dec. 23, 2009, all of which are hereby incorporated by reference in their entirety.
FIELD OF THE INVENTIONThe present invention is directed to the field of brachytherapy equipment. More specifically, the present invention relates to a brachytherapy needle and a brace to help minimize bending of the needle during needle insertion into a patient.
BACKGROUND OF THE INVENTIONImplanting brachytherapy seeds into a patient typically involves loading a number of such seeds, possibly including spacers between successive and either loosely or within a carrier strand, into a brachytherapy implantation needle. The needles are typically formed from a medically-compliant metal, such as stainless steel. The loaded needle typically includes the seeds at one end within the needle and a stylet extending from the seeds out the opposite end of the needle. A grid, or template, providing guide-holes is sometimes positioned against the patient so that the physician may accurately guide the seeds to their proper location in or about the target tissue by inserting the needle through the proper hole in the grid. The grid body, being about one-inch thick, receives and provides some support to the sharpened end of the needle. The physician typically drives the needle into the patient by grasping the needle by its hub at the free end. It is preferable to hold the needle by the hub so as to reduce the exposure of the hands to the radioactivity of the seeds at the far end. However, as the grid body holds the sharp end of the needle and the physician holds the needle by the hub at the opposite end, dermal resistance to being punctured can lead to buckling stresses on the needle, causing the needle to deflect or bow quite noticeably. Once the needle begins to penetrate the through the dermis into the perineum, the buckling problem dissipates as the inner tissue provides much less resistance than the dermis.
The buckling problem has been more pronounced as the delivery needles get smaller in size. For example, the brachytherapy seeds sold as THINSEED™ (marketed by the General Electric Company through its GE Healthcare business) may be implanted using a 20 gage needle. The buckling problem has been observed in some early procedures using THINSEED. As the needle passageway is typically filled throughout its length by seeds and/or spacers and the stylet, permanent deformation of the needle due to the penetration compression forces applied to it is less likely. Nevertheless, physicians report that the bowing of the needle can be a distraction in performing the operation. Physicians will typically hold the needle body with one hand as the other pushes on the needle hub to drive the needle into the patient. Such a manual technique increases physician exposure to the activity of the loaded needles. While thicker needles could be employed, thinner needles are desirable for the lower insult caused to the patient by the smaller tissue displacement as the needle passes and the thinner seeds remain implanted.
There is therefore a need for a device that will limit the deflection of a brachytherapy needle during penetration. The device should desirably allow the physician to maintain some stand-off from the seeds within the needle so as to help minimize extremity exposure to the activity of the brachytherapy seeds.
SUMMARY OF THE INVENTIONIn view of the needs of the prior art, the present invention provides a brachytherapy needle with a brace which reduces bending of the needle as the needle is inserted into a patient.
The present invention also provides a kit for brachytherapy device including at least one brachytherapy needle and a brace for minimizing the bending of the needle as it is inserted into a patient during a brachytherapy implantation procedure.
The present invention also reduces extremity exposure while providing long axis rigidity to the needle to reduce bowing.
In addition to reducing bowing, the needle assist can be used as a guide for steering the needle during the penetration process for correct three dimensional placement of the seeds being implanted. This is commonly done by twisting the luer fitting of the needle and repetitively inserting and withdrawing the needle until the desired location is reached. This is also done by guiding the needle by hand, again adding to extremity exposure for the physician.
In addition to eliminating bowing, aiding guidance, and reducing exposure, the needle assist can be used to lock the needle stylet to the luer fitting to ensure the materials within the needle are secured during insertion to the patient. This is done by creating a removable resistive material between the needle stylet and the needle luer fitting.
The present invention provides braces for brachytherapy needles in order to reduce bowing (or bending or buckling) of the needle due to the longitudinal loads during insertion into a patient. The braces offer convenience to the physicians using the needles by reducing the need to manually hold the needle at a location near the radioactive brachytherapy load during needle insertion. Thus, the braces of the present invention help reduce extremity exposure to the activity of the needle loads by either providing the physician some degree of stand-off from the needle while manipulating it, and/or through the additional shielding the brace provides. Certain of the braces are connected to a stylet lock at the hub of the needle so as to ensure that the brace does not come off of the needle during transportation or handling of the needle prior to implantation.
The braces may be made of suitable materials which provide the structural rigidity to minimize bending of the needles during insertion into a patient. It is further contemplated that the braces may be formed from a material, or materials, which provide additional shielding against the activity of the needle loads while also providing a sufficient grip on the needle to resist movement due to gravitational or inertial forces. It may be desirable for the braces of the present invention to be able to slide along the needle body should the needle penetrate the patient a distance that is greater than the brace's closest distance to either the patient or the needle grid through which the needle passes proximate to the patient. Certain braces are contemplated to be provided with the brace in position on the needle body, while other braces are to be applied to the needle by the physician prior to implanting the needle. It is further contemplated that any of the braces of the present invention could be provided with a brachytherapy needle in kit form. The needle may be either pre-loaded with a brachytherapy load. The brachytherapy load being either one or more brachytherapy seeds and/or spacers, or a stranded brachtherapy product where one or more seeds and/or spacers are provided in a carrier material or suture as is known in the art.
The operating principle of the present invention is to provide a holding force along the needle body so as to reduce the bowing stress, which is a function of body length. Desirably, the brace is applied generally about the position of maximum bowing (were it to occur), or at a point about mid-way between the needle hub and the placement grid after the needle has been inserted into the grid but prior to penetration of tissue, although the exact placement may be selected by the physician. Once the needle has penetrated the dermis, the bowing forces are generally dissipated as the tissue offers far less resistance to further needle penetration. Thus it is desirable that the brace is able to slide along the needle body should continued insertion of the needle cause the brace to run into the grid body.
With reference to
Needle 20 is a suitable for performing brachytherapy procedures, such as 16-gage, 18-gage, or 20-gage needle. Needle 20 has a tubular needle body 22 having opposed first and second open ends, 24 and 26 respectively, and an elongate cylindrical body wall 28 extending therebetween. Needle body 22 defines an elongate passageway 30 extending in fluid communication with first and second openings 32 and 34 respectively defined by first and second open ends 24 and 26. Needle 20 includes a brachytherapy load positioned within passageway 30 for dispensing out first end 24, as is known in the prior art. Needle 20 typically includes a needle hub 36 at second end 26 and an elongate stylet 38 which is extendable through opening 34 and passageway 30 for dispensing the brachytherapy load.
With particular reference to
Referring now to
In
Brace 110 may be formed as a unitary structure, as shown in
The longitudinal length of brace 110 may be selected to satisfy the purpose of the present invention, to reduce the bowing of its respective needle. For example, while brace 110 may be from about 0.25 inches to 1 inch in length, the present invention contemplates that the length is only limited by the length of needle extending between the needle hub and the grid body when the needle has reached its maximum insertion depth. The thickness of brace 10 is selected to be sufficient for the needle on which it is to be positioned. It is further contemplated that brace body 112 forms one or more detents or projections which may be deflected to engage the needle body onto which it has been positioned.
In
In
In
The present invention further provides a kit for a brachytherapy procedure, the kit includes an elongate needle having a tubular needle body and a brace of the present invention adapted to engage a portion of said body wall of said needle so as to reduce bending of said needle as said needle is inserted into a patient. The needle desirably includes at least one brachytherapy source positioned within said passageway thereof. The kit desirably also includes an elongate stylet adapted to be extendable through the needle so as to effect dispensing of the brachytherapy source. The kit is desirably provided sterilized within a sealed container which maintains the sterility of the kit components.
While the particular embodiment of the present invention has been shown and described, it will be obvious to those skilled in the art that changes and modifications may be made without departing from the teachings of the invention. The matter set forth in the foregoing description and accompanying drawings is offered by way of illustration only and not as a limitation. The actual scope of the invention is intended to be defined in the following claims when viewed in their proper perspective based on the prior art.
Claims
1. A brace for a brachytherapy needle comprising:
- an elongated body;
- an inner body received within the elongated body and defining an engagement member configured to slidably receive the needle; and
- wherein the brace is operative to both reduce bending of the needle during insertion into a patient and to provide shielding from radioactivity.
2. The brace of claim 1, wherein the inner body has a substantially cylindrical shape.
3. The brace of claim 1, wherein the elongated body defines an elongated transverse opening.
4. The brace of claim 1, wherein the elongated body and the inner body are formed from a first material and a second material, respectively, the second material different than the first material.
5. The brace of claim 1, wherein the elongated body and the inner body are formed from a first material and a second material, respectively, the second material softer than the first material.
6. The brace of claim 1, wherein the elongated body comprises at least one projection configured to deflect upon engaging the needle.
7. The brace of claim 1 further comprising:
- a hub-engaging member connected to the elongated body and operative to engage a hub of the needle.
8. A method of performing brachytherapy on a patient comprising:
- supporting a needle with a brace so as to reduce bending of the needle during insertion into a patient;
- providing shielding from radioactivity via the brace; and
- wherein the brace includes an elongated body and an inner body received within the elongated body, the inner body defining an engagement member that slideably receives the needle.
9. The method of claim 8 further comprising:
- implanting a brachytherapy seed into the patient via the needle.
10. The method of claim 8, wherein the inner body has a substantially cylindrical shape.
11. The method of claim 8, wherein the elongated body defines an elongated transverse opening.
12. The method of claim 8, wherein the elongated body and the inner body are formed from a first material and a second material, respectively, the second material different than the first material.
13. The method of claim 8, wherein the elongated body and the inner body are formed from a first material and a second material, respectively, the second material softer than the first material.
14. The method of claim 8 further comprising:
- engaging the needle with a projection disposed on the elongated body such that the projection deflects.
15. The method of claim 8 further comprising:
- engaging a hub of the needle with a hub-engaging member connected to the elongated body.
16. A kit for a brachytherapy procedure comprising:
- a needle operative to implant a seed into a patient;
- a brace for supporting the needle during implantation of the seed into the patient; and
- wherein the brace includes an elongated body and an inner body received within the elongated body, the inner body defining an engagement member operative to slideably receive the needle.
17. The kit of claim 16, wherein the inner body has a substantially cylindrical shape.
18. The kit of claim 16, wherein the elongated body and the inner body are formed from a first material and a second material, respectively, the second material different than the first material.
19. The kit of claim 16 further comprising:
- a stylet operative to be received by the needle.
20. The kit of claim 19 further comprising:
- a stylet lock operative to hold the stylet in place with respect to the needle.
Type: Application
Filed: Aug 23, 2017
Publication Date: Dec 7, 2017
Applicant: MEDI-PHYSICS, INC. (PRINCETON, NJ)
Inventors: ROBERT CHISHOLM (MARLBOROUGH, MA), JAY REED (ELK GROVE VILLAGE, IL), KEVIN HELLE (BARTLETT, IL)
Application Number: 15/684,309