Patent Application
20090088681
The invention relates to treating disease within a body, and more particularly to a system for thermally necrosing diseased tissue within the body and for preventing adhesion to necrosed tissue.
One disease treatable by such a system is endometriosis, a condition affecting millions of women. The condition is characterized by pelvic pain and dysmenorrhea, or painful menstruation, caused when endometrial tissue is present in areas other than the uterus, such as in the peritoneal cavity. Currently, endometriosis is treated with drug therapy, hysterectomy, and/or surgery to remove or coagulate the tissue.
Drug therapy includes administering pain medication and hormonal therapy to interrupt ovarian function and menstrual bleeding. Hormonal therapy may include use of estrogen and progesterone (such as in the form of oral contraceptive pills (OCPs)); progestins; synthetic androgens such as Danazol; Gonadotrophin Releasing Hormone (GnRH) agonists such as goserelin, nafarelin, Buserelin, and leuprorelin; mifepristone; selective progesterone receptor modulators (SPRMs) such as asoprisnil; or aromatase inhibitors. Drug therapy can suppress formation of new endometriosis lesions, but the treatment does not destroy or remove the disease. Drawbacks to drug therapy include problematic side effects. Additionally, many drug therapy treatments can only be administered for a limited time.
Hysterectomy is a treatment involving complete removal of the uterus. This treatment, however, only cures endometriosis some of the time. Furthermore, this treatment is not an option for those women seeking to become pregnant in the future.
The third type of treatment for endometriosis is minimally invasive surgery to remove or coagulate endometriosis lesions. This treatment, which is typically laparoscopic, can include mechanical excision of the tissue, radiofrequency ablation of endometrial lesions, plasma coagulation of endometrial lesions, or vaporization of the tissue by use of carbon dioxide laser. Even using such current surgical intervention-type treatments, however, endometriosis has a high rate of recurrence for a period from six to twenty-four months post-treatment.
Furthermore, adhesion formation may occur at the treatment site in the patient's body following a surgical treatment. Adhesions occur following an inflammatory process, like after a surgical incision, when new fibrous tissue forms and unites tissues normally separated. Resistance to adhesion formation is critical for the first one to two week period post-treatment.
Accordingly, an improved system for treating disease, such as endometriosis, that includes a minimally invasive procedure that thermally necroses the diseased tissue is needed. It is desirable that this improved system combines an improved procedure with direct delivery drug therapy. It is also desirable that this improved system combines an improved procedure with adhesion prevention. An improved medical instrument designed to perform the minimally invasive procedure and direct delivery drug therapy is also needed.
An apparatus, such as a medical device, includes an elongate member having a proximal end portion and a distal end portion. The elongate member defines a lumen extending from the proximal end portion to the distal end portion. The distal end portion of the elongate member is configured to be inserted into a body of a patient. The apparatus includes a heating element configured to heat the lumen defined by the elongate member such that a material within the lumen is heated and can be delivered to bodily tissue.
Generally, an embodiment of the invention is an apparatus, such as a medical device, configured to receive a material for necrosing bodily tissue, to heat or melt the material, and to deliver the material through a lumen of the apparatus and onto a target site in or on a body of a patient.
As schematically illustrated in
The elongate member 115 is configured to receive a material (not illustrated in
The delivery mechanism 150 is operatively coupled to the elongate member 115. The delivery mechanism 150 is configured to move at least a portion of the material through at least a portion of the lumen 140 of the elongate member 115. In some embodiments, the delivery mechanism 150 is configured to move at least a portion of the material through the lumen 140, out through the second opening 142, and onto a target site in a body of a patient. In some embodiments, the rate of material delivered into the body is in part controlled by the temperature used to heat the material. The more melted (or fluid-like) the material, the lower the viscosity of the material and the easier the material will flow. In one embodiment, the temperature of the heating element 160 is controlled by a thermocouple or similar temperature sensing equipment that is configured to provide feedback control to the heating element.
The insulation material 147 is disposed between an outer surface 145 of the elongate member 115 and the heating element 160. Additionally, in some embodiments, the insulation material 147 is disposed between the outer surface 145 of the elongate member 115 and the lumen 140. The insulation material 147 is configured to help prevent the outer surface 145 of the elongate member 115 from heating to an undesirably high temperature. For example, the insulation material 147 is configured to prevent the outer surface 145 of the elongate member 115 from reaching a temperature that would burn bodily tissue that contacts the outer surface.
The insulation material 147 also helps maintain the material passing through the lumen 140 at a desirable temperature, such as at a temperature capable of necrosing bodily tissue. In other words, the heating element 160 and the insulation material 147 are configured to control the temperature of the material passing through the lumen 140, thus allowing for a predictable thermal response when the material is delivered onto bodily tissue. For example, in one embodiment, the heating element 160 and the insulation material 147 are configured to maintain the material at a temperature that is within 5° C. of a desired temperature. In another embodiment, the heating element 160 and the insulation material 147 are configured to maintain the material at a temperature that is within 2° C. of a desired temperature.
Although the apparatus 100 is illustrated and described herein as including an insulation material 147, in some embodiments, the apparatus is otherwise configured to help prevent the outer surface 145 of the elongate member 115 from heating to an undesirably high temperature. For example, in some embodiments, the apparatus is configured with an air gap or space between the outer surface of the elongate member and the heating element. In such an embodiment, the air gap or space provides a layer of insulation.
As schematically illustrated in
The delivery mechanism 250 is operatively coupled to the elongate member 215 and is configured to move at least a portion of the material through at least a portion of the lumen 240. As shown in the embodiment schematically illustrated in
An apparatus 300, such as a medical device, according to one embodiment of the invention is illustrated in
The proximal end portion 320 of the elongate member 315 is configured to receive a material 400. In the illustrated embodiment, the proximal end portion 320 is a handle portion configured to receive the material 400 directly into the lumen 340. For example, the proximal end portion 320 can be configured to receive the material 400 into the lumen 340 via the first opening 322. In another embodiment, the apparatus is configured to receive the material 400 in a receiving chamber different than the lumen. For example, in such an embodiment, the receiving chamber may be disposed within the proximal end portion of the elongate member and may be fluidically connected to the lumen.
In some embodiments, the apparatus 300 includes two heating elements. In one such embodiment, the first heating element (not illustrated in
As illustrated in
When the actuator 352 of the delivery mechanism is actuated, the plunger moves the material 400 through at least a portion of the lumen 340. For example, the actuator 352 can cause the plunger to move the material 400 from a first location within the proximal end portion 320 of the elongate member 315 to a second location within the distal end portion 330. Specifically, in one embodiment, the plunger moves at least some of the material 400 through the second opening 342 at a distal tip 332 of the elongate member 315 and onto a target site in the body of the patient.
In one embodiment, the delivery mechanism is configured to deliver a specified amount of material 400 onto the target site in the body of the patient. For example, in one embodiment, the actuator 352 has one or more stops, wherein each stop corresponds to a different degree of extension of the plunger along the lumen 340 of the elongate member 315. The operator can select to move the actuator 352 to one of the one or more stops, and thereby select the degree of extension of the plunger through the lumen 340. Accordingly, the operator of the apparatus 300 can control the amount of material 400 moved through the lumen 340 and delivered onto the target site in the body of the patient.
In the embodiment illustrated in
In one embodiment, the delivery mechanism must be actuated to move the material 400 through the lumen 340. In other words, the material 400 moves through the lumen 340 only in response to the actuation of the delivery mechanism. For example, in the embodiment illustrated in
The distal end portion 330 of the elongate member 315 is configured to be inserted into a body of a patient. For example, the distal end portion 330 can be inserted into an insufflated bodily cavity. Specifically, in some embodiments, the distal end portion 330 has a relatively small diameter, which allows the apparatus 300 to be used in minimally invasive medical procedures, including laparoscopic and other procedures. For example, in one embodiment, the outside diameter of the distal end portion 330 is no greater than 10 mm (0.4″) in diameter. In this manner, the distal end portion 330 can fit through a trocar having an inner diameter no greater than 10 mm (0.4″). For example, the distal end portion 330 is configured to fit through a 10 mm (0.4″) trocar. In other embodiments, the outside diameter of the distal end portion 330 is greater than 10 mm (0.4″) in diameter.
In one embodiment, the distal end portion 330 is defined as the portion of the elongate member 315 extending from the distal tip 332 towards the actuator 352 and ending when the outside diameter of the elongate member increases in size. For example, the distal end portion can be the portion of the elongate member 315 extending from the distal tip 332 towards the actuator 352 and ending when the outside diameter of the elongate member is greater than 10 mm (0.4 inches). In another embodiment, the distal end portion 330 is the portion of the elongate member 315 extending from a distal tip 332 of the elongate member 315 to the actuator 352 of the delivery mechanism 350, the actuator being operatively coupled to the proximal end portion 320.
The distal end portion 330 of the elongate member 315 is of a length and configuration to reach a treatment site within a body of a patient. Accordingly, the distal end portion 330 of the elongate member 315 can be inserted into the body of the patient while the proximal end portion 320 remains outside the patient's body. For example, in one embodiment, the distal end portion 330 is no greater than 18″ (46 cm) in length. In another example, the distal end portion 330 is at least 12″ (31 cm) in length, but not greater than 18″ (46 cm) in length. In another embodiment, the distal end portion 330 is at least 18″ (46 cm) in length.
In the embodiment illustrated in
As illustrated in
In another embodiment, the material 400 is formulated to superficially necrose bodily tissue when the material is heated to a desired temperature. For example, when the material 400 is heated to a desired temperature and delivered or applied to bodily tissue, only the superficial layers of the bodily tissue are necrosed.
In one embodiment, the material 400 has a low thermal mass, such that the material cools quickly once delivered to a target site within a body of a patient. Thus, the material cools quickly to prevent prolonged exposure to the heat from the material which could otherwise damage healthy bodily materials or tissues proximate to the treatment site. A small amount of material 400 (low thermal mass) may also be used to ensure the material necroses only superficial bodily tissue when delivered to a target site within a body of a patient, and not underlying tissue.
In another embodiment, the material 400 is formulated to prevent adhesion of bodily material to necrosed bodily tissue. For example, the material 400 can be formulated to adhere to necrosed tissue and therein provide a barrier between the necrosed tissue and other bodily material or tissue, thus preventing adhesion. In yet another embodiment, the material is formulated to both thermally necrose bodily tissue when the material is heated and prevent adhesion of bodily material to the necrosed bodily tissue when the material cools.
In some embodiments, the material 400 includes a first material and a second material. For example, in one embodiment, the material includes a first material formulated to necrose bodily tissue and a second material formulated to prevent adhesion formation at the treatment site. In another example, the material includes a first material that is formulated to prevent adhesion formation and a second material that is formulated to enhance the first material's resistance to adhesion formation.
In one embodiment, the material comprises a polymer and a pharmaceutical agent. The pharmaceutical agent can be formulated to elute over a pre-determined period of time. In some embodiments, the pharmaceutical agent is formulated to treat disease. For example, the pharmaceutical agent can be at least one of estrogen and progesterone; progestins; synthetic androgens such as Danazol; GnRH agonists such as goserelin, nafarelin, Buserelin, and leuprorelin; mifepristone; SPRMs such as asoprisnil; or aromatase inhibitors. In some embodiments, the pharmaceutical agent can be formulated to address pain or otherwise provide pain relief. For example, the pharmaceutical agent can be a non-steroidal anti-inflammatory drug (NSAID).
The material 400 can be composed of biodegradable material, which allows the material to be left within a patient's body without requiring later retrieval. For example, the material 400 can be biodegradable material left at the treatment site within the patient's body to prevent adhesion, and then the material can degrade over time as bodily tissue at the treatment site heals.
In one embodiment, the material 400 is a polymer. In some embodiments, the polymer is selected for its melt viscosity, melt temperature, degradation time, or any combination of the foregoing. For example, the material can be a polymer with a desirable degradation time, such as polyhydoxyalkanoate, low molecular weight polycaprolactone, polyglycolic acid, and polylactic-coglycolic acid. In another embodiment, the material can be another polymer, such as polylactic acid, high molecular weight polycaprolactone, poly-3-hydroxybutyrate, and polyglycerol sebacate. In some embodiments, the polymer is biodegradable.
In the embodiment illustrated in
The apparatus 300 can be used in a surgical procedure to treat a disease, such as an intra-abdominal disease. In such a procedure, a material formulated to necrose bodily tissue is inserted into a proximal end portion of an apparatus, such as a handle portion of a medical instrument. The material is heated to a desired temperature and is melted within the medical instrument. In one embodiment, the material is melted within the handle portion of the medical instrument. In another embodiment, the material is melted within a lumen of the medical instrument.
As illustrated schematically in
The distal end portion 330 of the medical instrument 300 is inserted through skin S and into the body cavity C. In the illustrated embodiment, the distal end portion 330 is inserted into the body cavity C through a trocar T. In another embodiment, the distal end portion 330 can be inserted into the body cavity C without the assistance of a trocar.
The distal end portion 330 of the medical instrument 300 is positioned proximate to the target site D within the body cavity C. Positioning of the distal end portion 330 can be aided by light from light source L and/or a scope (not illustrated), both of which may be inserted into the body cavity C. The light source L in the illustrated embodiment is inserted through the skin S and into the body cavity C through a trocar T. In another embodiment, the light source L is inserted through the skin S and into the body cavity C without the assistance of a trocar.
The actuator 350 of the delivery mechanism is actuated to move the material through the lumen 340 of the medical instrument 300. Accordingly, an amount of the material is delivered to the target site D within the body cavity C. The material treats the bodily tissue at the target site D. Thus, in some embodiments, the material necroses at least a portion of the bodily tissue.
For example, when this procedure is used to treat endometriosis, the distal end portion is positioned proximate to an endometrial lesion and the material is delivered onto the lesion. The lesion is superficially necrosed, while underlying bodily tissue, like the peritoneum, remains undamaged.
In one embodiment, a surgeon or other medical operator can deliver two different materials to the target bodily tissue. For example, a surgeon can first insert a first material for necrosing bodily tissue into the instrument and deliver the material to target bodily tissue, and then insert and deliver a second material for preventing adhesion. In one embodiment, the second material is inserted into the handle or proximal portion of the medical instrument, which insertion can occur while the distal end portion of the elongate member is still inserted into the bodily cavity. The delivery mechanism is actuated to move the second material through the lumen and deliver an amount of the second material to the target site within the body cavity. Using this procedure to treat endometriosis, the surgeon can insert and deliver a first material to necrose the endometrial lesion, and then insert and deliver a second material to prevent adhesion to the necrosed tissue.
In another example, a surgeon can insert and deliver a first material to necrose bodily tissue, and then insert and deliver a second material for addressing pain, like an NSAID, or a second material for treating disease. In treating endometriosis, for example, the surgeon can insert and deliver a first material to necrose the endometrial lesion, and then insert and deliver a pharmaceutical agent, such as those identified above.
While various embodiments of the invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. Thus, the breadth and scope of the invention should not be limited by any of the above-described embodiments, but should be defined only in accordance with the following claims and their equivalents.
This application claims priority to U.S. Provisional Application Ser. No. 60/976,862, entitled “Device and Method for the Treatment of Intra-Abdominal Disease,” filed Oct. 2, 2007, which is incorporated herein by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 60976862 | Oct 2007 | US |
